Professional Documents
Culture Documents
Li ni u
Chng 1. i cng v cng ngh bo ch dc phm (PGS.TS. Hong Minh Chu)
Bi 1. S lc v s ra i v pht trin ca cng ngh bo ch dc phm
Bi 2. Qu trnh nghin cu, bo ch - sn xut thuc ra th trng
Bi 3. H thng qun l cht lng - cc GxP p dng trong sn xut dc phm
Bi 4. H thng tiu chun cht lng ISO 9000
Bi 5. An ton lao ng v v sinh cng nghip
Ph lc
Chng 2. Cc qu trnh cng ngh c bn trong sn xut dc phm (ThS. Nguyn Nht
Thnh)
Bi 6. Xay nghin vt liu
Bi 7. Khuy trn vt liu
Bi 8. Sy vt liu
Bi 9. Qu trnh nn dp vt liu
Chng 3. Cng ngh bo ch mt s dng thuc (TS. L Hu - PGS.TS. L Quan Nghim)
Bi 10. Cng ngh bo ch vin nn
Bi 11. Cng ngh bo ch vin bao
Bi 12. Cng ngh bo ch vin nang cng
Bi 13. Cng ngh bo ch thuc tim
B Y T
CNG NGH
BO CH DC PHM
(DNG CHO O TO DC S I HC)
M S: .20.Z.09
NH XUT BN GIO DC
H NI 2007
Ch o bin son:
V KHOA HC V O TO B Y T
Ch bin:
PGS.TS. HONG MINH CHU
M s: 7K727M7 DAI
Li gii thiu
Thc hin mt s iu ca Lut Gio dc, B Gio dc v o to v B Y t ban
hnh chng trnh khung o to Dc s i hc. B Y t t chc bin son ti liu dy
hc cc mn c s v chuyn mn theo chng trnh trn nhm tng bc xy dng b sch
t chun chuyn mn trong cng tc o to nhn lc y t.
Sch CNG NGH BO CH DC PHM c bin son da trn chng trnh gio
dc ca Trng i hc Y Dc Thnh ph H Ch Minh trn c s chng trnh khung
c ph duyt. Sch c PGS.TS. Hong Minh Chu (Ch bin) v cc tc gi PGS.TS. L
Quan Nghim, TS. L Hu, ThS. Nguyn Nht Thnh bin son theo phng chm: Kin
thc c bn, h thng; ni dung chnh xc, khoa hc; cp nht cc tin b khoa hc, k thut
hin i v thc tin Vit Nam.
Sch CNG NGH BO CH DC PHM c Hi ng chuyn mn thm nh
sch v ti liu dy hc chuyn ngnh o to Dc s i hc ca B Y t thm nh nm
2007. B Y t quyt nh ban hnh ti liu dy hc t chun chuyn mn ca ngnh trong
giai on hin nay. Trong thi gian t 3 n 5 nm, sch phi c chnh l, b sung v cp
nht.
V KHOA HC V O TO B Y T
LI NI U
Thc hin ng li cng nghip ho v hin i ho t nc, cc ngnh cng ngh
nc ta v ang c nhiu tin b v cng hin ng k. Trong , cng ngh dc phm
t s ng dng nhng tin b khoa hc k thut ca nhiu ngnh nh cng ngh ho hc,
cng ngh sinh hc, cng ngh c kh, in, in t, tin hc... nghin cu pht trin, v
ang c nhng ng gp nht nh. Tuy nhin, cng ngh dc phm vn cn tn ti nhiu
bt cp, cha p ng kp yu cu i hi ca kinh t x hi hin nay v cho tng lai.
tin kp v ho nhp vi cc nc trong khu vc, ngoi mt quyt tm cao, i hi i
ng khoa hc c chuyn mn su, l thuyt i i vi thc t, mun vy phi ch trng cng
tc o to. Chnh v th, gp phn nh b vo s nghip cng nghip ho v hin i ho
ngnh dc nc nh ni chung v trong cng tc o to nhn lc dc ni ring, B mn
Cng nghip Dc, Trng i hc Y Dc Thnh ph H Ch Minh bin son cun Gio
trnh cng ngh bo ch dc phm nhm cung cp cho hc vin nhng thng tin, kin thc
c s l thuyt chuyn khoa ct li nht, kt hp vi thc t i hi ca ngnh dc.
Trong khun kh chng trnh khung ca B Y t, c s trao i, hi tho v chng
trnh vi Trng i hc Dc H Ni v tham kho chng trnh ca mt s trng nc
ngoi c quan h hp tc o to v nghin cu nh Trng i hc Mahidol Thi Lan,
Trng i hc Paris Sud v Trng i hc Bordeaux II CH Php, ni dung chnh ca
gio trnh ny l cng ngh sn xut cc dng thuc. Trc ht, dng thuc rn phn liu v
dng thuc v (tit) trng c bin son.
Hy vng cun sch gp phn hu ch cho vic hc tp v nghin cu ca sinh vin dc,
cng nh bn c c nhu cu quan tm, tham kho khc.
Ln u tin xut bn, chc chn cun sch cn nhiu khim khuyt, cc tc gi mong
nhn c s gp ca bn ng nghip cng nh c gi ln ti bn sau c hon
thin hn. Xin chn thnh cm n.
TM. Cc tc gi
Ch bin
Hong Minh Chu
CND
: Cng ngh dc
SXT
: Sn xut thuc
CNBC
: Cng ngh bo ch
SXDP
: Sn xut dc phm
CNHH
: Cng ngh ho hc
CNHD
: Cng ngh ho dc
CNSH
CNKS
HTCL
KTCL
GLP
GSP
ISO
SOP
WHO
ASEAN
: Hip hi cc nc ng Nam
CHNG 1
I CNG V CNG NGH BO CH DC
PHM
Bi 1
S LC V S RA I V PHT TRIN
CNG NGH BO CH DC PHM
MC TIU
mang tnh chuyn nghip nh Xng Qun dc XF14, LK10, LK34, LK5, ln lt ra
i. Tuy c s trang thit b vn cn rt th s, t to, sn xut tiu th cng, nhng y
chnh l tin cho nn sn xut thuc mang tnh cng nghip sau ny. Thi gian ny nc ta
sn xut ra c mt s thuc nh Calci chlorid dc dng pha tim, Ether m,
Chloroform m, chit c Long no, Morphin, Strychnin, Cafein pha tim,
Thi k 19551975: Sau hip nh Geneve 1954, t nc tm chia lm hai min:
Min Bc hon ton gii phng, yu cu t ra cho ton ngnh l bo m nhng thuc
ch yu cho nhn dn, phn u sn xut trong nc nhng th thuc thng thng nht,
thng nht tn dc v ng dc. C s tp trung u tin c quy m ln, c kh ho,
thit b tng i hin i lc by gi l X nghip Dc phm Trung ng 1 (XNDPTW1),
X nghip Dc phm Trung ng 2 (XNDPTW2), v bt u xy dng x nghip a
phng cc tnh, phn u cc tnh thnh u c x nghip dc phm (XNDP) xy dng
b mn Cng nghip Dc ti Trng i hc Dc H Ni.
Min Nam cn nm trong ch thc dn kiu mi, cng nghip dc pht trin theo li
t bn, c nhng c s bo ch sn xut ln, c thit b hin i, nhng cng c nhiu c s
sn xut th cng, thit b chp v, Vo giai on ny, c khong trn 120 vin bo ch ln
nh, nhng nguyn vt liu hon ton ph thuc nc ngoi.
T sau 1975: Nc nh thng nht, ngnh Dc thng nht ch o, phng hng t
Nam ti Bc, tn dng mi c s vt cht, trang thit b bo ch sn xut tt c nhng thuc
no c th sn xut c vi mi ngun nguyn liu c th c c. Pha Nam tp hp v
thnh lp XNDPTW 21, 22, 23, 24, 25, 26 v Lin vin bo ch 7. Sau sp xp li nh sau:
XNDPTW 24, 25, 26 mt s x nghip thuc a phng qun l nh XNDP 29, XNDP 32,
XN Mebiphar, Pha Bc, cc XNDPTW1, XNDPTW2, XNDPTW3, v mi tnh, thnh
hu ht u c cc c s sn xut thuc ln, nh, Ch trng xy dng ngnh dc tin ln
chnh quy hin i cng nh Chnh sch quc gia v thuc Vit Nam (1996) ch ra: M
rng ging dy cc Trng i hc, xy dng v cng c i ng cn b, c i hc nc
ngoi, B Y t cng quyt nh thnh lp B mn Cng nghip Dc ti trng i hc
Y Dc TP. H Ch Minh (Quyt nh s 1899/BYTQ).
GMP c cp ti t 1984, bng nhiu cuc hi tho, tp hun v GMP.
Chnh sch quc gia v thuc c Chnh ph ban hnh t 2061996, theo c yu
cu Cng nghip Dc phi cung ng 70% nhu cu thuc cho nhn dn trong nc, phi phn
u t tiu chun GMP, ban hnh Quyt nh ca B Y t s 1516 ngy 991996 v vic
trin khai p dng cc nguyn tc tiu chun GMP ca Hip hi cc nc ng Nam , gi
tt l ASEAN GMP, v Thng t hng dn thc hin vic trin khai p dng cc nguyn tc
ASEAN GMP ca B Y t s 12/BYTTT ngy 1291996. Tt c cc doanh nghip sn
xut dc phm phi GMP ho chm nht l vo nm 2005. T 2005 p dng WHO GMP.
T nhng nh hng ln v c bn ca chnh sch thuc quc gia, vi nhng i hi bc
xc ca ngnh Dc, nc ta xy dng quy hoch tng th u t pht trin ngnh Dc
Vit Nam thi k 1996 2010, bao gm:
1. Nghin cu quy hoch pht trin cng nghip ho dc giai on 1996 2010
2. Nghin cu quy hoch u t pht trin cng nghip khng sinh
3. Quy hoch sn xut, pht trin dc liu v cc vng dc liu Vit Nam
4. Quy hoch sn xut, pht trin cng nghip bao b dc giai on 1996 2010
5. Quy hoch sn xut, pht trin cng nghip bo ch giai on 1996 2010
6. Quy hoch sn xut, pht trin v phn b cng nghip dc giai on 1996 2010
7. .
Nhn chung, trong mt thi gian kh di, t c ch bao cp chuyn sang c ch th trng,
cng ngh bo ch dc phm ni ring v cng nghip dc Vit Nam ni chung cn nhiu
lng tng, mc d cng c nhng ng gp nht nh, nhng hu nh khng c mt chin
lc lu di. n nay, ngnh Dc c nhng nh hng chin lc pht trin, m ra l
trnh pht trin ca cng ngh bo ch dc phm, phc v c lc nhu cu v thuc trong
nc v xut khu.
CU HI LNG GI * TR LI NGN:
1. Yu t thc y s pht trin cng ngh bo ch dc phm
a) S gia tng dn s
b)
c) S pht trin ca KH CN
d)
a)
b)
c)
d) ...
3. Vi nt v tnh hnh sn xut thuc Vit Nam (ghi ngn gn mt n hai dng)
Bi 2
QU TRNH NGHIN CU,
BO CH SN XUT THUC RA TH TRNG
MC TIU
1. V li c v gii thch s tng qut qu trnh nghin cu mt thuc mi ra th
trng.
2. Nu c mc tiu ca giai on nghin cu, bo ch v giai on sn xut.
3. Trnh by c nhng yu cu cn thit xy dng mt cng thc bo ch thuc.
4. K c 4 ni dung chnh ca mt h s xin php sn xut thuc v cc ni dung
chnh trong h s dc phm.
5. Trnh by c nhng bc c bn nghin cu, bo ch sn xut mt thuc generic
ra th trng.
6. K c tm tt cc bc tin hnh xy dng tiu chun mt thuc generic.
2.1. Qu trnh nghin cu, bo ch sn xut thuc mi
2.1.1. S tng qut
C th tng qut ho qu trnh nghin cu, bo ch sn xut mt thuc mi ra th trng
nh sau:
Thuc v dc
+ S phn phi
Tnh n nh
v
Tng k
Nhit
+ Sinh chuyn ho
+ Thi tr
Oxy khng kh
nh sng
+ Ni tc dng
Cc tc nhn khc
+ C ch
+ Tc dng ph
Sinh kh dng
a) Tnh cht vt l
Tnh tan ca hot cht l mt thuc tnh rt quan trng. Phi hiu bit chc chn v s ho
tan trong nc ca hot cht, bi v n s cho hng la chn dng thuc s dng (dng a
vo c th) v n ng vai tr ln trong tnh sinh kh dng. Quan trng hn na l nhng s
hiu bit v kh nng ho tan ca hot cht trong nc nhng pH khc nhau v phi bit n
phn phi nh th no ty thuc vo pH hay ty thuc vo s tham gia ca hai pha: nc v
du.
b) Tnh cht ho hc
Tnh cht ho hc rt quan trng trong nghin cu n nh ca thuc.
Phi bit hot cht chu nh hng ca nhit khc nhau nh th no.
Phi bit nh hng ca m ra sao.
nh hng ca oxy khng kh.
nh hng ca nh sng,...
V phi bit c sn phm phn hy cui cng c th xc nh sau nhng th nghim
v s n nh, xc nh tui th hay thi hn dng thuc.
bit c nhng iu phi tin hnh th nghim trong nhng iu kin nhit ,
m, nh sng v c oxy, t d on c gii hn s dng thuc (tui th ca thuc)
trong iu kin bo qun bnh thng trn th trng.
Mt cng vic nghin cu rt phc tp khc na l nhng nghin cu nhn bit nhng
tng k ca hot cht vi nhng thnh phn khc trong thuc v hot tnh ca n trong mi
trng sinh hc.
c) S phn ca hot cht trong c th
Nhng yu t lin quan ti s phn ca hot cht trong c th thng c kho st bi
cc nh nghin cu dc l v hon tt bi cc thy thuc lm sng.
Nghin cu dc ng hc, trc tin ch ra cho chng ta v s phn phi ca hot cht,
sinh chuyn ho trong c th, ri s thi tr (thanh thi) ca n.
gip cho tc dng iu tr mt cch hu hiu, chng ta phi c gng tm hiu, bit
nhiu v kh nng v ni tc dng, c ch tc dng ca hot cht.
Ung
Ngoi ng tiu ho
Dung dch nc
ng trc trng
ng sinh dc
Mt
Ngoi da
* ng ung:
Vin nn v vin nang l dng thuc rn phn liu thun tin cho bo qun, vn chuyn
v iu tr lu ng, thun tin cho sn xut cng nghip vi s lng ln.
Dng dung dch, hn dch nc cng l dng thuc thng dng. Di dng a liu,
thun tin dng cho mt s chng loi bnh nht nh.
* ng dng ngoi ung: Khng nhiu, thng l dng ng tim di dng dung dch
nc. Nu l bt tim, a phn c ng trong l, nhng c mt cu hi t ra cho vn
bo qun.
d) Nhng cht t dc v nhng cht ph gia
i vi nhng cht ny, yu cu quan trng nht l tr v mt ho hc, khng c tc dng
ph. bit c ti a s m bo v mt cht t dc hoc cht ph gia no , ngi ta s
phi nghin cu thnh phn ho hc, tinh khit,...
S la chn ngy nay rt d dng nh da vo Dc in, hoc nhng ti liu nghin cu
ca cc nh nghin cu cng nghip dc tng hp, gm c: Tn, tn khoa hc, cng thc
ho hc (cng thc nguyn, cng thc cu to), trng lng phn t, tnh cht vt l,... V
khng th thiu nhng kt qu nghin cu ca nh bo ch sn xut thuc, chng hn nh
trn chy ca n,...
Nh bo ch sn xut quan tm ti yu t nh hng n sinh kh dng ca thuc, la
chn t dc vi c tnh cho php, iu khin c tc gii phng hot cht. T , nh
hng s dng t dc vo nhng mc tiu nghin cu khc nhau hay vo nhng i tng
c th khc nhau.
e) Bao b ng gi l mt thnh phn khng th thiu c ca mt dng thuc, c vai
tr:
Bo v dc phm (Trnh cc s thay i ca kh hu, nh sng, cc ngun gy nhim
v cc va chm khi vn chuyn).
To gi tr thng mi cho mt hng (hp dn khch hng, tin s dng, xc nh v
cung cp nhng thng tin cn thit sm nht,...)
Cn ch nhng nguyn liu bao b ng gi tip xc trc tip vi thuc (bao b ng gi
u tin), cn la chn theo hng nhng nguyn liu c ghi trong danh mc ca cc
Dc in.
Nhng th nghim quan trng cho php xc nh thi gian ko di s dng (hn dng)
mt thuc phi thc hin trong iu kin c bao b xc nh.
2.1.3. Giai on xin giy php sn xut thuc a ra th trng
H s hon chnh xin giy php sn xut thuc a ra th trng, yu cu c 4 phn
chnh:
1. Phn thuc v dc (bo ch, phn tch, kim nghim,...)
2. Phn thuc v c tnh.
3. Phn thuc v dc l.
4. Phn thuc v lm sng.
H s dc thng gm c:
Thnh phn, s lng v cht lng.
M t quy trnh sn xut.
Kim tra nguyn liu u vo v bao b.
Kim tra trn sn phm trung gian, bn thnh phm v thnh phm.
M t nhng iu kin bo qun v cch dng.
Trng hp c bit cn c gii thch ngi dng c s la chn ng v chnh xc.
Km theo h s phi c nhng nghin cu v tnh n nh, v dc ng hc, sinh kh dng,
phm vi iu tr cng nh nhng iu lut bt buc v k thut v kinh t.
Mt im rt quan trng cn lu l nhng th nghim lm sng khng th lm li c
theo li c. Nhng th nghim trn ngi l hiu lc mt ln cho tt c vi nhng n v ca
l thuc nguyn mu. Theo thi quen (li c), mi l sn xut, nhng th nghim thay th
bng nhng th nghim ho l cho php xc nhn cht lng ca thuc.
H s lm theo Quy ch ng k thuc, ban hnh km theo quyt nh B Y t.
2.1.4. Giai on sn xut v kim tra
Mc tiu ca giai on ny l ti sn xut quy m cng nghip ra nhng thuc c cht
lng ph hp vi cht lng ca l nguyn mu (l ng k sn xut).
Ngoi ra, t c mc tiu trn, quy trnh sn xut cn phi la chn theo nhng mc
tiu nh, cng cn ty thuc vo c nguyn liu s dng.
Mi mt cng on phi c nhng thng s k thut quyt nh, thuc sn xut ra m
bo cht lng ton din. Mun vy cn phi kim tra cht ch, t nguyn liu u, sn phm
trung gian, n sn phm cui cng bng nhng thit b chnh xc c tin cy cao, c s
thm nh,... (kim tra cht lng).
Kim tra s ng nht gia cc l sn xut da trn tnh n nh ca thuc v trn tnh
sinh kh dng ca hot cht,...
Tm li giai on ny cn phi thc hin nghim ngt mi tiu chun, mi yu cu ca
GMP nhm m bo cht lng thuc n nh a ra th trng.
Qu trnh nghin cu mt thuc mi ra th trng i hi nhiu thi gian v kinh ph kh
ln. Trc y, k t khi bt u nghin cu tm ra c hot cht c tc dng n khi sn
xut c thnh phm bn ra th trng, thng phi mt 10 15 nm v tiu tn khong
hng trm triu USD. Ngy nay, thi gian ny c th rt ngn li.
2.2. Qu trnh nghin cu, bo ch sn xut mt thuc generic ra th trng
Thuc generic l mt thuc c cng thc ging nh thuc nguyn thy c quyn c
mt hay nhiu hng bo ch khc nhau sn xut khi tnh c quyn khai thc khng cn na.
Thc t, khi mt hng bo ch nghin cu thnh cng mt hot cht mi, cng hiu cao
i vi mt bnh no , th ch nhn xin ng k bn quyn sng ch trnh b sao chp,
v c khi h phi b ra c trm triu USD M trong nghin cu, nht l vi nhng khng sinh.
+ nh tnh.
+ nh lng.
Thuyt minh tiu chun
+ nh tnh: phng php, tiu chun, cch tin hnh,...
+ nh lng: phng php, m t cch tin hnh, kt qu,...
Ch : chnh xc, tin cy ca phng php
n nh ca thuc:
Phng php xc nh n nh. M t cch tin hnh. Kt qu, x l v bin lun,
Kt lun: Phi khng nh nhng cng vic thc hin l c tnh khoa hc v chnh xc vi
tin cy cao, c x l thng k hay theo phn mm no ca my tnh,... Ch km theo
nhng ti liu gc (photo), cc bn tnh ton c th...
2.2.3. Gi mu n c quan kim nghim
Gi mu thuc n c quan kim nghim, km theo cc ti liu lin quan n dc phm
, bao gm:
Nhng tiu chun xy dng v ngh.
Nhng h s ti liu cn thit km theo (theo yu cu ca mt hng).
2.2.4. Xy dng quy trnh sn xut (son tho)
Thc hin theo mu hng dn ca c quan qun l (Cc Dc B Y t).
2.2.5. Tp hp, son tho h s xin ng k sn xut
Theo iu khon quy nh i vi thuc sn xut trong nc, trong bn Quy ch ng k
thuc ban hnh km theo quyt nh ca B Y t.
2.2.6. Sn xut v kim tra cht lng
Sn xut v kim tra cht lng thc hin theo GMP.
CU HI LNG GI * TR LI NGN:
Bi 3
H THNG QUN L CHT LNG
CC GxP P DNG TRONG SN XUT DC PHM
MC TIU
1. Trnh by c mt s khi nim c bn v cc GxP (GMP, GLP, GSP), ISO; s cn
thit, mc tiu v vai tr trong cc c s sn xut thuc.
2. Gii thch c mi quan h m bo cht lng (BCL), GMP v kim tra cht
lng (KTCL).
3. Phn tch c 5 yu t, 3 nguyn tc v 10 yu cu c bn ca GxP.
4. K c 17 chuyn mc ca WHO GMP v phn tch tm tt theo 5 yu t v cc
nguyn tc c bn ca cc GxP.
5. Lin h v k ra c mt s c s sn xut thuc Vit Nam vn dng cc GxP
v t tiu chun GMP (hoc c ba: GMP, GLP v GSP).
CC KHI NIM C BN
1. CHT LNG
1.1. Khi nim v sn phm v cht lng ni chung
S 3.1. Mi quan h gia H thng m bo cht lng, GMP v kim tra cht lng
S 3.2. Nm yu t c bn ca GxP
Vit Nam ang p dng WHO GMP, GLP v GSP do B Y t ban hnh.
ch tng bc a cng nghip dc Vit Nam pht trin, nng cao cht lng thuc trong
nc, phc v tt s nghip chm sc sc khe nhn dn, to iu kin cho thuc Vit Nam
ho nhp th trng thuc ca khu vc v th gii... Phn u n ht ngy 31/12/2007, tt c
cc c s sn xut thuc tn dc phi trin khai p dng, t nguyn tc, tiu chun WHO
GMP v n ht ngy 31/12/2010, tt c cc c s sn xut thuc t dc liu phi t
nguyn tc, tiu chun WHO GMP (theo quyt nh s 19 ngy 05/07/2005). l mt yu
cu cp thit ca ngnh Dc.
1.2. Gii thiu s lc GMP cc nc v khu vc
c nhiu nc ra v thc hin GMP t lu.
Hoa K l mt trong nhng quc gia u tin c gng qun l ngnh dc. Sau mt s
s kin xy ra lin quan ti sc khe con ngi, nm 1962, mt o lut v thc phm, thuc
v m phm c C quan qun l thc phm v dc phm Hoa K (FDA) thng qua, ra
i nhng quy nh u tin v GMP.
+ Nm 1963: GMP n bn ln th nht.
+ Nm 1975: Hng dn v thm nh ra i (sau v 11 ca t vong do thiu kim tra
trong khi sn xut thuc).
+ Nm 1976: Mt b GMP mi ra i, vi trng tm hng vo Thm nh v m bo
cht lng hn l kim tra cht lng.
+ Nm 1978: GMP n bn ln th hai.
+ Nm 1979: GMP tr thnh lut v yu cu cc nh sn xut phi c cc quy nh v
thao tc chun c ph duyt v cc h thng c thm nh.
+ Nm 1984, qua s kin Tylenol ngi ta phi xem xt li trong quy ch cc vn lin
quan n ng gi.
c: GMP n bn ln th nht t 1969.
Anh: + Nm 1971: GMP n bn ln th nht.
+ Nm 1977: GMP n bn ln th hai.
+ Nm 1983: GMP n bn ln th ba.
Php: Vn bn Thc hnh sn xut tt (Pratiques de Bonne Fabrication PBF) ban hnh
u tin vo 3/10/1978.
+ 1/10/1985 ban hnh ng ngha GMP.
+ Nm 1993 thc hin GMP EEC.
+ Nm 1995 BPF GMP xut bn ln th ba.
Cng ng chu u ECC: ban hnh ti liu hng dn v GMP chu u vo thng
1/1989.
T chc Y t th gii (WORLD HEALTH ORGANIZATION WHO):
* Nm 1967: ban hnh bn d tho Draft requirements for good manufacturing practice
in the manufacture and quality of drugs and pharmaceutical specialities.
* Nm 1968: ban hnh GMP nh l mt ph lc trong bo co ln th 22 ca WHO v
sau c a vo bn ph lc ca The International Pharmacopoeia. 1971.
* Nm 1969: ban hnh vn bn GMP nh l mt phn trong Certification Scheme on the
Quality of Pharmaceutical Products.
1975: chnh sa ban hnh li.
2. Nhn s
4. Thit b, dng c
6. Sn xut
8. T thanh tra
10. Ti liu
phm tit trng, cc sinh phm, dc phm th lm sng trn ngi, dc tho. Tt c cc ti
liu ny c th truy cp trn trang web WHO:
(http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmpcover/htmlo).
