THM NH QUI TRNH Mc tiu: - K/n thm nh - Cc loi thm nh - Phn tch nh hng cc bin / thng s thm nh trong

QTSX vin nn, nang - Phn tch nh hng cc bin / thng s thit b trong QTSX vin nn, nang - Cc YC ca thm nh PP nh lng I. i cng 1. Lch s - c/m: Kim tra v trng ca sp cui khng m bo l sx v khun KTCL khng phi ch KT thnh phm m phi t trong cc bc ca QT - Hin nay: Thm nh QTSX tr thnh q YC bt buc trong GMP - WHO 2. Tnh khch quan / Tm quan trng - Qui nh ca php lut - Yu cu ca nh KD - Trch nhim v quyn li ca NSX Mc tiu: sx thuc m bo CL 3. K/n Thm nh QTSX = Bin php m bo QTSX to ra thnh phm ng nht, n nh CL qua tng l m Cung cp chng c / h s Cc bc then cht / QTSX c tnh ng nht v kh nng ti lp Lu : 2008 c s chuyn bin t thit lp cc chng c = VB hng ti cc bng chng khoa hc (FDA) 4. Mc ch - Sp t TC - Tnh n nh (qt, sp) - Sp hon chnh (k thut, tnh kinh t) - Gim thiu s c - Gim nguy c loi b sp - Kim tra v bo tr tt hn - Mi nhn vin c th kim sot v ci tin qt

5. Phn loi - Thm nh tin lng - Thm nh ng thi - Thm nh hi cu - Thm nh li Loi thm nh Tin lng Thi im thc hin Trc khi sx sp bn i tng p dng Phng Tin hnh / k php

Thc Tin hnh: nghim - D kin cc g trng yu / QTSX XD cng - Tin hnh thc nghim, phn tch cc yu t nh hng (ly mu, phn tch, x l, bin lun) - t: trin khai QT Khng t: sa i, b sung k - Chun b trc thm nh - Thc hin trn 3 l CN lin tip (c l ~ 100000 vin) ng ng QT c Nt Tin hnh trong cc trng hp: thi thi vi trin khai - Thm nh 1 s v | hon thin qui sx sp tng i trnh bn n nh v - Thm nh mc nh hng v vi c thay i nh (m, hm lng, hnh dng thm nh vin nn) - Thm nh 1 qui trnh c thm nh ti c s A ri chuyn giao cho c s B k: nh thm nh tin lng Hi cu Sp QT c Thng Tin hnh: c sx trin khai k Phn tch cc d liu lu tr n nh nhiu bng PP thng k x mqh nhiu nm, n gia cc k sx v kt qu phn nm nh, tch khng k thay i - QTSX c khng c s sa i nhng v BC, KN, IPC, thit b QT mi c nghin cu pht trin

cha c thm nh

Li

Theo k hoch nh k hoc khi c s sa i / QTSX

- QTSX c s thay i (thm nh li t xut) - QTSX c trin khai mt thi gian, cn nh gi li (thm nh li nh k)

Thc nghim

- ti liu h s v 2 cc g trng yu - d liu thng k ca 10 20 l sx lin tc: h s sx, biu kim tra IPC, kt qu KN sp, h s bo tr thit b, h s phn b nhn s, d liu v n nh sp - Khng c tin s loi b sp do sai st ca nhn vin or thit b lin quan n tnh thch hp ca h thng M tin hnh: c/m s thay i no / QTSX khng nh hng ng k n CL sp 2 loi hnh - Thm nh li t xut: khi c thay i bit trc Nguyn liu: d, , KTTP Nh SX nguyn liu Thng s qt: t trn, to sy Thit b sx (khng thay i c ch) C s VC (chuyn xng) Bn giao QT cho bn Pht hin bt thng - Thm nh li nh k: xem xt li cc d liu | m bo QTSX vn c kim sot k: nh thm nh tin lng

