Dear all,
for bio swab sampling using WFI for cleaning of equipment for sterile products and for bio swab sampling using WFI for cleaning of equipment for non-sterile products what are the acceptance criteria that should be set for the cleaning validation protocol? …cfu/SWAB (25cm2/swab)???
We use sterile Dacron swab saturated with a sterile diluent and the identified areas by the study are sampled so that we get 25cm2/swab.
Thank you all.
Best regards,
[quote=Gigastorm]Dear all,
for bio swab sampling using WFI for cleaning of equipment for sterile products and for bio swab sampling using WFI for cleaning of equipment for non-sterile products what are the acceptance criteria that should be set for the cleaning validation protocol? …cfu/SWAB (25cm2/swab)???
We use sterile Dacron swab saturated with a sterile diluent and the identified areas by the study are sampled so that we get 25cm2/swab.
Thank you all.
Best regards,[/quote]
For the sterile products I think we’ll be using 5cfu/swab and for non-sterile products 10cfu/swab.
Is there anyone having implemented different limits?
Thank you all.
Best regards,
Limits for the microbial status of product contact surfaces
Follow this formula for setting the microbial limits for swabbing.
Limits for implementations (CFU/25 cm2)
Class A G: < 1 W: 2 A: 3
Class B G: 5 W: 2 A: 5
Class C G: 25 W: 25 A: 50
Class D G: 50 W: 100 A: 200
where G means mean value from 10 values in sequence, W means alert limit and A means action limit