Millipore has developed a line of MicropreSure in-line filtration samplers to simplify microbiological testing of pharmaceutical water in a move designed to aid companies in their in-process quality control efforts. The line has just been introduced in the UK by Millipore's local subsidiary.
The closed design of the samplers allows for accurate sampling with minimal membrane manipulation in a contamination-free environment, according to the company.
"Rather than only testing finished products, companies are increasingly building quality into their products by monitoring microbiological conditions during the manufacturing process," according to Millipore's web site.
The company claims that while traditional methods involve multiple steps and the inconvenience of setting up lab equipment, MicropreSure in-line filtration samplers are sterile and ready to use. They use the pressure in tanks or pressurised lines to process and collect water samples in the enclosed chamber, while a one-step process speeds collection and secures the samples for tracking and trending results.
Also, because a 100 mL volume may not reveal all microbial contaminants in a water sample, the range can process any volume through its enclosed housing, said Millipore. This allows continuous sampling over an extended period of time with results reflecting the average contamination over a batch, shift or day.The sampler is available in a 48-pack.
Meanwhile, Millipore has announced that its Milli-Q and Elix water purification systems meet the US Pharmacopeia (USP) requirements for total organic carbon (TOC) analysis and conductivity tests of purified water. USP water quality standards are primarily used by pharmaceutical manufacturers in drug production, R&D and quality control laboratories.
The company has developed a series of protocols to comply with the USP's requirements for periodic checks of TOC analysis and water conductivity.
These indicate that purified water must be controlled by a calibrated TOC monitor (either in-line or off-line) with a detection limit less than 0.05 mg/L of carbon, while conductivity measurement must be obtained using calibrated instrumentation.