6. i tng thm nh - Nh xng - Thit b - Mi trng - Nguyn liu

- H thng - Qui trnh: quan trng nht v q sp t TC hay khng 7. Li ch - m bo QTSX cho ra sp t CL - Ti u ha QT m bo CL, gim gi thnh - Gim bt cng vic KN - Gii quyt s c nhanh chng - To k kim tra, bo tr h thng tt hn - Cho php mi nhn vin kim sot v ci tin qui trnh 8. Thng s thm nh - L thuc tnh or t/c cn thm nh - S bin i cc thng s ny c th tc ng ti CL thuc - Kim sot cc thng s ny gip m bo CL n nh - Phn tch cc thng s trng yu cn kin thc l thuyt ln kinh nghim sx - Phn loi Thng s tnh: thuc v thit k, TC Thng s ng: + Tnh nng: thng s k thut + Vn hnh: tc , cng , nng sut + CL: ch tiu l, ha, vs 9. Loi hnh thm nh Loi hnh Kim nh nh gi Thm nh i tng Thit b - Phn tch, o lng - Kim sot mi trng Thit b - Sn xut - H thng hu cn Qui trnh, mi trng - Sx, KN - Thao tc chun - KK - BM - Nhn vin

10. Cc giai on thm nh: 3 g Giai on 1. Trc thm nh 2. Thm nh 3. Sau thm nh c im Nghin cu xd CT, QTBC (qui m pilot, sx); nh gi trang thit b (lp t, vn hnh), nng lc QT; thm nh MTSX Thm nh cc thng s trng yu - Thm tra mi lim ca thng s trng yu - D on tnh hung xu Thng xuyn xem xt li mi ti liu lin quan n QTSX | m bo: - Khng c s sai khc vi QTSX - Tun th cc SOPs v cc bin php kim sot Khng c s thay i khi thm nh li QTSX

11. Ti liu thm nh - Phiu thm nh thng s - K hoch thm nh gc - cng thm nh - Bo co thm nh Ti liu Phiu thm nh thng s K hoch thm nh gc c im - M t c th cch tin hnh thm nh 1 thng s - Nhiu phiu thm nh thng s cng thm nh - P/ cc yu t c bn ca chng trnh thm nh - M t chi tit cc ND lin quan ti thm nh - Trnh by ton b cc H thm nh Chnh sch thm nh C cu t chc cc H Tm tt k nh xng, cc h thng, thit b my mc, cc QT cn thm nh Cc biu mu h s ti liu K hoch, lch trnh thc hin Kim sot thay i Tham chiu cc ti liu hin c - VB ha k hoch | hng dn c th cch thc tin hnh thm nh, c ph duyt trc khi thm nh - ND M, YC M t QTSX, cc th nghim

cng thm nh

BC thm nh

ND

Danh mc thit b, tnh trng hiu chun Cc thng s, bin s cn theo di Yu t nguy c, cc 2 ca sp cn theo di Mu th: ly u, khi no, cch ly, lng ly Cc PP th nghim, lim chp nhn Thi gian biu X l kt qu Phn cng nhn s M, YC M t QT Chi tit thit b Thng s thm nh Hng dn ly mu PP, lim chp nhn Kt qu thm nh B sung / sai khc So snh, nh gi KL, ngh

II. Thm nh nguyn liu u vo 1. L do - CL ngun nguyn liu u vo (DC + TD) nh hng trc tip ti CL sp - Khc bit v nguyn liu gia cc nh sx c th do: PP vn chuyn S t/x ca NVL vi nhng k khng mong mun: to, m, O2, /s QT, s tun th v kim sot QT C s VC, trang thit b Trnh , b quyt 2. ND - Kim tra QT phn tch ca nh cung cp xem c ng tin cy hay khng - Thm nh min 3 l mi nguyn liu u vo t nh cung cp u tin Kim tra tt c cc TC cng b: hm m, d lng tro d tha, tp KL nng nh gi n nh ca nguyn liu: vt l, ha hc, VS; b vi dng L or bn R

 Sx th 1 l CP vi nguyn liu u vo c cc thng s k thut v n nh chp nhn Sx 1 vi l CP vi nguyn liu u vo nm lim trn v di ca cc thng s k thut la chn - Kim tra c s sx ca nh cung cp 3. Thm nh nguyn liu DC T/c DC Ha hc Hm lng, tp cht Vt l KTTP, hnh dng, d tan, vtan, dng th hnh, hydrat ha, SBM v khun, lim nhim khun nh hng Mc tinh khit ca sp trn chy DC ng u khi trn SKD CL sp v phng din VSV