2.1. m bo cht lng
2.1.1. m bo cht lng: nh trnh by phn Cc khi nim c bn
2.1.2. H thng m bo cht lng ph hp cho sn xut dc phm: nh trnh by
phn Cc khi nim c bn
2.1.3. Nh sn xut phi chu trch nhim v cht lng sn phm m bo l chng ph
hp vi mc ch s dng, tun theo cc quy nh trong giy php lu hnh. Mc tiu cht
lng c thc hin ph thuc vo trch nhim cc nh qun l cao cp, cc phng ban
trong cng ty, nh cung cp, phn phi. C h thng m bo cht lng kt hp c GMP ln
kim tra cht lng. Hot ng H thng m bo cht lng phi c lu tr h s y
v theo di. C nhn vin, c s vt cht nh xng, my mc, trang thit b ph hp.
2.2. Thc hnh tt sn xut thuc (GMP)
GMP l mt phn ca m bo cht lng, gip m bo rng sn phm c sn xut
ng nht v kim sot theo ng cc tiu chun cht lng ph hp vi mc ch s dng
ca chng, cng nh theo ng cc quy nh ca giy php lu hnh.
Cc nguyn tc trong GMP trc ht hng ti vic gim thiu cc nguy c d xy ra
trong qu trnh sn xut dc phm (hai loi nguy c: nhim cho, ln do dn nhn sai) mang
tnh phng nga. 10 yu cu/yu t c bn trong GMP phi c tn trng (xem thm phn
Cc khi nim c bn).
2.3. Nguyn tc v sinh v thc hnh v sinh (NTVS v THVS)
Cc nguyn tc v thc hnh v sinh phi c thc hin nghim ngt trong qu trnh sn
xut.
Phm vi thc hin: nhn vin, nh xng, my mc thit b, nguyn liu u vo, bt
k th g c th l ngun ly nhim i vi sn phm. C chng trnh tng th (trnh by chi
tit tng mc, nh mc 11: v sinh c nhn, mc 12: nh xng).
V d:
Bng 3.1. Tiu chun cp v sinh (ca WHO v ASEAN)
WHO
US FED
STD
209E
ASEAN
Hiu
sut
lc
cui,%
100
IA Trng
100
10.000
S tiu phn ti a / m
khng kh
S vsv
ti a /
3
1m
khng
kh
S ln thay i
khng kh / gi
0.5 5
>5
99.997
3.500
Khng
<1
Lung khng
kh nh hng
IB Trng
99.995
3.500
Khng
Min. 20
II Trng
99.95
350.000
2.000
100
Min. 20
100.000
III Xm
95.0
3.500.000
20.000
500
Min. 20
IV en
85.0
>
>
>
10 20
2.4. Thm nh
Thm nh l mt phn c bn trong GMP v cn phi c thc hin theo ng
cng nh. Cn lp ra cc quy trnh thao tc (SOP) v quy trnh sn xut da trn c s
mt nghin cu thm nh v phi c thm nh li theo nh k m bo rng cc quy
trnh ny vn m bo cho kt qu mong mun. Cn c bit lu n vic thm nh cc
SOP trong pha ch, kim nghim v lm v sinh.
Thm nh l hnh ng nhm chng minh, bng cc phng tin thch hp, rng mi
nguyn liu, qu trnh, quy trnh, h thng, thit b c s dng trong sn xut hay kim tra,
cho ra mt cch n nh nhng kt qu nh mong mun. Thm nh quy trnh sn xut, cc
quy trnh sn xut trng yu phi c thm nh c trc v sau khi thc hin.
2.5. Khiu ni
2.5.1. Nguyn tc
Tt c cc khiu ni v cc thng tin khc lin quan n sn phm c kh nng b sai hng
u phi c xem xt theo cc quy trnh bng vn bn v cc bin php khc phc cn c
thc hin.
2.5.2. Thc hnh
C 10 ni dung c th (xem c th ti liu tham kho) nh:
Phn cng ngi chu trch nhim x l cc khiu ni v quyt nh bin php khc
phc.
C SOP m t bin php tin hnh, k c khi cn phai thu hi. Cn c bit ch n
nhng khiu ni v gi mo. Phi ghi thnh h s y chi tit bt k khiu ni no lin
quan n sai hng sn phm. Nhng khiu ni ny cn c iu tra thu o.
Tt c cc quyt nh v bin php x l v khiu ni u phi ghi vo h s.
H s v khiu ni cn c r sot thng xuyn tm ra nhng du hiu c bit hoc
ti din v c chng l thu hi nhng sn phm ang lu hnh.
Cn thng bo cho c quan c thm quyn,
2.6. Thu hi sn phm
2.6.1. Nguyn tc
Cn phi c mt h thng thu hi nhanh chng, hiu qu cc sn phm bit hoc nghi
ng b sai hng.
2.6.2. Thc hnh
C 7 ni dung (xem c th Ti liu tham kho) nh:
C mt ngi chu trch nhim iu hnh v phi hp vic thu hi.
C SOP c kim tra, cp nht thng xuyn gip cho t chc thu hi.
2.15.1 V nguyn tc
Qun l tt h thng h s ti liu l mt phn thit yu ca h thng m bo cht
lng, v th n c lin quan ti mi kha cnh ca GMP.
Mc tiu ca c ch qun l ny l xc nh cc tiu chun cho tt c nguyn vt liu v
phng php sn xut cng nh kim tra cht lng m bo l tt c nhn vin lin quan
n sn xut u hiu cng vic phi lm, khi no lm, m bo l nhng ngi c thm
quyn u nhn c mi thng tin cn thit khi quyt nh cho sn xut mt l thuc bn,
m bo c cc bng chng, du hiu, h s, cc thng tin cn thit cho php tin hnh iu
tra (khi cn thit).
Vic thit lp v s dng h s ti liu ty thuc vo nh sn xut.
2.15.2. Cc quy nh chung
1. H s ti liu cn c thit lp, chun b, r sot v phn phi thn trng. Tun th
nhng quy nh trong giy php sn xut v lu hnh.
2. H s ti liu phi c duyt, ch k ca ngi c thm quyn, ghi ngy thng r
rng. Khng c thay i khi cha nhn c s chp thun ca ngi c thm quyn.
3. Phi c ni dung r rng: tiu , tnh cht, mc ch ca h s ti liu. Trnh by th
t d kim tra. Ti liu sao chp phi r rng, khng c sai st.
4. Thng xuyn r sot v cp nht. Khi mt ti liu c sa i, th phi c bin
php ngn nga s dng ti liu c.
5. Cc h s ti liu phi nhp s liu r rng, d c, khng c ty xo, khong
trng nhp s liu.
6. Bt k thay i no i vi mt ti liu cng phi k v ghi ngy thng. Nhng vn th
hin sao cho c th c c thng tin gc, l do
7. Lp h s ti liu /in h s ti liu khi tin hnh bt k hot ng no, sao cho c
th truy cp li c. H s ti liu v SOP c lin quan phi c lu tr t nht mt nm
sau thnh phm lin quan ht hn.
2.15.3. H s ti liu cn thit
2.15.3.1. Nhn
1. Nhn dng cho bao b, thng cha, my mc thit b /nh xng: r rng, theo mu
thng nht ca cng ty, mu sc,
2. Tt c thnh phm thuc phi dn nhn theo quy ch Quc gia, phi c cc thng tin ti
thiu cn thit nh:
Tn sn phm.
Danh mc hot cht (v tn chung quc t), hm lng mi hot cht.
S l do nh sn xut quy nh.
Ngy ht hn dng dng khng m ho.
Nhng iu kin bo qun c bit/nhng lu khi x l.
Hng dn s dng v lu cn thit.
Tn v a ch nh sn xut/ cng ty/ hoc ngi chu trch nhim.
3. i vi cht chun i chiu, nhn/ ti liu i km phi ghi r ngy sn xut, ngy ht
hn dng, ngy m bao b ln u v iu kin bo qun, nu cn.
2.15.3.2. Tiu chun cht lng nguyn liu ban u v nguyn liu bao b
1. Tiu chun cht lng nguyn liu ban u v nguyn liu bao b trc tip v bao b in
sn cn m t chi tit, ph hp, bao gm:
Tn nguyn liu (v tn chung quc t khng ng k c quyn INN, nu c) v s
m ni b.
Tham chiu (reference) chuyn lun Dc in, nu c.
Quy trnh nh tnh v nh lng vi mc cht lng quy nh.
Ty thuc vo thc t cng ty, c th thm cc thng tin khc, (xem thm ti liu tham
kho). Nguyn liu bao b phi t tiu chun cht lng quy nh, c bit ch ti tng
k vi sn phm.
2) H s ti liu m t SOP kim nghim phi nu r tn sut nh lng li mi nguyn
liu, ty thuc hn dng ca chng. SOP phi c thm nh trong iu kin nh xng,
my mc thit b phn tch hin c.
Cn c cc tiu chun cht lng ph hp c ph duyt v ghi ngy thng, k c cc
php th nh tnh, nh lng, tp cht v xc nh cht lng i vi nguyn liu, bao b v
thnh phm; nu c th, cn c c tiu chun cht lng sn phm trung gian, bn thnh
phm, tiu chun cht lng ca nc, dung mi v thuc th (acid v base). Mi tiu chun
cht lng u c ph duyt v lu tr b phn kim tra cht lng/m bo cht lng
/trung tm h s ti liu.
Cc tiu chun cht lng cn c sa i b sung nh k p ng yu cu Dc
in Quc gia/ Dc in khc.
Cn c trang b y cc Dc in, cc tiu chun tham kho, ph i chiu.
2.15.3.3. Tiu chun cht lng sn phm trung gian v sn phm ch ng gi (bn thnh
phm:
Cn c ban hnh, tng t tiu chun cht lng nguyn liu, thnh phm, nu ph
hp.
2.15.3.4. Tiu chun thnh phm
Tn sn phm v m tham kho nu c. Tn mi hot cht (v tn chung INN)
Cng thc hoc tham kho cng thc.
M t dng bo ch v chi tit ng gi.
Hng dn cch ly mu v kim nghim hoc tham chiu quy trnh lin quan.
Quy trnh nh tnh v nh lng vi mc cht lng quy nh.
iu kin bo qun, cc lu nu c v hn dng.
2.15.3.5. Cng thc gc
3. Cn ghi li nhng thng tin (xem thm ti liu tham kho) nh:
Tn sn phm, s l, lng bn thnh phm c ng gi, s l v lng thnh phm d
kin v lng thnh phm thc t, s lng cn i.
Ngy gi thc hin thao tc ng gi.
Tn ngi chu trch nhim tin hnh thao tc.
Ch k tt ca nhn vin vn hnh cc cng on chnh.
Cc kim tra nh tnh v thao tc theo hng dn ng gi, c kt qu kim tra.
Cc thao tc thc hin, my mc thit b v dy chuyn s dng. v.v
2.15.3.9. Quy trnh thao tc chun (SOP) v h s s sch
1. Cc SOP v H s s sch v vic tip nhn mi chuyn hng nguyn liu, bao b,
cn thit lp v ban hnh. H s s sch, chng t v bin nhn bao gm 8 mc (xem thm ti
liu tham kho).
2. Cc SOP cho vic dn nhn, bit tr v bo qun ni b i vi nguyn liu ban u,
nguyn liu bao b v nguyn liu khc, nu cn cng phi thit lp c th.
3. Cn ban hnh SOP cho mi my mc thit b v dng c, gn my mc thit b.
4. SOP hng dn cch ly mu, ghi r ngi c quyn ly mu.
5. Hng dn ly mu cn phi c:
Phng php ly mu v k hoch ly mu, my mc thit b s dng.
Cc lu cn thit trnh nhim cho.
Lng mu cn ly.
Hng dn vic chia nh mu theo quy nh.
Loi bao b ng mu, ghi r dng cho mu v trng/thng.
Cc lu c bit, nht l mu v trng hay c hi.
6. SOP h thng nh s l (m) nhm nhn dng l sn phm trung gian, bn thnh phm
hay thnh phm.
7. SOP cho vic nh s l t cng on pha ch, ng gi.
8. SOP cho vic nh s l phi m bo khng trng lp cng mt s l.
9. Vic ra s l cn ghi li ngay (ghi trong nht k sn xut), ngy ra s l.
10. Cn c SOP cho vic kim nghim nguyn vt liu v sn phm mi cng on
(phng php v my mc thit b).
11. H s s sch phn tch t nht phi c cc s liu:
Tn nguyn vt liu/sn phm v dng bo ch, nu thch hp.
S l v nh sn xut/nh cung cp.
Tham chiu tiu chun cht lng v quy trnh kim nghim lin quan.
Kt qu kim nghim, c nhn xt v tnh ton v mc cht lng quy nh.
Ngy kim nghim v s tham kho ca thc nghim.
Ch k tt ca ngi thc hin php th.
Ch k ca ngi xc minh php th v tnh ton, nu thch hp.
Kt lun cho t hoc loi b, ngy, ch k ngi chu trch nhim.
12. Cn c SOP xut/loi b nguyn vt liu, sn phm, c bit xut thnh phm ra th
trng.
13. Cn lu gi h s s sch vic phn phi mi l sn phm, to iu kin khi thu hi.
14. C s nht k my mc thit b chnh quan trng, thm nh, ngy, ngi thc hin.
15. Ghi chp vic s dng cc my mc thit b chnh v khu vc pha ch theo thi gian.
16. SOP v sinh, phn cng trch nhim, chi tit lch, phng php, thit b,
2.16. Thc hnh tt trong sn xut thuc
2.16.1. V nguyn tc: Cc thao tc trong sn xut phi tun theo cc SOP xc nh r
rng ph hp, c ph duyt ca ngi c trch nhim v sn xut v kinh doanh, vi mc
tiu t c sn phm c cht lng cn thit.
2.16.2. Cc quy nh chung
1. Tt c cc vic x l nguyn liu v sn phm nh v sinh, bit tr, ly mu, lu kho,
dn nhn, ch bin, ng gi v phn phi phi thc hin theo SOP, phi ghi chp vo h s
lu.
2. Khng nn lm khc quy trnh nh. Nu phi lm khc trc th cng phi theo mt
quy trnh c duyt, c s tham gia ca phng kim tra cht lng.
3. Kim tra hiu sut bo m phn hao ht nm trong gii hn cho php.
4. Khng c tin hnh ch bin nhiu sn phm khc nhau trong cng mt lc hoc lin
tip nhau trong cng mt phng hay khu vc, tr khi xc nh khng c nguy c nhm
ln/nhim cho.
5. Trong qu trnh sn xut, phi dn nhn hoc nh du tt c nhng nguyn liu, thng
cha nguyn liu, sn phm, ang ch bin, bao gm c hm lng v s l.
6. Cn phi hn ch ngi ra vo khu vc sn xut.
7. Khng c dng thit b sn xut dc phm vo mc ch sn xut khc.
8. Cc kim tra, kim sot trong qu trnh sn xut phi c thc hin trong khu vc sn
xut.
2.16.3. Mt s yu cu phng nhim cho nhim khun
1. Cn thn trng khi sn xut bng cc nguyn liu kh trnh sinh bi v phn tn bi
thuc trong khu vc sn xut. Cn phi kim sot cht ch s lu chuyn khng kh. Nguy c
nhim bn nh bi, kh, vi sinh vt, t vt ca cc nguyn liu cn li trn thit b, my
mc
2. C cc bin php ngn nga nhim cho, phi c kim tra nh k.
3. Khu vc sn xut, ni nhng sn phm d b nh hng (nhy cm) trong qu trnh sn
xut phi kim tra nh k (nh kim tra vi sinh v cc tiu phn).
2.16.4. Mt s yu cu i vi giai on ch bin
1. Khu vc sn xut v cc thit b u sch s v khng cn cc nguyn liu, sn
phm, ca l trc.
2. Thc hin kim tra kim sot thit b.
3. Kim tra cc thit b v thit b cung cp kh, nc trc khi sn xut. Khng c s
dng cc thit b h hng, khng n nh.
4. V sinh sau khi sn xut, cn phi nu r thi gian gii hn tnh t khi thit b c v
sinh n khi s dng.
5. Cc yu cu i vi cc dng c sn xut nh thng cha thuc, cc phng tin vn
chuyn sn phm, cc dng c o lng, thit b phn tch, cng c ra.
2.16.5. Vi cng on ng gi sn phm, cc yu cu nghim ngt cng c ra
trnh nhm ln, nhim bn
1. Cn thn trng trnh nhm ln, nhim bn sn phm trong ng gi. Cc sn phm
khc nhau khng c ng gi cc khu vc gn nhau.
2. Khu vc ng gi, dy chuyn ng gi, my in nhn phi sch s v khng c c
cc nguyn liu, sn phm, h s ca l trc. S kim tra phi c thc hin theo check
list v kt qu kim tra phi c lu vo h s.
3. Phi c nhn ghi r tn thuc, s l mi trm ca dy chuyn ng gi.
4. Cn phi dn nhn ngay sau khi ng ng v hn ng. Phi c SOP thch hp trnh
ln ln hoc dn nhn nhm.
5. Kim tra cht ch ni dung in thm trn nhn, trnh mt ni dung trn nhn, kim tra
khi ct nhn bng my, qu trnh ng gi (xem thm ti liu tham kho).
2.17. Kim tra cht lng
y l ngi bn ng hnh ca sn xut.
2.17.1. Nguyn tc chung
Khng nh rng kim tra cht lng l mt phn ca GMP lin quan ti vic ly mu,
tiu chun cht lng v kim nghim, v t chc, h s ti liu (lin quan n cht lng).
Yu cu mi mt c s sn xut phi c mt phng kim tra cht lng. B phn kim tra
cht lng phi c lp. ngun lc, iu kin,... thc thi nhim v c giao.
2.17.2. Nhng yu cu c bn/ti thiu trong kim tra cht lng
Cn c vt cht v trang thit b, nhn vin, SOP ly mu v kim nghim nguyn
liu ban u, bao b, sn phm trung gian, theo ng GMP.
Vic ly mu phi theo ng phng php v do nhn vin b phn kim tra cht lng
tin hnh.
Phng php kim nghim phi c thm nh.
Phi lp h s chng minh cc SOP ly mu, thao tc, kim nghim c thc
hin v ghi li bt k s sai lch no.
Thnh phm phi c thnh phn theo ng cng thc nh tnh, nh lng sn phm
nh trong giy php quy nh.
Phi ghi chp li cc kt qu thanh kim tra v kim nghim cc nguyn vt liu, sn
phm trung gian, bn thnh phm v thnh phm theo tiu chun cht lng nh.
Khng mt l sn phm no c em bn khi cha c chng nhn sn phm t yu
cu theo quy nh trong giy php ca ngi c thm quyn.
b) 1987;
c) 1990;
d) 1996.
3. Mc tiu ca GMP
a) m bo mt cch chc chn dc phm c sn xut ra mt cch n nh;
b) Lun lun t cht lng nh nh (nh thuc ng k);
c) Sn xut ra thuc cht lng tt;
d) a, b kt hp ng.
4. GMP l
a) Ton b nhng khuyn ngh cn thc hin cho php m bo cht lng ca mt
thuc xc nh trong iu kin tt nht;
b) Nhng khuyn ngh ny m t nhng mc tiu khc nhau phi t ti;
c) V t chc, con ngi, c s;
d) a, b, c lin kt ng.
b) H s l;
d) b, c kt hp ng.
11. Vit Nam p dng WHO GMP t nhng nm... v c... iu khon
a) 2002 v c 15 iu khon;
c) 2004 v c 17 iu khon;
b) 2003 v c 16 iu khon;
d) 2005 v c 17 iu khon.
12. Thm nh l:
d) a, b u sai.
US FED
STD 209E
(b)
(c)
(d)
100
99.997
99.995
99.997
99.995
100
99.995
99.95
99.95
99.95
10.000
99.95
95.0
95.50
95.0
100.000
95.0
90.5
85.0
85.0
Bi 3 (tip)
THC HNH TT PHNG KIM NGHIM THUC
(GOOD LABORATORY PRACTICE GLP)
MC TIU
1. Pht biu c mc ch v phm vi p dng nguyn tc Thc hnh tt phng kim
nghim thuc (GLP).
2. K ra v gii thch c nhng ni dung chnh (12 iu) ca GLP.
3. Vn dng vo vic thc hin ti c s sn xut.
1. M U
1.1. Mc ch v phm vi p dng
1.1.1. Mc ch
Vic thc hnh tt cc nguyn tc kim nghim thuc nhm nng cao tnh hiu qu ca h
thng cc phng kim nghim thuc trn c hai mt qun l nghip v v qun l k thut, k
c khu vc qun l nh nc v doanh nghip, nhm m bo tnh khch quan, trung thc v
chnh xc trong vic nh gi cht lng thuc.
1.1.2. Phm vi p dng
Nguyn tc Thc hnh tt phng kim nghim thuc c p dng cho cc phng kim
nghim ca Nh nc v ca cc doanh nghip, k c cc doanh nghip c vn u t nc
ngoi, cc phng kim nghim t nhn hay phng kim nghim c lp.
1.2. Mt s thut ng s dng trong gio trnh
V d nh n v kim nghim, h thng cht lng, h thng phn tch, v,v (xem thm
ti liu tham kho).
2. NGUYN TC THC HNH TT PHNG KIM NGHIM THUC
Trn c s 5 yu t v cc nguyn tc c bn ca GxP, GLP c th ho vo ni dung 12
iu ph hp vi yu cu ca phng kim nghim thuc.
2.1. V con ngi
Th hin iu khon 1: T chc, nhn s v o to.
2.1.1. V t chc, b tr sp xp cc phng, cc n v qun l nghip v, k thut
Mt phng kim nghim thuc thng c chia lm nhiu n v kim nghim hoc cc
b phn c chuyn mn ho da trn k thut kim nghim (v d: Ho l, Vt l, Vi sinh
vt) hoc chia theo cc i tng l sn phm c kim nghim (v d: khng sinh, vitamin,
dc liu...). i khi phng kim nghim cn c cc n v kim nghim chuyn bit phc
v cc nhu cu nh th v trng, th ch nhit t, o lng vt l c bit...
Chc nng nhim v ca mi n v kim nghim cn phi c xy dng v c ngi
c thm quyn ban hnh chnh thc.
Ngoi cc n v kim nghim (hay cn gi l cc phng chuyn mn), mi phng kim
nghim cn phi c b phn ng k mu v b phn lu tr h s tiu chun cht lng. B
phn ng k mu c nhim v nhn mu v cc ti liu km theo, phn pht mu n cc
phng chuyn mn v tr li kt qu kim nghim. B phn lu tr h s tiu chun cht
lng phi m bo cung cp cc tiu chun cht lng cp nht v cc ti liu lin quan
cho cc n v kim nghim.
Ngoi ra, phng kim nghim cn c mt s n v hu cn phc v cho vic cung ng
trang thit b, vt t, ho cht, dng c v sc vt th nghim.
2.1.2. V nhn s
C SOP pha ch TT. Ngi pha ch phi c trnh thch hp. TT sau khi pha phi
c dn nhn y vi cc chi tit: tn TT, nng , yu t chun ho (h s hiu chnh
K), hn dng, iu kin bo qun, ngy pha ch v tn ca ngi pha ch.
Phi c s ghi TT pha ch, gm c cng thc pha, theo ti liu no v tn ngi pha
ch TT phi dng bao b sch v dn nhn vi cc chi tit nh nhn chai, l gc.
Phi nh k kim tra nng ca cc dung dch chun v dung dch ion mu. Khi
kim tra thuc th nu thy c hin tng vn c, kt ta hay bin mu th khng c s
dng.
Nc ct v nc kh khong (nc trao i ion) phi c coi l TT. Chng cn c
kim tra t nht mt ln trong thng bo m cht lng nc t tiu chun Dc in.
Yu cu khi nhn TT phi kim tra m bo cc chai l cn nguyn nim phong.
Nu cc kt qu nh tnh, nh lng v th tinh khit t th c th c chp nhn s
dng. Nu khng t, phi hy b.
Yu cu i vi cc TT d tr nn c tp trung bo qun ti kho trung tm.
Yu cu v an ton khu vc kho: phi c t v tr c th ngn nga c ho hon
v c trang b cc phng tin phng chy cha chy thch hp.
2.4.2. Cht i chiu
Cc cht i chiu dng trong phng kim nghim gm c cht i chiu gc v cc cht
i chiu th cp c to ra trong phng kim nghim.
Quy nh v vic qun l cht i chiu: do mt ngi chu trch nhim chnh v phi m
s theo di.
S theo di cht i chiu phi ghi li cc thng tin sau: s th t cht i chiu, tn cht
i chiu, ngun cung cp, s l hay m nhn dng (nu c), cng dng chnh (v d: cht i
chiu cho ph hng ngoi, cht i chiu tp cht cho sc k lp mng, HPLC), quy cch
ng gi v iu kin bo qun. Ngoi ra, tt c cc thng tin v c tnh, thng s k thut
ca cht i chiu cng c lu li trong mt h s ring. i vi cc cht i chiu th cp
c to ra ti phng kim nghim, h s phi lu li cc phng php v kt qu phn tch
nh gi cht i chiu, cng nh tn ngi thc hin cc phn tch.
Yu cu v bo qun phi ng iu kin quy nh v phi c nh gi nh k theo
quy trnh nh gi cht i chiu ca WHO m bo khng b h hng. Kt qu kim tra
phi c lu li trong s theo di cht i chiu cng vi tn ngi kim tra.
i vi cc loi cht i chiu th cp phi c ng gi theo nguyn tc dng
cho mt ln kim nghim nhm loi tr yu t mi trng nh hng n s n nh ca sn
phm.
