Microbiological testing of non-sterile pharmaceutical products
Microbiological testing of non-sterile pharmaceutical products is a fundamental aspect in the pharmaceutical industry. This analysis is crucial for the release of a wide variety of products, following the guidelines established in chapter 5.1.4 “Microbiological Quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use” of the European Pharmacopoeia. This regulation applies to oral, rectal, cutaneous, nasal, vaginal preparations, inhalers and transdermal patches, among other products.
What we offer in microbiological testing
- Diversified Analyzes: We perform analyzes that include the total aerobic microorganism count (TAMC) and the total fungal and yeast count (TYMC). In addition, we carry out tests to detect specific microorganisms such as Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Clostridia, Candida albicans and bili-tolerant Gram negative bacteria, following chapters 2.6.12 and 2.6.13 of the European Pharmacopoeia.
- High Quality Equipment: We have qualified equipment for microbiological analysis, including incubators and other instruments that meet the standards required by the pharmacopoeia. Our facilities are equipped with laminar flow cabinets, pipettes, filtration equipment and other essential instruments to perform aseptic analysis.
- Quality Certifications: We operate under the certification of Good Laboratory Practices and Good Manufacturing Standards, which guarantees the quality and traceability of our results.
- Comprehensive Services: We offer complete microbiological analysis services, both quantitative and qualitative, including the complete identification of isolated microorganisms. These services extend to healthcare and food products, ensuring the same level of reliability and quality.
At Netpharmalab we are dedicated to providing accurate, reliable and regulatory-compliant microbiological testing for non-sterile pharmaceutical products, as well as healthcare and food products. Our approach is based on precision, reliability and rigorous compliance with regulations, offering our clients high quality and reliable results. Our experience and advanced technology allow us to address the industry’s microbiological challenges, ensuring that our customers’ products meet the highest safety and quality standards.