FORMATPage 1 of 3

DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION

TITLE: AIR VALIDATION PROTOCOL

FORMAT NO.F-VAL-MD-005 SUPERSEDES

-

ISSUE DATE01/01/2007

EFFECTIVE DATE

04/01/2007

REVIEW DATE

Not later than Dec. 2008

Reason for review

Change in format.

VALIDATION PROTOCOL – I

Plates exposed on : Exposure Time :Plates observed on : 1) TAMC : Incubation Temperature :1) TAMC : 30°C To 35°C

2) TYMC : 2) TYMC : 20°C To 25°CTemperature: Relative Humidity:

AHUNO.

PlatesExposed

Plate No.

Grill No.

TAMC TYMC Pathogens E. coli Salmonella P.

aeruginosa

S. aureus

1 Sampling RM 1 S1

Material air lock 2 S2

Men air lock 3 S3

2 Micro section 4 S1

3 Liquid filling 5 S1

Air lock 6 S2

4 Men air lock 7 S1

Dispensing 8 S2

Material entry 9 S3

5 Comp - I 10 S1

6 Comp - II 11 S1

7 Comp - III 12 S1

8 Comp - IV 13 S1

Comp - passage 14 S1

  15 S2

  16 S3

9 Blender room 17 S1

  18 S2

Positive control -Negative control -

Done By : Checked By :Date : Date :

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

MICROBIOLOGIST Q. C. MANAGERASSISTANT

Q. A. MANAGER DIRECTOR

FORMATPage 2 of 3

DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION

TITLE: AIR VALIDATION PROTOCOL

FORMAT NO.F-VAL-MD-005 SUPERSEDES

-

ISSUE DATE01/01/2007

EFFECTIVE DATE

04/01/2007

REVIEW DATE

Not later than Dec. 2008

Reason for review

Change in format.

VALIDATION PROTOCOL – II

Plates exposed on : Exposure Time :Plates observed on : 1) TAMC : Incubation Temperature :1) TAMC : 30°C To 35°C

2) TYMC : 2) TYMC : 20°C To 25°CTemperature : Relative Humidity :

AHUNO.

PlatesExposed

Plate No.

Grill No.

TAMC TYMC Pathogens E. coli Salmonell

aP. aeruginosa

S. aureus

10 Granulation 19 S1

  20 S2

  21 S3

  22 S4

11 Capsule manufacturing 23 S1

  24 S2

12 Air lock 25 S1

EHG capsule 26 S2

13 Capsule 27 S1

Filling area 28 S2

14 Strip packing 29 S1

15 Bulk packing 30 S1

16 Blister packing 31 S1

17 Inspection area 32 S1

18 Inspection area 33 S1

19 Bulk packing 34 S1

20 Passage pack 35 S1

  36 S2

Positive control -Negative control -

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

MICROBIOLOGIST Q. C. MANAGERASSISTANT

Q. A. MANAGER DIRECTOR

FORMATPage 3 of 3

DEPARTMENT: QUALITY CONTROL – MICROBIOLOGY SECTION

TITLE: AIR VALIDATION PROTOCOL

FORMAT NO.F-VAL-MD-005 SUPERSEDES

-

ISSUE DATE01/01/2007

EFFECTIVE DATE

04/01/2007

REVIEW DATE

Not later than Dec. 2008

Reason for review

Change in format.

Done By : Checked By :Date : Date :

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

MICROBIOLOGIST Q. C. MANAGERASSISTANT

Q. A. MANAGER DIRECTOR