Advanced Microbiological Testing Solutions for Contamination Control and Product Quality
Achieve Regulatory Compliance and Healthy Quality Control
Microbiology laboratories in the pharmaceutical, cosmetics, water, beverage, and food industries are dedicated to ensuring the safe release of products. They depend on robust contamination control strategies, regulatory compliance, and rigorous validation of microbiological equipment to monitor ultra-purity levels and prevent contamination.
Sartorius offers a comprehensive range of microbiological testing solutions, including both instruments and consumables. The Sterisart® Universal | Gen 4 sterility testing pump and MD8 air samplers, provide precise and reliable testing capabilities. Complementing these instruments are consumables, such as gridded sterile membranes, filtration units, and culture media, all designed to support efficient and compliant microbial enumeration. Additionally, rapid sterility and mycoplasma detection qPCR kits ensure quick and accurate results. With these offerings, Sartorius supports high-quality microbiological testing across diverse applications.
Products for Microbiological Testing
Sartorius Microbiological Testing Products Offer:
For more than 60 years, Sartorius has manufactured gridded membranes available in various pore sizes, colors, and packaging options, either integrated into a filtration system or individually packaged.
Our focus is on both the sample and the operator; our equipment and consumables are designed to save time, reduce costs, ensure reliable microbial growth and detection.
We have enriched our growth-based solutions with rapid microbiological methods to facilitate faster product release and keep pace with the latest advancements in biotherapeutics.
Our solutions are designed to swiftly adapt to your evolving microbiological testing needs. Maintain regulatory compliance and stay ahead of industry changes with minimal hassle and maximum efficiency.
Applications for Microbiological Testing
Resources for Microbiological Testing
Frequently Asked Questions
Sartorius has implemented a robust quality management system that includes batch testing and validation for every production run. Our quality control processes involve physical, chemical, and microbiological testing to ensure that every batch meets the highest standards for consistency and reliability. We also conduct regular audits and process improvements to maintain the highest level of product quality.
Absolutely. We provide comprehensive documentation for all our products, including certificates of analysis, compliance with ISO standards, and adherence to relevant regulations such as USP and EP for pharmaceutical applications. Download Certificates & Technical documentation.
Sartorius microbiology membranes come in a variety of pore sizes, including 0.45 µm which the most represented in regulations like ISO 7704 for microorganism retention as it offers the optimal compromise between microbial retention and permeability with the nutrient media. In some applications, a pore size of 0.65-0.8 µm is sufficient to retain larger cells of yeasts and molds.
Sterility testing methods should be validated initially and then revalidated on a regular basis, or whenever significant changes are made to the test method or product, to ensure ongoing reliability and compliance with regulatory standards.
Download the guide: Sterisart® Second Supplier Validation Guide
Industrial microbiology is performed in a variety of activities across multiple industries, including but not limited to:
- Pharmaceutical Manufacturing: To ensure that drugs and vaccines are free from microbial contamination
- Food and Beverage Production: To detect spoilage organisms and pathogens to ensure food safety
- Cosmetics Industry: To ensure that cosmetic products are safe for use and free from harmful microorganisms
- Water Treatment Facilities: To test drinking water and wastewater for microbial contaminants
- Environmental Monitoring: To assess the presence of microorganisms in various environments, such as soil, air, and water (recreational, tap, swimming) to protect public health
- Agriculture: To test for soil health, plant pathogens, and ensure the safety of agricultural products
- Biotechnology Research: To monitor cell cultures and other biological materials for contamination
- Quality Control Laboratories: To validate the sterility and microbial limits of various products and environments
- Healthcare Facilities: To monitor the cleanliness and infection control measures in hospitals and clinics
- Microelectronics: To prevent surface contamination from ultrapure water, potentially altering adhesion properties or electrical characteristic
The primary method is membrane filtration, which involves filtering the beverage through a membrane to capture microorganisms for subsequent incubation and counting. Key equipment includes a filtration apparatus, a vacuum source, sterile membranes, and culture media for growing captured organisms.
They save time and minimize the risk of secondary contamination by providing pre-sterilized components that are ready for immediate use without additional preparation.
Nutrient pad sets offer a stable shelf-life of two years without the need for refrigeration, and they can be activated simply by adding sterilized water, which improves efficiency and reduces storage requirements.
Single-use filtration units save time by eliminating the need for flaming and sterilizing equipment, reducing preparation time by up to 43% compared to reusable stainless steel funnels.
What to know more? Watch the webinar: Time Saving in Microbiological QC Testing of Liquid Samples
Critical factors and practices that inhibit microbial growth include maintaining proper hygiene in the winery, controlling the temperature and pH of the wine, using preservatives like sulfur dioxide, and ensuring adequate alcohol content. Regular microbiological testing at critical control points is also essential to monitor and prevent microbial instability.
Download the brochure: In-House Microbiological Testing of Wine in Large Wineries