Aseptic facilities producing pre-filled syringes (PFS) are critical in providing safe, high-quality medical products. Maintaining stringent cleanliness standards in these facilities is paramount to ensure the safety and effectiveness of the final products. However, the battle against visible particle contamination has been a persistent challenge. The surprising revelation that lint-free sterile wipers used in these facilities are a significant source of fibers longer than 20 microns has raised concerns about product quality and yield. In response to this issue, Foamtec’s MiraWIPE has emerged as a groundbreaking solution to eliminate this critical source of visible particles and improve overall operational efficiency.
The Challenge of Visible Particle Contamination
Visible particles in aseptic facilities are a concern for several reasons, but they become particularly problematic in PFS production due to the use of silicone lubricant in the syringes. Silicone lubricants have an affinity for particles, making it crucial to eliminate any potential sources of contamination. The surprising discovery that lint-free sterile wipers in these facilities contribute significantly to visible particle contamination has prompted a search for a more effective solution.
Polycellulose fibers were found in an ISO 5 aseptic room that migrated from a gown room where polycellulose wipers were employed.
Gamma Irradiated knit polyester wipers shed fibers into an ISO 5 aseptic room.
Presaturated non-woven polypropylene wipers used in B & C suites cross-contaminated an aseptic filling suite.
Foamtec’s PolyCHECK Surface Analysis System
To address the issue of visible particle contamination in aseptic facilities, several forward-thinking facilities have turned to Foamtec’s PolyCHECK surface analysis system. This innovative tool has helped these facilities investigate the sources of visible particle contamination in detail. It has been revealed that white fibers longer than 20 microns are the number one source for visible particle rejects during the visual inspection process. Further analysis using the PolyCHECK system has determined that these fibers originate from gamma-irradiated polyester and polypropylene non-woven wipers used for cleaning and disinfection.
Introducing Foamtec’s MiraWIPE
Foamtec’s MiraWIPE represents a significant leap forward in addressing the issue of visible particle contamination in aseptic facilities, particularly in PFS production. Here’s how MiraWIPE can improve yield and quality in these critical environments:
- Elimination of Fiber-Shaped Particles: MiraWIPE is specially designed to eliminate the shedding of fiber-shaped particles longer than 20 microns, a significant concern in visible particle contamination.
- Lint-Free Performance: MiraWIPES abrasion-resistant woven microfiber fabric is a production proven to eliminate unwanted fibers left behind during cleaning and disinfection.
- Optimized Material: The materials used in MiraWIPE are carefully selected to minimize the risk of particle generation, making it an ideal choice for aseptic environments.
- Enhanced Quality Assurance: With MiraWIPE, aseptic facilities can enhance quality control processes, reducing the likelihood of visible particle rejects and improving overall product quality.
Visible particle contamination is a persistent challenge in aseptic facilities, especially in pre-filled syringe production where silicone lubricants are used. Foamtec’s MiraWIPE is a groundbreaking solution that can significantly improve yield and quality by eliminating the primary source of visible particles – lint-free sterile wipers. With MiraWIPE’s lint-free performance, optimized materials, and compatibility with silicone lubricants, aseptic facilities can enhance their cleanliness standards and ensure the safety and effectiveness of their products. It’s time for aseptic facilities to embrace MiraWIPE as the key to achieving higher quality and improved yield in their critical operations.
Learn more at: www.foamtecintlwcc.com