Introduction: Particle management is a critical concern in pharmaceutical manufacturing and distinguishing between extrinsic foreign materials and technically unavoidable particles (TUPs) is challenging. Manufacturers of excipients and active ingredients often struggle with maintaining product quality while dealing with TUPs that emerge during production. Foamtec International’s innovative combination of the PolyCHECK® Inspection and Sampling Wiper with the MiraWIPE® microfiber wiper offers a practical solution to detect, identify, and eliminate particle sources, simplifying pharmaceutical manufacturing processes.
Understanding Unavoidable Particles: In pharmaceutical manufacturing, ensuring particle control while upholding product quality is ongoing. Foreign particles in excipients and chemical raw materials can be troublesome, especially when distinguishing TUPs from extrinsic foreign materials. TUPs are a natural outcome of the manufacturing process and typically don’t pose direct risks to patients or product quality. However, it’s essential to differentiate them to avoid unnecessary product rejections and costs accurately.
Foamtec’s PolyCHECK® Wiper and MiraWIPE®: A Practical Collaboration: Foamtec International introduces a pragmatic approach for manufacturers dealing with TUPs and extrinsic foreign materials. By combining the capabilities of the PolyCHECK® Inspection and Sampling Wiper with the MiraWIPE® microfiber wiper, Foamtec offers a comprehensive solution for particle detection, identification, and removal.
PolyCHECK’ s® Practical Polyester Fabric: The PolyCHECK® Wiper uses highly statically charged fabric. This polyester fabric is black, improving visibility to help spot white and opaque-colored particles and fibers against equipment surfaces. This feature simplifies the process of distinguishing between TUPs and extrinsic foreign materials.
MiraWIPE® redefines lint-free wipers: In addition to the PolyCHECK® wiper, Foamtec’s MiraWIPE® microfiber wiper enhances particle management in pharmaceutical manufacturing. MiraWIPES® design ensures better abrasion resistance while enhancing cleaning efficacy. This quality is particularly valuable in eliminating particle sources like Polycellulose, polypropylene, and polyester fibers, often shed from wipers used for equipment cleaning.
Turning Unavoidable into Unnecessary: Combining PolyCHECK® and MiraWIPE® leads to a proactive approach to particle management. The PolyCHECK® wiper’s particle retention capability streamlines the transportation of samples to material science laboratories for thorough analysis. Equally important is the ease of transferring particles to SEM stubs and FTIR windows for forensic analysis and identification. This practical approach empowers manufacturers to pinpoint particle sources and take effective corrective actions accurately.
Real-world Example: Consider a scenario where Polycellulose and polyester fibers were shedding onto equipment during cleaning and sanitization. Despite being considered unavoidable, the introduction of MiraWIPE® transformed them from unavoidable to unnecessary. Samples collected from production equipment using PolyCHECK® confirmed the existing Polycellulose and polyester wipers as the source of contamination (previously, garments were suspected of polyester fiber contamination). Upgrading to MiraWIPE® SN microfiber wipers effectively eliminated fiber contamination, highlighting the effectiveness of this innovation.
Conclusion: Foamtec International’s PolyCHECK® and MiraWIPE® are practical solutions for efficient particle management in pharmaceutical manufacturing. By addressing the challenges posed by TUPs and extrinsic foreign materials, this combined solution empowers manufacturers to accurately detect, identify, and eliminate particle sources. With streamlined analysis and forensic capabilities, PolyCHECK® and MiraWIPE® offer a proactive approach that enhances regulatory compliance, quality assurance, and patient safety. These tools are valuable assets in particle management, guiding pharmaceutical manufacturing toward enhanced efficiency and unwavering product quality.
PolyCHECK® Cleanroom Cleaning Validation Wipes
MiraWIPE® SN Cleanroom Microfiber Wipes
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