Vi sinh

VD: nh hng ca KTTP KTTP SBM vtan SKD (DC km tan / H2O) trn chy ng u khi trn ng u hm lng QT to ht (bt mn cn nhiu TD dnh hn) T/c ht ( trn chy, bn c hc, kh nng chu nn, ng u m v hm lng) 4. Thm nh nguyn liu TD Cn ch : - Ngun gc r rng + uy tn nh sx - CL: cng b, thm nh - ng u gia cc l VD: Mg stearat lm TD trn T/c - KTTP - Hnh dng tiu phn - Phn b KTTP Nguyn nhn sai bit - L khc nhau - Khu vc sx khc nhau - Nguyn liu u vo khc nhau - Nh sx khc nhau nh hng - ng u khi trn - r, ha tan

III. Thm nh PP KN YC vi phng KN: Phi c 1 PP KN thch hp v sn c nh gi CL v hiu qu cc dng thuc R ND thm nh qui trnh KN Thng s Tnh c hiu Khong tuyn tnh chnh xc - lp li - sao li ng Lim pht hin Lim nh lng th nh tnh + nh lng + + Xc nh tp cht Gii hn Hm lng + + +

+ + +

+ -

+ + + + +

1. Tnh c hiu K/n: l kh nng nh gi chnh xc cht phn tch khi c mt nhiu thnh phn khc a. nh tnh A + TT P/ + B + TT P/ P/ c hiu vi A b. nh lng A Kt qu I A + tp Kt qu II I v II ging nhau th p/ c hiu vi A c. X tp cht Tp cn x + A kt qu phn bit 2. Khong tuyn tnh - Khong tuyn tnh gia bin ph thuc Y (vd: A, Spic ) vi bin c lp X (CDC) c x: Vi min 5 C Bng pp hi qui - S lin quan tuyn tnh c trnh by theo pt:

Y = 0 + 1X (Cc h s 0, 1 c xc nh nh pp bnh phng ti thiu v phi c th thng k) 3. chnh xc K/n: l kh nng 1 PP trong c tnh s lp li bt k gi tr nht nh, khng nht thit phi l gi tr tht th hin s dao ng gia cc kt qu phn tch nh gi: da vo sai s chun tng i RSD xtb =

SD = RSD =

YC: thng chp nhn mc RSD < 2% (n 6) Phn loi: - lp li: tin hnh php th trong cng 1 ngy, 1 ngi thc hin v trong nhng k ging ht nhau (thit b, dung mi) - chnh xc trung gian: tin hnh php th khc nhau gia cc ngy, ngi phn tch, thit b phn tch / cng labo - sao li: tin hnh php th trong cc labo khc nhau 4. ng K/n: l kh nng 1 PP c th o c, x gi tr tht ca mu th Phn loi: Gi l gi tr thc, x l gi tr x c bng php th - lch thc nghim: |x | | | - lch thng k: D = X: - Tin hnh ti thiu 9 ln nh lng (n = 9) trn t nht 3 mc C khc nhau, tnh Di ca mi ln - = YC: < 2%

5. Gii hn pht hin (LOD) K/n: l lng t nht ca cht th c trong mu m PP KN c th x c nhng khng nht thit phi chnh xc v ng Cch x - Da vo quan st (thng dng cho PP phn tch khng dng c) Quan st = mt Cmin ti c c p ng ca cht phn tch - Da vo t l / so vi nhiu (ch p dng cho cc PP phn tch c nhiu ng nn nh LC, GC) T l / trn nhiu c chp nhn thit lp LOD = 2:1 or 3:1 VD: HPLC vi tn hiu l chiu cao pic LOD = 3Hmax (mu trng). F vi F = C / H(mu th) - Da vo phng trnh hi qui tuyn tnh: Y = 0 + 1X LOD = 3.3 SD / 1 (SD ca pt hi qui) 6. Gii hn nh lng (LOQ) K/n: l lng t nht ca cht th c trong mu m PP KN c th x c vi chnh xc v ng cho php Cch x - Da vo quan st (thng dng cho PP phn tch khng dng c) Quan st = mt Cmin ti c nh lng c cht phn tch (vi chnh xc v ng cho php) - Da vo t l / so vi nhiu (ch p dng cho cc PP phn tch c nhiu ng nn nh LC, GC) T l / trn nhiu c chp nhn thit lp LOQ = 10:1 VD nt: LOQ = 10Hmax (mu trng). F vi F = C / H(mu th) - Da vo phng trnh hi qui tuyn tnh: Y = 0 + 1X LOQ = 10 SD / 1 (SD ca pt hi qui) 7. th K/n: ch ra mc tin cy ca PP khi c s thay i cc thng s ca PP Vai tr: nh gi th ch dn, kim sot | m bo tnh hiu lc ca QT phn tch VD: Cc bin i thng gp / LC - Thay i pH trong pha ng - Thay i thnh phn pha ng - Ct (khc l, khc nh sx) - to - Tc dng

