CNG THM NH

QUY TRNH SN XUT

KEM BI DA PESANCORT
B phn: Ban thm nh.

Trang: 1 / 10
M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

Son tho

Kim tra

Ph chun

Ngy 05/ 05/ 2014

Ngy 06/ 05/ 2014

Ngy 06/ 05/ 2014

Th k
Ban thm nh

Trng phng
m bo Cht lng

P. Tng Gim c
Qun l cht lng

DS. Trng Th Hnh Phc

DS. L Th Kim Thoa

ThS. Hong Th Hng Phng

Ni nhn
a.
b.
c.
d.

Phng m bo cht lng

Phng Nghin cu & Pht trin
B phn Kim tra cht lng
Xng KMN

 CNG THM NH

Trang: 2 / 10

QUY TRNH SN XUT

KEM BI DA PESANCORT
B phn: Ban thm nh.

M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

1. Mc ch yu cu
Hng dn tng qut v hot ng thm nh quy trnh sn xut:
Tn sn phm:
Kem bi da PESANCORT
M s:
H11PES1M101 - Hp 1 tup 10 gam
H11PES1M102 - Hp 1 tup 5 gam
Thuc k hoch thm nh:
-

Thm nh ng thi

Thm nh lui

Thm nh li (nh k)

2. M t quy trnh sn xut

2.1. Thnh phn cng thc
STT

Thnh phn

L sn xut
60 kg

Hm lng

Ngun gc

Tup 5 gam

Tup 10 gam

1. Acid Fusidic

105 mg

210 mg

1260 g

Ty Ban Nha

2. Betamethason
(di dng Betamethason valerat)
3. Emulsifying wax (Polawax )

5,25 mg

10,5 mg

63 g

M Lai

450 mg

900 mg

5,4 kg

Singapore

4. Alcol Cetostearyl

150 mg

300 mg

1,8 kg

M Lai

5. Alcol Cetyl

100 mg

200 mg

1,2 kg

M Lai

6. Surfacare (PEG 100 Stearat)

200 mg

400 mg

2,4 kg

Anh

7. Vaselin

150 mg

300 mg

1,8 kg

5 mg

10 mg

60 g

Nht Bn

1250 mg

2500 mg

15 kg

Singapore

5 mg

10 mg

60 g

H lan

10 mg

20 mg

120 g

Nht Bn

8. Polyoxyl 40 hydrogenated castor

oil
9. Propylen glycol
10. Natri EDTA
11. Methyl hydroxybenzoate
(Nipagin)

 CNG THM NH

Trang: 3 / 10

QUY TRNH SN XUT

KEM BI DA PESANCORT
B phn: Ban thm nh.

12. Propyl hydroxybenzoate

(Nipagol)
13. Nc ct

M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

2,5 mg

5 mg

30 g

Nht Bn

2573 mg

5146 mg

30,8 kg

Vit Nam

2.2. Tm tt quy trnh:

a. Pha ch tng du : un chy hon ton cc t dc Emulsifying wax (Polawax ), Alcol
Cetylic, Alcol Cetostearyl, Surfacare, vaselin , thu c tng du t nhit khong 85 90 0C.
b. Pha ch tng nc: un v khuy u cc t dc thn nc: Polyoxyl 40 hydrogenated
castor oil, Na EDTA, Nc tinh khit thu c tng nc t nhit khong 85 90oC.
c. Pha ch dung dch hot cht v cht bo qun: ho tan hon ton Methylparaben, Propyl
hydroxybenzoate trong Propylen glycol. Tip tc ha tan dc cht Acid Fusidic, Betamethason
valerat thu c hn hp dung dch dc cht v cht bo qun.
d. Pha ch t dc nh tng: Phi ch tng du (a) v tng nc (b) thu c t dc nh
tng t nhit 55 580C.
e. Phi ch dung dch dc cht v cht bo qun (c) trn vo t dc nh tng (t nhit
55 580C) thu c kem thuc PESANCORT.
e. ng thuc vo tup: Ci t cc thng s v s l, hn dng, ng lng kem thuc vo
tup v gp kn y tup, tc ca my ng tup: 52 58 tup / pht.
ng u khi lng thuc:
5g 15%; 10g 10%
g. ng hp: Cho mt tup thuc v mt t hng dn s dng vo hp gp, c in s l sn
xut, hn dng, ngy sn xut v ci np hp. 10 hp nh c co bi mt lp mng co b cht.
h. ng thng:
Tup 5 gam : 480 hp/thng
Tup 10gam : 320 hp/thng

 CNG THM NH

Trang: 4 / 10

QUY TRNH SN XUT

KEM BI DA PESANCORT
B phn: Ban thm nh.

