Contamination control in aseptic areas is paramount in the pharmaceutical and biotechnology industries. While traditional discussions have often centered on gowning procedures and operator practices as the primary sources of particle contamination, a closer examination reveals a more nuanced reality. Recent advancements have highlighted an unexpected culprit for particle contamination: fiber-based contamination generated by gown room wipers. In this blog, we delve into how PolyCHECK® and MiraWIPE®, innovative solutions by Foamtec International, are revolutionizing contamination control by targeting these often-overlooked sources of contamination.
The Nuanced Nature of Contamination
Particles smaller than 5 microns and larger than 20 microns play a crucial role in contamination control. While operator behaviors and adherence to proper gowning practices contribute to particle generation below 5 microns, particles larger than 20 microns are primarily attributed to an unexpected source—polypropylene and polycellulose wipers commonly used in gown rooms.
PolyCHECK® wipes and swabs can sample any type of surface.
Understanding the Impact of Gown Room Wipers
Aseptic facilities have embraced Restricted Access Barrier Systems (RABS) and isolators to prevent cross-contamination in the quest for optimal contamination control. However, even with these advancements, visible particle rejects remain a significant concern in sterile filling operations. Extensive research, coupled with applying Foamtec’s PolyCHECK® surface sampling system to cleanroom gowns, has revealed that gown room wipers significantly contribute to contamination issues.
PolyCHECK® wipe illuminated with UV light revealing foreign material contamination picked up from the surface.
Foamtec runs SEM/EDX and FTIR analysis to find the chemical make up of the fibers/particulates after collecting samples of foreign material found on surfaces, gowns and equipment.
Upon examining the operator’s gowns, Foamtec found polycellulose fibers on the gowns. Since the gown’s were not made from polycellulose, the fibers must of came from somewhere else.
It was later discovered operators were using gown room wipes made from polycellulose. After analyzing the wipes, it matched the contamination found both on the cleanroom gowns and inside the laminar flow hood.
Introducing Foamtec’s Solutions: PolyCHECK® and MiraWIPE®
Foamtec International has emerged as a pioneer in addressing contamination challenges, particularly those arising from gown room wipers. Their PolyCHECK® surface sampling system, combined with the industry-leading MiraWIPE® has proven to be a game-changer. MiraWIPE®, renowned for its efficacy, has undergone a transformation by introducing lower-cost versions, all while maintaining its production-proven ability to reduce particles larger than 20 microns by over 95%.
MiraWIPE® provides operators a cleanroom microfiber wipe with not only excellent cleaning performance but superior abrasion resistance as well.
The Power of MiraWIPE®
MiraWIPE’s® ability to drastically reduce particles larger than 20 microns is vital to minimizing visible particle rejects in post-filling inspections. MiraWIPE® maintains the highest product quality standards by effectively eliminating these larger particles while enhancing aseptic conditions.
After wiping the cleanroom surface with MiraWIPE®, the PolyCHECK cleaning validation wipe picks up no visible contamination.
In the ever-evolving landscape of contamination control, innovation is paramount. While gowning practices and operator behaviors undoubtedly influence contamination, it’s crucial to recognize the role of gown room wipers in contributing to more extensive particle contamination. Foamtec International’s PolyCHECK® and MiraWIPE® represent a paradigm shift, providing solutions that directly target and mitigate fiber-based contamination generated by gown room wipers. With the ability to significantly reduce particles larger than 20 microns, these solutions empower aseptic facilities to bolster their contamination control efforts and ensure the integrity of their sterile filling operations.
As the industry progresses, the insights gained from Foamtec’s solutions highlight the need for a comprehensive approach to contamination control, addressing even the most nuanced sources of contamination to achieve the highest levels of product quality and patient safety.
PolyCHECK® Surface Sampling Wipes
MiraWIPE® Cleanroom Microfiber Wipes
If you have any questions, please contact us today!