Validation Protocol for Hold Time Study of Sterilized Glassware and Accessories

1.0 OBJECTIVE

       The objective of this protocol is to provide documented evidence through the scientific data to establish and verify the microbial presence on sterilized glassware and accessories upon holding up to the specified time after sterilization by using the microbial detection method.

2.0 SCOPE

       The scope of this protocol is to evaluate the hold time of sterilized glassware and accessories after sterilization in an autoclave.

3.0 Reference Document

•  SOP for operation and cleaning of Autoclave

•  Cleaning of glassware

•  SOP for Handling of Glassware

4.0 Responsibility

4.1  Quality Assurance

       Review and approval of protocol

4.2  Quality Control

       Preparation, review and execution of protocol

5.0 ACCOUNTABILITY

       Head QA & QC

6.0 Procedure

6.1 Pre-Requisite

Environmental conditions should be maintained within the established limit.

6.2 Procedure For Hold Time Study

6.2.1  Perform the sterilization of the following material Screw capped bottles, Miliflex funnels, SS frits and tips as per the SOP for sterilization.

6.2.2  Store the sterilized material into the laminar air flow.

6.2.3  Collect the samples at regular intervals of 0 hr, 24 hr, 48 hr, 72 hr, 96 hr, and 120 hr and perform the sterility test.

6.2.4  Collect the bottles at the interval as mentioned above and pour SCD medium into the bottle aseptically.

6.2.5  Collect the Miliflex cup at the interval as mentioned above and filtration 100 ml sterile water as per SOP; aseptically transfer membrane into SCD medium.

6.2.6  Collect the SS frits at the interval as mentioned above and transfer aseptically SS frit into 100 ml SCD medium.

6.2.7  Collect the tips at the interval as mentioned above and transfers aseptically tip into 100 ml SCD medium.

6.2.8  Incubate the samples at the specified temperature for 14 days (20-25°C for 7 days and 30-35°C for 7 days).

6.3 Acceptance Criteria

This study is carried out to establish the hold time of sterilized glassware and accessories after sterilization but no growth should be observed.

7.0 Conclusion

After a complete evaluation of the hold time study for sterile glassware and accessories used in microbiology lab a final hold time study summary report shall be prepared which should essentially contain discussion and conclusion which clearly determine the hold time period for sterile glassware and accessories.

8.0 Abbreviations

8.1  SOP – Standard operating procedure

8.2  SCD – Soybean Casein Digest Medium

8.3  °C – Degree centigrade

8.4  SS – Stainless steel

                                                                   Annexure-I

Date of Test:                            Sample:                                               Date of Release:

           

Media lot No.                          Media Prepared on:                             Media Used Before:

Incubator ID	Start date	End date

Incubation: 20-25 °C for 7 days followed by 30-35°C for next 7 days.

S. No.	Incubation Condition	Date	Observations					Observed by	Remarks
			Bottle	Funnel	SS frit	Tip	-Ve control
1	20-25°C for 7days
2
3
4
5
6
7
8	30-35°C for 7days
9
10
11
12
13
14

+ve control:                                                                                   –ve control:

Result:  The sample complies / doesn't comply for sterility.

Done by:                                                                                              Checked by:

Date      :                                                                                              Date           :

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