2.4.3. Sc vt th nghim
Yu cu v tiu chun hin hnh nh thun chng, thc n, phng php chm sc Yu
cu chung tri phi m bo ng tiu chun hin hnh. nh gi cht lng theo SOP nh
k.
2.5. V phng php v h s ti liu
c th hin cc iu 6, 7, 8 v 9.
2.5.1. Tiu chun cht lng v phng php phn tch (mc 6)
Cc tiu chun cht lng dng trong phng kim nghim thng da vo cc chuyn
lun ca Dc in Vit Nam hin hnh, Dc in cc nc c B Y t Vit Nam cng
nhn v cc tiu chun c s. B phn lu tr tiu chun c trch nhim cp nht v lu tr
cc tiu chun cht lng cn thit cho cng tc kim nghim, gm c:
a) Dc in Vit Nam v cc Dc in nc ngoi, k c ph lc, bn b sung v bn
hiu nh.
b) Cc tiu chun cht lng khng c trong Dc in, i vi nhng thuc c kim
nghim da trn tiu chun ca nh sn xut. Cc phng php kim nghim khng c trong
Dc in do phng kim nghim nghin cu ban hnh.
V phng php phn tch c th c rt ra t cc tiu chun quc gia hay quc t, t
cc n bn khoa hc hay do chnh phng kim nghim nghin cu, ng dng.
Vic chn phng php phn tch ph thuc vo c th ca mi phng kim nghim
(yu cu c th c ghi trong ti liu tham kho).
2.5.2. Mu th (iu 7)
C cc quy nh v vic:
a) Ly mu
Phi c tin hnh mt cch khoa hc v ng k thut.
i tng ly mu l cc nguyn liu dng lm thuc, cc dng thnh phm bo ch v
cc sn phm c coi l thuc dng trong ngnh Y t.
Yu cu i vi trng hp t kim tra cht lng thuc ca cc c s sn xut, bo
qun, kinh doanh phn phi thuc, trng hp thanh tra, kim tra, gim st cht lng thuc
trong sn xut v lu thng phn phi. Vi cc trng hp c th, xem thm Ti liu tham
kho.
Vic ly mu cng c tin hnh trong trng hp c nhng thng tin v thuc km cht
lng, khng an ton, t hiu lc, c s khiu ni ca ngi s dng v cc trng hp nghi
ng c lu hnh thuc gi. Vic ly mu do thanh tra vin, cn b ca c quan qun l, kim
tra cht lng nh nc trc tip thc hin c s chng kin ca cn b c s c ly
mu.
Ni ly mu l ni sn xut, bo qun hay lu thng phn phi thuc. V tr ly mu phi
sch s, mi trng xung quanh khng c ly nhim bnh vo mu v tc ng lm thay
i tnh cht ca mu nh: nhit , m, nh sng... ng thi khng mu tc ng n
mi trng, nht l trng hp mu l cc sn phm bay hi c hi.
Ngi ly mu phi l ngi hiu bit nm vng chuyn mn, nm c cc vn bn
php quy v qun l cht lng thuc, cc th tc php l v cc thao tc k thut ly mu.
+ Cc o lng nhm xc nh tnh cht vt l nh pH, nng sut quay cc, ch s khc
x, im nng chy
Khi kt qu thu c khng r rng hoc khi sai lch gia nhng ln lp li th nghim
vt ra ngoi gii hn cho php:
t nht phi lp li th nghim hai ln na v do mt kim nghim vin khc tin hnh.
Nu kt qu cho bi hai kim nghim vin khng trng khp i vi cng mt mu th
phi tm hiu nguyn nhn, c th do thao tc ca kim nghim vin cha thnh tho, thuc
th hng, cht i chiu hng hoc do thit b gy sai s, m cao Nu xem xt thy
khng phi v cc l do trn th kt qu trung bnh ca mi kim nghim vin c ghi ring
vo phiu.
Mi d liu lin quan vic kim nghim mu u phi c ghi vo hoc km vi h s
kim nghim (s liu cn, kt qu, th, sc k , quang ph ...).
b) nh gi kt qu phn tch
Kim nghim vin phi i chiu kt qu thu c vi cc ch tiu trong tiu chun quy
nh. C cc trng hp sau:
Nu kt qu kim nghim ph hp vi cc yu cu ca ch tiu hay mc cht lng
trong tiu chun th ghi kt lun t. Ch khi tt c ch tiu u t mu mi c kt lun l
t phm cht theo tiu chun quy nh.
Nu c s khc bit gia kt qu thu c v mc ch tiu hay mc cht lng trong
tiu chun quy nh th mu s c lm li bi mt kim nghim vin khc hay bi trng
n v.
Nu kt qu kim nghim ln th hai ph hp vi ln u th kt qu c ghi vo
phiu v chuyn n th trng n v quyt nh v ghi kt lun. Trng hp mu khng t
hoc kt qu phn tch khng lp li, th trng n v (hay Trng phng kim nghim ca
doanh nghip) l ngi c thm quyn a ra kt lun sau cng.
Trong trng hp phng kim nghim c nhiu n v cng tham gia kim mu, nn
n v kim nghim chnh nh gi kt qu mt cch tng th.
2.5.4. H s v ti liu (iu 9)
Gm c:
1. S tay kim nghim vin.
2. H s phn tch.
3. Phiu kim nghim, phiu phn tch.
(xem Ti liu tham kho)
H s kim nghim phi c lu li trong sut thi hn s dng ca thuc v theo cc
quy nh hin hnh v lu tr h s ti liu. Khi ht thi hn lu phi lm th tc hu theo
ng quy nh.
Cc quy trnh thao tc chun SOP c ngi c thm quyn ph duyt. Cc quy
trnh ny hng dn nhn vin tin hnh cc thao tc chung nh:
Ly mu, nhn mu lu tr.
B Y t, Nguyn tc Thc hnh tt phng kim nghim thuc Ban hnh theo quyt nh
s 1570/2000/QBYT ngy 22/05/2000 ca B trng B Y t.
CU HI LNG GI
Xem cng phn cu hi vi bi GSP.
Bi 3 (tip)
THC HNH TT BO QUN THUC
(GOOD STORAGE PRACTICES GSP)
MC TIU
1. K ra c mc ch v phm vi p dng GSP.
2. Trnh by c ni dung chnh ca GSP (nhn s, nh kho, v sinh, cc qu trnh,...)
3. Vn dng theo hng dn thc hin.
1. M U
1.1. Mc ch v phm vi p dng
1.1.1. Mc ch
m bo cung cp thuc c cht lng n tay ngi s dng i hi phi thc hin
tt tt c cc giai on lin quan n sn xut, bo qun, tn tr, lu thng, phn phi thuc.
Thc hnh tt bo qun thuc l cc bin php c bit, ph hp cho vic bo qun v
vn chuyn nguyn liu, sn phm tt c cc giai on sn xut, bo qun, tn tr, vn
chuyn v phn phi thuc m bo cho thuc c cht lng nh khi n tay ngi tiu
dng.
1.1.2. Phm vi p dng
Cc nguyn tc Thc hnh tt bo qun thuc c p dng cho cc nh sn xut, xut
khu, nhp khu, bun bn, tn tr thuc, khoa dc bnh vin, vin nghin cu v trung tm
y t.
1.2. Mt s thut ng s dng trong gio trnh
V d nh: bo qun thuc, thuc, nguyn liu, hot cht, v.v... (xem ti liu tham kho)
a) Yu cu chung
i vi thuc, nguyn liu cn c bo qun trong cc iu kin m bo c cht
lng ca chng. Vic lun chuyn theo nguyn tc nhp trc xut trc (FIFO:First In /
First Out) hoc ht hn trc xut trc (FEFO: First Expired/ First Out) cn phi c
thc hin.
i vi thuc ch loi b cn phi c nhn r rng v c bit tr nhm ngn nga vic
a vo sn xut, lu thng, s dng.
Quy nh v chng trnh kim tra, nh gi nh k hoc t xut xc nh cht lng
sn phm.
Phi c h thng s sch, cc SOP m bo cho cng tc bo qun, kim sot, theo di
vic xut, nhp v cht lng thuc.
b) V nhn v bao b
Bao b thch hp, khng nh hng xu n cht lng ca thuc, ng thi c kh
nng bo v thuc khi cc nh hng ca mi trng, trong mt s trng hp, khi c yu
cu, bao b gip c vic chng nhim khun.
Phi c nhn r rng trn tt c cc bao b ca thuc, d c, c cc ni dung, hnh
thc p ng cc quy nh ca php lut v nhn v nhn hiu hng ho ca thuc. Khng
c dng tn thuc vit tt, tn hoc m s khng c php. Tun th cc yu cu ca
Dc in v cc quy nh php lut lin quan n nhn v bao b.
Phi c cc h s ghi chp ring bit mi loi bao b, nhn hoc sn phm, trong ch
ra cc iu kin bo qun, cc bin php phng cn c ch v hn dng (nu c).
Phi c khu vc ring bo qun nhn thuc v cc bao b ng gi c in n.
Phi c quy nh c th cho vic nhp, xut cc loi nhn v bao b ny.
c) V tip nhn thuc
Vic tip nhn thuc phi c thc hin ti khu vc dnh ring cho vic tip nhn
thuc, tch khi khu vc bo qun. Khu vc ny phi c cc iu kin bo qun trnh cc
nh hng xu trong sut thi gian ch bc d, kim tra thuc.
Thuc trc khi nhp kho phi c kim tra, i chiu vi cc ti liu chng t lin
quan v chng loi, s lng, v cc thng tin khc ghi trn nhn.
Cc l hng phi c kim tra v ng nht, v nu cn thit c chia thnh cc l
nh theo s l ca nh cung cp.
Tt c cc bao b ng gi cn c kim tra cn thn v nhim bn v mc h
hi. Tt c cc thuc c bao b b h hi, mt du nim phong hoc b nghi ng c tp nhim
th phi c bo qun khu bit tr ch x l.
Cc thuc i hi iu kin bo qun c bit (cc thuc gy nghin, thuc c, cc
thuc cn bo qun nhit lnh...) phi nhanh chng kim tra, phn loi bo qun theo cc
ch dn ghi trn nhn v theo cc quy nh ca php lut.
Phi c lu cc h s ghi chp cho tng ln nhp hng, vi tng l hng.
Vic ly mu thuc kim tra cht lng phi c tin hnh ti khu vc dnh cho
vic ly mu v do ngi c trnh chuyn mn thc hin. Vic ly mu phi theo ng quy
nh ti Quy ch ly mu thuc xc nh cht lng.
Ch bit tr phi c thc hin hoc bng vic s dng khu bo qun ring bit,
hoc bng h thng x l d liu in t.
C cc bin php an ton phng trnh vic s dng hoc cp pht thuc, nguyn
liu cha kim sot, kim nghim hoc khng p ng yu cu quy nh.
Cc thuc, nguyn liu lu gi trong ch bit tr cho n khi c vn bn chp nhn
hoc loi b ca phng kim tra cht lng phi c cc bin php an ninh trong khi ch quyt
nh hy, ti x l hoc tr li nh cung cp. Cc thuc, nguyn liu nay phi c bo qun
ring bit vi cc thuc, nguyn liu khc.
d) V cp pht quay vng kho
Ch c cp pht cc thuc, nguyn liu t tiu chun cht lng, cn trong hn s
dng.
Phi c v lu cc bn ghi chp (phiu theo di xut nhp thuc, phiu theo di cht
lng thuc...)
Vic cp pht cn phi tun theo cc nguyn tc quay vng kho (nhp trc xut trc
hoc ht hn trc xut trc), c bit l thuc, nguyn liu c hn dng. Ch khi mt
loi thuc, nguyn liu nhp sau c hn dng ngn hn thuc, nguyn liu cng loi c
nhp trc th thuc, nguyn liu c hn dng ngn hn phi c xut, cp pht trc.
Cc thng, bao thuc, nguyn liu c s dng mt phn cn phi c ng kn li
mt cch an ton trnh vic ri vi hoc tp nhim, nhim cho trong thi gian bo qun.
Cc thng, bao thuc nguyn liu b h hng, khng cn nguyn nim phong, mt nhn
hoc nhn b rch, khng r rng th khng c bn, cp pht, v phi thng bo ngay vi b
phn kim tra cht lng.
e) V bo qun thuc
Cc iu kin bo qun c yu cu nh: chng loi bao b, gii hn nhit , m,
vic bo v trnh nh sng... Cn c duy tr trong sut thi gian bo qun. Cn phi c s
ch ti cc thuc cha hot cht km bn vng i vi nhit , m, nh sng... (xem ti
liu tham kho)
Bao b thuc phi c gi nguyn vn trong sut qu trnh bo qun.
Quy nh v ch bo qun i vi:
+ Cc thuc c, thuc gy nghin, thuc hng tm thn phi c bo qun theo ng
cc quy nh ti quy ch lin quan.
+ Cc thuc nhy cm vi nhit , cc thuc nhy cm vi nh sng, cc thuc d bay
hi v cc thuc nhy cm vi m, cc thuc c mi,v.v
+ Yu cu bo qun dc liu phi c kho kh, thng thong, v.v
Yu cu i vi cc cht d chy, n phi c bo qun ti kho ring, p ng cc quy
nh ca php lut.
C k hoch nh k tin hnh vic i chiu thuc trong kho so vi thuc hin cn v
lng hng tn theo phiu theo di xut nhp. Trong mi trng hp, vic i chiu phi tin
hnh khi mi l hng c s dng ht.
Thng xuyn kim tra s l v hn dng m bo nguyn tc nhp trc xut
trc hoc ht hn trc xut trc c tun th, v pht hin hng gn ht hoc ht
hn dng.
nh k kim tra cht lng hng lu kho pht hin cc bin cht, h hng trong qu
trnh bo qun do iu kin nhit , m hoc cc yu t khc.
Thuc, nguyn liu khng t tiu chun cht lng, ht hn dng phi c bo qun
khu vc ring ch x l. Phi c cc bin php phng vic cp pht, s dng thuc,
nguyn liu ht hn dng, nguyn liu khng t tiu chun cht lng.
Phi c cc phng tin vn chuyn v bo qun thch hp nhm m bo cho thuc,
nguyn liu trnh v v h hng.
2.4.2. H s ti liu
c c th ho iu 7 ca GSP
a) Quy trnh thao tc (SOP) c ph duyt, k xc nhn v ghi ngy thng xt duyt
bi ngi c thm quyn. Cn phi c sn, treo ti cc ni d c xc nh phng php lm
vic trong khu vc nh kho. Phi m t chnh xc cc quy trnh v tip nhn v kim tra thuc
nhp kho, bo qun, v sinh v bo tr kho tng, thit b dng trong bo qun (bao gm c cc
quy trnh kim tra, kim sot cn trng, chut b...) quy nh v vic ghi chp cc iu kin
bo qun, an ton thuc ti kho v trong qu trnh vn chuyn, vic cp pht thuc, cc bn
ghi chp, bao gm c cc bn ghi v n t hng ca khch hng, thuc tr v, quy trnh thu
hi v xc nh ng i ca thuc, v cc thng tin v thuc...
b) Yu cu c mt h thng s sch thch hp cho vic ghi chp, theo di vic xut nhp
cc thuc, bao gm tn thuc, s l, hn dng, s lng, cht lng thuc, nh cung cp, nh
sn xut... p ng cc quy nh ca php lut. Nu cc loi s sch c vi tnh ho th phi
tun theo cc quy nh ca php lut. Phi c cc quy nh, bin php phng nga c th
trnh vic xm nhp, s dng, sa cha mt cch bt hp php cc s liu c lu gi.
Phiu theo di xut nhp thuc.
Phiu theo di cht lng thuc.
Cc biu mu khc theo quy nh ca cc B, Ngnh c lin quan.
Phi c phiu theo di xut nhp thuc ring cho tng loi sn phm cng nh cho tng
loi quy cch sn phm.
i vi vic cp pht, tip nhn thuc c, thuc gy nghin, thuc hng tm thn phi
tun theo ng cc quy nh v h s ti liu ti cc quy ch lin quan.
2.5. Yu cu v v sinh
c ra, c th ho iu 3 ca ti liu GSP.
a) Khu vc bo qun phi sch, khng c bi rc tch t v khng c c cn trng, su
b. Phi c vn bn quy nh chng trnh v sinh, xc nh r tn s v phng php v sinh
nh xng, kho. Ni cch khc l phi c SOP v sinh.
b) Tt c th kho, cng nhn lm vic ti khu vc kho phi c kim tra sc khe nh
k. Ngi mc cc bnh v ng h hp, hoc c vt thng h u khng c lm vic
trong khu vc bo qun c trc tip x l thuc (nguyn liu, thnh phm) cn h.
Ni ra tay, phng v sinh phi c thng gi tt v b tr ph hp (cch ly vi khu vc
tip nhn, bo qun, x l thuc).
c) Cng nhn lm vic trong khu vc kho phi mc qun o bo h lao ng thch hp.
CU HI LNG GI
1. Cht lng c xy dng vo trong sn phm c ngha l:
a) Cht lng sn phm (CLSP)ph thuc nguyn liu ban u;
b) CLSP ph thuc nguyn liu, nh xng, thit b v quy trnh sn xut;
c) CLSP ph thuc cht lng o to, hun luyn nhn vin v cht lng kim sot
ca nhn vin trong qu trnh sn xut;
d) Cht lng sn phm ph thuc c nhng yu t c ni n trong a, b, c.
2. m bo cht lng
a) L hot ng mang tnh d phng;
b) L cc hot ng p ng cu hi Ci g c lm m bo CLSP;
c) L hnh ng c lm trc khi tin hnh sn xut sn phm;
d) Khng cu no ng.
3. Kim sot cht lng
a) m bo cht lng thnh phm cui cng;
b) m bo cht lng nhng vic ang din ra;
c) L hnh ng tc nghip trc v trong qu trnh sn xut;
d) Khng cu no ng.
4. Hin nay u t pht trin GMP l yu cu khng bt buc i vi cc cng ty sn
xut dc phm nu cng ty mun tn ti v pht trin trong tng lai (/S).
5. Ni n cht lng thuc phi ni n tnh hiu qu, tnh an ton v kh nng chp
nhn ca ngi tiu dng (/S).
6. Nm yu t nh hng n cht lng sn phm trong sn xut: Mi trng sn xut,
nguyn liu, nh xng, thit b, quy trnh phng php sn xut, v yu t con
ngi. (/S)
7. Ni dung kim sot cht lng trong qu trnh sn xut: Kim sot con ngi, kim
sot phng php v qu trnh, kim sot u vo, kim sot nh xng thit b, kim
sot mi trng. (/S)
8. Hiu qu hot ng ca mt phng th nghim t chun GLP c nh gi bng s
tho mn nhu cu ca khch hng. (/S)
9. Phng th nghim t chun GLP phi qun l c hiu qu c v nghip v ln k
thut. (/S)
10. Chc nng ca phng kim nghim thuc l nh gi phn loi thuc c t chun
cht lng ng k hay khng. (/S)
11. m bo thun tin trong giao tip cng vic, b tr cc phng chuyn mn ho l,
vt l, vi sinh, dc l cng cn k nhau cng tt. (/S)
12. Phng th nghim t chun GLP phi l phng th nghim c nhiu thit b phn tch
hin i. (/S)
13. Phi lp chng trnh v k hoch hiu chnh thit b nh k, thng xuyn cho cc
thit b cn kim nh, hiu chun. (/S)
14. Trong phng th nghim ch s dng cc ho cht thuc th c tinh khit P (Pure
tinh khit) v PD (Pure Analysis phn tch tinh khit). (/S)
15. Ch c Dc in Vit Nam hin hnh v Dc in cc nc c B Y t Vit Nam
cng nhn c s dng trong phng th nghim. (/S)
16. Thc hnh tt bo qun thuc nhm:
a) Hng ho trong kho khng b mt mt;
b) Hng ho khng b ht hn dng;
c) Hng ho c bo qun ng quy nh cht lng cn nguyn vn khi n tay
ngi s dng;
d) Tt c u ng.
17. Kho thuc c th l ni trung chuyn ca nhn vin v thit b t cc b phn khc.
a) Nu ca kho khng thng sang cc b phn ny;
b) Nu iu l cn thit trong trng hp khn cp;
c) Khng c v s gy nhm ln, ln xn v nhim cho;
d) Nu SOP c quy nh v iu ny.
18. Khi xut hng, cn tun th nguyn tc:
a) Nhp trc xut trc (FIFO);
b) Nhp sau xut trc (LIFO);
c) Ht hn trc xut trc (FEFO);
d) a v c ng;
e) b v c ng.
19. Cc loi thuc c, thuc hng tm thn c bo qun khu vc ring
a) V ch c dc s i hc mi c quyn cp pht cc loi thuc ny;
Bi 4
H THNG TIU CHUN CHT LNG ISO 9000
MC TIU
1. K c s ra i ca ISO, ISO 9000.
T nhiu nm nay, B h thng tiu chun cht lng c nhiu cng ty, doanh nghip
trn th gii p dng nhm hi nhp quc t theo xu th ton cu ho, l B tiu chun ISO
9000. Vy: ISO l g? Do ai hay T chc no xy dng? H ISO 9000? ISO 9001 phin bn
2000 nhng iu khon (yu cu) v phm vi p dng? Mi quan h ISO 9000 v GMP?
4.1. S lc vi nt v s ra i ca ISO v b ISO 9000
4.1.1. H tiu chun quc t ISO
ISO l ch vit tt ca International Standard Organization International Organization
for Standardization, l T chc tiu chun ho quc t, cn c gi l T chc tiu chun
quc t, gi tt l ISO.
T chc ISO c thnh lp nm 1946, c s tham gia ca gn mt trm nc trn th
gii, nhm mc ch son tho mt s tiu chun chung cho sn xut, kinh doanh v truyn
thng. Cho n nay ISO hot ng trn nhiu lnh vc nh vn ho, khoa hc, cng ngh,
kinh t, mi trng, v.v...
1985, T chc tiu chun quc t (ISO) a ra d tho b tiu chun quc t v h thng
qun l cht lng v c chp nhn vo nm 1987, b Tiu chun ISO 9000 c chnh
thc s dng, tip c hng lot nhng b sung.
1994, b Tiu chun ISO 9000 c sot xt ln u tin, nm 2000 xt li ln hai. T
chc tiu chun quc t d nh s sau mi 5 nm sot xt li mt ln.
ISO 9000 l mt b tiu chun hng dn cng tc qun l cht lng v xc nh cc
yu t cht lng chung cn thit cho vic m bo cht lng. ISO 9000 khng ph thuc
vo bt c mt ngnh ngh no. Mi cng ty, doanh nghip c th c th xc nh cho mnh
mt phng thc ring vn dng cc tiu chun ny nhm p ng nhng nhu cu ca
mnh v ca khch hng.
ISO 9000 cp mt phm vi rng ri cc yu t c bn v c th ca h thng cht
lng, khi c iu kin ng k ISO 9000, cc cng ty, doanh nghip s c c mt h
thng cht lng vi y ti liu, cn c, c trin khai ton din v c theo di mt
cch nht qun. Tuy nhin iu khng c ngha sn phm ca cng ty hay doanh nghip
ny s tt hn sn phm ca cc i th khc.
Nhng tiu chun ISO 9000 khng phi l nhng tiu chun i vi sn phm. Chng
khng h bao hm nhng yu cu k thut. N c vai tr b sung nhng khng thay th cho
nhng yu cu k thut c th i vi sn phm.
Nhng Tiu chun ISO 9000 nu ra nhng iu cn t c ch khng hng dn
phng php thc hin. Vic la chn phng php thuc v cp qun l ca cng ty hay
doanh nghip.
Xem xt hp ng
...
...
...
...
Mua sn phm
...
...
...
...
...
...
nh gi cht lng ni b
o to
Dch v
...
Cc k thut thng k
B tiu chun ny nhn mnh n nhu cu phi theo di s tho mn ca khch hng,
theo st cc nguyn tc qun l cht lng, gn gi hn vi ngi s dng bng ngn ng
n gin, r rng. B tiu chun mi m bo s nht qun gia tiu chun v hng dn.
Ngy 14/12/2000, ISO cng b b tiu chun quc t c sa i v h thng qun l
cht lng. B tiu chun ISO 9000 n hnh nm 2000 gm cc tiu chun di y:
ISO 9000: 2000, thay th ISO 8402: 1994, m t c s ca cc h thng qun l cht
lng v quy nh cc thut ng cho h thng qun l cht lng.
ISO 9001: 2000 thay th ISO 9001/2/3: 1994 (xem bng 4.1) quy nh cc yu cu i
vi mt h thng qun l cht lng khi mt tiu chun cn chng t nng lc ca mnh trong
vic cung cp sn phm p ng cc yu cu ca khch hng v cc yu cu ch nh c th
p dng, v nhm nng cao s tho mn ca khch hng.
ISO 9004: 2000, thay th ISO 9004 1: 1994, cung cp cc hng dn. Xem xt c tnh
hiu lc v hiu qu ca h thng qun l cht lng. Mc ch l ci tin vic thc hin ca
mt s t chc v tho mn khch hng.
ISO 19011: 2001 thay th ISO 100111/2/3 cung cp hng dn v nh gi cc h
qun l cht lng v mi trng. Tiu chun ny s c ban hnh sau.
Cc tiu chun ca b ISO 9000 nm 2000 u c chuyn dch sang tiu chun Vit
Nam tng ng l TCVN ISO 9001: 2000.
4.2.1. c im ca b tiu chun mi
Nhng thay i ch yu ca tiu chun mi trong cp tiu chun h thng qun l cht
lng ISO 9001 v ISO 9004 l:
Cu trc c nh hng theo qu trnh v ni dung sp xp logic hn.
Qu trnh ci tin lin tc c coi l mt bc quan trng nng cao h thng qun
l cht lng.
