Validation Protocol for Hold time study of Garments

The validation Protocol for the Hold time study of Garments has been done to ensure that the suggested method of the sterile garment is capable of being free from microbial contamination for daily use in the Sterile section.

Aim: To validate the Hold time study for ‘STERILE GARMENTS’ and to establish documented evidence to ensure that the suggested method of the sterile garment is capable of being free from microbial contamination for daily use in the Sterile section.

Scope: This protocol is applicable for the Hold Time Study of the ‘STERILE GARMENTS’ for the manufacturing area and microbiology area. It covers the sampling of microbial contamination of the used garments in the manufacturing area and microbiology area by using sterile swabs & transferring these swabs to a nutrient medium & following incubation to evaluate whether the sterile garment is free from microbial contamination.

Responsibility: To conduct the Hold Time Study of ‘STERILE GARMENTS’ a team shall be formed. The team shall contain members from:
Production
Quality Assurance
Quality Control
Engineering
(individual to be named in the report)

PROTOCOL CONTENTS

1.0 Protocol Approval
2.0 Overview
2.1 Objective
2.2 Purpose
2.3 Reason for Validation
2.4 Responsibility
2.5 Requalification
2.6 Periodical Validation

3.0 Definition
4.0 Temperature monitoring equipment
5.0 Sterilization Cycle Development Study

6.0 Qualification Procedure
6.1 Steam quality test
6.2 Vacuum leak test and Bowie–Dick test
6.3 Empty chamber study
6.4 Heat Distribution study
6.5 Heat penetration study
6.5.1. Fo Concept
6.5.2. Biological challenge test

A. Unit operation: Holding period of the sterilized Garments.

B. Objective: To ensure that the sterilized Garments remain sterile during the storage and usage period (3 days or 72 Hrs).

C. Site of study: Injectable Department – XYZ Pharmaceutical.

D. SOP for operation

• Preparation of Garments SOP
• As per Sterilization of the Garments SOP
• Storage of Garments SOP

E. Control:

• Garments should be prepared as per their respective SOP
• Sterilized the garments in Autoclave as per the loading pattern described in Sop No.:
• transfer the sterile garments in a closed ss container to the garment cubicle.
• Sterilized Garments are to be stored in the garment cubicle.

F. Acceptance Criteria: Sterilised Garments should pass the Microbial Limit test during the storage period of 3 days or 72 Hrs.

G. Type of Validation: Prospective validation.

H. Frequency: Once in the year for concurrent validation.

I. Experimental Details:

• The Garments used for the validation should be sterilized.
• Transfer of garments should follow as per their respective SOP.
• Storage of garments should be done in a garment cubicle started before ½ hours and UV light should be on throughout the storage.
• The differential pressure of the Magnehelic pressure gauge should be monitored.

J. The sample should be collected from the Garment cubicle :

Sr. No.	Sample	Microbial Limit Test Observation	Done By
1	0 Hrs, After sterilization	Complies/Does not Complies
2	8 Hrs, After sterilization	Complies/Does not Complies
3	16 Hrs, After sterilization	Complies/Does not Complies
4	24 Hrs, After sterilization	Complies/Does not Complies
5	32 Hrs, After sterilization	Complies/Does not Complies
6	40 Hrs, After sterilization	Complies/Does not Complies
7	48 Hrs, After sterilization	Complies/Does not Complies
8	56 Hrs, After sterilization	Complies/Does not Complies
9	64 Hrs, After sterilization	Complies/Does not Complies
10	72 Hrs, After sterilization	Complies/Does not Complies

Approval

Initiated by:

	DESIGNATION	NAME	SIGNATURE	DATE
	Quality Control Supervisor

Checked by:

	DESIGNATION	NAME	SIGNATURE	DATE
	Quality Control Manager

Reviewed by:

	DESIGNATION	NAME	SIGNATURE	DATE
	Quality Assurance Manager-Review

Approved by:

	DESIGNATION	NAME	SIGNATURE	DATE
	Quality Assurance Manager

K. Protocol Approval :

_______________ __________ Quality Assurance G.M. QA/QC Date :