As EU GMP annex 1 takes effect, many pharmaceutical manufacturers struggle to update cleaning and environmental monitoring practices. Many facilities have added extra cleaning steps to comply with new regulatory expectations. Given the additional costs and time required to carry our extra cleaning and rinsing steps, facilities are also looking at how to improve cleaning performance and productivity. Doing so often requires reviewing existing cleaning materials and potential alternatives, which involves the time-consuming cleaning validation step.
Any review of cleaning and disinfection SOP’s is incomplete without assessing before and after surface cleanliness, which is never an easy task.
Foamtec has partnered with pharmaceutical, biotech and medical device facilities to enhance cleaning validation and particle investigation studies with our PolyCHECK sampling and analysis system.
PolyCHECK is production-proven to improve and simplify cleaning validations. Moreover, the accuracy and ease of use allow PolyCHECK to improve cleaning robustness through cleaning verifications.
How does it work?
PolyCHECK is a sampling wiper constructed from a fabric with a high static charge to capture particles from cleanroom equipment surfaces. The fabric is black, allowing operators and technicians to use a UV light to fluoresce particles that are organic in makeup. Typical examples of materials that generate organic particles to surfaces are disinfectants, mops, disposable head covers, shoe covers, gloves, and garments. The most significant sources of organic particles are polyester, polycellulose, nylon and polypropylene fibers from so-called “lint-free” wipers.
The chart below summarizes numerous foreign material assessments and highlights that wiping is the most significant source of particles above 5 microns in size.
The picture below is a filled vial that had been inspected and failed for particulate contamination identified as polyester.
Polyester contamination was found in the depyrogenation oven when sampled with PolyCHECK.