BO CO Cng Ngh Sn Xut Hp Thc Phm Ch 4: Trnh by quy nh v sn xut hp thc phm axit thp ca Cc Qun l Dc & Thc

Thc phm Hoa K FDA (CFR-113).

DANH SCH NHM 3: 1. Lng nh Anh 511300 2. Nguyn nh Cng 51130167 3. Phm Th Hi H 51130538 4. u Th L Hng 51130617 5. inh Th Hin 51130309 6. Nguyn Th Huyn 5113 7. Hunh Th Bo Khuyn 51130692 8. Nguyn Hoi Nam 5113 9. Phm Th Bch Nhi 51131068 10. V Th Tn 51131944 11. ng Th Thy 51131604 12. Hong Th Thanh Tr 51131794

PHN I: M U Khi nn kinh t pht trin, thi gian dnh cho vic nu n b rt ngn, v vy sn phm hp thc phm l la chn ph bin ca mi gia nh. Thc phm cng nghip, thc n ch bin sn nh th c iu kn pht trin ngy cng phong ph v khng th thiu trong cuc sng hin i. Khong 5 -7 nm gn y, thc phm ca cc nc phng ty nh ph mail, xc xch , hp mi c bit n trong thc n ngi Vit. Nh chng ta bit, mt sn phm hp thc phm cn phi c ng vo hp kn cch ly hon ton vi mi trng ngoi, v c thi gian bo qun di (trn 6 thng), v vy c th ni qu trnh to ra mt sn phm hp ng ngha, th 2 cng on cn ch nht l ghp kn hp v thanh trung

PHN II: TNG QUAN I/ hp thc phm acid thp. hp thc phm c th phn lm 2 nhm: t chua (pH4.2) Chua (pH4.2). Nhm thc phm t chua l thc phm c acid thp.

PHN III: NI DUNG CHNH I/ HOT NG X L NHIT 1.gii thiu X l nhit hp thng phm thc phm: Tn ti t nm 1874 H thng tit trng u tin dung hi nc c p sut. Dng hi nc bo ha p xut cao. Ngy nay vn l mt h thng c s dng ch yu c bit l i vi hp thy sn

2.Cc nguyn tc x l nhit 2.1 C s x l nhit Vi sinh vt gy h hng thc phm: Hu nh c mt tt c cc nguyn liu thc phm. Chng khng th pht trin trong mi trng khng thun li v chng s cht nu mi trng xung quanh khng ph hp. Cn chn nhit v khong thi gian thch hp kim sot vi sinh vt. C quan qun l nh nc ca M( US FDA) yu cu cc quy trnh s l nhit phi do mt c quan c thm quyn, c kin thc su rng v x l nhit thit lp.

2.2 Quy trnh x l nhit Quy trnh x l nhit c thit lp bi c quan c thm quyn v tit trng thng phm hoc sn phm khng bin i trong iu kin bnh thng

Cc thng s nh nhit ban u ca sn phm, nhit x l v thi gian x l hoc cc yu t ti hn khc c th nh hng n kt qu tit trng thng phm. Cc yu t ti hn gm: bn thn sn phm, hp cha, quy trnh chun b hay h thng ch bin

2.3 Thit lp quy trnh x l nhit

Da trn hai yu t:
S bn nhit ca vi sinh vt. Tc xm nhp nhit ca sn phm c th.

Mt quy trnh c thit lp, c trng cho mt loi thc phm, c cng thc ring, phng php chun b ring, kch c hp ring v loi h thng x l nhit c s dng ring. Quy trnh ny khng c sa i tr khi c hng dn c th t c quan c thm quyn v x l nhit.

2.4 Cc phng php x l nhit

C nhiu phng php x l sn phm trong hp ghp m, nhng s dng ph bin nht l h thng x l nhit c truyn( cho sn phm vo hp, ghp m v x l trong ni tit trng). Cc th tc vn hnh ni tit trng phi do c quan c thm quyn v x l nhit thit lp.

