Precision and cleanliness are paramount in advanced wafer fabs, and cleaning validation techniques that have successfully reduced particle defects have been applied to aseptic processing areas. Aseptic processing areas responsible for producing parenteral medicines now benefit from innovative technologies initially designed for semiconductor equipment procedures. Foamtec’s PolyCHECK wiper is leading the charge in transforming cleaning validation practices, ensuring the highest surface cleanliness in closed-rabs and isolators.
The Challenge in Pharmaceutical Cleanliness
In the pharmaceutical industry, maintaining the highest standards of cleanliness is not just a best practice; it’s a regulatory requirement. Ensuring that equipment surfaces, processing tools, and production areas are free from microbial contaminants and process residues is vital for the safety and efficacy of parenteral medicines. However, the existing cleaning validation methods have their limitations.
Current practices in the pharmaceutical industry often rely on visual inspections of equipment surfaces, contact plates for microbial contamination, and swabbing to monitor drug substances or other process residues. While these methods are valuable, they lack a comprehensive way to validate that surfaces are essentially free of nonviable particles. This is especially important in ISO 5 suites, particularly closed-rabs and isolators. This gap in the validation process can lead to the persistence of nonviable particles, such as fibers, which are a leading cause of product rejects.
PolyCHECK: Bridging the Gap in Cleaning Validation
Foamtec’s PolyCHECK wiper, initially developed for semiconductor equipment procedures, is now making waves in the pharmaceutical industry by addressing the critical need for surface cleanliness validation. At the heart of PolyCHECK’s effectiveness is its black fabric, which has a high static attraction for particles. This allows equipment surfaces to be checked for cleanliness, as operators can easily see particles as small as 20 microns unaided. Augmenting inspection with UV light provides a revolutionary solution for identifying even the most challenging white-colored particles on stainless and aluminum tool surfaces.
The Power of PolyCHECK
- Visual Reference: PolyCHECK’s black fabric provides a stark visual contrast against equipment surfaces, making white particles generated by lint-free wipers extremely easy to spot. Technicians can now confidently validate surface cleanliness, leaving no room for uncertainty.
- UV Light Technology: UV light takes cleanliness validation to the next level. It illuminates particles that would otherwise remain hidden to the naked eye. This enhanced visibility ensures that nonviable particles, including elusive fibers, are identified and removed from pharmaceutical production areas.
- Reduced product Rejects: Studies in aseptic processing have consistently shown that fibers cause product rejects. Using PolyCHECK to validate surface cleanliness, pharmaceutical companies can significantly reduce the likelihood of these costly and potentially dangerous incidents.
- Compliance Assurance: Regulatory compliance is non-negotiable in the pharmaceutical industry. PolyCHECK empowers pharmaceutical manufacturers to meet and exceed cleanliness validation standards, ensuring product safety and patient well-being.
In conclusion, Foamtec’s PolyCHECK wiper is ushering in a new era of cleaning validation in the pharmaceutical industry. By leveraging its black fabric and UV light technology, PolyCHECK provides an unparalleled solution for identifying and eliminating nonviable particles, such as fibers, from aseptic processing areas. With PolyCHECK, pharmaceutical companies can enhance product quality, reduce rejects, and maintain the highest standards of cleanliness and compliance. It’s a groundbreaking innovation that is reshaping the future of pharmaceutical manufacturing.