 Cc lu khc: - Cn nh gi li PP KN nu pht hin n cha ti u hoc ny sinh qu nhiu sai st / QT KN - PP KN phi m bo thc hin c trong k t, trang thit b v k k thut cho php - PP KN phi chc chn v: nh hng trc tip n v kim sot QT v m bo CL sp Sai st lng ph ln - T ng ha PP - Trch nhim thm nh: Nhm pht trin PP Cc chuyn gia k thut Nh qun l kim sot CL IV. Thm nh trang thit b v dng c 1. K/n - nh gi s ph hp trang thit b dng trong g pht trin vi sx qui m ln - X, nh gi trang thit b thay th Lu + Thm nh ton b trang thit b (c, mi) c sd sx sp mi + Protocol thng gm: TC thit k, vn hnh, hiu nng, bo dng + Phn cng thao tc / 1 thit b khng quan trng bng thm nh ton b h thng + Kim nh tng trang thit b khng thay th cho thm nh ton b h thng 2. ND thm nh a. nh gi v thit k (DQ) Da trn h s ca nh cung cp my nh gi b. nh gi v lp t (IQ) - G c bn ca nh gi thit b mi - Thng m trch bi phng k thut - Tin hnh: Thu thp ti liu Nhn dng tng bp, kim tra ton b thit b (theo TC nh cung cp): chnh thc, c h thng, ghi chp thnh ti liu Tin hnh lp t theo k hoch, ghi nhng thay i (nu c) trong h s X cc YC lm VS, bo tr; son SOP lin quan

- VD: My ng nang i chiu ND n t hng Kim tra nhn hiu Xem xt cc 2 vn hnh: kch thc, bi trn, lp sn, vt liu, BM, bp che chn Kim tra s y ca ti liu Kim tra k thut mt ni trung gian Kim nh, hiu chnh cc bp c. nh gi v vn hnh (OQ) - m bo thit b H ng chc nng vi cc thng s n nh trc - Phi c QT kim tra s thay i t lc bt u n lc kt thc qu trnh nh gi vn hnh - Phi tun theo QT c ph chun, kim tra ton b thng s k thut - C th dng sp m phng nh gi vn hnh thit b k bnh thng v xu nht - Kt thc: thm nh SOP vn hnh d. nh gi v hiu nng / hiu sut V. Kim nh thit b v dng c 1. K/n a. Cc loi thit b thng gp / sx v kim tra CL - Thit b phn tch - Thit b o lng - Thit b ch th - Thit b kim sot - Thit b t ghi - Thuc th - My tnh iu khin thit b b. ng, chnh xc ca thit b nh hng n QTSX or CLsp cn kim nh c. Td: gp phn m bo CL, gim sai st, ph phm h gi thnh d. ND - X mqh gia gi tr quan st v gi tr chun - Thit lp lim chp nhn i vi kt qu quan st e. Lu - Khng sd thit b or thuc th khng t TC - Thm nh phi theo SOP v thm nh li theo k hoch