2.5 Xc nh quy trnh vn hnh ni tit trng.

C quan c thm quyn v x l nhit s dng cc th nghim v phn b nhit gip thit lp quy trnh vn hnh cho cc loai ni tit trng. i vi ni tit trng bng hi truyn thng, th nghim phn b c s dng xc nh s ui kh ban u hoc s loi b kh, chu k trit trng ca ni trit trng. Trong dng th nghim ny, cp nhit in c t gia cc hp trong khi xp vo ni. i vi ni tit trng s dng hi lm mi trng truyn nhit( khng kh trong ni c loi b trc kh x l nhit v khng kh lm gim hiu qu truyn nhit ca hi). Hi ngng t trong ni v nhit truyn t ni hi sang ni tit trng.

tO nhit k thy ngn

ng biu din d Liu din bin Nhit

3. Trang b dng c, thit b v vn hnh ni tit trng. Ngi lp t h thng x l nhit l nhng ngi qua o to vn hnh, duy tr h s v ghi chp y . Cc quy nh ca FDA M v GMP u yu cu trang b mt s dng c nht nh cho cc h thng x l nhit

3.1 Trang thit b, dng c. 3.1.1 thit b o nhit cho thc phm c acid thp. 3.1.2 thit b t ghi nhit / thi gian cho thc phm c axit thp. 3.1.3 H thng kim sot nhit 3.1.4 H thng kim sot in t. 3.1.5 Cung cp khng k cho thit b. 3.1.6 Thit b o p sut. 3.1.7 Thit b o thi gian

C ch khi ng mng chn van kim sot

Mng chn ca h thng kim sot nhit n gin vn hnh bng kh

3.3 Thit b. 3.3.1 Cung cp hi 3.3.2 cc loi van v cch s dng 3.3.3 b phn bi kh 3.3.4 b phn phi hi hoc nc 3.3.5 b phn gim m 3.3.6 ni thanh trng Pasteur 3.3.7 Bo tr thit b 3.3.8 vn hnh bun x l

3.2 Bo tr. L vic nn lm sau khi lp t thit b, bt c khi no c nghi ng v chnh xc ca thit b. Cn bo tr cc thit b, dng c mt cch ph hp kim sot v t liu ha y cc hot ng x l nhit.

3.3 Thit b. 3.3.1 Cung cp hi. Hi l mi trng truyn nhit ph bin nht trong h thng x l nhit. theo khuyn ngh chung, lng hi cung cp ti thiu cho bung lm vic phi t 90 psi hoc 6kg/cm2. 3.3.2 cc loi van v cch s dng C hai loi van c bn: Van hnh cu loi van ng kn rt tt. Van cng loi van dng dng chy ton phn. Ngoi ra cn mt loi van khc cng c s dng l van bong c th dng dng chy ton phn hay dng dng chy mt phn.

3.3.3 b phn bi kh B phn bi kh l cc l nh trn ni tit trng dng to s lu thng trong ni tit trng, to s lu thng hi trong mi trng truyn nhit, loi b mi loi kh i vo ni tit trng cng vi hi, to dng mi trng truyn nhit i vo bu nhit k, hoc loi b s ngng t hi nc di y ni tit trng 3.3.4 b phn phi hi hoc nc L ng ng hi hoc ng ng nc c lp thm vo bn trong ni tit trng nhm to ra s phn phi ng u hi hoc nc.

3.3.5 b phn gim m C th s dng cho cc l bi kh hoc cc l ui kh nhm lm gim mc ting n khi hi hoc khng kh thot ra. Nu s dng th cn c bng chng t khng cn tr: vic loi b kh hoc hi nc, s ng nht nhit bn trong ni. Thng tin ny c th a vo biu mu d liu phn b nhit.

3.3.6 ni thanh trng Pasteur Ni thanh trng Pasteur l dng c bit ca thit b x l nhit cho thc phm ch bin c axit thp hoc thc phm c bo qun lnh ko di thi hn s dng. S dng hi nc, nc nng hoc dng nc nng. Duy tr p sut kh quyn. Dng ni s dng dng nc nng c s dng ph bin nht. C th kt hp ni thanh trng v thit b lm ngui vi nhau. S dng mt bng ti lin tc chuyn hp i qua ni thanh trng. Khi hp vo ni thanh trng phi c phn b u. Cc b phn ny cn c kim tra, bo tr v lm v sinh thng xuyn.

