Viable contaminants or microorganisms, when not detected and controlled, can play havoc in a pharmaceutical manufacturing facility in terms of stalled productions and held up batches, retesting, investigations, corrective and preventive actions leading to much increased, unwanted documentation.
mdi offers a wide range of validated membrane filters, devices, and support equipment for microbiological applications in pharmaceutical quality control and quality assurance empowering microbiologist through reliable and functionally convenient test systems for critical microbiological analysis such as sterility testing, microbial limit testing, and cleaning validation etc. These innovative products, backed by more than 30 years of technology development and expertise, are designed to incorporate unique performance advantages and come with complete validation support to help the microbiologist improve efficiency and productivity, comply with good lab practices, and meet stringent regulatory requirements.
mdi membranes and devices for microbiology are made in class 10,000 facilities under ISO 9001:2008 certified quality management systems.
This along with careful selection of raw materials, validated production processes, and testing procedures based on international standards and guidelines such as CFR, ASTM and USP ensures manufacture of consistently high quality products. These products are validated and tested on lot basis for critical performance parameters such as microbial retention, sterility and microbial recovery, as well as other functional parameters such as integrity, flow rates, burst pressure, and package integrity. All products are accompanied by a certificate of quality and validation documents are available on request.