Nhn mnh hn n vai tr ca lnh o cp cao, bao gm c s cam kt i vi vic
xy dng v ci tin h thng qun l cht lng, xem xt cc yu cu ch nh v php lut,
v lp cc mc tiu o c ti cc b phn chc nng v cc cp thch hp.
Vic thc hin phng php cc ngoi l c php i vi tiu chun p ng c
mt din rng cc tiu chun v hot ng.
Tiu chun yu cu t chc phi theo di thng tin v s tho mn hay khng tho mn
ca khch hng. Thng tin ny c coi l mt php o v cht lng hot ng ca h
thng.
Gim ng k s lng th tc i hi.
Thay i cc thut ng cho d hiu hn.
Tng thch cao vi h thng qun l mi trng (b ISO 14000).
p dng cht ch cc nguyn tc ca qun l cht lng.
Ch n cc nhu cu v quyn li ca cc bn quan tm.
4.2.2. Tm tt cc yu cu ca ISO 9001: 2000
Phn gii thiu cc tiu v yu cu ca tiu chun ISO 9001: 2000, s hiu cc mc
chnh c gi nguyn (nh trnh by bng 4.1).
ISO 9000 v GMP
Ging nhau: C nhng im ging nhau c bn v mc tiu, ch khc nhau cch h thng
ho h s v cch p dng.
Cng xy dng nn cc tiu chun (yu cu iu khon), cht lng v dng cc tiu
chun ny nh gi h thng cht lng ca mt doanh nghip.
Khc nhau:
ISO 9000
GMP
Vai tr ca h thng tiu chun ISO 9000 trn th trng quc t tr nn r rng. Nhiu
khch hng mong mun rng bn cung ng tin hnh ng k ISO 9001 i vi nhng cng
ty/ x nghip c sn phm thuc phm vi ch o ca Lin Hip chu u (EU) ng k ISO
9001 l mt yu cu php l c th tham gia th trng chung chu u (EU). Vic ng k
cng c th gip doanh nghip, cng ty p ng c nhng quy nh trong nc.
Nm 2003, Vit Nam tham gia vo khu vc mu dch t do ASEAN gi tt l AFTA.
Chng nhn ISO 9000 tr thnh giy thng hnh cc doanh nghip hi nhp vo th
trng khu vc v th gii.
Ngy nay, hu nh cc c s sn xut, nghin cu, kinh t x hi,... phn u thc hnh
v ly chng ch ISO 9001 phin bn nm 2000.
CU HI LNG GI * CHN CU TR LI NG
1.
a) ISO l ch vit tt ca International Standard Organization;
b) ISO l ch vit tt ca International Organization For Standardization;
c) L t chc tiu chun ho quc t;
c) a, b, c u ng.
2.
a) B ISO 9000 c chp nhn a vo p dng t nm 1985;
b) B ISO 9000 c chp nhn a vo p dng t nm 1987;
c) B ISO 9000 c chp nhn a vo p dng t nm 1990;
d) B ISO 9000 c chp nhn a vo p dng t nm 1994.
3.
a) ISO 9000 l mt b tiu chun hng dn cng tc qun l cht lng v xc nh cc
yu t cht lng chung cn thit cho vic m bo cht lng;
b) ISO 9000 khng ph thuc vo bt c ngnh ngh, khu vc kinh t no;
c) ISO 9000 khng p t mt phng thc c th no cho mt cng ty, doanh nghip no;
d) a, b, c kt hp ng.
4. ISO 9001 phin bn 2000 gm c:
a) 17 iu khon;
b) 19 iu khon;
c) 20 iu khon;
d) 21 iu khon;
5. ISO 9000 c p dng trn ton cu cho cc doanh nghip:
a) Sn xut thuc;
b) Sn xut thc phm;
c) Cc c s hnh chnh s nghip;
d) Tt c cc c s kinh t x hi.
Bi 5
AN TON LAO NG V V SINH CNG NGHIP
MC TIU
1. Nu c mc tiu ca an ton lao ng v v sinh cng nghip.
115 Y t
114 Cu ho
113 Cng an
Ch
Tiu lnh cu ho.
C dng c v phng tin phng chy cha chy (cc bnh CO2, cc bnh xt
khc,).
S dng thnh tho mi phng tin phng chy cha chy, mun vy cn phi c s
hun luyn nh k cho mi ngi trong x nghip, doanh nghip,...
Nhng ni d chy n cn phi c bin php phng nga hiu qu nht.
Nhng ni d xy ra nguy him phi c tn hiu r rng, d nhn bit c ban ngy v
ban m. V d bng bo hiu c ch sn hay du sn trn nn trng, c n vo ban
m hoc bin bo pht quang,...
Nhng phng tin, cc thuc s cp cu cn thit (t thuc cp cu).
Nhng cu dao in, nhng in,... cn phi c hp bao che,...
Nhng thit b chu p lc, thang my,... cn phi c s kim tra nh k v cho php s
dng ca c quan chc nng,...
5.4. V sinh cng nghip theo GMP trong c s sn xut thuc
Xut pht t c im ca ngnh Dc l sn xut ra mt loi hng ho c bit:
l nhng sn phm ng gi phn liu, i hi cht lng, an ton, hiu qu v kinh
t.
Sch s v v sinh trong sn xut.
Quy nh cao v cht ch trong tng ch phm.
Sn xut theo tng l, m.
Sn phm c hn dng.
Mi dng bo ch ph hp theo ng s dng.
Tha hng v p dng nhng tin b khoa hc ca cc ngnh khc.
V th v sinh trong sn xut c ra v l mt trong cc vn quan tm hng u
ca c s sn xut thuc nhm mc tiu:
Loi b/ trnh nhim bi mi trng v ngi thao tc.
Loi b/trnh nhng sai phm, sai st, lm li, trong qu trnh sn xut.
Loi b/ trnh cc tc nhn nguy him cho ngi lao ng.
WHO GMP ghi khon mc 3, 11 v 12 yu cu v iu kin v sinh c nhn, nh
xng, trang thit b (xem c th ni dung WHO GMP Ti liu c thm).
a) Mt s im cn lu
Ngun nhim, c th phi k t nguyn liu, con ngi, thit b/dng c, bao b, nh
xng, khng kh v cc nguyn nhn khc (nh ln ln, sai st,).
Tc nhn nhim: Nhng tiu phn, vi sinh vt (V d: tng s khi lng vi sinh vt trn
tri t gp 25 ln tng s khi lng cc ng vt. ngi: trn da c ti 20.000 con vi sinh
vt/cm2, trong rut c 1012 hay mt ngn t con/1gam phn), nhim cho (l vic nhim ca
mt nguyn liu hay mt sn phm bi mt mguyn liu hay mt sn phm khc).
Cc yu t chuyn ch s nhim: con ngi, khng kh mi trng (bn ngoi, bn
trong v s lc), lu cht (nh nc,) v lung di chuyn nguyn liu.
Hng ro ngn cn s nhim: cc cht gi (airlock), trang phc, chnh lch p sut,
khu vc kn, bao b kp, lc khng kh v v sinh.
Quy nh chung v:
iu kin v sinh
V sinh c nhn
V sinh nh xng
V sinh thit b, dng c sn xut
b) iu kin v sinh
cp ti cc vn :
S dng cht ty ra, cht ty u sao cho ph hp v bin php kim sot vi sinh vt.
Thu gom rc thi, cc vt liu loi b,
Vic dng cc cht ph gia khi cung cp hi nc (trnh cc cht gy ung th).
V vic lm v sinh cc khu vc, trnh nhim cho khi nhn vin qua li,
Cc tiu chun v sinh v SOP lm v sinh phi c thm nh trc v ti thm nh
theo nh k. Ch cc vn cn phi xc nh trc khi thm nh, v d cc iu kin lm
v sinh my cn phi xc nh (xem c th mc v sinh thit b).
c) V sinh c nhn
Cn quan tm ti cc yu cu v:
Sc khe ca nhn vin (khm sc khe, trc khi tuyn, trong thi gian lm vic theo
nh k hoc t xut khi c vn e v sc khe c lin quan n cht lng sn phm).
Thi quen v sinh (mt s iu cm k trong khu vc sn xut nh n ung, ct gi cc
n ung, thuc l, chi tc, ngoy mi, h mi,). thc gi gn v sinh nh trang phc,
ra tay,
Phi c cc SOP v sinh c nhn v thc hnh v sinh v phi c o to, hun luyn.
d) V sinh nh xng phi m bo cc nguyn tc v nhng quy nh chung t thit k
xy dng n lp t thit b, b tr mt bng, v sinh d dng, thun tin cho thao tc trnh
cc nguy c nhim, nhim cho, cho mt nh xng sn xut thuc. Mi mt khu vc c
cc yu cu v sinh ph hp v phi c hng dn (cc SOP) c k hoch v sinh cho tng
khu vc nh:
CU HI LNG GI * CHN CU NG
1. i vi c s sn xut thuc, yu cu v sinh theo quy nh WHO GMP gm:
a) iu kin v sinh, v sinh c nhn, v sinh nh xng, v sinh my mc thit b
(MMTB);
b) V sinh mi trng, MMTB, con ngi, nh xng, c nhn, tp th;
c) V sinh nh xng, MMTB, mi trng, c nhn, chng nhim;
d) a, b, c u ng.
b) 116;
c) 111;
d) 115;
5. S in thoi cp cu Y t nc ta l:
a) 114;
b) 115;
c) 110;
d) 113;
PH LC
Trn c s nhn thc v cc GxP, theo nhng ni dung khuyn co ca WHO GMP,
GLP, GSP ta c th xy dng nhng cng vic c th cho mi c s doanh nghip nh mt
vi v d di y:
1. Quy trnh thao tc chun
2. Bn m t cng vic
3. Thm nh
4. Nhn
V d:
Quy trnh (SOP) pha ch gc
1. Tn doanh nghip
5. Trang
6. Ngy ban hnh
3. B phn
7. S
4. n v
8. Ngy sot li
9. Thay th s ngy
Ngy:
Ngy:
Ngy:
Tn sn phm
M s
S m
C m
Dng bo ch
n v ng gi
Ngy bt u
Ngy kt thc
5. Trang
6. Ngy ban hnh
3. B phn
7. S
4. n v
8. Ngy sot li
9. Thay th s ngy
12. Ph chun
Ngy:
Ngy:
Ngy:
Tn sn phm
M s
S m
C m
Dng bo ch
n v ng gi
Ngy bt u
Ngy kt thc
T s: 1/2
Vn hnh cn in t HR200
S: SOP 312.00
KHOA DC
Ngy: 7/7/1999
B mn:
Phng:
C hiu lc t:
Cng nghip Dc
9/7/1999
Ngi son:
Ngi duyt:
DS. H..
DS.Nguyn
PGS. Hong
9/7/2002
Ngy 7/7/1999
Ngy 8/7/1999
Ngy 9/7/1999
Thay th s:
Ngy:.
1. Mc ch
m bo cc thao tc vn hnh c thc hin ng b t c s n nh v mt
cht lng sn phm, vn hnh an ton v hiu qu i vi thit b.
2. Phm vi p dng
Quy trnh ny c p dng trn Cn in t HR200, t ti tng 3 phng Thc tp
thuc vin B mn Cng Nghip Dc.
3. Quy trnh
Kim tra sch ca cn.
Cm ngun in cho cn.
Nhn nt ON/OFF ch vi giy cho n khi hin ra s: 0,0000
* Ch :
+ Nu cn khng hin ra s 0,0000 th bm nt REZERO ch hin ra s 0,0000.
+ Trong trng hp cn khi lng ln hn 50g nn iu chnh nhy ca cn nhm
bo v cn bng cch bm nt RANGE chuyn thnh 0,000 ri tin hnh cc bc k
tip. Nu bm nt RANGE mt ln na tr li 0,0000 nh ban u.
+ Trng lng ti a ca cn l 200g (k c b) do khng c cn qu 200g nhm
trnh h hng cn.
+ ng tc bm nt cn phi dt khot khng nn bm lu v bm lu cn s chuyn
sang chc nng khc khng ng mc ch s dng l cn khi lng v s lm hng cn.
+ Cc nt chc nng khc (dng vi mc ch khc) khng c bm s dng trnh lm
sai lch kt qu cn v gim chnh xc.
M lng cn v t b nh nhng ln a cn, ng lng cn, ch vi giy ri bm nt
REZERO ch hin ra s 0,0000.
M lng cn, cho nh nhng v t t vt cn cn ln a cn, ng lng cn. c kt qu
cn trn mn hnh (khi n nh).
Cn xong, ly b v vt cn ra. Bm nt ON/OFF cn tr v ch ngh.
Ngt ngun cung cp in cho cn.
V sinh cn theo SOP lm sch Cn HR200.
4. Trch nhim
Tt c cc cn b ging dy, k thut vin, sinh vin c phn cng vn hnh thit b k
trn phi c hun luyn v kim tra theo quy trnh thao tc chun ny trc khi tin hnh
thao tc trn my. Cn b hng dn thc tp chu trch nhim hun luyn, kim tra, gim st
vic thc hin ca sinh vin.
T s: 1/2
S: SOP 311.00
Ngy: 3/7/1999
B mn:
Phng:
C hiu lc t:
Cng nghip Dc
6/7/1999
Ngi son:
Ngi duyt:
PGS. Hong
6/7/2002
Ngy 3/7/1999
Ngy 6/7/1999
Thay th s:
Ngy 4/7/1999
Ngy:.
1. Mc ch
m bo cc thao tc vn hnh c thc hin ng b t c s n nh v mt
cht lng sn phm, vn hnh an ton v hiu qu i vi thit b.
2. Phm vi p dng
Quy trnh ny c p dng trn Cn xc nh m bng hng ngoi Shimadzu Libror
EB 340 MOC t ti tng 3 phng Thc tp thuc vin B mn Cng nghip Dc.
3. Quy trnh
Kim tra sch ca cn.
Cm ngun in ca c cn v h thng un nng bng tia hng ngoi.
Bt nt < ON/OFF > ca b phn un nng (Heater unit):
n < POWER > chy sng.
n < 100 > nhp nhy.
Bm nt < ON > ca b phn cn:
Tt c n trn mn hnh (display) bt sng.
n nt < TARE > tren bn phm hoc nt < TARE > trn b phn cn mn hnh hin
s: 0.000 (cho mu th 60g).
Nu xc nh lng mu th 60g < P < 330g th n nt < RANGE > mn hnh hin
ra s: 0.00. Vic s dng kt qu ny s gip bo v c nhy v chnh xc ca cn. Nu
mun tr li nh ban u vi 3 s l th bm < RANGE >.
iu chnh nhit sy bng nt < HEATER TEMP > ty theo yu cu ca mu th
gm cc giai on:
+ Gt kho v pha ngc chiu kim ng h m b chnh nhit .
+ Xoay nm vn (c 5 vng) chn nhit thch hp sy (0 5000C).
+ Gt kho v pha cng chiu kim ng h ng v c nh nhit ci t.
* Ch :
+ Nhit ci t l nhit ca ngun nhit pht ra cn nhit thc sy mu l
nhit o trc tip bng nhit k gn trn a cn cha ng mu, nhit ny ph thuc
vo lng mu sy, th tch, din tch b mt khi mu sy, hm m ca mu, Do
thng phi qua th nghim vi ln mi chn c nhit ci t thch hp.
+ S tng quan mt cch tng i gia nhit ci t v nhit thc sy ti a cn
theo mi quan h ca hm s m.
V d:
+ Nhit ci t l 300oC th nhit thc sy khong 100oC.
+ Nhit ci t l 400oC th nhit thc sy khong 150oC.
05
2 pht
20
5 pht
50
Khng cn iu khin
99
4. Trch nhim
Tt c cc cn b ging, k thut vin, sinh vin c phn cng vn hnh thit b k trn
phi c hun luyn v kim tra theo quy trnh thao tc chun ny trc khi hun luyn thao
tc trn my. Cn b hng dn thc tp chu trch nhim hun luyn, kim tra, gim st vic
thc hin ca sinh vin.
T s: 1/2
S: SOP 312.00
Ngy: 7/7/1999
B mn:
Phng:
C hiu lc t:
Cng nghip Dc
9/7/1999
Ngi son:
Ngi duyt:
DS.
Nguyn..
DS.Nguyn
PGS. Hong
9/7/2002
Ngy 8/7/1999
Ngy 9/7/1999
Thay th s:
Ngy 7/7/1999
Ngy:.
1. Mc ch
m bo cc thao tc vn hnh c thc hin ng b t c s n nh v mt
cht lng sn phm, vn hnh an ton v hiu qu i vi thit b.
2. Phm vi p dng
Quy trnh ny c p dng trn my o pH Meltrohm t ti lu 3 phng thc tp thuc
vin B mn Cng Nghip Dc.
3. Quy trnh
M l thng p trn in cc v ngm in cc vo nc ct khong 10 pht phc hi
in cc.
Cm in, n nt < ON/OF > trn my pH ch hin ra cc thng s.
n nt < pH/mV/ oC > ch hin ra cc thng s.
Nhng in cc vo dung dch m chun 1 (pH = 7.00).
n nt < pH CAL > mn hnh s hin ln: nhit , du ngn tay, CAL/U.
i n khi mn hnh xut hin
th ly in cc ra khi dung dch m chun 1
(pH = 7.00), ra in cc bng nc ct v lau kh in cc bng khn giy mm ri nhng
vo dung dch m chun 2: (pH = 4.00) nu dng o trong mi trng acid; (pH = 9.00)
nu dng o trong mi trng base.
5. Trang:
Tn Chc danh:
6. S:
Trng
1.Tn c s/
doanh nghip
1/1/2004
3. B phn
4. n v
Ngy:
Ngy:
Tn cng vic:
Bo co cho:
Gim st:
1. Kin thc:
K nng:
Kh nng:
2. Tm tt cng vic:
Ngy:
15. Ngy:
a)
b)
T s
S
Ngy
Phn xng
B phn
Hiu lc t
Ngy sot xt li
Ngi son
Ngi duyt
Thay th s
Ngy
Ngy
Ngy
Ngy
1. Mc ch
Hng dn cc nguyn tc tng qut vic thm nh cc quy trnh v sinh thit b trong
sn xut. Thm nh ny nhm chng minh rng mt quy trnh v sinh xc nh khi c p
dng lm v sinh b mt thit b trong nhng iu kin xc nh trc, s m bo mt
cch n nh rng b mt khng cn b nhim ( nhim cho hay cht ty ra cao hn
gii hn c n nh trc).
2. Phm vi p dng
Tt c quy trnh v sinh cc thit b thit yu trong sn xut.
3. Trch nhim
Tt c nhn vin lin quan n vic thm nh cc quy trnh lm v sinh.
4. Cc iu kin cn thit trc khi thm nh
Cc thit b sn xut c nh gi t (nh gi lp t v vn hnh).
Nhn vin lm cng tc v sinh phi c o to v l thuyt v thc hnh lin quan
n cng tc v sinh.
Cc thit b dng lm v sinh phi c nh gi: my ht, my ra,
Cc tc nhn s dng trong khi lm v sinh phi c thm nh (v d cc cht st
khun ).
Thm nh thit b lm v sinh hay mt tc nhn s dng trong khi lm v sinh l nhm
chng minh rng cc phng tin ny ph hp vi phng php lm v sinh, khng gy tn
hi cho b mt phi v sinh, khng pht sinh cng nh khng a vo cc cht gy nhim.
5. Ni dung
5.1. Cc mc sch khc nhau phi t c
Quy trnh ny phn loi 4 mc v sinh thay i ty theo mc tip xc vi sn phm.
Mc A: Tt c b mt ca khu vc v thit b. Khu vc ny c quy nh khng
c cha mt vt g khc ngoi dng c cn thit cho vic pha ch.
Mc B: Cc b mt bn ngoi ca cc thit b dng pha ch hay ra l.
Mc C: Cc b mt ca thit b c tip xc vi sn phm.
Mc D: Nc thi sau khi ra.
5.2. Vic la chn trng hp xu nht
Mi thit b c s dng sn xut nhiu sn phm cng lc, do nguyn tc la
chn sn phm thm nh l phi chn trng hp xu nht.
La chn hot cht thm nh da theo nguyn tc:
Chn sn phm no m liu iu tr ti thiu hng ngy (DMT) ca hot cht thp nht.
i vi nhng sn phm c cng hot cht ch khc nhau v hm lng chn sn phm c
hm lng hot cht cao nht.
Chn sn phm no m hot cht kh loi b ( tan thp) nht trong dung mi lm v
sinh.
Sn phm c ngng pht hin nh lng rt thp (di hay bng microgram).
La chn sn phm lm sn phm k tip:
Chn sn phm no c liu ti a hng ngy (DMP) cao nht (g/ngy) lm sn phm
k tip khi thm nh.
Trong trng hp khng tnh n cc hot cht c th, c th p dng mt gii hn pht
hin chung l 10ppm tc l khng c c qu 10ppm hot cht A c pht hin trong sn
phm k tip. Khi vic tnh ton cho tng thit b cng nh trn:
hay:
Lng tp nhim ti a (Maximum contamination = MC):
Lng tp nhim ti a ca hot cht c php c trong 100cm2 thc hin bng phng
php Swab, c tnh theo cng thc sau:
Trong :
+ F: liu iu tr cn chp nhn c hoc liu c, mt cch tng qut 0.001 F 0.025.
+ DMT: liu iu tr ti thiu hng ngy ca hot cht c thm nh..
+ DMP: liu ch nh ti a hng ngy ca sn phm k tip
Bit X tnh c gii hn nng hot cht trong dung dch trng LD:
Bit LD tnh c X:
6. Ti liu thm nh
6.1. cng thm nh
Mt cng thm nh phi c thit lp v ph chun cho tng thit b kho st, trc
khi thc hin vic thm nh.
cng t nht phi gm c:
Mc tiu phi t.
Ngi thc hin v trch nhim.
La chn trng hp xu nht.
S v k hoch ly mu.
Phng php ly mu.
Tiu chun chp nhn.
Chu k thm nh.
Bng ghi kt qu vic thm nh.
6.2. Bo co thm nh
Bo co thm nh c thit lp sau khi thm nh. y l cng c y kt
qu v kt lun.
7. CHU K THM NH
Nu phng php v sinh khng c thay i, tin hnh phn tch mi 2 nm/ ln.
Mt khi phng php v sinh thay i, phi thm nh.
Nhn
Nhn tnh trng thit b
CHNG 2
CC QU TRNH CNG NGH C BN
TRONG SN XUT DC PHM
Khi kho st mt s vt, hin tng hay mt qu trnh, ngi ta thng quan st n di
hai trng thi:
Trng thi tnh: Kho st vt hay h vt trng thi cn bng.
Trng thi ng: Nghin cu v ng hc v ng lc hc ca cc qu trnh chuyn
ng:
+ ng hc nghin cu s chuyn ng ca vt hay h vt m khng tnh n nguyn
nhn gy ra chuyn ng.
+ ng lc hc kho st nhng quy lut chuyn ng ca vt v nguyn nhn gy ra hoc
lm thay i cc chuyn ng .
Chng ny ny i su vo kho st trng thi ng ca cc qu trnh cng ngh c bn
thng gp trong cng ngh dc phm, ni dung ca n bao gm ba vn chnh:
Trnh by cc c s l thuyt.
Bi 6
XAY RY VT LIU
MC TIU
1. K tn c cc loi my xay thng dng trong ngnh dc.
2. Trnh by c nguyn l cc loi my xay.
3. Phn tch c nh hng ca cc yu t n hiu sut ca qu trnh ry.
4. Bit cch chuyn i c ry gia Dc in Vit Nam v c ry theo USP (mesh).
C ht c xay
Xay th:
840mm
74 840mm
Xay mn:
74mm
Trong : n nghin
D ng knh ca vt liu trc khi xay.
d ng knh ca vt liu sau khi xay.
ng dng ca xay trong sn xut dc phm: Din tch b mt ca mt n v khi lng
tng ln khi gim kch c ht, iu ny s nh hng n hiu qu iu tr v khi vo c th
cc ht s c din tch tip xc vi dch c th tng ln, s rt ngn thi gian ho tan hn cc
ht th.
6.1. My xay vt liu
6.1.1. My xay ba
My xay ba dng xay s b v xay nh
ln cui cc vt liu c m khng qu 15%.
Cu to ca n gm c v my, trn trc quay
nm ngang c gn a, trn a gn cc ba lp
ng, ba thng lm bng thp cng khng g.
Vt liu a vo my qua ca cp vt liu (hnh
6.1). Khi trc quay, di tc dng ca lc ly tm
ba ging thng theo chiu hng tm v p
mnh vo vt liu lm cho vt liu v nh ra.
Vt liu sau khi xay c tho qua ry. Ry ny
c th iu chnh thu c sn phm c kch
c mong mun bng cch thay i cc ry c l
to nh khc nhau.
6.1.2. My xay ct
My xay ct gm mt lot cc li dao c
gn c nh vo mt rotor quay theo phng
nm ngang, khi rotor hot ng, cc li dao
gn trn rotor c chiu ngc vi cc li dao
gn c nh trn v my (hnh 6.2). Trong qu
trnh xay, vt liu b ct thnh nhng phn t
nh gia hai b li dao. Mt li ry c gn
trn v my v gi li nhng vt liu c kch
thc ln hn l ry thc hin qu trnh ct
xay tip tc cho n khi t c c ht thch
hp c th i qua li ry. My c tc ct cao
c bit thch hp cho xay dc liu.
Hnh 6.2. My xay ct
6.1.4. My xay a
Cu to ca my gm c a 1 khng chuyn
ng, a 2 quay nh gn vo mt trc nm
ngang 3. a 2 c th iu chnh qua li thay
i khong cch khe h gia 2 a bng b phn
iu chnh, nh ngi ta c th iu chnh
c xay (hnh 6.4).