3.3.7 Bo tr thit b Mi h thng x l nhit cn c kim tra t nht 1 nm/ln bng mt nhn vin khng trc tip vn hnh thit b. Vic kim tra ny bao gm nhng khng gii hn: Van kh v van nc c b r r khng. B phn gim m v ui kh c b cn tr lm gim hiu qu khng. B phn phn phi nc c b n mn, nt v hoc b bt kn hay khng. Cn lu tr h s cho cc ln kim tra. Nhn vin bo tr hoc i ng k s khng nn thay i bt c yu t/thng s no ca ni tit trng hoc cc dng c m khng c t vn ca cc qun l k thut. Cn lu tr cc h s ghi chp v ngy bo tr, dng bo tr thc hin v ngi tin hnh bo tr.

3.3.8 vn hnh bn x l 3.3.8.1 Cng b qu trnh x l nhit 3.3.8.2 Ngn nga vic b qua khu tit trng 3.3.8.3 M s cc hp 3.3.8.4 H thng t ghi nhit /thi gian 3.3.8.5 Nhit ban u 3.3.8.6 Trc nghim sn phm 3.3.8.7 Cc sai lch quy trnh

3.4 Cc ni tit trng tnh dng hi nc 3.4.1. M t ni tit trng

NI TIT TRNG THEO M KHNG C ST CHA

3.4 Cc ni tit trng tnh dng hi nc (tip) 3.4.2. Lp t v vn hnh ni tit trng 3.4.2.1 Trang b dng c 3.4.2.2. Cung cp hi v ng cp hi nc 3.4.2.3. u cp hi: 3.4.2.4. B kim sot hi t ng vo ni: 3.4.2.5 ng cp hi: 3.4.2.6 : ui kh: 3.4.2.7 Cc l thot hi 3.4.2.8 B phn tiu m 3.4.2.9 Cung cp kh 3.4.2.10 cung cp nc 3.4.2.11 Kt cu gi, xe y v cc tm phn cch:

3.5 Nhng vn lin quan n x l nhit: 3.5.1. ui kh: 3.5.2. nh hng ca tm phn cch hp i vi vic ui kh: 3.5.3. Nhit ban u 3.5.4. Thi gian x l nhit: 3.5.5. Lm ngui hp: 3.5.6. X l nc lm ngui: 3.5.7. Yu cu v h s:

II/ GHP KN HP 1. Gii thiu V hp l yu t quyt nh s thnh cng ca qu trnh ng hp thc phm Cht lng ca v hp ph hp m bo rng sn phm lun nm trong hp. Ngn chn s xm nhp ca vi sinh vt, oxy, tp cht v cc cht ly nhim khc t mi trng lm gim cht lng sn phm. Cc lp ph (enamel) bn trong hp phi tt ngn nga s suy gim v mt vt l hoc ha hc ca sn phm, ngn nga cc hng v v mi t sn phm vo v hp hay ngc li. bn vt l ca v hp phi ph hp chu c cc tc ng trong qu trnh x l nhit v phn phi sn phm.

2. Hp cha c np L loi hp gm hai mnh hay ba mnh c mt np hp c ghp m sn vo thn hp. Gn y, loi hp cha c np khng ngng ci tin thm v xut hin nhiu loi hp mi nh: hp hn cnh, hp thp ba mnh v loi hp hai mnh khng c m ghp cnh c lm t nhm hoc thp ko.

3. Tm kim loi ch to v hp: Loi hp thic c lm t cc tm thp c nhng trong thic nng chy. Thay th bng phng php m in cho php ph mt lp thic u v mng hn, d dng tng hoc gim lp thic ph ln b mt, to ra nhng tm thp m thic c chiu di lin tc. Cc loi thp tm khng m thic (m ch ph nh mt lp crom) ngy cng s dng rng ri. c tnh ca tm kim loi s dng sn xut v hp s nh hng c tnh m ghp kp. cng ca thp m thic hay khng m thic thng c k hiu l T1, T2, T3, (T1 = cc k mm, T5 = rt cng). cng hay trng lng c s ca tm kim loi c th thay i.