M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

2.3 S sn xut:
Thng s k thut

Ch tiu kim sot,

kim nghim
Nguyn liu

t 0 tng du:
85-95 OC
t 0 tng nc:
85-90 OC

Pha ch tng du
(My nh ho chn khng)

Pha ch tng nc
(Thng inox)

- Khuy trn : 50 v/ ph v nh ho
2200 v/ ph, trong 20 pht
Pha ch t dc kem
-Duy tr nhit >80 0C trong 10
(My nh ho chn khng)
pht
-Nhit t dc kem: 55-58 OC

-Khuy trn: 50 v/ ph trong 60 pht

-Nh ha : 2000 v/ p,trong 20 pht
-p sut: -700 n - 400 mmHg
-Nhit kem thuc: 40-43 0C

-Tc : 52-58 tup/pht

Pha ch dung dch dc cht

(Soong inox)

Pha ch kem thuc

(My nh ho chn khng)

ng tup
(My ng tup )

ng gi cp 2
(ng hp, ng thng)

Thnh phm
(Nhp kho,
xut xng)

p v
(My p v TQ)

- ng u hm lng
hot cht
- ng nht
-Bt kh
-pH

- Hnh thc
- ng u khi lng
thuc ng tup
- nhim khun

KN thnh phm theo TCCS

 CNG THM NH

Trang: 5 / 10

QUY TRNH SN XUT

KEM BI DA PESANCORT

M s: I105120T

B phn: Ban thm nh.

Ban hnh:
Ngy: 06/ 05/ 2014

3. Danh sch thit b:

3.1 Thit b sn xut:
STT

Tn thit b

M s

Cng dung

1.
2.
3.

Cn bn in t TFW 150
Cn ng h Nhn Ha 100 kg
Cn k thut in t 300 g Vibra
(Nht)
My trn nh ho chn khng
SY-HME-100/2
My ng tup t ng E-250
MATIC
T sy tnh 2 ca KBC-TST- 2M3

D034294GB
D034487VN
D043377JP

Cn nguyn liu
Cn nguyn liu
Cn tup thuc

D013927TW

Pha ch kem

D014037IT

ng thuc vo tup

D014107VN

Sy kh tup

4.
5.
6.
7.
8.
9.

My in phun DOMINO
D014057GB
My mng co Vit Nam
D014067VN
Ni un nc ct, nhit k v cc
dng c khc (xoong inox, que
khuy, ....)

In s l, hn dng
Co bc cc hp thuc
Dng c Pha ch

Thng s k
thut (cng
sut, dung
lng,...)
Max: 150kg
Max: 100 kg
Max: 300g
Dung tch lm
vic 50- 60 kg
52-58 tup/pht
Dung tch max:
2 m3
1-4 dng

3.2 Thit b kim nghim:

ST
T

Tn thit bi

Ma s

Cng dng

1.

T m Memmert

D023471DE

mu

2.

T sy Vit nam

D023571VN

Sy dng c

3.

My quang ph UV-Vis Agilent 8453

D023271US

nh lng

4.

My soi bn mng sc k

D023671FR

Soi bn mng

5.

Cn Precisa XT 220

D023691CH

Cn mu

6.

Cn K thut Precisa 610

D023701CH

Cn mu

7.

Cn phn tch Precisa 205

D023721CH

Cn mu

 CNG THM NH
QUY TRNH SN XUT
KEM BI DA PESANCORT
B phn: Ban thm nh.

Trang: 6 / 10
M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

4. Phn tch nguy c:

Cng on

Nguy c d kin

Mc nh Thng s k thut
hng
lin quan

Tin hnh
thm nh
(*)
tng Xc nh nhit Khng
thch hp

Pha
ch -T dc khng Trung bnh
tng du
ng nht

-Nhit
du

Pha
ch
tng nc
Pha ch t
dc kem

-Nhit tng
nc
-Thi gian khuy
trn
-Tc khuy
trnk
-Nhit phi ch
-Thi gian khuy
trn
(Khuy trn th
cng)

Xc nh nhit Khng
thch hp
-Xc nh thi Khng
gian khuy trn
thch hp

-Tc khuy trn;

nh ha
-Thi gian khuy
trn; nh ha
-Nhit phi ch
hot cht

C nh tc C
khuy trn-nh
ha v thi
gian nh ha,
xc nh thi
gian khuy trn

-Tc ng tup

Chn tc
thch hp

-T dc khng Trung bnh

ng nht
-Th cht t dc Trung bnh
khng t

Pha
ch -Hot cht khng Trung bnh
dung dch tan hon ton
hot cht
Pha
ch -Th cht, ng Nghim trng
kem thuc
nht ca
kem
thuc khng t
-Hot cht phn Nghim trng
tn khng u
ng tup

-Khi lng thuc Nghim trng

ng tup khng
u
-Hnh thc tup Trung bnh
khng t

Bin php

Xc nh thi Khng
gian khuy trn
bng cm quan

(*) Cc cng on trng yu c nh gi l c nguy c nh hng Nghim trng n cht

lng sn phm u phi c thm nh.

 CNG THM NH
QUY TRNH SN XUT
KEM BI DA PESANCORT
B phn: Ban thm nh.

