PRODUCTS 4 Manual biocleaning of equipment Fabrics Class A & B hAs an integral part of the Contamination Control Strategy (CCS), particle decontamination and disinfection of aseptic areas classified as A & B must be the subject of written procedures. As stated in Annex 1 of the GMP - Good Manufacturing Practices - disinfection of classified A & B areas is only effective if there is prior particle decontamination. Eliminating these contaminants inevitably leads to a substantial drop in microbiological contamination (which can exceed one log4), making the next stage of disinfection easier. hSeveral options: - At the start of the new biocleaning cycle: thorough particle decontamination with a solvent that does not leave residues (water or alcohol). Detergency may sometimes be necessary, in which case it replaces particle decontamination and must be followed by a scraping rinse. - At the end of the biocleaning cycle after disinfection: rinse and scrape with water or alcohol (e.g. during clean-up) hThe biocleaning programme must include the management of disinfection residues and their eventual disposal. hSo while some steps are necessary, others are optional: - Rough waste disposal (Optional) - Particle decontamination - Chemical detergent and scraping (Optional) - Disinfection - Rinsing (Optional) hEach stage requires validation. hWiping cloths, detergents and disinfectants used in these areas are sterile. hAnnex I of the GMP indicates the periodic use of a sporicide. hWe distinguish between manual cleaning of equipment and cleaning of floors, walls and ceilings. CLASS A & B BIOCLEANING Part no. Product name Designation Weight (g/m2) Dim. (cm) Pack -aging Fabrics/ bag Bags/ box € excl. tax/ carton 133031 WX-KP13L28C2S KP13 Laser Cut Sterile Series Polyester fabrics 140 28 x 28 Triple 5 x 20 10 NC - hEquipment is considered critical, with potentially abrasive surfaces hSingle- or double-ply polyester knit fabrics (KP12, KP13, KP17 or KP22) are preferred hFor smooth, non-critical surfaces, cellulose/polyester fabrics can be used Particulate decontamination Single-ply polyester knitwear Part no. Product name Description Weight (g/m2) Dim. (cm) Pack -aging Fabrics/ bag Bags/ box € excl. tax/ carton 133056 WX-NW69C30C2S NW69 Non-Woven Sterile Series Fabrics 55% Cellulose - 45% Polyester 68 30 x 30 Triple 5 x 20 10 NC - Polyester cellulose non-wovens for non-critical and smooth surfaces
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