4. Kt cu ca v hp: a. Mp bch:

b. M ghp cong

c. Lp m

5. M ghp kp:

Mt ct ngang ca mt m ghp kp

Mn cp ghp m v cc con ln cun

Chu k vn hnh ln th nht 2 chu k vn hnh Chu k vn hnh ln th 2

6. Mi ghp kn: Lp m cng vi vic lin kt c hc gia np v thn hp s gip m ghp kp tr thnh mt mi ghp kn. M ghp kp phi c to thnh ng quy cch. Lp m, mc d c th ph kn nhng khe h trong m ghp, nhng khng th b p cho mt m ghp c hnh thnh sai quy cch.

7. Cu trc m ghp kp: Nhng hng dn v kch thc ghp m thng do chnh nh cung cp thn v np hp a ra. Khi gii hn iu chnh vt qua cc kch thc ti hn, cn tin hnh cc hnh ng sa cha. Khng th ch s dng vic o kch thc m ghp quyt nh cht lng ca m ghp kp. Vic thm nh cui cng m ghp kp ch c th thc hin thng qua vic kim tra bng mt m ghp sau khi tin hnh x m ghp, kt hp vi vic o cc phn cu thnh m ghp. Cc kch thc m ghp c xut trong hng dn ny th hin dy v cht cn thit to ra mt m ghp ti u nht.

8. Cc thng s o m ghp: a. Chiu su m ghp: b. dy ca m ghp: c. rng ca m ghp (chiu di hoc chiu cao ca m ghp) d. Mc thn v mc np: e. Phn chng m: l phn lin kt vo nhau gia mc thn v mc np. f. kn ca m ghp: g. Ch m ghp gp nhau:

Chiu su ca m ghp

dy ca m ghp

rng ca m ghp

Mc thn v mc np

Phn chng m

9. nh gi ti hn m ghp kp a) Chiu su m ghp qu ln b) M ghp ln th nht qu lng c) M ghp ln th nht qu cht d) Mc thn qu ngn e) Mc thn qu di f) M ghp ln th hai qu lng g) M ghp ln th hai qu cht h) Mc np qu ngn i) Mc np qu di j) Phn chng m b ht k) M ghp b g

Chiu su m ghp qu ln

a) M ghp ln th nht qu lng

M ghp ln th nht qu cht

Mc thn qu ngn

M Ghp Ln 2 Qu Lng Mc np qu ngn M ghp Sc cnh

Phn chng m b ht

Phn chng m b ht

Mc thn qu di

10. Nhng khuyt tt v cu trc

M ghp b s

M ghp c dng ch V hay hnh mi

2.10.4 M ghp b nt u:

M ghp b nt u

2.10.5 M ghp b nhy qua hay b qua. L phn m ghp nm tip gip vi ch ghp ni, khng c p cht. (hnh nh)

M ghp b nhy qua hay b qua

2.10.6 u m ghp b li hoc c hnh con thoi:

u m ghp b li hoc c hnh con thoi

2.10.7 M ghp sai:

Mp bch b tut khi m ghp

2.10.8 Mp cong ca np hp b hng: L phn mp cong ca np hp b dt phng mt hay mt s im lm cho mp cong b gp ngc li ng sau. Nguyn nhn:
Thao tc vn chuyn, x l np hp khng ng quy cch Vic a thn hp v np hp vo my ghp m khng ph hp

Thn hp b vnh

Thn hp b on

2.10.11 Lp rp sai: Np v thn hp khng c t khp vo nhau trong my ghp m. Dn n, m ghp khng c gn kn vng quanh hp. Nguyn nhn:
Ci t my ghp m khng ph hp hoc ci t nhp ghp m khng ph hp Cc trc nng ca con ln ghp m hot ng khng linh hot.

2.10.11. M ghp b nt:

L hin tng m ghp b nt lp ngoi cng ca m ghp. Nguyn nhn:
M ghp qu cht. Mi hn cnh qu dy. Lng lp m trng vo qu nhiu. Tm kim loi lm np hp c khuyt tt.