2. Phng tin kim nh a. Thit b chun - Cp II: dng kim nh thit b cn sd (chnh xc > 4 ln) - Cp I: dng kim nh thit b chun cp II (chnh xc > 4 ln) VD: Qu cn chun - Pht hnh bi Vin o lng Quc gia VN: cp II - t ti Vin o lng Quc gia VN: cp I b. Cht chun i chiu - Cht chun lm vic: dng i chiu cht phn tch (vd: ph IR, UV-VIS, HPLC, SKLM) - Cht chun gc: dng kim nh cht chun lm vic VD: Cht chun Acetylcystein - Ca vin KN thuc TW, chun DVN 0109260: cht chun gc - T pha t cht chun gc ti cc PTN sd trong cc php th: cht chun lm vic 3. Tn s kim nh + Lin quan: - Tn s sd - chnh xc - nhy - H s kim nh trc - Khuyn co ca nh sn xut + nh hng tng qut: - Thit b ti cn: 6 thng / ln (vd: thit b trong qt sx) - Thit b c bn: 2 thng / ln - Thit b i chiu: khi lp t 4. Ti liu kim nh - TC KT - SOP kim nh - BC kim nh - Phiu kim nh 5. VD k hoch kim nh a. Kim nh trc khi sd - Cn chnh phn tch: qu cn chun - pH k: d2 m chun - HPLC: lp li / sao li (tim nhiu ln)

b. Kim nh mi ngy - T m / t lnh: kim tra to c. Kim nh mi thng - Cn phn tch: qu cn chun d. Kim nh mi qu - Quang ph IR: phn gii (mng polystyrene) - HPLC: tc dng (th tch) - GC: tc dng kh (lu lng k) e. Kim nh 6 thng / ln - My th mi mn: kim tra s vng quay / pht - Phn cc k: d2 chun - L nung: kim tra to f. Kim nh mi nm - Khc x k: nc kh ion - My o im chy: kim tra im chy chun - Nht k: du chun 6. VD: SOP kim nh nhit k - t nhit k chun bn cnh nhit k th (1) - c to trn 2 nhit k sau > 1h 25oC (2) - Lm li bc (2) 3 ln (3) - Lm li bc (2) v (3) 30oC (4) - Lm li bc (2) v (3) 40oC (5) - Sai khc to gia nhit k th v nhit k chun khng c qu 0.5oC - Ghi kt qu kim nh vo h s

VI. Kim sot cc bin qui trnh 1. K/n - Cng c nh gi QT - Q kim sot bin no | m bo sx n nh sp 2. Cch tin hnh - Thu thp d liu v TT quan trng / g tin cng thc, b sung / qt pht trin - Tng ng vi mi g sx cn x mi bin lin quan - nh gi cc TT: q ch tiu no trong QT c kim sot Thu thp d liu KN X lim cc thng s k thut mc chp nhn c Chy th: sd cc thng s gi tr min or max, YC mi sp t CL

 Chng nhn CL thit b: m bo k vn hnh nm trong khong gii hn cho php 3. Kim sot trong QTSX (bn thnh phm) Ch : Ch tiu quan trng nht l ch tiu nh hng n: kh nng chu nn, cng, dy, r, ha tan, ng u khi lng v hm lng vin a. Hm m (ht sy kh) - nh hng: kh nng lin kt, cng, r, trn chy, ng u hm lng, bn DC - X: mt khi lng do lm kh - YC: thng < 2% b. Phn b kch thc ht - nh hng: trn chy, s phn lp, ng u khi trn - X: ry nhiu tng c. ng u khi trn - nh hng: ng u hm lng - X: nh lng ( phn tn hm lng) - Ch : K thut ly mu rt quan trng (v tr ly mu, c mu) T trn phi ph hp (khng qu ngn, khng qu di) d. ng u khi lng vin - n nh khi khi bt / ht c trn chy tt & trang thit b H n nh - Dao ng do: Cng thc v QT cha ti u Trang thit b cn bo tr sa cha - YC: nm trong khong q VD: vin nn thiamin nitrat (thc tp): 7.5 % e. cng vin - YC: t/m vin cng & khng nh hng ha tan DC - c q trong tng g - Ph thuc: Fnn, tnn, hm m (bt / ht, mi trng), TD dnh, TD r, TD trn f. dy vin - Y/n: Lin quan gin tip n cng vin Cho bit cng thc vin c t trn chy v kh nng chu nn khng - c q trong tng g

