Whitepaper: Feasibility of a Rapid Microbiological Method for filterable raw materials

The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples…

The analysis of pharmaceutical products for microbial contamination is a critical component of pharmaceutical manufacturing. All raw materials and additives must be free of contaminants before they can be used in the manufacturing process to ensure that only the highest quality products are developed and safely administered to patients. Traditional approaches used to detect microbial contamination in filterable samples are quite time consuming, requiring up to two weeks to complete. There is now rising demand among pharmaceutical manufacturers and quality control laboratories for the development of more rapid microbiological methods and technologies for contamination testing. Use of an alternative rapid test could ensure a faster pace of manufacturing and ultimately accelerate time to market, resulting in significant cost savings. Additionally, rapid testing could enable timely implementation of corrective actions.

The compendial methods for detecting microbial contamination in filterable samples, which are based on morphological and biochemical characterisation of microorganisms, are nearly a century old. These methods include traditional membrane filtration, which uses a filtration apparatus for liquid and soluble raw materials, and the pour plate technique, which involves direct plating for solid and non-soluble raw materials. However, recent technologies have emerged for more rapid detection of microorganisms. In 2000, the Parenteral Drug Association (PDA) published the first guidance document on the validation and implementation of alternative rapid microbiological methods. In 2012, the United States Pharmacopeia (USP) and European Pharmacopeia (EP) also published guidance documents on alternative methods.