Pharmaceutical and medical device manufacturers need to ensure the safety of the materials used in their products. Particulate contamination is a risk in production facilities. Good Manufacturing Practice (GMP) and proper risk management require the identification of root causes and evaluating the impact that particulate matter findings can have on product safety. Understanding the risk as quickly as possible is crucial when deciding whether to release or recall affected product batches.
There are several international standards governing particulate testing and it is a daunting task to know where to start to ensure the safety of your products. SAXOCON has the facilities and expertise to quickly process and assess unexpected particulate findings and provide a mitigation strategy. Once completed, we send a comprehensive report of the results.
Why Particulate Contamination Testing Matters:
- Patient Safety: Contaminants can cause severe adverse reactions in patients, leading to complications or even life-threatening situations.
- Regulatory Compliance: Strict guidelines from agencies like the FDA and EMA mandate rigorous testing to ensure products meet safety standards.
- Product Integrity: Maintaining the highest levels of purity ensures the efficacy and reliability of medical devices and pharmaceuticals.
- Brand Reputation: Consistent quality control fosters trust and loyalty among healthcare professionals and patients.
Check out how we can help here and here.