Hold Time Study Protocol of Sterilized Garments for their Sterility

1.0 OBJECTIVE

The objective of this protocol is to provide documented evidence to establish and verify the microbial presence on sterilized garments upon holding up to 5 days after sterilization by using the microbial detection method.

2.0 SCOPE

The scope of this protocol is to evaluate the hold time after sterilization of garments. This shall be done by using the established microbiological method to determine the microbiological growth.

3.0 REFERENCE DOCUMENTS

Following documents are referred during preparation of the protocol 3.1  SOP for Sterility Testing
3.2  SOP for Garment Cabinet

4.0 PURPOSE OF STUDY

The purpose of this protocol is to establish the rate of microbial proliferation in the Sterilized garments for the specified holding period after its sterilization.

5.0 RESPONSIBILITY

Responsibilities of Quality Assurance and Quality control Microbiology personnel involved in activities related to the General validation protocol are defined below:
5.1  Quality Assurance:  Review and approval of the protocol.
5.2  Quality Control:  Preparation, review and execution of the protocol.

6.0 PROCEDURE

6.1  Pre-requisite

6.1.1  Environmental conditions should be maintained within the established limit.

6.2  Procedure for Hold Time Study

6.2.1  Prepare a Dacron bag contains 1 pair of garments used in sterility testing area, and place 10 cut pieces (6x5 cm) of old dress in-between the dress.
6.2.2  Perform the sterilization of the bag as per the SOP for sterilization of dresses.
6.2.3  After sterilization place the Dacron bag in Garment cubicle for Hold time study.
6.2.4  Collect one cut piece from the dress bag aseptically and direct immerse into the sterilized SCD medium and check for the sterility, this sample shall be treated as the initial sample. (0 Hour)
6.2.5  Similarly collect the dress pieces from the hold bag at regular intervals of 24 hr, 48 hr, 72 hr, 96 hr, and 120 hr and perform the sterility test.
6.2.5  Incubate the samples at the specified temperature for 14 days (20-25°C for 7 days and 30-35°C for 7 days).
Note: 0 Hrs starts when the sterilized garments placed in Garment cubicle after sterilization.

7.0 ACCEPTANCE CRITERIA

This study is carried out to establish the hold time of sterilized garments after sterilization.
Microbial determination: No growth should be observed in sterility test.

8.0 CONCLUSION

After the complete evaluation of the hold time study for sterilized garments used for sterility testing 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 sterilized garments.

9.0 ABBREVIATIONS

9.1  SOP - Standard operating procedure
9.2  cm - Centimetre
9.3  Hrs - hours
9.4  SCD medium - Soybean Casein Digest Medium
9.5  °C - Degrees centigrade
9.6  Hr - Hour

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