g. r - c q / QTSX - D bo trc ha tan SKD ca vin nn 4. KN thnh phm a. Hnh thc: Kim tra xem c vt bn, lch dng ch, phim ha, ba via, u mu khng (nu vin c mu) b. nh lng: Theo TC c. ng u hm lng - Tin hnh / QTSX l thuc (b, gia, kt thc) | m bo dng thuc t TC (15% so vi hm lng trn nhn) hoc trong lim cho php - L dh cho bit cc tp c b tch ra / QTSX khng d. cng vin e. b vin: thng YC < 1% f. ha tan: phi ph hp, ng nht gia cc l m 5. Mt s bin qui trnh - t, v / qt trn, to ht - T l dm, TD dnh thm vo / qt to ht - t, to, k thi gi / qt sy, bao mng / ng - Kch thc mt li, v a nguyn liu, v nghin / qt nghin - v, F / qt dp vin - v, V lm y / qt ng nang VII. Thm nh QTSX vin nn bao A. Nguyn liu u vo 1. DC T/c tan / pH sinh l KTTP Trng thi vt l (dng th hnh) d (tuyt i, biu kin) trn chy, kh nng chu nn tonc /n X vic sd cht tng tan X mc TD sd, TD dnh, TD tr tan Ngn cn s bin i dng th hnh La chn TD pha long c d ~ dDC | gim s phn lp DC TD La chn PP BC, TD La chn PP BC (DC c tonc thp nn dp thng)

 n nh, tnh ho m 2. TD - L do sd (td) - Lng sd - T/c lu 3. Cc v khc - TC - Nh cung cp - Gi thnh B. QT, thit b 1. G trn ND T/c vt l ca nguyn liu - dth - Phn b KTTP - Hnh dng tiu phn - SBM KT trn - Phn tn (nho trn) - i lu (kiu hnh tinh or cao tc) - Nn kh (tng si) Tc trn

La chn PP BC, cc lu / QT BC

/n ng u khi trn NX: Nguyn liu c t/c vt l tng t d to h2 ng nht, hn ch tch pha - ng u khi trn - ttrn - La chn thit b - Tc ng ti cc tp / cng thc - Mc phn tn (VD: trn DC & TD YC trn mc cao hn so vi trn TD trn vi ht) - ttrn X ttrn ti u: - Trn khng t s khng t ng u mong mun - Trn qu lu c th lm tng phn tch cc thnh phn, lng ph v t, kinh t P/ ng u khi trn (hiu qu trn) - Ly mu trong sut qu trnh trn. - KT ly mu v x l nguyn liu rt quan trng (vd: c mu, cc v tr ly

ttrn Ph thuc cng thc, k thut, tc trn ng u hm lng

 ng u TD

Cng sut thit b

mu q mu c ly c mang tnh i din khng) TD cng YC ng nht trong h2 trn, b: - TD trn: nh hng kh nng lk tiu phn, chng dnh, tan DC - TD to mu: m bo hnh thc cc vin ng nht - Kim tra cc Vtrn (30, 50, 70 %) | ti u ha qu trnh: qu nhiu or qu t nguyn liu / thit b c th lm qt phn tn km

2. G to ht t ND Thit b to ht /n - tto ht - Tc ng ti cc tp / cng thc - Kh nng kim sot qu trnh - Kh nng t ng ha - Chi ph - Dng TD dnh: TD dnh L or dm + TD dnh kh - CTD dnh: ti u cho mi cng thc, thit b | to ht m khng lm t khi bt - Lng TD dnh: lin quan C Qu t: hiu qu to ht thp Qu nhiu: khi bt qu m, ko di t lm kh - Tc thm TD dnh | trnh vn cc X ttrn ti u: Nho khng t: ht yu or nguyn liu khng to ht ton b trn chy km, chu nn km Nho qu lu: ht cng gim vtan ca DC, nh hng ti SKD - X im dng ca qt to ht - Kh nng kim sot im dng

TD dnh

ttrn

im dng ca qu trnh to ht

 Bng thit b (vd: o in th) Thng qua kim sot thng s qui trnh (vd: ttrn) 3. G xt ht t M: To BM rng | sy Kim sot phn b kch thc ht ND Cng sut, dung tch thit b Kch thc li /n Chn my ln | x l ton b l trong t hp l, trnh lm kh nguyn liu trong qu trnh xt ht X kch thc li hp l - nh | ph v cc ht to - Khng qu nh: tn t; c th dn ti tng to qu mc, nh hng ti n nh nguyn liu X tc xt ti u m khng lm nh hng ti thit b X tc a nguyn liu ph hp (lin quan kch thc li, kch thc cn xay, tc xt)