6.1.5. My nghin bi
My nghin bi gm mt thng bng kim loi
hay s, bn trong cha mt phn bi bng kim
loi hay bng s v vt liu cn nghin mn
(hnh 6.5).
Hnh 6.5. My nghin bi
ngi ta hay chia loi li theo kch thc di ca l. Mi h thng hay mt thang gm nhiu
ry, c trng bng t l khng i ca l li loi ny vi l li loi tip theo ngha l bng
mt i lng khng i gi l modun.
Ry c l khng phi l vung thng k hiu bng s, c ry quy nh cc nc khng
ging nhau. Dc in Vit Nam III quy nh s c ry theo t chc tiu chun ho quc t
ISO da trn c s chiu rng ca l mt ry (vung) (xem bng1).
Trong cc ti liu k thut quc t hoc ca cc hng nc ngoi thng s dng cch
phn loi theo tiu chun ca USP gi l mesh, trong c trng bng s l li trn chiu
di 1 inch. V d: 200 l/1 inch ngha l 200 mesh.
Khi phn tch c ht phi ghi r p dng theo thang tiu chun no hoc ghi c th theo
loi c mt li c p dng.
Cht lng ca qu trnh ry c biu din bi hiu sut ry. Vt liu em ry gm cc
ht kch thc khc nhau, n gm cc ht c kch thc c th lt qua ry v cc ht khng
th lt qua ry. Sau khi ry thu c sn phm nm di ry gm cc ht lt qua li v sn
phm nm trn ry gm c cc ht khng th lt qua mt ry. Thc t khi ry khng phi cc
ht c kch thc nh hn l ry u lt qua, nn lng ht di ry bao gi cng nh hn
lng ht c kch thc lt qua ry.
Bng 6.1. C ry theo tiu chun Dc in Vit Nam
S ry (mm)
C mt ry (mm)
ng knh si (mm)
2000
2,000
0,900
710
0,710
0,450
500
0,500
0,315
355
0,355
0,224
250
0,250
0,160
212
0,212
0,140
180
0,180
0,125
150
0,150
0,100
125
0,125
0,090
90
0,090
0,053
75
0,075
0,050
45
0,045
0,032
C mt ry
mm
9,52
9520
4,76
4760
2,38
2380
10
2,00
2000
20
0,84
840
30
0,59
590
40
0,42
420
50
0,297
297
60
0,250
250
70
0,210
210
80
0,177
177
100
0,149
149
120
0,125
125
200
0,074
74
Hiu sut ry
T s lng ht qua ry vi lng ht c th lt qua ry ta gi l hiu sut ry, biu din
bng %.
a) My xay inh;
b) My xay bi;
c) My xay keo;
d) b v c.
2. Hiu sut ry khng ph thuc:
a) dy lp vt liu trn ry;
b) m vt liu;
c) Vn tc v t trng ca vt liu trn ry;
d) Tt c u sai.
3. Tc chuyn ng ca ht vt liu trn ry:
a) Cng nhanh cng tt;
b) Cng chm cng tt;
c) Vn tc chuyn ng nh, ng i ca ht cng di cng tt;
d) Khng cu no ng.
4. My xay mn cho c ht:
a) 840m;
b) 300 840 m;
c) 100 300 m;
d) <74m.
5. Kch c ht trong qu trnh xay ch ph thuc:
a) Loi my c s dng;
b) Loi vt liu c xay;
c) Loi li ry c lp vo my xay;
d) Khng cu no ng;
e) C a, b, c u ng.
6. Di phn b c ht sau xay ph thuc vo:
a) Loi my xay;
b) Loi vt liu c xay;
c) Loi li ry c lp vo my xay;
d) Tc np vt liu khi xay;
e) Tt c u ng.
7. Mun tng tc ry:
a) Tng tc chuyn ng ca ht vt liu trn ry;
b) Tng tc ca my ry;
c) Dng tay ch vt liu xung mt ry;
d) Khng cu no ng.
8. Mun tng hiu sut ry:
a) Tng tc ry;
b) Np nhiu nguyn liu ln ry;
c) Np u n mt lp vt liu khng qu dy ln ry;
d) iu chnh cho vt liu chuyn ng vi mt tc nh v lp vt liu mng.
9. Trong xay ry, c ht trung bnh c kch thc trong khong:
a) Ln hn hoc bng 1200m;
b) Ln hn hoc bng 850m;
c) T 100 840m;
d) Nh hn hoc bng 75m.
10. Trong quy trnh xay, di phn b c ht khng ph thuc vo:
a) Tc np nguyn liu vo my xay;
b) Cht lng vt liu a vo xay;
c) Kch c l ry;
d) My xay ca hng no ch to.
11. Ry c c l mt ry 10mesh (tnh theo tiu chun USP) tng ng vi c s mt ry
tnh theo tiu chun quc t l:
a) 2000m;
b) 1000m;
c) 4000m;
d) 500m.
Bi 7
KHUY TRN VT LIU
MC TIU
1. Nu c cc ng dng ca qu trnh khuy trn trong cng nghip dc.
2. Phn bit c cc qu trnh khuy trn theo trng thi lin kt ca vt liu.
3. Trnh by c nguyn tc cu to ca thit b khuy.
4. K tn cc dng cnh khuy v phm vi ng dng ca mi loi.
5. Phn tch c cc yu t trong ch thy ng lc ca thit b khuy.
6. Phn tch c ch cng ngh khuy.
7. Trnh by c nguyn l trn hi chuyn.
8. Trnh by c ch trn trong thng trn v cc yu t nh hng n hiu qu qu
trnh trn.
Khuy trn c ng dng rng ri trong cng nghip dc ch bin huyn ph, nh
tng v cc hn hp rn, cng nh lm tng cng qu trnh chuyn khi v trao i
nhit. Ty theo mc ch t c ca ch phm v mi trng tin hnh sn xut m ngi
ta la chn phng php v thit b khuy ph hp.
Khi la chn phng php khuy trn v iu kin ca thit b phi ch n trng thi
lin kt ca vt liu em khuy trn. Hai trng hp ph bin:
Khuy trn trong mi trng lng.
Khuy trn trong mi trng rn, xp, nho.
7.1. Khuy trn mi trng lng
Trong cng ngh dc thng phi thc hin cc qu trnh lin quan n mi trng cht
lng, vi s phn b tng i ng u v vt cht v nhit , cc yu cu c th p
ng c nh khuy trn mi trng lng.
Phng php khuy c hc c thc hin bng cc cch khuy khc nhau t cc
mc ch sau y:
Thc hin qu trnh thy c: to nh tng, huyn ph, ho tan, ng ho.
Thc hin qu trnh nhit: c c dung dch, un nng, lm ngui.
Thc hin cc phn ng ho hc.
Thc hin cc phn ng sinh hc.
Nh vy khuy mi trng lng, trong :
+ Pha lin tc l mt cht lng.
+ Pha phn tn c th l: pha lng, pha rn hoc pha kh.
Khuy cht lng l cung cp nng lng to mt dng chy thch hp trong thit b
nhm p ng cc yu cu nu trn.
Qu trnh khuy c th thc hin trong thit b gin on hoc thit b lin tc theo yu
cu ca mt cng ngh sn xut c th, iu kin ca mi trng khuy trn c xc nh
bi:
Nhit .
p sut.
Nng pha phn tn.
Do vy thit b khuy c th thc hin dng kn hoc dng h. Thit b khuy thng
c ch to dng hnh tr thng ng, tuy nhin cng c trng hp p dng thit b khuy
nm ngang.
7.1.1. Nguyn tc cu to thit b khuy
Mt cch tng qut, thit b khuy gm cc b
phn ch yu sau (hnh 7.1): Thng khuy (1) hnh tr
vi y trn hoc hnh nn, pha trn y np (3) ghp
vi thn (2) bng bch theo ng tm ca thng lp
trc khuy (10) vi cnh khuy (11). Trc khuy
thng xuyn qua np v c bt kn bi hp m (4),
truyn chuyn ng cho trc khuy t ng c (7) qua
hp gim tc (6) to tc thch hp cho cnh
khuy. Vic tho v lp trc khuy thng qua khp ni
(5). Thng c gn tai (12) nh bu lng gn vo
chn (13). Thc hin nhp liu qua ca (8) trn np
thit b, c khi ngi ta b tr ca sa cha v ca quan
st (9).
Trong thc t, thit b khuy c thit k v ch
to rt a dng v kiu v hnh dng, ty thuc vo
mc ch s dng. Thit b khuy c th ch to dng
h tc l khng c ngn cch vi mi trng bn
ngoi. Trong trng hp thit b lm vic vi iu kin
nhit v p sut khc vi mi trng kh quyn th
phi ch to dng thit b kn, ngha l c s ngn cch
vi mi trng bn ngoi. Trc khuy lp vo thit b
Khuy l qu trnh to dng chuyn ng ca khi cht lng trong thit b nh cc cnh
khuy. V kt cu cc dng cnh khuy c nhiu dng nhiu kiu khc nhau (hnh 7.2). Tuy
nhin, theo quan im v tc quay, ngi ta chia cc cnh khuy thnh hai nhm chnh:
1. Nhm cnh khuy tc nhanh.
2. Nhm cnh khuy tc chm.
Nhm cnh khuy tc nhanh gm: Bn 2 cnh (mi cho), bn 3 cnh, bn 6 cnh,
chn vt, tuc bin kn, tuc bin h.
Nhm cnh khuy tc chm: m neo, cnh khuy khung, cnh khuy vis, cnh khuy
mi cho.
7.1.3. Ch thy ng lc trong thit b
7.1.3.1. Phng chuyn ng
Mi kiu cnh khuy khi lm vic s to ra dng chuyn ng khc nhau. s chuyn ng
ca cht lng c th xem hnh 7.3.
Hnh 7.3. Hng chuyn ng chnh ca dng cht lng trong khi khuy
0 th t
Thc hin qu trnh khuy t hiu qu ty thuc vo loi cnh khuy, quan h kch thc
hnh hc v ch thy ng lc trong thit b.
b) Ch cng ngh khuy
Qu trnh thy c c thc hin to ra cc hn hp vi mc ng nht cn thit c
gi l s ng ho. S ng ho nhm phn b tng i ng u trng vt cht v trng
nhit .
Ch cng ngh ca qu trnh ho tan, huyn ph ho hoc nh tng ho l to ra mt
ch thy ng lc thch hp, trong khong thi gian ngn nht, chi ph nng lng thp
nht t c ng nht cao.
Mun vy cn quan tm nghin cu cc c tnh s bin i mi trng khuy:
Khi lng ring ().
nht ().
Kch thc (ng knh) cc phn t pha phn tn (dp).
iu kin tn ti vng bn ca hn hp. S tng quan v khi lng ring ca hai pha
hoc hai cu t ho trn c nh hng ln n hn hp, thng qua gi tr tc lng hoc ni
ca phn t.
7.2. Khuy trn trong mi trng ht rn ri v bt nho (hn hp)
Trong cng nghip bo ch cc dng thuc dng rn: thuc bt, thuc vin, cng ngh
khuy trn trong mi trng rn ri v bt nho c s dng rng ri.
Qu trnh khuy trn trong thit b loi ny tin hnh cng vi s mit cc b khi vt
liu v xy ra nhng qu trnh khc ngoi yu cu. Tng ng vi chc nng, trn nhng thit
b loi ny thng c gi l my nho trn.
C ch phn ly:
Cc cht rn dng ht hng ti s phn ly bi cc tc dng khc nhau v c ht, t trng,
hnh dng v cc c tnh khc ca ht.
Qu trnh phn ly c th xy ra trong qu trnh trn cng nh trong cc cng on tip
theo nh dp vin, ng nang.
Hiu qu trn:
Hiu qu trn ph thuc vo tc quay ca thng trn. Tc quay qu chm khng to
ra c cng chuyn ng p xung hay chy xung nh thc nh ta mong mun
hoc khng to ra c tc trt cao. Mt khc khi chuyn ng qu nhanh s dn n
vic to ra lc ly tm hay phn ly bt ra pha thnh thng trn. Tc quay ti u ph thuc
vo hnh dng, kch thc ca thng trn. Thng th tc khong 30 100 v/pht.
Hiu qu trn ph thuc vo c tnh loi vt liu c trn, lng vt liu c np vo
thng trn.
Thi gian trn: Thi gian qu ngn dn n hu qu trn khng u. Thi gian qu di s
lm trn cnh cc ht d dn n phn ly.
Trong qu trnh trn c th xut hin hin tng vn cc do hin tng tch in ca ht
trong qu trnh trn, c th x l bng cch hi tng m ca bt.
Bi 8
SY VT LIU
MC TIU
1. Phn tch c c ch qu trnh sy.
2. Phn bit c cc thng s ca trng thi khng kh m.
3. Phn tch c cn bng vt liu trong qu trnh sy v trng thi cn bng nhit m
ca vt liu.
4. Phn tch c cc giai on ca ng cong sy.
(8.1)
(8.2)
Trong : j Mt dng.
X ng lc ca qu trnh.
L H s ng lc hc, ph thuc vo tnh cht ho l ca vt liu.
ng lc ca qu trnh sy c th l: Gradien hm m, gradien nhit , gradien p sut
ton phn hoc gradien p sut thm thu trong vt liu.
Theo phng trnh (8.2) mun tng cng qu trnh sy c th tng cng h s ng hc
L, hoc tng ng lc X. Thng thng trong qu trnh sy ng lc qu trnh b gii hn bi
iu kin cht lng trong vt liu. V vy mi c gng trong nghin cu u nhm ci thin
h s ng hc. Cng c nhng cng trnh nghin cu nhm tm kim cc gii php k thut,
trong s kt hp tc ng ca cc dng ng lc khc nhau. Ni chung cc cng trnh nghin
cu v sy u hng n cc bin php lm th no cho chi ph t nng lng nht, thu c
cc sn phm cht lng tt nht trong cc thit b c nng sut cao nht.
nh gi hiu qu ca mt thit b sy, ngi dng i lng hiu sut nhit hu ch (k
hiu ) c biu din nh l t s:
Trong :
+ m tng i ca khng kh c tnh bng phn n v hoc bng %.
+ ph p sut ring phn ca hi nc trong khng kh nhit ca hn hp kh.
Thc nghim chng minh rng, trong trng thi cn bng hm m ca vt liu phn b
u theo th tch, lc hm m mi im ca vt liu c gi tr nh nhau v gi l hm m
trung bnh.
8.4. ng hc ca qu trnh sy
8.4.1. Khi nim chung v din tin qu trnh sy
ng hc nhm nghin cu s bin i hm m ( m) v nhit trung bnh ca vt
liu theo thi gian sy, tc l tm
hai hm ny c xc nh bi tnh cht ho l
ca vt liu. Trng hm m v trng nhit c xc nh bi cc quy lut ca truyn
vn m v nhit bn trong vt liu, cng nh s trao i nhit m vi mi trng xung quanh.
S bin i nhit v hm m trung bnh ca vt liu theo thi gian, trc ht c xc
nh bi cc quy lut tc dng tng h gia vt liu vi mi trng xung quanh, tc l s
trao i nhit m vi mi trng bn ngoi.
8.4.2. ng cong sy
Trc ht, cn nm c cc quy lut cn bn ca qu trnh sy vt liu m. Trong qu
trnh sy, vt liu nhn nhit t bn ngoi v thi m ra mi trng xung quanh.
S ph thuc (trn th) gia hm m ca vt liu v thi gian sy c gi l ng
cong sy (hnh 8.4). tm c s ph thuc ny, em vt liu m sy i lu n gin
bng khng kh nng (xem nhit khng kh tk, m khng kh k v tc vk khng i)
v gi s hm m phn b u trong vt liu (lp vt liu mng). Phn tch ng cong sy v
nhn thy din bin ca qu trnh nh sau (hnh 8.4):
sy
Ba giai on chnh hnh thnh lp gi lng trn mt li phn phi c biu din thng
qua tc ch o ca dng kh qua l li phn phi nh sau:
Trong :
S trao i nhit m trong tng l lng ph thuc vo tnh cht vt liu v ch sy.
Trn hnh 8.10 v hnh 8.11 m t s v my sy tng si.
So snh hai loi thit b sy:
T sy i lu, nhit phi thm nhp v hi phi khuch tn qua mt ng dn di.
T sy tng si: Cc ht nh c bao quanh bng khng kh nn nhit phi thm nhp
v hi khuch tn qua mt ng dn nh bng bn knh ca ht nn qu trnh sy nhanh din
ra hn.
Nhit phn b trong sy tng si thp. Sn phm dng sy kh chu mt iu kin nhit
ging nhau nn kt qu sy ng nht.
Trong t sy tng si, vt liu tip xc khng kh sy bao quanh nhit rt thp trong
khong thi gian ngn nn c t s thay i nhng tnh cht l ho ca sn phm, l mt h
thng sy thch hp cho nhng sn phm nhy cm vi nhit. S khuch tn mu, trng hp
chai ho v caramen ho trnh c. y l mt s li ch ln ca tng si.
Glatt
Tit kim lao ng: t sy khay tn cng ri vt liu sy ra cc khay. Sy tng si ton
b vt liu t trong mt thng chnh, tit kim thi gian v lao ng trong np liu v lm
sch.
T sy tng si chim din tch sn bng 1/3 so vi t sy c in v cng mt thi gian
cho nng sut cao gp ba ln.
8.5.3. Sy phun
Sy phun dng sy cc dung dch v huyn ph trong trng thi phn tn. Thit b sy
phun c kt cu tng i phc tp, trong qu trnh sy xy ra rt mnh lit. S trao i
nhit m xy ra ngay trong lng th tch cc git cht lng. Ngha l qu trnh sy thc hin
i vi tng git cht lng phun ra. Do vy sn phm ca sy phun l mt dng bt mn.
CU HI LNG GI
Chn cu tr li sai
1. ng lc ca qu trnh sy phi l:
a) Gradient nhit ;
b) Gradient hm m;
c) Gradient p sut hi m;
d) S ng p ti b mt bc hi ca vt liu.
2. Sy l qu trnh:
a) t nng vt liu;
b) Lm kh vt liu;
c) Tch m bng nhit;
d) b v c ng.
3. C ch ca qu trnh sy bao gm cc qu trnh:
a) Cp nhit cho b mt vt liu;
b) m di chuyn ra b mt vt liu;
c) Nung nng vt liu;
d) Dn nhit t b mt vo bn trong vt liu.
Chn cu tr li ng
4. ng lc ca qu trnh bay hi l:
a) Nhit kh ca tc nhn sy;
b) Nhit t ca khng kh;
c) Nhit im sng;
d) Th sy tk.
5. Hin tng ngng t nc trong phng sn xut l do:
a) Nhit phng qu lnh;
b) m trong phng qu cao;
c) Khng kh m trong phng trng thi qu bo ho;
d) Khng cu no ng.
6. m tng i ca khng kh l:
a) Lng hi nc cha trong mt m3 khng kh m;
b) T s gia m tuyt i v bo ho ca khng kh m;
c) T s gia m tuyt i v lng hi nc bo ho ca trng thi khng kh cng
p sut v nhit ;
d) a v b ng.
7. Hm m ca khng kh l:
a) Lng hi nc cha trong 1kg khng kh m;
b) Lng hi nc cha trong 1kg khng kh;
c) Lng hi nc cha trong 1kg khng kh kh;
d) Lng hi nc cha trong 1kg khng kh kh tuyt i.
8. S dng gin khng kh m, c th xc nh:
a) Hm m ca khng kh;
b) Nhit kh, nhit t ca khng kh;
c) Entanpy ca khng kh trng thi ;
d) Cc thng s trng thi ca khng kh m iu kin th nghim.
9. K thut sy i lu khng tch c m trong vt liu trng thi:
a) Lin kt ho hc;
b) Lin kt ho l;
c) Lin kt c l;
d) Lin kt mao dn.
10. Khi xc nh m cn li ca cm trong qu trnh sn xut vin nn ta dng cch tnh:
a) m vt liu tnh theo phn trm khi lng ca vt liu t;
b) m vt liu tnh theo phn trm khi lng ca vt liu kh tuyt i;
c) m vt liu tnh theo hm m tng i;
d) C th dng c hai cch tnh a v b.
11. tng cng qu trnh sy trong iu kin ng p mt nhit nht nh ta c th:
Bi 9
QU TRNH NN DP VT LIU
MC TIU
1. Phn tch c vai tr cc thng s ca ht vt liu.
2. Trnh by c cc khi nim v hiu ng lc ng dng.
3. Trnh by c nguyn l to ht t v nh hng ca tnh cht ht n qu trnh
nn dp.
4. Trnh by c s thit b nghin cu qu trnh nn dp.
Hin tng ny c nh hng trn mt vi cng on thao tc: S chy ht t phu hay
thit b cp liu, chuyn ng tng i trong my trn hay my dp trong sn xut ht v
vin nn.
Ton b s n nh i vi chuyn ng tng i ca cc ht c th b nh hng bi
hai yu t khc. Th nht: Nhiu loi bt dc phm c s tch tnh in, c bit khi phi
chu ma st bn trong. Th hai: S c mt ca lp m hp th trn ht lm gim nh hng
ca tnh in. Tuy nhin, mng m ny c th hnh thnh cu m gi cc ht li vi nhau bi
hiu qu ca sc cng b mt v p lc mao dn.
9.1.2. Gc ngh (hnh 9.2)
Gc ngh ca bt xc nh theo cng thc:
o tc chy Q ca bt qua mt my o tc
chy hoc mt l trn (v d: mt ci dp vin) gn
trn mt ci gi, th nghim o chy vi nhng
hn hp ht c kch c khc nhau ca cng mt loi
vt liu, sau xc nh c mt t l phn b ht
ti u nu c chy ti a. Khi t l bt mn trong
hn hp vt qu khong 40% s c hin tng tc
chy gim t ngt.
nh gi tc chy ca ht, mt cch n
gin ngi ta p dng khi nim ch s nn (I) tnh
theo cng thc:
Trong :
+ V Th tch chim ch ca mu bt sau khi
chu mt quy trnh g chun ho.
+ V0 Th tch ca mu bt trc khi g.
Gi tr ca I di 15% cho mt c tnh chy tt,
nhng khi ch s khong 25% kh nng chy km.
Trong :
V L th tch ca mu trong iu kin th nghim c th. Th tch tng i gim xung
v hng ti mt khi khong trng b loi khi khi bt. Hin tng ny xy ra trong qu
trnh dp vin.
Cc ch trng hoc l trng trong cc ht to thnh mt mng mao dn tinh vi c tc dng
lm tng tc ht cht lng v lm tng tc tan r cho cc vin nn.
H = Ho H
Khi bin dng nn z c tnh theo cng thc:
Ghi ch: Bin dng n hi l bin dng bin mt sau khi b ti trng gy ra n. i vi
vt rn, bin dng n hi thng l nh v t l vi ng sut t vo n.
V d: Khi nn aspirin, CMC, c ch nn n
hi chim u th.
Trong mt nhm bt khc, khi x nn, qu
trnh phc hi thun nghch khng xy ra ngay
lp tc, khi bt vn gi c trng thi gim th
tch. Bin dng ny c gi l bin dng do
(plastic).
Ghi ch: Bin dng do l bin dng vn cn
li sau khi b ti trng tc dng ln vt th,
hnh thc bin dng do ch yu l hin tng
trt gia cc phn tinh th theo cc mt v
phng nht nh gi l mt v phng trt, do
hnh thnh cc ht block, do mng tinh th b x
lch sau khi bin dng do nn bn v cng
tng ln, do v dai gim i.
Nguyn nhn ca s gim th tch khi ca
vt liu bt l mt s phi hp cc c tnh l ho
ca vt liu. Tt c cc hiu ng bin dng c th
km theo s b gy v hnh thnh lin kt mi
gia cc ht lm tng chc khi cc b mt mi
c p li vi nhau.
S nn gim th tch khi bt ng vo
vin nang cng t c bng cch sp xp li v
c lng bin dng ti thiu.
Trong qu trnh nn dp vin hoc cc k
thut c bit tng t, cc trc nn c nn
cao, v vy thng ng thi xy ra s sp xp
li, bin dng n hi, bin dng do v s gy
dn.
9.3. To ht (Granulation)
9.3.1. To ht m (moist granulation)
Thm cht lng vo khi bt c th c c trng bng mt lot cc giai on (m t bi
Newitt v Conxay Jones, hnh 9.8).
Nu cc ht bt c lm t trong giai on u (a) mng lng s hnh thnh trn b mt
ht v cc ht c th kt hp vi nhau to ra nhng cu cht lng ri rc cc im tip xc,
sc cng b mt v p sut mao dn ring trn nhng cu ni nh vy cung cp mt lc kt t
v a n mt trng thi gi l dao ng (ung a, lc lc) c cng c hc thp.
Khi lng cht lng tng ln mt s cu ni c th hp li lm tng ln mt s cu ni c
th km theo s tng cng lin kt ca cc ht m ln mc va phi (b).
Khi lng cht lng a vo nhiu hn v khi bt c nho trn mang cc ht li
gn nhau hn, cc khong trng khng kh bn trong ht c loi tr ton b, thi im
ny cc cu lin kt l kt qu ca cc lc b mt gia cc ht v p sut mao dn dn m
vo cc khong trng cha cht lng bn trong, trng thi ny gi l trng thi mao dn (c).
Thm tip cht lng s to ra trng thi git (d). Trong trng thi git, cc ht cn dnh vi
nhau bi sc cng b mt nhng khng c lc ni ht, cu trc nh vy l yu. Trng thi
mao dn tng ng vi cng ti a ca ht t v ti u ho, nhiu quy trnh to ht phi
m bo chc chn t c trng thi mao dn.
V d: Mt thit b to ht c th trang b thit
b o momen xon cm nhn c s thay i
trong cng sut khuy trn yu cu trng thi
mao dn.
