Protocol for hold time study of sterile garments

PROTOCOL FOR HOLD TIME STUDY OF STERILE GARMENTS

S. NO. TITLE PAGE NO.
1. PROTOCOL PRE APPROVAL
2. OBJECTIVE
3. SCOPE
4. RESPONSIBILITY
5. REASON FOR VALIDATION
6. TRAINING RECORD
7. OVERVIEW FOR HOLD TIME STUDY OF STERILE GARMENTS
8. PROCEDURE
9. ACCEPTANCE CRITERIA
10. FAILURE INVESTIGATION AND CORRECTIVE ACTION
11. DOCUMENTATION
12. REVALIDATION CRITERIA
13. FREQUENCY OF QUALIFICATION
14. CONCLUSION
15. REFERENCE
16. ABBREVIATIONS
17. REVISION HISTORY

1. OBJECTIVE:
To validate the Hold time study for ‘STERILE GARMENTS’ and to establish a documented evidence to ensure that the proposed method of sterile garment is capable of free from microbial contamination to daily used in Sterile section.
2. SCOPE:
This protocol is applicable for Hold Time Study of ‘STERILE GARMENTS’ in Injection manufacturing area and microbiology area at M/s company
It covers the sampling of microbial contamination of the garments worn by the personnel working in manufacturing area and microbiology area by using sterile swabs & to transfer this swab to a nutrient medium & subsequent incubation to assess the sterile garment is free from microbial contamination.
3. RESPONSIBILITY:
To conduct the Hold Time Study of ‘STERILE GARMENTS’ a team shall be formed. The team shall contain the members from the Quality Control, Engineering, Production and Quality Assurance Departments. The Validation team is described through the following responsibility:

4. REASON FOR VALIDATION:
Initial Hold Time Study of sterile garments:
5. TRAINING RECORD:
Training to the Validation Execution Team shall be provided for execution of Protocol before starting the validation activity. The training records should be recorded in the report.
6. OVERVIEW FOR HOLD TIME STUDY OF STERILE GARMENTS:

7. PROCEDURE:
Take 7 pieces of garments (5 x 5 inch) and sterilized as per SOP
After completion of sterilization process store the 7 pieces of garments in garment storage cabinet as per SOP
Sampling of the sterilized garments as per sampling plan and perform the sterility testing as per SOP for sterility testing SOP
8. SAMPLING PLAN:

No. of Sterile Sample Garments	Sampling Frequency
07 Pieces of Sterile Garments	0 Hour
	12 hours
	24 hours
	36 hours
	48 hours
	72 hours
	96 hours

8.1 ACCEPTANCE CRITERIA:
This study is carried out to establish the hold time of sterilized garments after sterilization.
No growth should be observed in sterility test (In both medium SCDM and FTGM) at the completion of incubation period (14 days).
9. FAILURE INVESTIGATION AND CORRECTIVE ACTION:
If result is comes out of limit then investigate the route cause. On the basis of investigation necessary corrective action shall be implemented. Again repeat the hold time study for sterile garments.
10. DOCUMENTATION:
After analyzing the Swab samples, record the result and observation in report.
11. REVALIDATION CRITERIA:
Any change in washing and sterilization procedure.
Change in testing procedure
Change in cleaning agent
Periodic revalidation

12. FREQUENCY OF QUALIFICATION:
Once in a year +1 month.
13. CONCLUSION:
Provide the conclusion and recommendation on the basis of execution results of the hold time study for sterile garments.
14. REFERENCE:
Validation Master Plan
SOP for Handling Of Sterile Garments SOP
SOP for sterility testing SOP
15. ABBREVIATIONS:
Pvt. : Private
Ltd. : Limited
GVP : General Validation Protocol
SOP : Standard Operating Procedure
PD : Production
QM : Quality Control Microbiology
SCDM : Soyabine Casiene Digest Agar
FTGM : Fluid Thyoglycolate Medium
IP : Indian Pharmacopoeia
BP : British Pharmacopoeia
USP : United State Pharmacopoeia
16. REVISION HISTORY: