Garment Hygiene Excellence: SOP for Washing and Sterilization of Cleanroom Garments

• by Abdul Hai
• 17 Sep 2009
• Coaching

Maintaining the highest standards of cleanliness in cleanroom environments is paramount for pharmaceutical and biotech industries. This article introduces a comprehensive Standard Operating Procedure (SOP) for the washing and sterilization of cleanroom garments. Delve into step-by-step guidelines, recommended detergents, sterilization methods, and best practices to ensure the integrity of garments and compliance with stringent cleanliness protocols.

A Standard Operating Procedure (SOP) for washing and sterilizing cleanroom garments is essential to maintain the cleanliness and sterility of cleanroom environments. Cleanroom garments are worn to prevent contamination of the cleanroom and the products or processes within. Here&39;s a sample SOP for washing and sterilizing cleanroom garments:

Title: Standard Operating Procedure for Washing and Sterilizing Cleanroom Garments

Objective: To ensure the cleanliness and sterility of cleanroom garments before use in a controlled environment.

Scope: This SOP applies to all personnel responsible for wearing cleanroom garments in cleanroom environments.

Responsibilities:

• Cleanroom Garment Users: Responsible for collecting, wearing, and returning cleanroom garments.
• Laundry Personnel: Responsible for washing and sterilizing cleanroom garments.
• Quality Assurance: Responsible for ensuring compliance with this SOP and periodic audits.

Materials and Equipment:

1. Cleanroom garments
2. Washer and dryer
3. Sterilization equipment (e.g., autoclave)
4. Detergent and sterilization agents
5. Cleanroom hangers or storage bins

Procedure:

1. Collection of Used Garments:

   • Cleanroom users must collect used garments after each use.
   • Place used garments in designated bins or bags labeled for "Used Garments Only."

2. Transportation to Laundry Area:

   • Used garments must be transported to the laundry area in a manner that prevents contamination.
   • Use a dedicated cart or container for this purpose.

3. Sorting and Pre-Wash Inspection:

   • In the laundry area, sort garments by size and type.
   • Conduct a visual inspection to check for stains, tears, or damage.
   • Remove any contaminated garments from circulation and mark for repair or disposal.

4. Washing Procedure:

   • Place the sorted and inspected garments in the washer.
   • Use a recommended detergent suitable for cleanroom garments.
   • Follow manufacturer&39;s guidelines for washing temperature and cycle settings.
   • Avoid overloading the washer to ensure proper cleaning.
   • Ensure that only cleanroom garments are washed together.

5. Drying Procedure:

   • Transfer washed garments to the dryer.
   • Use a recommended drying temperature and cycle suitable for cleanroom garments.
   • Ensure that garments are fully dry to prevent moisture-related contamination.

6. Sterilization Procedure:

   • Transfer clean and dry garments to the sterilization area.
   • Follow manufacturer&39;s guidelines for sterilization equipment (e.g., autoclave).
   • Sterilize garments at the recommended temperature and pressure for the specified duration.
   • Record sterilization parameters for quality assurance.

7. Storage and Distribution:

   • After sterilization, store cleanroom garments in clean, designated storage areas.
   • Use cleanroom hangers or storage bins to prevent contamination.
   • Garments must remain sealed until they are worn in the cleanroom.

8. Documentation:

   • Maintain records of each cleanroom garment&39;s washing and sterilization cycle.
   • Document any repairs or disposals of damaged garments.
   • Regularly audit the process to ensure compliance.

9. Training:

   • Ensure that all personnel involved in the process are trained in this SOP.
   • Conduct periodic refresher training as needed.

References:

• Manufacturer&39;s guidelines for cleanroom garment care and maintenance.
• Cleanroom policies and procedures for the specific cleanroom environment.

Revision History:

• Document all revisions to this SOP with dates and descriptions of changes.

Approval:

This SOP is approved by [Insert Name and Title of Responsible Authority] on [Insert Date].

Distribution:

Distribute copies of this SOP to all relevant personnel.