Trang: 7 / 10
M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

5. Thng s thm nh
Mc tiu
thm inh

Thng s
trng yu

Chi tiu

Thi gian khuy trn sau

khi phi ch hot cht:
kho st 3 thi im 45, 60,
75 pht k t khi phi ch
hot cht n khi thu ly sn
phm.
(Tc khuy 50vng/pht;
tc nh ha 2000
vng/pht v thi gian nh
ha: 20 pht)

CV Betamethason valerat < 2%

(Hm lng Betamethason
valerat t 90,0-110,0 % so vi
hm lng ghi trn nhn)
ng nht: Kem thuc phi
ng nht
Bt kh: Khng c c bt
kh
pH: 4,5 -6,0

ng tup:

-Khi lng thuc ng tup:

Kim sot bi biu Shewhart
XTB v R (Khi lng thuc
ng tup kim sot nm trong
gii hn ca tiu chun)
- nhim khun: t TCCS
-Sn phm khuyt tt: Kim
sot bi Shewhart P
Theo TCCS ca Kem bi da
PESANCORT

Tc : 55 tup/pht

Kim
nghim l
sn phm
Tnh lp li
ca 3 l

Phng php
thm inh

Thng s

Cc tiu ch cht lng ca

sn phm Kem bi da
PESANCORT
Cc tiu ch cht lng ca
sn phm Kem bi da
PESANCORT

3 l t cht lng v c tnh

lp li

Thc nghim
v thng k

Thc nghim
v thng k
Php
ANNOVA 2
yu t khng
lp

6. Ly mu kim nghim
Mc tiu thm
inh
Thng s trng yu

Thng s

Thi gian khuy trn

Tc ng tup: kho

Thi im ly mu
Kho st ti 3 thi
im: 45, 60, 75 pht
k t khi phi ch
hot cht n khi thu
ly sn phm.
Kho st 6 l cho 2
dng ng gi: 3 l

Cch ly mu
Mi thi im, ly 5
mu ti 5 v tr theo
s ly mu
Mi dng ng gi,
ly mu cho mi l

 CNG THM NH
QUY TRNH SN XUT
KEM BI DA PESANCORT
B phn: Ban thm nh.

Mc tiu thm
inh

Thng s

M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

Thi im ly mu

st ti tc 55
tup/pht

Trang: 8 / 10

cho dng 5g v 3 l
cho dng 10g

Kim nghim l sn Cc tiu ch cht lng

phm
Kem bi da
PESANCORT

Sau khi kt thc

qu trnh sn xut

Tnh lp li ca 3 l Cc tiu ch cht lng

ca Kem bi da
PESANCORT

Sau khi kt thc

qu trnh sn xut

S ly mu
3

7. Phng php tin hnh

Theo cng thm nh li quy trnh sn xut v cc SOP lin quan:

Cch ly mu
nh sau:
-Ly 10 tup x 20
mu cch nhau 5 pht
kho st ng
u khi lng thuc
ng tup.
- Ly 50 tup x 20
mu cch nhau 5 pht
kho st sn phm
khuyt tt
-Ly ngu nhin 1
mu x 3 tup kim
tra nhim khun.
Ngu nhin

Ngu nhin

 CNG THM NH

Trang: 9 / 10

QUY TRNH SN XUT

KEM BI DA PESANCORT
B phn: Ban thm nh.

SOP thm nh thng s trng yu

SOP thm nh tnh lp li ca quy trnh

SOP thm nh lui

SOP thm nh li (nh k)

M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014

8. K hoch sn xut thm nh

*Dng 10g:
STT

L s

C l

Thi gian

01

50 kg

Thng ../ 2014

02

50 kg

Thng ../ 2014

03

50 kg

Thng ../ 2014

*Dng 5g (chi thm inh cng on ng tup)

STT

L s

C l

Thi gian

01

50 kg

Thng ../ 2014

02

50 kg

Thng ../ 2014

03

50 kg

Thng ../ 2014

9. Ti liu lin quan

-

Quy trnh sn xut ch phm cn thm nh.

Cc SOP vn hnh thit b sn xut lin quan.
Cc Hng dn an ton lao ng lin quan.

10. Phn cng nhn s

a. Phng m bo Cht lng:
- Ch o son tho v hon thin ban hnh cng, cc Phiu thm nh v Bo co thm
nh quy trnh sn xut.
- Ch o v theo doi cng tc thm nh quy trnh sn xut.
- Thnh l p Bo co thm nh quy trnh sn xut.
b. Phng NC & PT:
- Son ni dung quy trnh v cc thng s cn thm nh.

 CNG THM NH
QUY TRNH SN XUT
KEM BI DA PESANCORT
B phn: Ban thm nh.

c.
d.
-

Ch o sn xut theo quy trnh.

Xng sn xut: h tr.
B ph n Kim tra cht lng: .
Son ni dung quy trnh v s lng ly mu.
Phn tch cc mu thm nh v tr li kt qu.

Trang: 10 / 10
M s: I105120T
Ban hnh:
Ngy: 06/ 05/ 2014