Trong nhiu cng thc, mt hoc nhiu cu t
ho tan trong cht lng (t dc dnh) to ht t n
to thnh cht dnh khi sy kh, cc cu cht rn
c to thnh trong ht khi cc nguyn liu ho
tan kt tinh hoc kt ta li. Qu trnh ny s lm
tng cng ca ht.
Trong qu trnh sy, s di chuyn ca cc cu
t ho tan ra b mt ht to nn mt b mt ht
khng in hnh c th tr gip hoc ngn cn qu
trnh lm chc ht tip theo. Tc di chuyn ca
thnh phn ho tan c th gim bng cch tng
nht ca cht lng to ht v dng t sy tng si Hnh 9.8. Cc trng thi pht trin ca ht
m
rt ngn thi gian sy ht.
9.3.2. Tnh cht ca ht
Cn phi quan tm n mt s c tnh ca ht
thnh phm v chng nh hng ln tin trnh dp
vin v tnh cht ca vin dp ra. Cc tnh cht
l:
Kh nng sp xp v c tnh chy ca ht.
xp v bn ca ht.
Hnh dng v c ht c vai tr quan trng trong
kh nng sp xp v chy ca ht, cc ht c hnh
dng gn vi hnh cu c gc chy thp hn v t
trng khi cao hn s c tnh chy tt hn. Kt qu
l chnh lch khi lng gia cc vin trong qu
trnh dp vin s nh hn, cc vin s bn chc
hn.
Phn b c ht c xc nh tt nht bng quy
trnh ry th nghim, s phi ch cc c ht theo
mt t l thch hp l kh ni mt cch tng qut,
nhng thng c mt t l ti u cc ht mn cn
thit t c mt s tnh cht chy ti u.
Hnh 9.9. Thit b phn loi c ht,
hiu ERWEKA hiu ERWEKA
S khc nhau gia lc ca hai chy phi c gim n mc ti thiu trong dp vin
thuc khng c s khc nhau ng k trong gi tr nn v lm chc gia vng ny v vng
khc ca vin. Gim hiu ng ma st thnh ci bng cch gim t s chiu cao trn ng
knh vin v thm cht lm trn.
9.3.5. Hiu ng ma st
C hai thnh phn chnh ca lc ma st cn phi xem xt:
Ma st gia cc ht: Pht sinh do tip xc gia cc ht v c th biu din bng thut
ng: H s ma st gia cc ht (I), ma st ny tr nn quan trng hn khi ti trng s dng
mc thp nht. Nhng vt liu lm gim hiu ng ny gi l cht trt. Trong sn xut thuc
vin thng dng colloidial silica (Aerosil).
Ma st thnh ci l kt qu t nguyn liu ang b nn chng li thnh ci v i xung.
N c biu th bng h s ca ma st thnh ci (w). Ma st ny tr nn quan trng nht khi
lc nn cao, khi vic sp xp li cc ht dng li v l mt yu t quan trng trong thao tc
dp vin. a s cc vin cha mt lng nh cc cht t dc trn lm gim ma st vi
thnh ci: magie stearat,...
9.3.6. Phn b lc
a s cc cng trnh nghin cu c bn v dp vin
c tin hnh trn my dp vin 1 chy hoc trn nhng
b chy ci c lp lin kt vi h thng nn thy lc.
Trn hnh 9.11 trnh by s mu ct ngang v
nghin cu dp vin vi lc tc ng t trn nh khi bt
hnh tr. H thng nn n gin ny l mt phng tin
thch hp kim tra qu trnh chi tit hn, chnh xc
hn. m bo mt trc cn bng lc, ta xem xt mi
quan h c bn di y:
FA = FL FD
FA Lc cung cp ln chy trn.
FL Phn lc c truyn xung chy di.
FD Phn lc ca thnh ci do ma st b mt ny.
R H s hiu qu bi trn.
Khi t s t n gi tr cc i (R 1) chng t qu trnh lm trn hon thin (khng c
ma st thnh ci). Trong thc t R 0,98 c th thc hin c. Khi R < 0,8 cho ta thy mt
h thng bi trn km hiu qu.
H s hiu qu bi trn R ch c xem xt trong nhng th nghim c th, bi v chng
b nh hng bi cc bin s khc nh lc nn v t s H / D ca vin.
9.3.8. Lm trn thnh ci
a s cc cng thc vin yu cu
thm t dc trn gim ma st thnh
ci. Chc nng lm trn thnh ci c
thc hin bng cch t mt mng c
cng trt thp gia b mt phn
cch ca khi vin v thnh ci. Cht
lm trn tt nht l nhng cht c
cng trt thp. Cng trt
Nguyn liu
Cng trt
(MPa)
Nguyn liu
Cng trt
(MPa)
Acid stearic
1,32
Natri stearat
3,32
Calci stearat
1,47
Talc xay
6,2
Parafin cng
1,86
7,85
Magie stearat
1,96
Acid boric
7,16
Kali stearat
3,07
Graphit
7,65
tin hnh bng cch t vin ln trn hoc tri chiu vi mt ci e c nh v truyn lc ti
n bng cch nh mt pitton chuyn ng cho n khi vin b nt gy.
b) mi mn
Th nghim cng nhiu khi khng nh gi
c tnh trng tim n ca vin khi x l v ng
gi. mi mn b mt trong nhiu trng hp l
thng s thch hp hn.
Trong th nghim ny, o khi lng mt i
trn mt i tng vin chu mt qu trnh nho
ln c chun ho, ph bin l my th mi
mn.
Ly khong 6,0g vin (Wo) thi bi, cho vo
my, cho my quay 100 vng, ly vin ra cn li
(W), mi mn (F) tnh theo cng thc:
Hnh 9.13. My o cng, hiu
ERWEKA
CU HI LNG GI
* Chn cu tr li sai:
1. Hin tng bt vn cc (cohesion) l do:
a) S tch tnh in gia cc ht;
b) Cc cu m gia cc ht;
c) Nng lng b mt t do ca ht;
d) a, b, c u c th xy ra.
2. Trong sn xut, o gc ngh () ca ht :
a) nh gi s ng nht gia cc l m sn xut;
b) nh gi lc c kt bn trong ca ht;
c) nh gi ma st gia cc ht;
d) bit ma st ca ht.
3. Tc chy ca ht nh hng n:
a) Khi lng trung bnh ca vin;
b) cng ca vin;
c) ng u khi lng vin;
d) mi mn vin.
* Chn cu tr li ng:
4. Xc nh th tch ht c nhi vo ci khi dp vin ta s dng khi nim:
a) Th tch thc ca ht;
c) Th tch ht;
b) Th tch khi;
d) Th tch tng i;
c) T trng ht;
b) T trng khi;
d) T trng tng i;
7. Cu no ng:
a) Bin dng n hi khng bin mt sau khi x nn;
b) Bin dng do l bin dng bin mt sau khi loi b ti trng gy ra n;
c) Bin dng do ging nh bin dng ca l xo hay dy cao su;
d) Bin dng do l bin dng vn cn li sau khi x nn.
8. m ti u cn li trong cm dng cho dp vin l:
a) 0,02%;
c) 2,0%;
b) 5,0%;
d) xp ca ht.
c) Ht rn chc;
b) Ht do;
d) Ht c xp v b v cn thit.
c) cng;
b) tan r;
c) Calci stearat;
b) Magie stearat;
d) Talc.
CHNG 3
CNG NGH BO CH MT S DNG THUC
Bi 10
CNG NGH BO CH VIN NN
MC TIU
1. Phn tch c nhng c im thuc vin nn.
2. Trnh by c nguyn l hot ng ca my dp vin tm sai v my dp vin xoay
trn.
3. Phn tch c cc tnh cht ca ht.
4. Phn tch c cc vn k thut ca cc phng php sn xut vin nn.
5. V v phn tch c s quy trnh sn xut vin nn bng phng phap xt ht t.
10.1.1. Hnh thc cm quan l mi quan tm hng u ca ngi dng thuc, do , cc vin
nn c sn xut quy m cng nghip phi khng c nhng khim khuyt c th quan st
c.
10.1.2. Khi lng trung bnh
Vin nn c thit k c mt khi lng dc cht nht nh trong mt khi lng
vin c tnh ton trc. S kim tra khi lng trung bnh vin l mt bin php gin
tip xc nh hm lng dc cht. Tuy nhin, cch ngoi suy ny ch c th cho kt qu
tin cy khi (a) hot cht chim mt t l ln trong vin v (b) s phn b hot cht trong ht
hoc bt dng dp vin ng nht. Dc in Hoa K cho php dng th nghim ng
nht khi lng ngoi suy hm lng khi hm lng dc cht trn 50mg hoc t l dc
cht trong vin nhiu hn hoc bng 50%.
10.1.3. Hm lng v ng u hm lng
Hm lng trung bnh. Cc Dc in u quy nh gii hn hm lng chp nhn c
ca vin nn quanh gi tr hm lng ghi trn nhn. i vi cc vin cha dc cht hm
lng thp, hm lng dc cht phi trong khong 90 110% so vi hm lng ghi trn
nhn. i vi cc vin c hm lng trung bnh v cao, hm lng dc cht phi trong
khong 95 105% so vi hm lng ghi trn nhn. xc nh hm lng trung bnh, c
mu phi ly ti thiu l 20 vin, tuy nhin trong nhng trng hp vin c hm lng thp
(v d vin Digitoxin), phi ly s vin sao cho tng hm lng t n 5mg v lng mu
cn cho mt ln xc nh phi t n 2mg hot cht.
ng u hm lng. ng u hm lng c xc nh bng cch nh lng
tng vin mt, vi c mu 10 vin. Vin c xem l t ng u v hm lng khi c t
nht 9 vin c hm lng nm trong gii hn cho php v lch chun tng i nh hn
hoc bng 6%. Trng hp khng t c th thc hin thm vi 20 vin v kt qu c xem
l t nu khng c vin no trong s 20 vin th ln hai nm ngoi gii hn cho php v
lch chun tng i tnh trn 30 vin khng qu 7,8%.
t c tiu chun v ng u hm lng, nht l i vi nhng vin c hm
lng nh, quy trnh sn xut phi ht sc n nh sao cho (a) s phn phi dc cht trong
khi ht trc khi dp vin l ng nht, (b) hn hp ht khng b tch lp trong nhng giai
on khc nhau ca quy trnh sn xut v (c) sai s khi lng nm trong gii hn cho php.
10.1.4. cng v mi mn l hai thng s quan trng nh gi bn c hc ca
vin nn. Ch tiu v cng cha c quy nh c th trong cc Dc in, tuy nhin
cng c lin quan cht ch n cht lng ca thuc nh thi gian r v ho tan, nn thng
s ny phi c quan tm ngay t giai on u tin ca qu trnh nghin cu xy dng cng
thc.
Cho n nay c nhiu loi thit b ca nhiu nh sn xut khc nhau c dng trong
cng nghip dc xc nh cng. Cc thit b o cng khc nhau c th c nguyn l
hot ng khc nhau, do , c th cho nhng kt qu khc nhau. n v o cng thay i
theo nh sn xut, cc n v thng dng gm:
1kP (KiloPound) = 1kgf = 9,807N
1 SCU (Strong Cobb Unit) = 0,714kP
mi mn. Cc vin nn thng c khuynh hng mn, m cnh hoc nt khi chu cc
tc ng c hc. Nhng thay i ny lm vin thi bi ra gy nhim cho trong qu trnh sn
xut, ng thi cng nh hng n khi lng vin. mi mn phn trm l mt ch tiu
nhm nh gi kh nng chu va p ca vin trong qu trnh sn xut. Vin nn thng thng
nu c mi mn phn trm n 0,5% hoc n 1% (tu theo quy nh ca nh sn xut) v
khng nt, m cnh, bong mt c xem l t mi mn. Vin nn dng bao phim hoc
bao ng nn c mn thp (t hn 0,2%). Th nghim mi mn thng c tin hnh
trn 10 vin nu vin c khi lng ln hn hoc bng 650mg, i vi vin c khi lng
nh hn 650mg phi ly s vin sao cho tng khi lng t t nht 6,5g.
10.1.5. Thi gian r ( r)
c th hp thu, dc cht phi c ho tan trong dch tiu ho. i vi nhiu thuc
thng thng, vin phi r thnh cc tiu phn nh trc khi c ho tan. Trn thc t, kh
c th xc lp c mi tng quan gia thi gian r v ho tan, tuy nhin s r l giai
on gii hn tc ho tan, nht l i vi nhng dc cht kh tan trong nc. V vy,
mc d hin nay Dc in dn dn thay th th nghim r bng th nghim ho tan,
nhng th nghim xc nh thi gian r vn l mt ch tiu cn c quan tm trong nghin
cu nhm xy dng cng thc ti u nht, ng thi l mt phng tin nh gi quy trnh
sn xut thuc, m bo ng nht ll.
10.1.6. ho tan
Cc vin nn dng ng ung phi ho tan dc cht trong dch tiu ho c th c
hp thu.
Mc tiu chnh ca th nghim ho tan trong sn xut l chng minh (a) dng thuc c
th phng thch c gn 100% dc cht ra khi dng thuc v (b) tc ho tan dc cht
ng nht t cc l khc nhau trong qu trnh sn xut v tc ho tan ny tng t nh tc
ho tan ca l thuc dng trong nghin cu tng ng sinh hc v th nghim lm
sng.
10.1.7. n nh
Ngoi cc th nghim c quy nh trong Dc in, nh sn xut cn phi chng minh
n nh ca ch phm, hn dng ca sn phm phi c xc nh cn c vo th nghim
n nh y v ng quy nh v s lng l, c l, thi im ly mu, thi gian th
nghim n nh ca ch phm phi c chng minh bng s n nh ca dc cht v
n nh v cc ch tiu vt l ca dng thuc nh cm quan, thi gian r, ho tan
Khi kim tra cc ch tiu k thut, cc vin trong cng mt l thng c ly kim
tra. Tuy nhin, m bo mt quy trnh sn xut c tnh n nh v cho ra nhng sn phm
c cng mt cht lng v cht lng phi duy tr n hn dng d kin cn phi quan tm
n cc vn sau:
ng u gia cc sn phm trong cng mt l.
n nh gia cc l sn xut.
Hn dng.
Bao b, ch bo qun v vn chuyn.
Glucose (Dextrose). C v ngt v d tan nn thch hp cho vin nhai hoc vin ho tan
trc khi ung, thng c dng nh t dc n v dnh trong phng php dp thng
hoc xt ht.
Mannitol. Thch hp cho vin nhai v ngm do li cm gic mt lnh khi tan
ming. Lu tnh ca mannitol rt km, nn nu dng cho phng php dp thng phi thm
nhiu t dc trn bng. Trn th trng cng c loi mannitol dp thng, c ch to bng
phng php kt tinh c bit, mannitol thch hp vi cc dc cht d h bi m,
RH=90%, mannitol ch ht m khong 1%.
Sorbitol l ng phn quang hc ca mannitol, ht m rt mnh nu hm m tng i
ca mi trng 65%.
Tinh bt: c dng lm t dc n, r v dnh. Vin nn c s dng nhiu tinh bt c
khuynh hng mm v kh sy ht. Hm m trung bnh ca tinh bt trong khong 11 14%,
mt s tinh bt sy c bit c hm m 2 4%, khng nn dng tinh bt loi sy c bit
lm t dc trong phng php xt ht t do cc k thut sy thng thng ch c th lm
cho ht t hm m trong khong 68%.
Mc d c m cao (1114%), tinh bt li c tc dng nh mt cht ht m n nh
cc dc cht nhy cm vi m.
Tinh bt dp thng c bn vi tn thng mi l Starch 1500 l loi tinh bt c tnh
trn chy tt v c tnh chu nn cao. Tinh bt 1500 c dng nh t dc n trong vin
nn dp thng, t dc r, ng thi c th c dng nh t dc trn nu dng t l cao
hn 10% trong vin nn.
Cellulose vi tinh th, tn thng mi l Avicel, l mt loi t dc n kh t nn t khi
c dng ring m thng phi hp vi cc t dc khc ci thin tnh cht ca vin. C
nhiu loi Avicel khc nhau dng cho nhng phng php dp vin khc nhau: Avicel PH
101 dng cho phng php xt ht t, Avicel PH 102 dng cho phng php dp thng v
xt ht kh Avicel cn c dng nh t dc dnh v t dc r.
Vin nn c Avicel hm lng cao c th b mm khi bo qun mi trng c m
cao.
Dicalci phosphat. C hai dng dicalci phosphat khan v ngm nc u c tnh chu nn
rt tt, gi r nn c s dng nhiu. Vin iu ch bng t dc n ny thng r km,
nn thng phi phi hp vi cc t dc r mnh.
Tricalci phosphat l hn hp ca tricalci ortho phosphat v calci phosphat, cng dng
ca cht ny tng t nh dicalci phosphat, thng dng trong vin nn cha vitamin v
nguyn t vi lng v va cung cp calci va c tc dng nh t dc n.
Magie carbonat c s dng lm t dc n trong vin nn dp thng. T dc ny
c tnh thm ht mnh nn thch hp cho vin nn cha cc cht lng nh tinh du, cao dc
liu.
Cc t dc n khc: Magie oxyd, calci lactat tribasic.
d) T dc dnh
Gip cho cc tiu phn rn lin kt li vi nhau to thnh ht hoc vin c cng thch
hp. T dc dnh c th c dng di dng bt mn hoc pha thnh dung dch hoc hn
dch. Dng dng ph thuc vo phng php sn xut c p dng v tnh cht l ho ca
dc cht. T l s dng ph thuc vo tnh cht ca dc cht, phng php xt ht v tnh
cht ca my dp vin.
Mt s t dc dnh thng dng:
Gm Arabic dng di dng bt mn t l 2 3%, hoc dng di dng dch th 10
30%. Gm Arabic cho vin c cng ln, kh r, nn thng phi phi hp vi t dc
dnh khc.
H tinh bt dng dng dch th 5 10%.
Tinh bt tin gelatin ho dng dng bt mn trong phng php dp thng hoc dng
dch th trong cc phng php xt ht.
Acid alginic dng dng bt t l 1 5%, cn dng lm t dc r vi t l tng t.
Gelatin c dng di dng dung dch 3 20%, cn cho thm cht bo qun nh
nipagin, nipasol, natri benzoat. Gelatin c tnh dnh tt nhng lm vin kh r.
Glucose c dng di dng bt mn trong phng php dp thng.
Methyl cellulose (Tylose) dng dng bt mn hoc dung dch trong cn.
CMC hoc Na CMC thng dng dng dung dch trong phng php xt ht t.
Cellulose vi tinh th (Avicel) l t dc dnh rt tt dng cho vin nn dp thng v xt
ht kh.
Polyme acrylate: loi thng s dng nht trong nhm lm t dc dnh l Eudragit
E c dng dng dung dch 5 20% trong cn.
Polyvinyl pyrrolidon (PVP) dng dng dung dch 5 10% trong cn hoc hn hp cn
nc.
PEG 4000 hoc PEG 6000 dng dng dung dch trong cn hoc nc.
Cc t dc dnh c ngun gc t nhin (h tinh bt, gm arabic, gelatin) thng khng
n nh v cht lng gy kh khn cho qu trnh sn xut v nh hng n cht lng vin
nn hin nay t c dng.
e) T dc r
Cc loi t dc r ph bin hin nay l:
Tinh bt cc loi (ng, sn, khoai ty, la m).
Sodium starch glycolat (Explotab, Primogel, DST).
Tinh bt bin tnh.
Tinh bt bp bin tnh (Starch 1500).
Algins (natri alginat)
T dc r thng c trn chung vi cc thnh phn khc trc khi xt ht (t dc r
ni). Tuy nhin t dc r c th cho thm sau khi xt ht (t dc r ngoi) gip cho vin
nn r d dng hn khi tip xc vi dch tiu ho hoc mi trng th, hoc c th chia t
R tin.
Khng c.
C bn c hc cao.
Khng thm m hoc thm m mt mc chp nhn c.
Khng tng tc, khng nh mi, khng nh mu, khng hp ph mi ca thuc.
D nh hnh trong cc my p v.
D in ch hoc cc logo.
Ph hp vi cc my ng bao b, t l loi thp.
D m v d ng (chai l), c kh nng ngn nga tr em.
D sn xut v d bo qun (chng c nhim bn v vi sinh vt).
Cc loi nguyn liu dng ch to bao b vin nn bao gm: Giy, carton, thu tinh, kim
loi, nhm l, bng, cc loi nha.
k) Nguyn liu lm chai ng thuc vin
Thu tinh. Nguyn liu c ngun gc v c, khng thm m v kh. Hu nh khng tng
tc vi bt k nguyn liu no. Thu tinh mu h phch c kh nng chng nh sng.
HDPE (High density polyethylen) v PE (Polyethylen): Nh, d bo qun, vn chuyn.
Kh nng chng m ca nha polyethylen rt km.
l) Nguyn liu lm v bm
Lp v trn
PVC (Polyvinyl clorid): Nhit nh hnh trong khong 120 140oC, thch hp cho tt
c cc my p v. Kh nng chng m km.
PP (Polypropylen): Nhit nh hnh trong khong 140 150oC, i hi my p v phi
gia nhit nhit cao v chnh xc, c hin tng co ko lm nhn v ngay sau khi to hnh.
Chng m tt v khng sinh clo khi t, c s dng nhiu chu u.
PVC trng PVDC (Polyvinyliden clorid): Kh nng chng thm m cao, PVDC c
trng mt trong (mt tip xc vi thuc).
PET (Polyethylen terephtalate) v PS (Polystyren): To hnh rt d nhng kh nng chng
m rt km.
Bng 10.1. Tnh thm m ca mt s plastic
Loi plastic
Tc thm m
2
(g/ 100 inch / 24 gi)
HDPE
0,3
LDPE
1,3 1,5
PP
0,7
PS
7 10
PVDC
0,2 0,6
PVC
2,0 5,0
Mt lng. Thng lm bng giy nhm, giy nhm trng PET hoc giy trng nhm v
PET. Tnh chng m tu thuc vo dy ca mng nhm, mng nhm dy t 25m tr ln
hu nh khng thm m.
m) Nguyn liu lm v x
Nguyn liu lm v x c th l plastic hoc giy nhm trng plastic tu thuc vo yu cu
chng m ca ch phm. V x thch hp cho vin c kch thc ln hoc vin cn chng m
tt.
10.3. Yu cu cn bn trong sn xut vin nn
10.3.1. Quy trnh sn xut
Cng thc v quy trnh sn xut phi c tnh kh thi, ph hp vi iu kin trang thit b
ca c s sn xut. Cn phi c s phi hp cht ch gia cc nh nghin cu xy dng cng
thc v nhn vin cc b phn sn xut. Yu cu ny rt quan trng khi xy dng mt quy
trnh sn xut vi mt thit b mi hoc s dng t dc mi.
10.3.2. Thit b
La chn ng thit b, vn hnh thit b thnh tho, bo qun thit b tt l mt yu cu
quan trng cn phi quan tm ngay t khi xy dng quy trnh sn xut. Ngi tham gia vo
dy chuyn sn xut khng nhng phi am hiu v thit b chu trch nhim chnh m cn
phi c nhng hiu bit nht nh v nhng trang thit b phi dng trong quy trnh sn xut.
10.3.3. Nh xng
Nh xng phi c xy dng theo nhng yu cu ca GMP. Din tch xy dng phi
ph hp cho tng cng on ca quy trnh. Vt liu xy dng phi khng c hp ph, nh
mi hoc c th phn ng vi nguyn liu.
Khi thit k tng th v cc b phn trong phn xng thuc vin nn phi lun lun ch
chiu di chuyn ca nguyn vt liu v phi kim sot c s nhim cho. Mc tiu quan
trng nht l c s cch ly gia cc sn phm ang trong giai on bit tr v sn phm
khng t tiu chun. Tu thuc din tch sn c v nhu cu sn xut c th thit k khu vc
sn xut theo cc m hnh sau:
a) Khu vc sn xut bao quanh kho trung tm (perimeter manufacturing center
warehouse)
Hnh 10.1. S thit k theo m hnh Khu vc sn xut bao quanh kho.
(1) Vn phng; (2) Phng tip nhn nguyn liu; (3) Bit tr nguyn liu; (4) Phng bao vin;
(5) Khu vc nn vin; (6) Khu vc xt ht; (7) Kho cha nguyn liu c chp nhn;
(8) Phng cha sn phm bit tr; (9) Kho cha sn phm c c duyt;
(10) Cp pht nguyn liu; (11) Khu vc sn xut thuc dng lng hoc bn rn; (12) Khu vc ng
gi;
(13) Phng in v cp pht nhn; (14) Khu vc giao thnh phm.
Theo thit k ny, khu vc cha nguyn liu v ph liu duyt pht v khu vc cp
pht c b tr nm hn v mt khu vc c ngn cch vi khu sn xut, bit tr thnh
phm, kho bn thnh phm v ng gi bi mt hnh lang. ng di chuyn ca nguyn vt
liu tng t nh m hnh kho trung tm. Tuy nhin, nguyn vt liu ch di chuyn theo mt
chiu, nn hn ch c s nhim cho hoc nhm ln.
c) Di chuyn theo ng thng (straight line flow)
Nguyn vt liu c di chuyn theo ng thng. S nhim cho trong trng hp ny
c hn ch n mc ti thiu. Thit k ny c nhc im l cn nhiu din tch.
Mt trong nhng vn phi quan tm hng u trong thit k c s sn xut dng phn
liu rn l h thng x l khng kh. C s phi c thit k sao cho khng kh trc khi vo
cc phn xng phi qua h thng lc, n cc khu vc vi cc p sut khc nhau sau
c lun chuyn tun hon ra khi phn xng.
