The manufacturing of parenteral drugs requires the highest level of cleanliness and sterility. Any deviation from the required standards can lead to severe consequences for the end-users, including infections and other adverse effects. The pharmaceutical industry is heavily regulated to ensure that the products are safe and effective. One of the critical regulatory requirements for parenteral drug manufacturing is CFR 211.194(a)(2), which mandates that “there shall be appropriate controls in place to prevent contamination of equipment or product by substances that could reasonably be expected to harm product quality.”
Visible particles are one of the primary causes of recalls and rejected batches in parenteral drug manufacturing. The presence of visible particles in a drug product can indicate contamination from various sources, including the manufacturing environment and equipment. Therefore, pharmaceutical manufacturers need to identify and eliminate particle contamination sources to ensure product safety and compliance with regulatory requirements.
Foamtec International, a leading provider of specialized products and services for contamination control, has developed the PolyCHECK particle identification system to aid pharmaceutical manufacturers in complying with CFR 211.194(a)(2) regulatory requirements. The PolyCHECK system allows production surfaces to be sampled and analyzed for particles to identify particle contamination sources.
The PolyCHECK system uses a proprietary sampling method that captures particles on a specially designed adhesive fabric. The captured particles can be analyzed using an automated particle counting and identification system. The PolyCHECK system can identify the type, size, and quantity of particles on a surface, enabling manufacturers to determine the contamination sources accurately.
Once the sources of particle contamination are identified, preventive measures can be installed to eliminate or reduce the risk of contamination.
Implementing the PolyCHECK particle identification system in parenteral drug manufacturing facilities can significantly reduce the risk of particle contamination and improve compliance with CFR 211.194(a)(2) regulatory requirements. The system can help manufacturers identify particle contamination sources, allowing them to take proactive measures to prevent contamination.
In conclusion, parenteral drug manufacturing requires the highest cleanliness and sterility to ensure product safety and compliance with regulatory requirements. Visible particles are one of the primary causes of recalls and rejected batches in parenteral drug manufacturing, highlighting the need for effective particle identification and control measures. The PolyCHECK particle identification system from Foamtec International offers a comprehensive solution to identify and eliminate particle contamination sources, ultimately ensuring product safety and regulatory compliance.
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