Millipore has launched a new pump designed to improve sterility testing of materials in aseptic manufacturing. The Steritest Equinox pump is a liquid transfer pump for sterility testing in laminar flow hoods.
The software controlled peristaltic pump allows the safe, uniform transfer of drug samples from various packaging to testing devices, according to Millipore. It has been designed for use alongside Millipore's range of Steritest devices.
For more than two decades, the Steritest system of closed sterility testing has used in pharmaceutical testing. It is based on membrane filtration methods. A false positive can mean thousands of dollars in investigative, quarantine and even batch rejection costs. With Steritest systems, the risk of false positives from adventitious contamination is minimised because there are no open containers, membrane manipulations, or media transfers, the filtration process is completely closed.
The new pump fits in with this approach. It has an intelligent system that enables analysts to download custom procedures from a desktop onto the pump and, in automated mode, the pump will prompt analysts through selected standard operating procedures (SOP), thereby supporting good manufacturing practices. The pump speed and related information are also displayed for improved repeatability and reliability.
"Sterility testing is one of the most crucial steps in pharmaceutical product release. False positives, equipment failure and human error can cost you time, money and ultimately your product," said Millipore.
A patented auto-close pump head simplifies the loading and unloading of the device's tubing, and a built-in timer enables analysts to pre-set the time required for transferring the desired volume of products and buffers into the Steritest canisters.
In addition, a patented pressure control system consistently monitors the pressure inside each canister ensuring that the system is running within acceptable limits at all times. The pump fits in horizontal and vertical Class A/Class 100 laminar flow hoods, and its design prevents undesirable air turbulence, which Millipore claims eliminates the risk of false positives.