M ghp b nt

2.10.12. Mp bch c dng hnh nm:

2.10.14. M s rp ni/ rp chm b nt:

c im: phn v kim loi ch rp ch b ct xuyn qua. Nguyn nhn: B tr sai cc ch rp B tr sai mm cp rp ch. ln ln cc ch mi v c Ghp sai ch rp ni v rp chm Lc nn rp qu ln to ra cc du ch qu su

2.10.15. Mm cp ca m ghp m b h: c im: phn mi ca mm cp b v/ gy, khin cho mi ghp nhng ch ny b lng. Nguyn nhn: My ghp m b kt nng Cc con ln ghp m b b cht Kim loi s dng khng ph hp vi mm cp Cy mm cp khc phc tnh trng kt my

Phn 2.11 nh gi mc hon chnh ca mi ghp kn:

Yu cu m ghp kp phi c k thut vin qua o to, kim tra mc hon chnh ca cc m ghp trong sn xut hng ngy. Tin hnh: bng trc quan v ct m ghp ra. Nhn vin kim tra kn ca hp s chu s gim st ca cn b tt nghip c cng nhn nng lc o to ca cc gim st vin ngnh hp

2.11.1 Kim tra bng mt thng: Kim tra cc c im bn ngoi ca m kp pht hin li tng th v kn: m ghp b nt u, m ghp st cnh, mp bch b gp xung, m hp sai, m ghp b s, v h hng ti phn loe ming. GMP quy nh tin hnh kim tra hp mt cch tng th nhm pht hin s r r sn phm, cc khuyt tt d nhn thy. ng thi ghi chp li cc kt qu quan st c, v thc hin cc hnh ng sa cha. Thng thng, khong cch gia hai ln kim tra m hp bng mt thng nh hn 30 pht i vi my ghp m lm vic lin tc vo thi im bt u sn xut ( hoc sau khi xy ra s c kt my ghp m, hiu chnh my, sau mt thi gian my ngng hot ng)

2.11.2. kim tra bng cch ct m ghp: Kim tra m ghp bng cch ct m ghp mi hp tng u my ghp m. Kim tra c tnh c t yu cu v kch thc v cht lng ca m ghp.

2.11.3. Cc dng c: Tnh chnh xc v la chn loi dng c quyt nh kt qu kim tra m ghp. o v ghi chp chnh xc(1/1000 inso). Ngi chu trch nhim ct m ghp phi c o to mt cch bi bn v k thut o. Nu dng c v k thut o thiu chnh xc: Khng pht hin c m ghp km cht lng Chn gi li mt cch khng cn thit cc hp c m kp t tiu chun. Hiu chnh my ghp m mt cch khng ph hp

2.11.3.1 thc panme o ghp m: Cu to: gm mt trc vi k tiu chun gn vi phn chui ph hp. Chc nng: o cc kch thc ca m kp. Cch o: t tht panme ln trn b nt cn o ri dng ngn tay tr gi cho thc panme thng bng v tr vung gc vi b mt. Sau , thc panme c h xung cho n khi phn e chm vob mt cn o. Trc iu chnh ca thc panme s gip a phn thn tip xc vi mt bn kia cu b mt cn o m khng phi dng sc p qu mc.

2.11.3.2 my o phn loe ming: Chc nng: o chiu cao phn loe ming, tnh t im cao nht n im thp nht ca m ghp st thnh phn loe ming. 2.11.3.3 dng c m hp: M hp bng tay Chc nng: iu chnh theo ng knh ca hp v tho ri ming kim loi trn np hp m khng lm hng m ghp hoc thn hp. 2.11.3.4. km: Chc nng: dng git di np hp m dng c m hp cn st li. Km thch hp c ph bin nht l km s 5.

2.11.3.5 Ca m: Tin hnh: dng mt chic ca kim loi st( hoc ca in) ct m ghp theo mt ct ngang. 2.11.3.6. My chiu m ghp: Chc nng: o chng m hp Tin hnh: ct ri mt ming mt ct ngang nh ri khi m ghp v kp ng vo v tr. Cc compa o ngoi ca my chiu s o trc tip hnh nh ca phn chng m hp, mc np v mc thn. ng thi, my chiu kim tra cu to tng th ca m ghp. u im: my chiu in c cc ai gt o c kt ni vi my tnh, cho kt qu chnh xc, ng nht cao v khng c li. Nhc im: nh gi m ghp mt cch khng ton din, ch quan st mt ct ngang ca m ghp.

