Foreign particles are a significant concern in parenteral medicines, as they can lead to batch rejections and even patient harm. Despite adopting various technologies such as RABS, Isolators, and online particle monitoring, particle contamination remains a significant issue. In fact, at the recent PDA meeting on the visible inspection of injectable drugs for particles, the 2023 PDA Visual Inspection Survey reported that visible particles are the primary reason for rejected product. This report is approved for publication and will appear in the upcoming PDA Journal of Pharmaceutical Science and Technology (JPST) mid-year. Moreover, the report highlighted that fibers above 30 microns constitute a significant category of particles that leads to rejects.
The PolyCHECK particle sampling and identification system is a new technology that allows engineers to sample equipment surfaces for particle contamination. It has been found that even when airborne counts report zero particles at or above 0.5 and 5 microns, critical equipment surfaces such as stopper bowls, product conveyors, lyophilizers, and depyrogenation ovens have numerous amounts of particles, especially fibers larger and longer than 30 microns. These particle sizes are visible to manual visible inspection procedures and even automated equipment but resist becoming airborne due to their high static charges and mass, making them undetected by in-line particle monitoring equipment. Despite good airborne counts, this explains why lots are still rejected for visible particles.
Further analysis of PolyCHECK samples has revealed that the primary source of fiber contamination is the wipers used to clean and disinfect the ISO 5 cleanroom. This highlights the importance of using high-quality wipers, such as MiraWIPE, to reduce visible particles in parenteral medicines. MiraWIPE is a woven microfiber wiper designed to minimize particle generation. It features a high-density, super-smooth woven polyester/nylon fabric that reduces the shedding of particulates during heavy-duty equipment cleaning tasks. The non-stretch fabric and ultrasonic sealed edge eliminate a significant source of particle generation. The non-symmetrical microfiber structure enables stubbornly adhered contamination to be dislodged, entrapped, and removed from product contact surfaces and components. By adopting MiraWIPE, pharmaceutical sites and other cleanroom environments can reduce visible particles in parenteral medicines and improve quality control procedures. Combined with the PolyCHECK particle sampling and identification system, engineers can identify the failure mechanisms for particle contamination and take proactive steps to reduce particle generation. This can ultimately lead to improved patient safety and reduced lot rejections in the pharmaceutical industry.
In conclusion, visible particles in parenteral medicines are a significant concern for pharmaceutical manufacturers and patients. However, the PolyCHECK particle identification system and MiraWIPE offer a solution to this problem. By using these technologies together, engineers can identify particle contamination sources and take proactive steps to reduce their generation. Ultimately, this can improve patient safety and minimize product rejections in the pharmaceutical industry.
PolyCHECK Particle Identification System
MiraWIPE Cleanroom Microfiber Wipes
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