What are the Criteria for Selecting Clean Room Clothing in Pharmaceutical Industry?
When selecting cleanroom garments for use in sterile areas, several key criteria must be considered to ensure compliance with quality and safety standards. Here are the main criteria:
Material Selection:
- Use durable materials that generate minimal particulate matter.
- Common materials include polyester, polypropylene, and polyethylene-coated fabrics.
Design and Fit:
- The design should cover the entire body to minimize contamination.
- Garments should have tight seams to prevent particle leakage.
- Elastic cuffs at the wrists and ankles to keep the garments securely in place.
- Should be comfortable and allow freedom of movement for prolonged use.
Electrostatic Discharge (ESD) Control:
- Use materials that reduce the buildup of static electricity.
- Incorporate conductive fibers to dissipate static charges.
Contamination Control:
- High Particle Filtration Efficiency (PFE) to filter out fine particles.
- Resistance to microbial penetration to protect both the product and the personnel.
Sterilization:
- Garments must be sterile, often achieved through gamma irradiation or other methods.
- Packaging that maintains sterility until the point of use.
Compliance with Standards:
- Garments must meet cleanroom air cleanliness classifications according to ISO 14644.
- Adherence to ASTM standards that define material performance in cleanroom garments.
- Compliance with Good Manufacturing Practices (GMP) set by regulatory authorities in the pharmaceutical industry.
Cost-Effectiveness:
- Consideration of the cost for purchase, laundering, sterilization, and disposal of disposable garments.
Environmental Impact:
- Use of sustainable materials and environmentally friendly manufacturing processes and disposal methods.
- Preference for recyclable or biodegradable materials to reduce environmental impact.
These criteria help ensure that cleanroom garments provide a sterile manufacturing environment, protect both the product and the personnel, and comply with stringent regulatory requirements in the pharmaceutical industry.
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Resource Person: Eslam kourani