Khu vc cn v cp pht nguyn liu phi l khu vc kn c nhng trm hoc bung cn
ring bit thao tc cn v ly mu c th c tin hnh trong cng mt thi im. Khu
vc ny c th c thit k vi nhng lung khng kh tri thnh lp mng di chuyn theo
chiu ngang hoc c cc thit b thu ht bi. Khng kh cung cp cho khu vc ny phi c
lc qua h thng lc HEPA.
Khi thit k khu vc xt ht phi quan tm n lung di chuyn ca nguyn liu. Khi
nguyn liu di chuyn d dng vo cc khu vc ch bin th kh nng nhim s gim. Thng
thng p sut trong khu vc trn v xt ht phi thp hn hnh lang pha ngoi trnh bi
thuc thot ra hnh lang.
Mi my dp vin phi c t trong mt phng ring. Phng cha my dp vin c th
c kch thc khc nhau ph hp vi kch c ca my dp vin. Nu c th, my dp vin nn
c t trn mt k kim loi chc chn, k ny c th di chuyn d dng bng xe nng dng
in a n khu vc v sinh my v thay chy ci (thay v v sinh v lp rp chy ci ti
phng dp vin). Cc phng cha my dp vin nn c p sut thp hn p sut hnh lang
trnh bi thot ra hnh lang gy nhim bi sang cc phng khc khi m ca phng dp vin.
Phng dp vin cn m thp phi c xy dng bng vt liu c tnh thm m rt thp v
nn c cht gi (airlock). Khng kh cung cp cho cc phng ny phi c lc s b ngay ti
thit b thu ht bi v c lc, sau qua h thng lc HEPA.
m v nhit trong khu vc sn xut vin nn phi c duy tr va bo m
nguyn liu v ch phm khng b hng, ng thi phi to cm gic d chu cho cng nhn
tham gia v dy chuyn sn xut. Ngoi tr nhng trng hp c bit, phng dp vin v
bao vin nn c duy tr nhit 25oC v m tng i khong 45%.
10.3.4. Nhn s
(1) Phu tip liu np cm vo ci; (2) Phu tip liu li ra sau gt ht tha;
(3) Nn vin; (4) Chy di a vin ln mt ci;
(5) Phu tip liu i ti y vin ra v np ht cho chu k tip theo
li.
10.5.4. bn v xp
bn v xp ca ht l yu t quan trng nh hng n:
Phn b c ht.
Kh nng nn ht dnh vo nhau: ht qu cng s kh dp vin.
10.5.5. Tnh chy ( trn chy lu tnh)
c tnh chy ca dng tiu phn cht rn chu tc ng lc ma st, sc cng b mt, lc
c hc gy ra bi s ci vo nhau gia cc ht c gc cnh khc nhau, lc tnh in, lc dnh
hoc lc Van der Waals
Tt c cc lc ny c th nh hng ln tnh cht chy ca ht. Chng cn c th nh
hng ln cc tnh cht khc ca ht:
C ht v phn b c ht.
Hnh dng ht.
Kt cu ht hoc th ca ht.
Nng lng b mt.
Din tch b mt.
Vi bt mn ( 150m) lc ma st v lc Van der Waals chim u th.
Vi ht ( 150m) c sn xut bng phng php xt ht t, lc ma st thng
chim u th hn lc Van Der Waals.
Khi kch thc ca ht tng ln cc tnh cht vt l, tnh cht c hc v s sp xp ca
chng thay i theo.
10.5.6. Gc ngh
Phng php xc nh gc ngh l phng php n gin nh gi lu tnh mt cch
gin tip. thu c kt qu tng i n nh cn chun ho thao tc ht. Ht c
qua mt phu gn c nh. o ng knh v chiu cao ca khi ht hnh chp t tnh
c gc
Kch thc tiu phn dc cht. tng tc ho tan v tng sinh kh dng ca thuc
vin nn, nhiu dc cht c sn xut di dng bt siu mn, cc loai dc cht ny c
tnh chu nn v lu tnh rt km do ma st gia cc tiu phn ln.
Tuy nhin, dc cht c nghin mn li gip cho s trn u d dng hn trong trng
hp iu ch cc vin c hm lng nh.
Rt kh phi hp ng u cc cht mu trong phng php dp trc tip, khc phc
c th dng mu khng tan c nghin n dng siu mn.
Do c nhiu cht rn di dng ht mn nn thng phi dng nhiu t dc trn hn cc
phng php xt ht. Cn xc nh c th loi t dc trn, t l s dng v thi gian trn. S
dng t t dc trn s lm vin c sai s hm lng v khi lng, nhiu t dc trn lm
vin c khuynh hung mm. Ch nn trn trong thi gian khong 3 5 pht v nn trn sau
khi trn tt c cc thnh phn khc.
Dc cht dp thng. Cc dc cht dp thng c sn xut nhm ci thin lu tnh v
tnh chu nn ca dc cht. Cc dc cht dp thng c cung cp di hai dng:
Dng kt tinh tinh th ln. Mt vi dc cht c th c kt tinh dng tinh th ln v
c th dng dp thng nh Vitamin C, Aspirin
Dc cht c xt ht sn. Dc cht kt tinh dng Otinh th ln c khuynh hng
dn nn tnh chu nn khng cao, khc phc mt s nh sn xut cung cp nguyn liu
di dng c xt ht sn nh:
C 90 (Roche): Vitamin C xt ht sn vi 10% tinh bt.
C 95 (Roche): Vitamin C xt ht sn vi 5% methyl cellulose.
C 97 (Takeda): Vitamin C xt ht sn ch cha khong 3% t dc.
Acetaminophen dp thng (Cornpap): hm lng 90%, c tnh chu nn v lu tnh cao.
Ibuprofen dp thng (Mallinckrodt): hm lng 63%.
T dc dng trong phng php dp thng phi l loi t dc a chc nng, t nht phi
bao gm chc nng chnh l n, dnh, r... mt s t dc dp thng cn c thm chc nng
trn nh tinh bt 1500.
Tn thng mi
Lactose
Emcocel
Calci sulfat
Delaflo
Saccharose
Dipac
Dicalci phosphat
Di Tab, Emcompress
Sorbitol
Tricalciphosphat
Tritab
Lactose phun sy
Giai on trn t
Cc my dng trn t dc dnh vo khi bt phi c kh nng trn mnh nh my
trn hnh tinh, my trn Z.
Giai on xt ht: Khi m c th c to ht bng my xt ht u a hoc my p n
(extruder).
Nguyn l hot ng ca my xt ht u a l p khi bt m qua mt li to thnh
cc ht c kch thc tng i bng nhau v c xp cao.
My p n to ra cc si cm ngn, do lc p mnh nn si cm t c xp, ht to
thnh sau giai on sy s cng hn ht c iu ch bng my xt ht u a.
Giai on sy
Ht c th c sy bng t sy c dng kh i lu hoc bng my sy tng si. Hin
nay my sy tng si c ng dng nhiu do kh nng sy cao, gim c thi gian sy nn
c th tng nng sut v hn ch c h hng dc cht.
Giai on ry sa ht
Bng phng php to ht tng si, kch thc ca ht c kim sot d dng nn c th
khng cn phi qua giai on sa ht.
10.7. Kim tra kim sot trong qu trnh sn xut vin nn
Cng vi nhng quy nh ca GMP, s thm nh quy trnh sn xut vin nn phi c
thc hin nhm m bo quy trnh sn xut n nh, m bo thnh phm v cc bn thnh
phm ca tng giai on sn xut t cc tiu chun cht lng nh d kin. S thm nh
quy trnh sn xut vin nn gm cc mc tiu chnh l thit lp qun l h s, cc kim tra
kim sot trong qu trnh sn xut v kim nghim thnh phm.
S thm nh quy trnh phi c cp n ngay t giai on nghin cu xy dng cng
thc (giai on RvD) v phi c thc hin tt giai on sn xut trn quy m cng
nghip.
Theo FDA, s m bo cht lng ca sn phm bt ngun t cc kim sot cht lng
thn trng v c h thng tt c cc giai on ch yu ca quy trnh sn xut bao gm: la
chn nguyn liu, xy dng v thit k m hnh sn xut, thc hin cc kim tra kim sot
trong qu trnh sn xut v kim tra cht lng sn phm.
Trc khi dp vin, nhn vin m bo cht lng phi tin hnh kim tra tnh trng v
sinh v nhn ca cc thng nguyn liu, cc thit b dng trong dy chuyn sn xut phi
trong tnh trng v sinh sch s v c phiu ghi tn sn phm, hm lung v s l ca sn
phm s tin hnh.
Khi bt u dp vin tin hnh hiu chnh my c th dp c vin t nhng tiu
chun cht lng nh d kin trn cc ch tiu cm quan, khi lng trung bnh, cng,
mi mn v thi gian r. Cc vin c dp trong giai on hiu chnh my phi c
ring v tiu hu.
Trong giai on dp vin cc ch tiu vt l ca vin nh hnh dng cm quan, mu, mi,
dy, ng knh, mi mn, cng, sai s khi lng v thi gian r s thng xuyn
c kim tra v ghi thnh h s. Cc th nghim kim tra trong qu trnh dp vin nhm
pht hin nhng s c xy ra trong qu trnh dp vin. Nguyn nhn ca nhng s c thng
Vin dnh chy hoc my kh y vin ra do nguyn nhn chnh l thiu t dc trn, c
th khc phc bng cch:
Thm t dc trn.
Dng t dc trn hu hiu hn (v d Aerosil).
Ry t dc trn qua ry mn trc v trn t dc trn vi mt t bt mn trc khi
trn vo khi ht.
Gim kch thc ca ht.
Tng hm m ca khi ht.
Cc t dc trn bng nng chy nhit cao cng l mt nguyn nhn gy dnh vin
vo chy, trong trng hp ny phng dp vin phi c nhit thp v nn vn hnh my
tc chm.
10.8.3. Vin t chm hoc bong mt
t chm l hin tng phn trn ca vin b t ri ra ngay sau khi dp. Nguyn nhn
thng do khi khng kh trong ht b nn mnh nhng khng thot ra c v to thnh mt
lp m khng kh, lp m ny trng n nhanh thi k gii nn. Hin tng ny thng
gp khi khi ht c qu nhiu bt mn hoc khong cch gia chy v ci qu nh (chy v
ci mi a vo s dng).
Cc nguyn nhn khc c th gy nn hin tng t chm l do thiu t dc trn hoc
hm m ca ht qu cao.
Bong mt l hin tng mt phn trn ca vin b tch ri ra, s bong mt c th xy ra
do cc nguyn nhn ging nh trng hp t chm. khc phc s c t chm c th:
Thay i quy trnh xt ht.
Tng lng t dc dnh.
Thm t dc dnh kh nh tinh bt tin gelatin ho, PVP, gm arabic
Thay i t l (tng hoc gim) hoc thay t dc trn bng.
10.8.4. Vin m cnh, nt
Vin m cnh c th do chy qu mn nn vin b m quanh g vin (cnh vin khng
sc) hoc do vin cha ln khi mt ci b ht ra khi my (do phu tip liu ca my dp
vin tm sai hoc thanh gt trn my xoay trn).
Nt vin l hin tng vin b nt ngang trn b mt vin, nguyn nhn thng do vin
dn n mnh thi k gii nn.
Cc bin php sau y c th p dng trnh hin tng nt vin hoc m cnh:
Sa li mt chy.
Gim lng bt mn trong khi ht.
Gim kch thc ht.
Thay chy b mn qu nhiu.
b) 20 vin;
c) 30 vin;
d) 40 vin;
e) 50 vin.
d) 30 pht.
b) Hm m;
d) Kch thc ht v phn b kch thc ht;
e) Mu, mi, v.
5. Bin php no tt nht nn p dng lm tng sinh kh dng ca thuc vin nn cha
dc cht kh tan:
a) Dng t dc siu r;
b) Nghin dc cht n dng siu mn;
c) Nn vin n cng va phi;
d) Chia lng t dc r thnh hai phn khi phi hp;
e) Khng c bin php no ph hp.
6. Nguyn nhn c th gy nn cng khng ng u ca cc vin trong cng mt l:
a) Lng t c dnh s dng qu nhiu;
b) Phn tn t dc dnh khng u;
c) Sau khi ti t dc dnh, thi gian nho trn qu di;
d) T dc dnh c kh nng kt dnh qu cao;
e) Khng cu no ng.
7. Tnh cht no ca ht cn thit cho vin c cng cao:
a) Phn b kch thc ht khng qu rng;
b) Ht phi cng;
c) Ht phi c th bin dng c khi c mt lc nn tc ng;
d) Ht c m trong phm vi cho php.
8. Tnh cht no ca ht gip cho vin t ng u khi lng
a) Phn b kch thc ht khng qu rng;
b) Ht phi cng;
c) Ht phi c th bin dng c khi c mt lc nn tc ng;
c) Chiu di chy;
d) Chiu di u dp.
Bi 11
CNG NGH BO CH VIN BAO
MC TIU
Nu c mc ch bao vin.
K c cc giai on ca quy trnh bao ng.
Nu c c im k thut trong sn xut vin bao ng.
Nu c cc s c k thut lin quan n vin bao ng v cch khc phc.
Chn c cc cht bao thch hp iu ch vin bao bo v, bao tan trong rut.
Nu c u, nhc im ca cc thit b dng trong bao phim vin nn.
Phn tch c cc nguyn nhn v cch khc phc cc s c lin quan n k thut
bao phim vin nn.
Ci thin sinh kh dng vin nn bng cch iu chnh v tr tc ng (vin bao tan
trong rut), iu chnh tc phng thch dc cht (vin phng thch ko di)
Trong cng ngh sn xut dc phm c bn k thut cn bn c s dng to mng
bao l: bao ng, bao phim, vi nang ho v bao dp.
Trong phm vi chng ny ch cp n hai k thut thng dng nht l bao ng v
bao phim.
11.2. Sn xut vin bao ng
Cng ngh bao ng c s dng t rt lu trong cng nghip thc phm v l cng
ngh bao vin kinh in nht trong sn xut dc phm.
Mc d c nhiu n lc nhm ci tin v t ng ho thit b, tuy nhin cht lng
vin bao ng vn ph thuc rt ln vo tay ngh v s kho lo ca ngi thc hin quy
trnh bao, nn nhiu nh sn xut vn xem bao ng l mt ngh thut hn l mt k thut.
Vi s pht trin mnh m ca k thut bao phim, bao ng ngy cng t c quan tm
nhng nhiu nh sn xut trn th gii vn duy tr vin bao ng v nhiu l do:
Bao ng s dng cc nguyn liu r tin, d kim v cht lng n nh.
Thit b n gin, d lp t, d vn hnh.
Quy trnh bao ng thng khng qu phc tp v khng phi kim tra cht ch cc
thng s nh trong quy trnh bao phim.
Tuy nhin quy trnh bao ng c vi nhc im:
Kch thc v khi lng ca vin c th tng n 50100% nn khng ph hp i vi
vin nhn c hm lng hot cht cao hoc c khi lng ln.
Lp bao ng kh dn nn d b m nu bo qun v vn chuyn khng thch hp.
Quy trnh bao kh t ng ho, ph thuc phn ln vo k nng ca ngi thc hin
quy trnh bao.
11.2.1. Nguyn liu dng sn xut vin bao ng
Cc loi ng:
ng saccharose l nguyn liu chnh trong sn xut vin bao ng. ng saccharose
rt t ht m v l nguyn liu rt d tan trong nc, cho dung dch c nng rt cao. tan
ca ng saccharose tng theo nhit . nht ca ng gim nhit cao. Sir ng
nng t 65% hoc thp hn khng b kt tinh nhit thng. Dung dch ng
nng trong khong 50 60% ( nht thp hn 2 poise) c xem l ph hp nht khi bao
bng sir ngui.
ng saccharose c th b thu phn thnh cc ng nghch chuyn l glucose v
fructose. S thy phn xy ra nhanh khi c cc iu kin thun li sau:
Nhit cao.
pH nh hn 6,0.
Bao phim l qu trnh ph mt lp mng mng ln cht rn. Lp bao trn cc sn phm
bao phim thng rt mng ch vo khong 10200 m. Cc cht rn c th l cc vin nn, vi
ht, cm hoc cc tinh th dc cht.
u im ca quy trnh bao phim:
So vi vin bao ng, lp bao phim thng rt mng khong 10100m, nn khi
lng vin ch tng khong 25%.
Thi gian bao nhanh hn.
Hiu qu v nng sut cao hn.
C th s dng cc cng thc bao v quy trnh bao ph hp ci thin sinh kh dng
ca thuc.
Quy trnh c th t ng ho d dng.
L phng thc thch hp iu ch vin tan trong rut, vin tc dng ko di.
Quy trnh bao phim c th c thc hin bng phng php ti hoc phun, hin nay ch
p dng phng php phun dch bao.
11.3.1. C ch to thnh mng phim
Trong phng php phun, cc cht bao to thnh nhng git t rt nh, cc git cht bao
thm t b mt vin v kt t li thnh lp phim khi dung mi bay hi. Trong k thut bao
phim cn iu chnh cc thng s sao cho t c cn bng gia tc phun dch bao v
quy trnh sy cc git cht bao c th kh ngay sau khi thm t b mt vin.
Do s bay hi dung mi xy ra nhanh chng ngay khi cc git cht bao bm u vo vin,
nn s phn b cht bao va ph thuc vo s o trn ca ni va ph thuc vo cch phun
dch bao ng nht hay khng. Trong bao ng s phn b cht bao ch ph thuc ch yu
vo s o trn dch bao chuyn t vin t sang vin kh cho n khi c khi vin t
u, nn khng cn thit tt c cc vin nhn phi di chuyn qua vng ti dch bao. Trong
bao phim, s sy kh phi vin kh ngay, nu c s di chuyn dch bao cha kh t
vin ny sang vin khc s gy nn hin tng vin b lc v cam hoc r mt, nn cn thit
tt c cc vin nhn phi di chuyn ngang qua vng phun dch bao.
Cc quy trnh bao phim thng c xem l quy trnh lin tc, do cht bao c phun lin
tc t khi bt u cho n khi kt thc. Tuy nhin, y l mt quy trnh gin on, bi v ch
c mt phn ca khi vin nhn di chuyn ngang qua vng phun dch bao, tip sau l giai
on sy vin trc khi vin di chuyn n vng phun.
Bao phim bng dung dch polyme l phng php c ng dng t rt lu. Cc
polyme c ho tan trong dung mi hu c nh aceton, isopropanol, cn, methyl chlorid.
Qu trnh hnh thnh lp phim t dung dch polyme ph thuc rt ln vo tc bay hi
ca dung mi. Hai yu t chnh nh hng n tc bay hi ca dung mi l nhit ho hi
ca dung mi v iu kin sy ca quy trnh bao. Qu trnh bay hi ca dung mi xy ra ngay
t khi git cht lng ra khi u phun dch bao, git cht lng s co th tch ngay trc khi
tip xc vi vin v nht ca dung dch polyme s tng ln. Khi tip xc vi vin, dung
mi tip tc bay hi vi tc chm hn, c kim sot bi s khuch tn ca dung mi
qua mng polyme, cc phn t polyme sp xp li vi nhau ti im ho rn. Sau khi hon tt
m bao, dung mi vn tip tc bay hi vi tc chm trong mt khong thi gian di. Tc
H thng cung cp kh nn c th cho dy phun nhiu kiu khc nhau t hnh trn cho n
oval dy phun c th m rng v ph ln chiu ngang ca khi vin ang chuyn ng.
Cn rt thn trng khi iu chnh lung kh nn, nu lung kh nn qu mnh c th lm ri
lon chuyn ng ca khi vin hoc gy ra hin tng phun sy i vi git dch bao (dch
bao kh trc khi chm vo vin nhn). Trong trng hp cn c dy phun vt qu gii hn
iu chnh ca h thng, cn phi s dng nhiu sng phun t song song.
H thng phun khng dng kh thng c dy phun rng hn h thng dng kh nn;
ph chiu ngang mt khi vin ang chuyn ng trong ni bao vi kch thc 120cm c th
dng hai sng phun khng dng kh nn, nhng phi dng n 3 4 sng phun dng kh nn.
quy m sn xut ln, c hai loi sng phun u c th c s dng mt cch hiu qu,
tu thuc vo cng thc dch bao v tng sn phm c th.
H thng phun dch bao dng kh nn c s dng ph bin quy m nh v c th iu
chnh c tc phun v mc phun mt cch chnh xc, h thng ny cng rt thch hp
khi bao vi dung mi l nc.
11.3.3. Nguyn liu bao phim
Dch bao phim gm bn thnh phn chnh: polyme (cht to phim), cht ho do, cht
mu v dung mi. bao phim trong sut, c th khng s dng cht mu hoc cht to
c. Trong mt s trng hp cn thit c th s dng thm cc cht ph gia khc nh: mi
thm, cht din hot, cht lm bng v cht ph bt.
Nguyn liu bao phim l tng phi c cc tnh cht sau:
Tan c trong dung mi dng pha dch bao, trong trng hp khng tan c th cht
bao phi d dng phn tn thnh dng hn dch mn, c lng tht chm.
bn c hc
Tng
Gim
Tng
(a)
(b)
Hnh 11.11. Vin phng thch dc cht ko di bng p sut thm thu
(a) nh chp b mt; (b) nh chp mt ct
Cht ho do
Khi nim v trng thi knh v nhit ho knh. Hu ht cc polyme dng bao phim l
cc cht v nh hnh, khi nhit polyme b h thp n mt nhit ti hn gi l nhit
ho knh (Glass transition temperature Tg) th polyme s c mt s thay i ng k v tnh
cht, do s chuyn ng tng i ca cc phn t polyme b ngng li. Khi polyme cn
c cung cp nng lng tr v trng thi bnh thng, nu nng lng nhit cung cp
khng , nhit ca polyme thp hn Tg, polyme s th hin tnh cht ca knh: cng v
dn.
Do nhit ho knh ca hu ht cc polyme u cao hn nhit sy p dng trong cc
quy trnh bao, nn cn thit phi thay i nhit ho knh ca cc polyme. S dng cht ho
do l phng php hu hiu nht iu chnh tnh cht c nhit ca polyme. Cc cht ho
do l cc cht c phn t lng thp so vi polyme, cht ny lm gim nhit ho knh
(Tg) v lm polyme t th rn thnh polyme dng mm do hn. Yu cu cn bn ca cht
ho do l phi tng thch vi polyme. S tng thch vi polyme th hin kh nng trn
ln c vi polyme v phi to c nhng lin kt lin phn t vi polyme. Kh nng
tng hp vi polyme c xc nh bng cc phng php nhit ng hc.
Mi loi cht ho do u c nhng tnh cht ho l ring, nn vic la chn cht ho
do phi cn c vo loi polyme c dng. Khng c cht ho do no c th dng cho tt
c cc loi polyme. Do , nu dng nhiu loi polyme phi hp vi nhau, c th phi dng
nhiu loi cht ho do tng ng.
Trong trng hp to mng bao bng h phn tn polyme trong nc, cht ho do ng
mt vai tr quan trng trong vic to ra v duy tr th tch t do nhit bao nhm gip cho
s to thnh mng polyme lin tc.
Ngoi tnh cht lm cho mng phim bt dn, cht ho do cn c th ci thin c nhiu
tnh cht khc nhau ca mng phim, nn cht ho do c vai tr quan trng trong iu ch
mng phim phng thch ko di.
Bng 11.2. nh hng ca cht ho do n tnh cht ca mng phim
Tnh cht
C th tng
Nhit ho knh
Nhit si ( C)
Nhit ho hi (J/g)
Ethanol
78,3
855
Methanol
64,7
1102
Isopropanol
82,3
667
Aceton
56,2
520
Dichloromethan
40,1
321
Trichloromethan
61,2
247
Dung mi
Nc
100,0
2264
K hiu
Brilliant blue
FD&C blue # 1
Indigotin
FD&C blue # 2
Erythrosine
FD&C red # 3
Ponceaux
FD &C red # 4
Tartrazine
FD &C yellow 5
Sunset yellow
FD&C yellow # 6
K hiu
Allura red AC
E132
E133
Carmin
E120
Erythrosine
E127
Oxyd v hydroxyd st
E172
Patent blue
E131
Ponceau 4R
E124
Riboflavin
E101
Titan dioxyd
E171
Indigotin
E132
Quynollin yellow
E104
c) Bc cu logo
Bc cu logo l hin tng mng phim khng
bm vo vin nhng ch chm khc, to nn nhng
khng kh gia mng bao v vin nhn, ng thi
lm cho logo b mt nt.
a)
b)
Nguyn nhn ca hin tng bc cu logo c th do: (1) logo trn nhn qu mnh hoc
qu chi tit (2) dch bao c dnh qu cao v (3) tc phun dch bao qu cao.
d) Lp y logo
Logo c th b mt nt do cc cht c trong thnh phn
dch bao lp logo y hoc vin nhn b mn ti v tr logo;
khng kh trong dch bao v cht bao kh sm cng l mt
nguyn nhn gy nn hin tng lp y logo.
S c lp y logo c th c khc phc bng cch:
Tng bn c hc ca vin nhn (tng lc nn hoc
thay i cng thc vin nhn).
Loi kh trong dch bao trc khi phun dch.
Gim p sut kh nn hoc gim nhit sy hoc tng tc phun dch, trnh
trng hp cc git dch bao kh trc khi tip xc b mt vin.
e) Trc lp bao (lc v cam = orange peeling) l hin tng lp bao b bong, trc tng
mng ln. Hin tng ny thng gp khi bn c hc ca lp bao km hoc lp bao khng
dnh vo nhn.
