Introduction: Maintaining sterile conditions is of paramount importance in aseptic manufacturing suites. With new regulatory guidance, parenteral drug manufacturing facilities are reevaluating their cleaning practices. One of the biggest challenges in cleaning aseptic equipment is effectively removing sticky disinfectants, sporicides, protein-based residues, and sugar-based residues. These stubborn residues pose a risk to the equipment and contribute to the shedding of particles from traditional wiping materials. However, Foamtec’s MiraWIPE microfiber wipers, with their market-leading abrasion resistance, offer a practical solution to eliminate post-wiping fibers and particles while effectively cleaning pharmaceutical sterile filling equipment.
The Challenge of Sticky Residues: Pharmaceutical sterile filling equipment often comes into contact with various substances, including disinfectants, sporicides, protein, and sugar-based materials that form sticky residues. Because these residues stubbornly adhere to equipment surfaces, operators use more elbow grease when cleaning. Traditionally knitted or nonwoven wipers shed large volumes of particles when used in Heavy-duty wiping activities, raising the risk of nonviable particle levels exceeding alert and action limits.Foamtec’s MiraWIPE: A Game-Changer in Cleaning Practices: Foamtec, a leading provider of contamination control solutions, has developed MiraWIPE microfiber wipers to address the unique challenges faced by pharmaceutical sterile filling equipment. These innovative wipers offer exceptional abrasion resistance and have proven highly effective in eliminating post-wiping fibers and particles, providing a significant advantage in achieving optimal sterility.
The Power of Microfiber Technology: Microfiber technology lies at the heart of MiraWIPE’s exceptional performance. The microfiber material consists of ultra-fine fibers, typically smaller than human hair, densely woven to create a highly effective cleaning surface. The small fiber size allows for increased surface area contact, ensuring thorough and efficient cleaning, even in hard-to-reach areas of the equipment.
Market-Leading Abrasion Resistance: One of the standout features of MiraWIPE is its market-leading abrasion resistance. Unlike conventional wiping materials, MiraWIPE’s microfiber composition provides excellent durability and longevity, making it ideal for heavy-duty cleaning tasks. This resilience allows for more vigorous wiping motions without compromising the wiper’s integrity, effectively removing stubborn residues without shedding particles.
Foamtec uses Tabor abrasion, a common method used to evaluate fabric durability.
Air Particle Count (APC) Comparison
| APC (particle/wiper) | Competitor A Leading Sterile Polyester Wipe | Competitor B Woven Microfiber Wipe | HT5790S MiraWIPE Woven Microfiber Wipe |
| Particle size at 0.3 – 0.5 um | 380 | 74 | 35 |
| Particle size at 0.5 – 5.0 um | 198 | 31 | 15 |
MiraWIPE sheds a lot less fibers compared to other leading cleanroom wipes.
Weight Loss by Abrasion Testing Comparison
| Weight Loss | Competitor A Leading Sterile Polyester Wipe | Competitor B Woven Microfiber Wipe | HT5790S MiraWIPE Woven Microfiber Wipe |
| Sample 1 | 0.010 g | 0.084 g | 0.006 g |
| Sample 2 | 0.012 g | 0.112 g | 0.006 g |
| Sample 3 | 0.009 g | 0.081 g | 0.005 g |
| Average | 0.010 g | 0.092 g | 0.006 g |
MiraWIPE generated 66% less fibers compared to Comp A in weight.
MiraWIPE generated 66% less fibers compared to Comp B in weight.
Abrasion Testing Comparison
Fiber Shedding from Fabric as a result of abrasion damage during Tabor Abrasion Testing.
Effective Removal of Sticky Residues: MiraWIPE’s microfiber structure captures and removes sticky residues from pharmaceutical sterile filling equipment. The microfibers create a capillary action that draws in and retains the residues, preventing them from being redeposited on the equipment’s surface. This feature significantly reduces the need for excessive wiping motions, minimizing the risk of shedding particles and potential contamination.
Production-Proven Results: MiraWIPE has undergone extensive testing and has proven to excel in real-world production environments. Pharmaceutical facilities implementing MiraWIPE have reported significant improvements in cleanliness and sterility assurance. By effectively eliminating post-wiping fibers and particles while removing sticky, stubbornly adhered process by-products, MiraWIPE sets a new standard for cleaning practices in the pharmaceutical industry.
Conclusion: Foamtec’s MiraWIPE microfiber wipers represent a breakthrough in cleaning pharmaceutical sterile filling equipment. By combining market-leading abrasion resistance with microfiber technology, MiraWIPE effectively removes sticky disinfectant, sporicide, protein, and sugar-based residues, while eliminating the shedding of particles. As parenteral drug manufacturing facilities adhere to the regulatory guidance set by Annex 1, adopting innovative solutions like MiraWIPE becomes crucial for achieving optimal sterility and maintaining the highest standards of pharmaceutical production. With MiraWIPE, pharmaceutical facilities can confidently enhance their cleaning practices, ensuring the integrity and safety of their sterile manufacturing processes.
Learn more about Foamtec’s MiraWIPE Cleanroom Microfiber Wipes:
https://www.foamtecintlwcc.com/products/cleanroom-wipes/microfiber/mirawipe
Also available in Sterile configurations:
https://www.foamtecintlwcc.com/products/cleanroom-wipes/sterile/mirawipe