Why Cleanroom Gowning Should Be Performed In Change Rooms ? -

Cleanroom gowning should be performed in change rooms of an appropriate cleanliness grade to ensure gown cleanliness is maintained. Outdoor clothing including socks (other than personal underwear) should not be brought into changing rooms leading directly to grade B and C areas.

Single or two-piece facility trouser suits, covering the full length of the arms and the legs, and facility socks covering the feet, should be worn before entry to change rooms for grades B and C. Facility suits and socks should not present a risk of contamination to the gowning area or processes.

 

Gloves should be regularly disinfected during operations. Garments and gloves should be changed immediately if they become damaged and present any risk of product contamination.

Reusable clean area clothing should be cleaned in a laundry facility adequately segregated from production operations, using a qualified process ensuring that the clothing is not damaged and/or contaminated by fibres or particles during the repeated laundry process.

Laundry facilities used should not introduce risk of contamination or cross-contamination. Inappropriate handling and use of clothing may damage fibres and increase the risk of shedding of particles.

After washing and before packing, garments should be visually inspected for damage and visual cleanliness. The garment management processes should be evaluated and determined as part of the garment qualification programme and should include a maximum number of laundry and sterilisation cycles.

PIC/S PE009-17 PERSONNEL HYGIENE

2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.

Keeping specific protective clothing inside areas where products with high risk of cross-contamination are processed