S c c khc phc bng cch chn cht bao c bn c hc cao hn v/hoc c
dnh tt hn.
g) Vin dnh i
Vin dng cho bao phim nn c b mt tip xc gia
cc vin tht nh, nn vin c dng cng gn hnh cu
cng tt. Tc phun dch qu cao gy t cc b hoc
ton khi vin u c th lm cho vin b dnh i. Vin
cng c th b dnh nhau nu tc ni bao qu chm.
h) Vin nhn b mn
Vin nhn c th b bo mn nhanh trong giai on
u ca quy trnh bao do s chuyn ng mnh trong ni
bao. S bo mn vin nhn c th lm cho mt vin x x
do cc bi thi ra t vin ny bm vo b mt ca vin
khc.
l) Nt vin
Nguyn nhn ch yu gy nt vin l do bn c
hc ca mng phim qu thp, mng phim qu dn hoc do
s dn n ca vin khng ng nht, c bit l i vi
trng hp cc vin cha dc cht c tnh chu nn thp
gy nn hin tng trng n chm thi k gii nn.
Khc phc :
iu ch li dch bao, thm hoc thay cht ho do.
Trnh dng cc t dc n thuc nhm v c (Ca
carbonat, Ca sufat, Mg carbonat) khi iu ch vin nhn.
vin n nh mt thi gian sau khi dp.
b) Xylitol;
c) Mannitol;
d) Glucose;
e) Maltitol.
2. Nng ng saccharose thch hp dng trong k thut bao ng:
a) 2030%;
b) 3040%;
c) 4050%;
d) 5060%.
e) trn 65%;
3. Tnh cht no khng thuc v u im ca ng saccharose trong k thut bao ng?
a) Tan d dng trong nc;
b) Kt tinh nhanh
d) Khng ln ng n
4. H s kt tinh ca ng saccharose:
a) 1,03;
b) 1,13;
c) 1,23;
d) 1,33;
e) 1,43.
5. Yu cu v tnh kt tinh ca ng:
a) Kt tinh ngay khi va c vo khi vin;
b) Kt tinh thnh tinh th rt mn;
c) Kt tinh dng tinh th hnh kim;
d) Ch bt u kt tinh sau khi phn phi u trn khi vin.
6. S hin din ca ng glucose gy nn hin tng:
a) Mt vin r;
b) Vin dnh i hoc dnh thnh khi;
c) Lp bao khng kh;
d) Mu trn mt vin bao thnh phm khng sng;
e) Mu khng u.
7. Nguyn nhn c ng nghch chuyn trong sir ng:
a) C sn trong nguyn liu;
b) C sn trong cht mu;
c) Do nu sir nhit qu cao;
d) Sinh ra trong qu trnh bao, nht l giai on sy vin.
8. Nguyn liu no cho lp bao chng m tt, nhng tan rt nhanh?
a) Saccharose;
b) Xylitol;
c) Mannitol;
d) Glucose;
e) Maltitol.
9. Cch khc phc dn ca lp bao xylitol:
a) Thm gelatin vo dch bao;
b) Bao nhit thp;
c) Thm gm Arabic vo dch bao;
d) Cho ni quay chm trong qu trnh bao;
e) dch bao n nh qua m trc khi bao.
10. Cc cht bao thng dng trong giai on bao bo v ca quy trnh bao ng:
a) Cc loi cht rn v c;
c) PEG;
b) Shellac;
d) Ethyl cellulose;
e) Gelatin.
11. Nguyn liu chnh dng trong bao lt ca quy trnh bao ng:
a) Sir ung vi nng cao;
b) Cc cht v c dng rn;
c) Cc loi tinh bt;
d) ng lactose;
e) Cc dn cht cellulose.
12. Phng php no nn p dng rt ngn thi gian bao lt?
a) Phun bng sng phun khng dng kh nn;
b) Bi bng dch bao bt lun phin;
c) Bao bng hn dch;
d) Thm cc polyme vo dch bao.
13. Hin nay k thut bao phim c p dng nhiu l do:
a) Vin bao phim bng lng, nhiu mu sc p;
b) Thi gian thc hin bao phim nhanh hn bao ng;
c) Mng phim c tnh khng m v cc iu kin bt li ca mi trng tt hn bao
ng;
d) Trang thit b n gin.
14. u im ca h thng phun dch bao khng dng kh nn.
a) C th iu chnh di phun d dng;
b) Di phun khng b nh hng bi nht ca dch bao;
c) Di phun n nh khi phun tc cao;
d) Git dch bao rt mn.
15. u im ca h thng phun dch bao dng kh nn:
a) Di phun hp;
b) t tiu tn dch bao;
c) C th iu chnh mc v tc phun dch bao chnh xc;
Bi 12
CNG NGH BO CH VIN NANG CNG
MC TIU
Trnh by c cc dng thuc vin nang.
Nu c cc tnh cht ca v nang v cch bo qun thch hp.
Phn tch c nguyn l hot ng ca cc my ng nang bn t ng v t
ng.
Thit lp c cng thc c bn cho vin nang cha thuc dng bt v cm.
Trnh by c s quy trnh sn xut vin nang cng.
00
0,95
0,67
0,48
0,38
0,28
0,21
0,13
c) Bo qun v nang
V nang cng c hm m khong 13 16%. Hm m ca nang ng vai tr nh mt cht
ho do gi cho nang khng b dn v m bo bn ca v nang. Khi hm m trong v
nang thp, v nang s b dn; khi hm m cao, v nang s b mm. Hm m trong v nang
cng nh hng n kch thc v nang. Cc nghin cu tng quan gia nh hng ca
hm m c trong v nang cng v kch thc cho thy nu hm m trong v nang thay i
1% th kch thuc s thay i 0,5%. S gim hoc tng hm m c trong v nang khng mang
tnh cht thun nghch, nu hm m b mt qu nhiu th s kh c th phc hi li hm m
bnh thng khi c bo qun li iu kin ti u cho v nang (RH 35 50%). V nang
dng cho my ng nang tc cao cng cn phi c bo qun trong iu kin nghim
ngt hn kch thc khng b thay i.
Cc nh sn xut v nang thng ng gi v nang trong bao b kn, chng m tt. Cc v
nang s c tui th cao nu c bo qun trong bao b kn, iu kin nhit trong khong
10 35oC v hm m trong khong 20 60%. Trnh bo qun v nang rng gn ngun
nhit, nh sng chiu trc tip.
d) Tiu chun v nang cng
Kch thc: Kch thc ca v nang phi c ch to theo ng tiu chun c th
dng c trong tt c cc my ng nang khc nhau.
tan: V nang khng c tan trong nc nhit 25oC trong vng 15 pht v phi
tan hoc r hon ton trong dung dch acid hydrochlorid 0,5% nhit 36 38oC trong
vng 15 pht.
Hm m v dn ca v nang: Hm m ca v nang rng phi trong khong 13 16%,
xc nh bng phng php sy 105oC. dn ca v nang c th c kim tra bng cch
bp nh: v nang khng c v.
Mi: V nang phi khng c thi ra mi l sau khi bo qun trong bnh y kn nhit
30 40oC trong thi gian 24 gi.
e) Cc khim khuyt ca v nang
Cc v nang c th c nhng khim khuyt nht nh trong qu trnh sn xut. Cc khim
khuyt ny c chia thnh ba loi, tu theo mc quan trng khc nhau:
Khim khuyt ti hn l nhng khim khuyt c th nh hng trc tip n qu trnh
ng thuc vo nang bao gm: nang qu ngn hoc qu di, v nang b bp, b rn nt, c l
hoc bin dng.
Khim khuyt ln l nhng khim khuyt c th gy nhng hu qu nht nh khi s
dng, hoc nh hng n hiu qu tr liu ca thnh phm vin nang nh: nang b h np,
y hai np, thnh nang mng, hoc nt dc theo thn nang.
Khim khuyt nh l nhng khim khuyt khng nh hng n kh nng tr liu ca
thnh phm m ch nh hng n hnh dng cm quan ca thuc nh v nang b , c m,
c bt kh.
Trong trng hp dc cht x nc, c th thm cc cht din hot nh Na lauryl sulfat,
Na docusat hoc Tween gip b mt tiu phn dc cht thm t nhanh.
12.3. Quy trnh sn xut thuc vin nang cng
ng thuc vo nang
Trong trng hp iu ch mt lng nh vin nang dng cho mt s bnh nhn hoc
th nghim lm sng cc thuc mi, khi thuc c th c ng vo nang bng tay (khng
dng thit b).
Trong sn xut c th s dng cc my ng nang th cng, bn t ng v my ng
nang t ng tu theo quy m sn xut khc nhau.
12.4. Cc my ng nang thng dng
12.4.1. My ng nang th cng
Trong sn xut quy m nh, c th dng cc my ng nang th cng. My ng nang
th cng c nhiu kch c v nng sut khc nhau:
Loi ng 24 nang/ln c cng sut khong 2000 vin/ngy.
Loi ng 150 nang/ln c cng sut khong 200 vin /gi.
Loi ng 300 nang/ln c cng sut khong 5000 vin /gi.
Nguyn l ng thuc vo nang.
Cc v nang c xp bng tay vo khay mang nang. Cc khay mang nang l cc tm kim
loi c cc l vi ng knh va cho thn nang qua. Khay c lp vo my, trn my c
cc l c v tr tng ng vi cc l ca khay mang nang v c ng knh va kht vi thn
nang. Cc l ny c g kho gi li than nang khi khay mang nang c nng ln.
Tnh trn chy ca khi bt thuc l yu t quan trng nht m bo s ng nht khi
lng.
Cc my ng nang c th c dng ng bt thuc, ht cm, vi ht, vi nang.
11.4.2. My ng nang bn t ng v t ng
Cc my ng nang bn t ng v t ng u c mt c ch hot ng ging nhau,
gm cc giai on:
Chnh hng nang. Cc v nang c vo phu mt cch ngu nhin, cc nang s ri
vo cc khe phn cui phu tip liu di chuyn theo tng hng dc vi chiu di chuyn
khng nht nh, c th v thn nang i trc hoc np nang i trc, sau khi ra khi rnh
nh hng, cc v nang s c y hai ln vi tm kim loi thit k c bit, cc v nang s
xoay u phn thn nang lun lun i trc.
M np nang. Cc v nang c sp xp vo trong cc a mang nang (hoc cc bush)
nh lc ht ca mt h thng chn khng. Cc a mang nang c kt cu gm hai phn, phn
trn c kch thc va kht vi np nang, phn di c kch thc va kht vi thn nang
(phn di) v np (phn trn).
trnh sai s khi lng, khi bt phi c trn chy tt c th chy vo nang vi
mt tc n nh. Thnh phn ca khi bt thuc nn c thm cc t dc iu ho s chy
v t dc chng dnh nh talc, Mg stearat hoc acid stearic
Chu trnh ng nang gm cc giai on sau:
Nang rng c cp vo phu tip liu: Giai on np nang ngu nhin
Nang i vo cc ng dn nh hng: Cc v nang chuyn ng tnh tin theo nhng
hng dc.
V nang c chnh hng: Tt c cc v nang chuyn ng theo mt chiu, thn nang
i trc, np nang i sau. S chnh hng trn c s s khc nhau v ng knh ngoi gia
phn np nang v phn thn nang.
Np nang: V nang c np vo cc vng khay. Vng khay c cu to gm hai vng
ring bit chng kht ln nhau, trn vng c cc l mang nang, l phn vng khay trn c
ng knh bng ng knh ngoi ca np nang, l phn vng khay di c ng knh
bng ng knh ngoi ca thn nang.
Tch nang: Khi vng khay c quay, chn khng mt di vng mang nang s ht
phn thn nang xung vng di trong khi np nang li vng trn.
ng thuc: Hai phn ca vng khay np nang c tch ra, vng cha np ra bn
cnh, vng cha thn nang c t trn mt mm quay c th iu chnh tc nm di
phu bt, trong phu c vt p bt hnh mi khoan. Sau mt hoc nhiu vng quay ca vng
khay, phu bt c nhc ra.
ng np: Hai phn ca vng np nang c nhp li chng kht ln nhau v t vo
pha trc vng inh ng np v tm y. V tr vng ng np c th quay quanh trc mt
gc 1800, p sut hi c cung cp cho vng ng y thn nang vo np nang v tm
y gi np nang nguyn
v tr.
Tho nang: tho nang, p sut c x, tm ng c a v v tr ban u v nang
c tng ra ngoi qua phn trn ca khay i theo mng trt ra ngoi.
b) My ng nang t ng
Kiu ng thuc bng vt phn liu (Dosator).
Cc my thng dng: MG2, Macophar, Pedino, Seteco,
Zainasi.
Nguyn l ng thuc vo nang.
Vt phn liu ca h thng c cu to l mt ng hnh tr,
bn trong c mt piston c th di chuyn c. cao ca
piston c th iu chnh c th ly c mt th tch bt
nht nh (tng t nh iu chnh th tch bung nn trong
my dp vin). Chiu cao ca khi bt chy ra t phu tip
liu phi lun lun cao hn chiu cao ca piston, vt phn
liu c th ly lng bt, khi vt phn liu cm vo khi bt
trong phu tip liu, piston s nn nh khi thuc dnh thnh
mt khi. Vt phn liu sau ri khi phu tip liu v di
chuyn sang v tr nang rng m np v piston s p khi
bt thuc vo nang.
Khi lng thuc trong nang c kim sot bi hai yu
t:
Chiu cao ca piston trong vt phn liu.
Chiu cao ca khi bt thuc ti v tr vt phn liu nhn
bt.
CU HI LNG GI
Chn cu tr li ng nht
1. Ngoi gelatin, nguyn liu no cn c s dng lm v nang cng:
a) Gm Arabic;
b) Shellac;
c) Dn cht cellulose;
d) Dn cht methacrylic.
b) 7 10%;
c) 10 13%;
d) 13 16%.
b) Hm m rt thp;
d) a v b ng;
e) a v c ng.
Bi 13
CNG NGH BO CH THUC TIM
MC TIU
1. Tnh ton c cng thc pha ch.
2. Trnh by c nguyn tc b tr c s pha ch, tiu chun phng sch, nguyn tc x
l, cung cp khng kh cho phng sch.
3. Trnh by c phng php m bo v trng ch phm tim.
4. Trnh by c quy trnh cng ngh pha ch:
Dung dch tim, tit trng sn phm
Bt pha tim theo k thut iu ch v trng
5. Trnh by c nguyn tc v cch vn hnh cc thit b:
My ct nc
H thng ra ng v ng ng bng chn khng.
My ng ng v hn ng.
Ni hp tit trng.
13.1. i cng
13.1.1. Cc hnh thc phn phi thuc tim
Thuc tim liu nh c phn phi di cc hnh thc:
Dung dch sn sng tim.
Hn dch sn sng tim.
Nh tng tim.
Sn phm dng rn sn sng kt hp vi dung mi to thnh dung dch ngay trc khi
dng.
Sn phm dng rn sn sng kt hp vi cht dn to thnh hn dch ngay trc khi
dng.
Trong :
+ m: Khi lng nguyn liu cn phi cn
+ a: Khi lng ca nguyn liu l thuyt tnh theo lng dung dch cn pha
+ b: m ca nguyn liu
13.2.2. Tnh ton lng dc cht, dung mi, th tch pha ch theo nng yu cu
a) Nng phn trm
Trng lng/ th tch (g/100ml)
Trng lng/ trng lng (g/100g)
Th tch/ th tch (ml/100ml)
Th tch/ trng lng (ml/100g)
V d: Pha ch 1000ml dung dch magnesie sulfat 5% (5g/100ml).
V d:
Cn b cho mu cho mt lng cht in gii l 63 mEq Na+, 17 mEq K+ v 150 mEq
Cl . Tnh cng thc pha ch?
Mt dung dch cha 409,5mg NaCl trong 1000ml. Tnh s mEq Na+ v Cl (bit NaCl =
58,5)?
C bao nhiu mEq Mg++ trong 10ml dung dch 50% Magnesie sulfat tim
(MgSO4.7H2O = 246)?
Mt chai dung dch tim NaCl cha 3 mEq/ml, hm lng ca dung dch l bao nhiu?
(NaCl = 58,5)
d) Nng mol/l v mmol/l
i vi phn t: 1 milimol (mmol) l trng lng tnh bng mg tng ng vi khi
lng phn t.
i vi ion: 1 milimol (mmol) l trng lng tnh bng mg tng ng vi khi lng
nguyn t.
V d: 1 mmol NaCl = 58,8mg
1 mmol NaCl c 1 mmol Na+ v 1 mmol Cl
V d:
Tnh s mmol ca dextrose v Na+ trong 1 lt hn hp NaCl 0,9% v dextrose 5%?
(PTL glucose: 180,2 v NaCl: 58,5)
Tnh s mmol ca Mg++ v Cl trong 1 lt dung dch 2% MgCl2 (MgCl2.6H2O: 203)
Tnh s lng ca mui cn thit pha ch dung dch in gii sau:
Na+
12 mmol
K+
4 mmol
++
Mg
++
Ca
Cl
6 mmol
6 mmol
Nc ct va
40 mmol
1000ml
Hnh 13.1. Phng pha ch thuc tim c tit trng sn phm cui cng
0,5 5,0m
> 5,0m
0,5 5,0m
> 5m
3.500
3.500
3.500
350.000
2.000
350.000
2.000
3.500.000
20.000
3.500.000
20.000
Khng quy nh
Khng quy nh
Cp
sch
S VSV
3
trong 1 m khng
3
kh (CFU/ m )
t a thch
ng knh 90mm
(CFU/4 gi)
a thch tip xc
ng knh 55mm
(CFU/a)
Phng php
nhng gng 5
ngn (CFU/gng)
<3
<3
<3
<3
10
100
50
25
khng p dng
200
100
50
khng p dng
S lng VSV
3
trong 1m
0,5 5m
> 5m
3.500
Khng
II
350.000
2.000
100
III
3.500.000
20.000
500
IV
>3.500.000
>20.000
>500
iu ch dung dch c lc v
tit khun
Cp C
Phn ln cc thuc tim c tit trng sn phm cui cng phi c pha ch trong iu
kin t nht l cp sch D nhm gim thiu s lng vi sinh vt v tiu phn thch hp
cho vic lc v tit trng.
Khi c nguy c nhim vi sinh vt do c tnh thun li cho s pht trin hoc phi gi lu
trc khi tit trng hoc khng c pha ch trong cc bnh kn phi pha ch thuc tim
trong mi trng sch cp C.
Cng on ng thuc phi c thc hin mi trng sch cp C tr ln, tuy nhin
khi c nguy c cao nhim t mi trng nh chai l ming rng hoc phi h trong vi
giy trc khi ng nt, qu trnh ng thuc tim phi thc hin trong mi trng sch cp
A vi mi trng xung quanh l cp C tr ln.
b) Quy nh iu kin sn xut ch phm theo k thut pha ch v trng
Giai on pha ch
Gi cc vt liu v khun
Tiu chun yu cu
Cp A trong khu vc loi B
Cp C: nu dung dch c lc v trng trong
quy trnh sn xut
iu ch dung dch
A. u vo
E. Gin nng I
I. HEPA
B-K. B gim sc
F. Gin ngui
J. HEPA (nu cn)
C. Tin lc (30%
G. Gin nng II
D. Tin lc 85%
H. Qut gi
H thng x l khng kh vi lc HEPA
Hin nay lc HEPA (High Efficiency Particulate Air Filter) thng c dng lc
khng kh cung cp cho phng sch.
Mng lc HEPA c ch to t nguyn liu dng si nh si cellulose, si thu tinh, si
amiant v s xp. Mng lc HEPA c phn loi da trn kh nng ngn cn cc tiu phn
c kch thc 0,3m c trong lung khng kh.
Mng lc HEPA chun lc c 99,97% tiu phn, mng HEPA siu lc c th lc c
99,99% s tiu phn c kch thc 0,3m.
duy tr v ko di tui th ca mng lc, khng kh trc khi i vo khu vc sch phi
i qua 2 mng lc:
Mng tin lc nhm loi b cc tiu phn bi c kch thc ln v c tc dng bo v
mng lc chnh.
Khng kh sau khi i qua mng tin lc s c nn qua mng lc HEPA chnh c kch
thc l lc t 0,2 n 0,25m v i vo khu vc pha ch.
C nhiu cch b tr, thit k lc HEPA cung cp khng kh cho phng hoc khu vc
pha ch sch:
M hnh thi kh mt chiu (hnh 13.2)
M hnh thi kh khng theo mt chiu (hnh 13.3)
M hnh thi kh kiu hn hp (hnh 13.4)
Cc hnh thc thit k ny quyt nh tc thng kh do nh hng n sch. M
hnh thi kh kiu hn hp cho php tit kim chi ph x l khng kh m vn duy tr khu vc
sch t theo yu cu.
Ngoi ra c th pha ch trong khu vc sch hn ch bng cc t khng b nhim t bn
ngoi hoc hon ton c lp cch ly vi mi trng ngoi (hnh 13.5, 13.6, 13.7). Hnh thc
ny rt tin li khi pha ch cc hn hp v trng ti bnh vin.
Nhm duy tr s v trng ca cc thnh phn v ca thuc tim trong qu trnh pha ch
cn ch : mi trng, nhn vin pha ch, cc b mt tip xc quan trng, s v trng ca bao
b, nt, qu trnh di chuyn, thi gian lu gi cc sn phm trc khi ng chai, l, lc v
trng
C th cn thc hin:
Nguyn liu c tit trng trc theo phng php ph hp.
Dng c c tit trng.
Kim sot mi trng sch mc cao: cp A.
Bnh cha c tit trng trc.
K thut pha ch thch hp, m bo v sinh v trng c thc hin bi nhn vin
c hun luyn.
Tu theo cu trc v dng c th, cc giai on pha ch v tit trng thuc tim c th
c trnh by tm tt theo s sau:
i tng
Thao tc k thut
ng tim, chai l
X l
Ra ngoi
Ra trong
Sy kh
Nhit
Tit trng
Thi gian
Thao tc k thut
Cng thc
Dc cht
Cn, ong
T dc
Dung mi
Ho tan
Dung dch
Lc
trong, hm lng
ng ng, hn ng
Th tch ng ng
Nhit
Hp tit trng
Thi gian
ng thuc
Soi
In nhn
ng hp
Thnh phm
Bit tr
Nhp kho
Ngoi ra cc dung dch tim khi tit trng bng cch lc cng cn p dng cc nguyn
tc ca k thut iu ch v trng.
Quy trnh cng ngh vi bt pha tim c th nh sau:
i tng
Thao tc k thut
Cng thc
Dc cht
T dc
Bt n
Hm lng, ng nht
Bt kp
Phn phi
Trng lng
ng np
Dn nhn
ng hp
Thnh phm
Bit tr
Nhp kho
15ml,
5. pH v cc ch s khc:
Dung dch nc: kim tra pH
Dung dch du phi xc nh ch s acid, ch s iod, x phng ho
6. Th tch
7. Chnh lch khi lng (dng bt tim)
8. nh tnh
9. nh lng
Hnh 13.9. S my ct nc
Hnh 13.10. My ct nc c tc ng kp
P N
Bi 1
1. b) Gia tng v bnh tt.
2. a) X hi
c) Cng ngh bo ch/ sn xut thuc.
d) Li nhun.
b) Sc kho.
d) Ca ci vt cht.
b) Bo ch thuc nguyn mu
3. b) Dng bo ch thch hp
h) Bo qun
4. a) Tnh cht vt l
b) Tnh cht ho hc
6. a) m
b) nh sng
7. a) Phn hu
b) Tng k
8. a) Nghin cu Dc ng hc
b) C ch
9. a) Vo c th
c) Tr liu
b) Sinh kh dng
10. b) ng a thuc vo c th
d) T dc v cht ph gia
2.d
3.d
4.d
5.d
6.a
7.d
8.d
9.d
10.d
11.d
12.c
13.d
14.a
1.d
2.d
3.d
4.S
5.S
6.S
7.S
8.S
9.
10.
11.S
12.S
13.
14.S
15.S
16.d
17.c
18.d
19.d
20.c
21.c
22.C
23.C
2.d
3.d
4.c
5.d
1.a
2.d
3.c
4.a
5.b
6.c
7.d
8.c
9.d
1.c
2.d
3.c
4.d
5.e
6.d
7.d
8.a
9.c
10.d
11.a
12.d
13.e
1.a
2.d
3.c
4.c
5.b
6.c
7.c
8.b
9.d
10.d
11.b
12.b
13.c
14.a
15.c
16.d
GLP v GSP
Bi 4
1.d
Bi 5
Bi 6
Bi 7
17.d
18.c
19.d
20.b
21.b
22.c
23.d
25.d
26.d
27.d
28.a
29.b
30.d
31.b
1.d
2.a
3.c
4.d
5.c
6.c
7.d
8.d
9.a
10.a
11.c
12.b
13.d
14.d
15.b
16.c
17.e
18.b
19.c
20.b
21.a
22.c
23.b
24.d
25.c
26.c
27.d
1.b
2.d
3.a
4.c
5.c
6.d
7.d
8.d
9.c
10.b
11.d
12.c
13.c
14.a
15.a
16.a
17.c
18.d
19.d
20.c
21.d
22.d
23.c
24.d
25.c
26.b
27.c
28.c
1.e
2.b
3.a
4.c
5.d
6.b
7.c
9.d
10.c
11.b
12.d
13.c
14.c
15.c
1.e
2.d
3.c
4.c
5.d
6.d
7.c
8.b
9.c
10.b
11.b
12.b
13.b
14.c
15.c
16.c
17.d
18.b
19.c
20.b
1.c
2.d
3.d
4.d
5.a
6.b
7.d
8.a
9.e
24.d
Bi 8
Bi 9
Bi 10
Bi 11
Bi 12
8.a
Bin tp v sa bn in :
PHM TH PHNG
Trnh by ba :
BI QUANG TUN
Ch bn :
INH XUN DNG