STERILIZED GARMENTS HOLD TIME STUDY PROTOCOL

1.0 OVERVIEW

The Sterilized Garment Hold Time is defined as the maximum permissible period between the completion of garment sterilization and its use within the classified Cleanroom area, beyond which the sterility assurance of the garment cannot be guaranteed.

The Sterilized Garment Hold Time study shall be conducted to establish and validate the maximum duration for which sterilized garments (coveralls, hoods, booty, goggles, etc.) can be stored in a controlled environment without compromising their sterility or integrity prior to use.

The study shall be designed to simulate actual storage and handling conditions under which garments are maintained in the sterile garment storage Cabinet.

A minimum of three independent sterilization and storage cycles (three lots) shall be evaluated to establish reproducibility and consistency of results.

Garment hold time validation shall include:

• Sterilization of garments through validated sterilization cycles (autoclaving or dry heat, as applicable).

• Controlled storage of sterilized garments in designated sterile garment storage areas.

• Sampling at pre-defined time intervals (e.g., Initial/0 Hour, 24 Hours, 36 Hours, 48 Hours, and 72 Hours).

• Microbiological testing of garments at each interval to verify continued sterility and integrity of packaging (if applicable).

The study outcome will define the maximum hold time after sterilization during which garments can be used in aseptic processing areas with assurance of sterility.

2.0 PURPOSE

The purpose of this Sterilized Garment Hold Time Study is to:

• Establish a scientifically justified and documented maximum hold time for sterilized garments used in aseptic processing areas.

• Ensure that sterilized garments maintain their sterility, integrity, and suitability for use during the defined hold time period under routine storage conditions.

• Demonstrate through microbiological evaluation that garments stored within the validated hold time period remain free from microbial contamination and maintain sterile barrier integrity.

• Provide evidence to support that garments are fit for aseptic manufacturing operations when used within the validated hold period.

3.0 SCOPE

This protocol applies to the Sterilized Garments used in the aseptic processing and sterile manufacturing areas of Smayan Healthcare Pvt. Ltd., including:

• Sterilized coveralls

• Sterilized hoods/caps

• Sterilized goggles/spectacles

• Sterilized booty

4.0 REFERENCES

• WHO Technical Report Series No. 961, Annex 6 – GMP for Sterile Pharmaceutical Products

Clauses 5.11–5.12: Require validation of hold time for sterilized garments to ensure maintained sterility during storage.

• EU-GMP Annex 1 (Revision 2022): Manufacture of Sterile Medicinal Products

Clauses 8.47–8.53: Mandate defining and justifying maximum hold times for sterilized items such as garments, and verifying sterility integrity during storage.

• USFDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing (2004)

Sections IX & X: Recommend establishing validated hold times for sterilized garments and components to demonstrate sterility maintenance.

• ISO 14644 Series – Cleanrooms and Associated Controlled Environments

ISO 14644-5:2004 & ISO 14644-7:2014: Specify validation of storage conditions for maintaining sterility and cleanliness of garments.

• PDA Technical Report No. 27 – Pharmaceutical Steam Sterilization (Revised 2018)

Sections 10.3.3 & 11.2: Require post-sterilization hold-time studies to verify sterility and package integrity of stored items.

• Internal SOPs References:

SOP on Garment Sterilization and Storage

SOP on Environmental Monitoring

SOP on Sterility Testing

5.0 Training

The validation team member shall be trained on the protocol execution of activity and report compilation. The training record shall be attached.

6.0 STERILIZED GARMENT HOLD TIME STUDY APPROACH

The Sterilized Garments Hold Time Study shall be executed through an approved protocol, and upon completion of the study, a detailed summary report shall be prepared.

After completion of sterilization, each batch of sterilized garments shall be visually inspected for package integrity (e.g., absence of tears, punctures, condensation, or discoloration). Only garments found acceptable during visual inspection shall be considered for hold time study sampling.

The purpose of this study is to establish and verify the effectiveness of the sterilization and storage procedure of garments to ensure that sterility is maintained throughout the defined hold period. Sterilized garments shall be stored under controlled environmental conditions in the designated sterile garment storage Cabinet.

Garments shall be withdrawn at predefined intervals Initial/0 Hour, 24 Hours, 36 Hours, 48 Hours, and 72 Hours) and subjected to microbiological testing (sterility test) to confirm the maintenance of sterility during the storage period.

At the end of the defined hold period, data obtained from all intervals shall be evaluated. The maximum acceptable hold time shall be established based on the latest time interval where garments meet all acceptance criteria for sterility and packaging integrity.

Revalidation of sterilized garment hold time shall be performed whenever there is a significant change in the sterilization cycle, garment material, packaging configuration, or storage conditions, or as defined in the site Validation Master Plan (VMP)

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