Tc xt Tc a nguyn liu

4. Sy kh ND K thut sy, thit b sy /n - La chn lin quan ti 2 DC, cng thc, trang thit b - nh hng t/c vin: cng, r, ha tan, n nh X hm m ti u - Qu cao: gy b vin, dnh vin vo mt chy; gim n nh DC, TD - Qu thp: gim cng, c th khng dp vin c - to u vo: q hiu qu qt sy, cn cao | ti u ha qt sy m khng nh hng n nh ca ht - to u ra: cho bit toht, ph thuc to u

Hm m khi ht

tosy: u vo, u ra

Thi kh (lu thng kh) Cng sut, kh nng cha ca thit b

ng u hm m

vo, hm m b nh hng n hiu qu sy, s ng u ca qu trnh sy, n nh DC (thi km ko di tsy) - Nguyn liu a vo c lm kh tt / 1 khong n v nht nh - Sy tng si: nguyn liu a vo ti a ngha l qua mc s vt qu kh nng vn chuyn ca dng kh Cc yu t nh hng: - ng u to ca thit b - m ht - Dng cc ht (thit b tng si)

5. Sa ht kh ND Kch thc, phn b kch thc ht ti u PP nghin: nn hay sng C ry Tc nghin /n nh hng ti t/c ht: trn chy, kh nng chu nn, r, ha tan nh hng ti kch thc ht - nh hng ti kch thc ht - Ry qu nh to nhiu bi - nh hng ti kch thc ht, phn b kch thc ht: tng tc nghin kch thc ht cng nh, khong phn b cng rng - Tng to: c th nh hng ti n nh sp Ph thuc cng sut, dung tch cha ca my, c ry, tc nghin

Tc a nguyn liu

6. Dp vin ND trn chy ca ht Kh nng chu nn ca ht Thit k chy ci /n nh hng ti ng u m v hm lng vin nn nh hng ti s to thnh vin, Fdp - S ng u ca b chy ci nh hng ti ng u ca cc vin

Tc dp

F dp

- X v tr khc, su, cch khc ch | vin khng b b / qu trnh nn, qt bao khng lm y ch khc nh hng bn c hc vin (dp qu nhanh c th gy bong mt), ng u m vin (tc ht chy vo ci c u hay khng) X F dp ti u | vin t bn c hc cn thit (ch vin qu cng ko di tr)

Cc thng s kim tra / qu trnh dp vin: Hnh thc m vin ng u m cng b, mi mn r 7. G bao vin

ND c tnh vin (hnh dng, bn c hc) Loi thit b Lng vin bao

Tc quay ni bao Sng phun

Tc phun

/n nh hng hnh thc vin bao, hiu sut bao Nt - Ni bao: qu nhiu vin / ni bao c th dn ti bo mn vin nn do qu ti - Tng si: qu nhiu vin / thit b c th khng lu thng kh VC vin Lin quan cc thng s bao khc: to u vo, tc phun dch, tc thi gi - X s lng, loi sng, kch thc vi phun | phn b u dch bao trn dng vin nn; trnh hin tng dnh, tc vi phun - X v tr t, gc ca sng phun | bao ph tt nht X tc phun ti u - Phun qu nhanh: vin qu m, vn

Dng vin

D2 bao to, thi kh dy mng bao Dm tn d nh gi hnh thc vin bao: Nt v or bong mng Lm y vt khc Mc th rp ca BM vin ng u mu sc

cc, c th ha tan mt vin - Phun qu chm: mng b kh trc khi dnh ti vin mt vin th rp, gim hiu sut bao - Vin nn chy theo mt dng x: m bo phn b u dch bao - C th thm 1 s tc nhn cn tr | m bo C chnh xc ca dng vin - Cdd q lng cn sd - X n nh ca dch bao nh hng tc sy vin, CL mng bao, hiu sut bao, n nh DC v TD Cn ph hp | to cc vin c hnh thc ng nht, t yu cu nh hng CL vin: cn m bo khng nh hng ti SK ngi sd