SOP For Washing, Preparation, and Sterilization of Sterile Garments

SOP For Washing, Preparation, and Sterilization of Sterile Garments

1.0 Objective

1.1 To establish a procedure for the washing, preparation, sterilization, inspection, and handling of sterile garments to ensure their suitability for use in sterile areas.

2.0 Scope

2.1 This SOP is applicable to all sterile garments used in the Production Department, including their washing, sterilization, storage, and disposal.

3.0 Responsibility

3.1 Operator – Production

• Responsible for washing, preparation, sterilization, and handling of sterile garments as per this SOP.

3.2 Officer or Above – Production

• Responsible for preparation of SOP and monitoring of activities.

3.3 Executive or Above – Production

• Responsible for review of SOP and ensuring compliance.

3.4 Head – Production or Designee

• Responsible for implementation and adherence to this SOP.

3.5 Head – Quality Assurance (QA)

• Responsible for approval of this SOP.

4.0 Accountability

4.1 Head – Production

• Accountable for overall implementation of this SOP.

5.0 Definition & Abbreviations

5.1 Definitions

5.1.1 Standard Operating Procedure (SOP)
A written authorized document providing instructions to perform routine activities consistently and effectively.

5.1.2 Sterilization
A process that eliminates all forms of microorganisms, including spores, from a surface or material using methods such as heat, chemicals, or irradiation.

5.2 Abbreviations

6.0 Precautions, Safety & EHS

6.1 Inspect garments for physical integrity before washing.

6.2 Ensure proper handling to avoid contamination or damage.

7.0 Materials & Equipment

7.1 Materials

• Sterile garments (boiler suit, headgear, booties, inner garments)

• Teepol (detergent)

• Butter paper

• Purified water

7.2 Equipment

• Washing machine

• Autoclave

8.0 Procedure

8.1 Inspection Before Washing

8.1.1 Collect used garments from the designated bin.

8.1.2 Segregate components such as booties, headgear, boiler suits, and inner garments (upper, lower, cap, booties).

8.1.3 Inspect each item for damage, discoloration, tears, or deformities.

8.1.4 Segregate damaged garments and send them for repair or destruction as applicable.

8.1.5 Only intact and acceptable garments shall be transferred to the washing bin.

8.2 Collection and Handling of Used Garments

8.2.1 At the end of each shift, collect all used sterile garments and transfer them to a closed SS container at the first airlock.

8.2.2 Clean and dry the SS container and wipe it with 70% IPA before returning it to the airlock.

8.2.3 Transfer garments to the designated garment washing area.

8.3 Washing and Drying of Garments

8.3.1 Load garments into the washing machine (maximum 10 garments per cycle).

8.3.2 Wash using approximately 50 mL of detergent (Teepol) with purified water.

8.3.3 Rinse garments thoroughly at least three times with purified water to remove detergent residues.

8.3.4 Dry the garments using the washing machine or designated drying system.

8.4 Preparation and Sterilization

8.4.1 Transfer dried garments to the garment preparation area.

8.4.2 Wrap each garment in butter paper and place them in SS bins.

8.4.3 Keep the lid closed but ensure proper steam penetration by adjusting the bin frame.

8.4.4 Sterilize garments in an autoclave at 121°C for 30 minutes.

8.4.5 After sterilization, transfer the bins under LAF in the garment cubicle (2nd airlock) and store them for use.

8.4.6 Ensure that each garment set does not exceed 100 sterilization cycles. After completion, garments shall be destroyed.

8.5 Inspection After Sterilization

8.5.1 Inspect garments after each sterilization cycle for:

• Tears

• Holes

• Broken zippers

• Fabric degradation

8.5.2 Segregate defective garments into:

• Repairable garments → Send to repair area

• Non-repairable garments → Send for destruction

8.6 Handling of Torn or Damaged Garments

8.6.1 Non-repairable or worn-out garments shall be cut using scissors and disposed of in the designated scrap area.

8.6.2 Garments exceeding 100 sterilization cycles shall be mandatorily destroyed.

8.6.3 Record details of damaged garments, including:

• Type of damage

• Action taken (repair/destruction)

8.6.4 Maintain complete records for traceability of garments.

9.0 Annexures