2.11.3.7 Bt o m ghp: Cu to: bt ging nh knh lp c gn mt ngun sng. Trn thn bt c mt chic thc dng trc tip c cc thng s v di ca mc thn, mc np v chng m trn mt ct m hp chnh xc n 1/1000 inso.

2.11.4 Tn sut ct m hp: Do k thut vin qua o to v ghp m hp tin hn ct m hp kim tra m bo kn ca m ghp. Cch ly mu: ly t nht mt hp mi u ca my ghp m Tn sut ct m hp kim tra khng qu 4 gi mt ln. Kim tra vo thi im bt u sn xut, ngay sau khi c s c tt nghn hc sau khi khi hiu chnh, thay i my ghp m. USDA yu cu phi tin hnh ghp m hp kim tra ghp y hp vi t l t nht l 1 hp trn 1 my ghp m trong mi ln kim tra. USDA quy nh nh ch bin phi duy tr vic thc hin cc ch dn c th v m bo cht lng ca m ghp kp v lun c sn h s kim tra.

2.11.5 Cc phng php o bt buc: c 2 phng php kim tra hp bng cch ct m: 2.11.5.1 H thng vi k: Tin hnh o 3 im cch nhau khong 120 trn chu vi ca m ghp kp (tr m ghp cnh) v cch m ghp cnh t nht 0.5 inch. Ghi li cc gi tr ln nht v nh nht ca mi ln o. Khng nn s dng kch thc trung bnh ly t kt qu cc ln o ca bt k b phn no ca m hp Cc thng s cn o:
Chiu di ca mc np Chiu di ca mc thn Chiu di ca m hp (cao) kn Chiu dy nh gi mi ghp m cnh Ngoi ra, cn o cc thng s (ty chn): chng m hp, chiu su cu m ghp.

Cc php o nh gi cht lng ca m ghp

2.11.5.2 H thng quang hc: Cc mt ngang cu m hp nn c ct t nht t 2 v tr khc nhau trn m hp (tr mi ghp cnh) Cc thng s cn o: chiu di, mc np, chiu su ca m hp 2.12 quy trnh ct m hp: Tin hnh o pha ngoi: chiu di(cao), chiu dy v chiu su ca m hp. Panme k o chiu dy v chiu cao ca m hp My o su o chiu su ca m hp. mi ghp.

2.13 T l ni ghp v kn: T l kn biu th di dng s cho bit phng hoc nhn ca mc np. Cc h thng s c s dng nh gi t l kn: 0 n 3%, 0 n 10%, 0 n 100%. Nhng s dng ph bin l 0 n 100% da trn t l phn trm khng c np nhn. nh gi kn da vo rng ca np nhn ln nht. nh gi t l ni ghp ( i vi loi hp hn) cho bit t l phn trm kim loi phn mc np dng chng m khi lin kt vi mc thn. Cng tc nh gi m hp, da vo kinh nghim v s nh gi cu k thut vin kim tra m hp.

T l mi gp cho bit t l % kim loi mc np dng chng m khi lin kt vi mc thn

Mt s h thng o dng s c s dng trong nh gi cc t l kn

2.14. gii thch kt qu kim tra: Khi kt qu kim tra mt s mu khng p ng yu cu, th tin hnh ly mu im ghp m ang c nghi vn. Nu kt qu khng tha mn, th xc nh bn cht ca khuyt tt ngng sn xut hay tip tc hot ng. Nn hn ch vic hiu chnh my. Mt s khuyt tt: Khuyt tt nh Khuyt tt nghim trng

2.15 H s nh gi m hp:
Lu tr cc hotng kim tra bng mt v o m hp Pht hin tnh trng khuyt tt v cc hnh ng sa cha Cc trng thi bt thng hoc khng ng k

Lu tr h s y v chnh xc.