PARTICLES AND FIBRES: Garments are tested for particle and fibre contamination using test methods AS 1807.9 and 1807.19. Garments tested are randomly selected, this method requires garments to be vacuumed in predetermined areas and the air to be passed through a membrane filter. The filter is then counted microscopically and the result calculated to assess garment class. Refer IEST RP CC 003.3
BIOBURDEN: Garments processed by CRG are monitored weekly in all machines for bioburden contamination. The methods used for processing and recording will include the use of contact plates applied directly onto the processed garments. These samples are assessed for bioburden level and expressed in Colony Forming Units (CFU). Counts are assessed against limits defined in PIC/S Code of GMP Annex 1.