HOLD TIME STUDY PROTOCOL FOR STERILISED GARMENTS FOR THEIR STERILITY

PROCEDURE

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.

2. Perform the sterilization of the bag as per the SOP for sterilization of dresses.

3. After sterilization place the Dacron bag in Garment cubicle for Hold time study.

4. Collect one cut piece from the dress bag aseptically and direct immerse into the sterilized Soyabean Casein Digest medium and check for the sterility, this sample shall be treated as initial sample. (0 Hour)

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. 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.

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.

CONCLUSION

After 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.