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Eng023-Fm01 3
Eng023-Fm01 3
Title: Temperature & RH data logger/A Pressure Manual Daily Check in Production
Department
HIKMA EGYPT
STANDARD OPERATING PROCEDURE
Eng023-FMS I
Version: 3 Page: 1 of 5
_....14::'
Prepared by/date: tved by: Approved by: Effective date:
7A ....\ - ‘5
-
_________ I-01-241
11
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, .2 2 . 0
i-2 i i 0 c --
z_a•,■.1.9
Item AP T e m
p . RH
15-30°C
Limit 10 20 Pa 30-65 %
15 — 25 °C (For staging areas)
-
Check
sign I,
Check
Zero
Zero
AP C° RH % AP C° RH % sign
Comment.......................................................................................................................................................................................
Engineering Weekly check (sig./date). ..............................................................................................................................................................................................................
Zero
Zero
Check
Cheek
AP C' RH % AP C° RH % sign
Granulation G-SD-33
Drying 1 Tray oven G-SD-34
Empty room G-SD-35
Compactor G-SD-36
IPC G-SD-37 B.S B.S B.S B.S
Tool Shop G-SD-09 B.S B.S B,S B.S
Fette 2200 1 G-SD-I1
Killina G-SD-12
PAM -90 G-SD-38
PAM -25 G - S D - 3 9
Fette 2200 G-SD-40
Bosch G-SD-41
Coating fayroze G-SD-42
Production PAL G-PL-43 A B.S B.S B.S B.S
Production PAL G-PL-43 B B.S B.S B.S B.S
Production MAT G-MT-49 A B.S B.S B.S B.S
Production MAT G-MT-49 B B.S B.S B.S B.S
Sejong Coating M/C G-SD-13
Solution prep G-SD-19
Air Pack Coating G-SD-I8
Comment.
Engineering Weekly check (sig./date)-..................................
Version: 3 Page: 3 of 5
Check
Cheek
Zero
Zero
AP C° RH % AP C0 RH % sign
Comment.
Eng023-FM0 I
Version: 3 Page: 4 of 5
Zer©
sign
Zero
Check
Cheek
C0 RH % AP C° RH % sign
PAL G - PL -104A
<1
PAL G - PL -104B
PAL G-PL-70
MAT G-MT-109A 13.S 13.5 B.S B.S
MAT GMT-109 B
Suppository G-SS-71
MAT G-MT-79 13.S 13.5 13.S 13.S
Ointment Prep G-SS-68
Ointment Filling G-SS-69
Corridor G-MC-78
MAT G-MT-077
New Liquid Filling G-LQ-82
Liquid Prep PAL G-PL-51 13.S 13.5 B.S B.S
liquid Preparation G-LQ-52
MAT G -MT -53
5.5 Staging G-SS-55
MAT G-MT-56 A 133 B.S I3.S I3.S
MAT G-MT-56 B 13.S 13.S B.S I3.S
Comment.
Engineering Weekly check (sig./date)•......................................................................................................................................................................................................
Area : Primary Packaging & Secondary Packaging & Production entrance Date : / 201
1st reading 2n reading d
Time:.............................. T
ime:............................................................ Doer
Doer Checker Checker
Room name Code sign
sign sign sign
oiaz
maaqp
Zero
Check
AP C° RH % AP C° RH % t,
Comment..........................................................................................................................................................................................................................................................
Engineering Weekly check (sig./date)•......................................................................................................................................................................................................
CONFIDENTIAL INFORMATION HIKMA EGYPT
NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL