On-Line Sampling and Filtration
Validation engineers and Quality Control specialists regularly sample the drops and tanks of process water loops to ensure low bacterial levels and to identify bio-contamination problems early. Traditional multi-step sampling methods are often inconvenient and a potential problem for time-pressed personnel. The routine of setting up lab equipment and processing samples can be rushed, sometimes at the expense of proper aseptic procedures.Most bacteria in pharmaceutical water systems are likely to exist as biofilm attached to internal surfaces of the system. As such, the contaminants are not likely to be uniformly distributed throughout the system. As a consequence, a QC (quality control) sample taken at any given time may not be representative of the real level of contamination.
One of the most important parameters of pharmaceutical water for injection (WFI) quality is low to no bioburden. Developing QC processes to ensure low to no bioburden is key to a company’s manufacturing success. By reducing the sampling process to a few simple steps performed within a closed system, the MicropreSure on-line filtration sampler improves microbiological testing of purified water at the point-of-use.
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