The pharmaceutical industry mandates rigorous control of microbial contamination in purified water and water for injection (WFI) to ensure product safety and compliance with regulatory standards. Microbial presence in these critical components can compromise patient health and lead to significant consequences for manufacturers, including product recalls and loss of consumer trust.

The membrane filtration method is a gold standard for detecting microorganisms in water samples. It concentrates potential contaminants on a membrane surface, which is then cultured to allow for the growth and enumeration of colonies. This method is particularly effective for analyzing large volumes of water and is sensitive enough to detect low levels of microbial contamination.

Sartorius addresses the need for reliable water testing with its Microsart®@filter system, which is specifically designed to optimize the membrane filtration process. The system consists of a pre-sterilized funnel and base, streamlining the workflow and reducing the risk of secondary contamination. After filtration, the membrane is transferred to an R2A agar plate using the Microsart^®@media, which simplifies the process and minimizes handling.

Microsart^®@filter system

The Microsart^®@filter system is versatile, accommodating various sample volumes and compatible with different types of culture media. This flexibility is crucial for meeting diverse testing requirements and pharmacopeial standards. The system's touch-free membrane transfer is a critical feature, maintaining aseptic conditions for accurate microbial enumeration.

Download the application note to learn more.