Mesa Labs presents SterilFlex™, a glass-free, liquid submersible biological indicator (BI) designed specifically for pharmaceutical manufacturers and manufacturers of thermally processed food products. The SterilFlex™ BI is safe, rugged, and small enough to be placed into a can for retort processing or directly into a thermal continuous flow system.
Being a completely self-contained unit, SterilFlex™ is extremely easy to use. Approximately 17mm x 10mm x 3mm in size, this sealed plastic biological indicator can be embedded into particles, placed into sealed containers, used in aseptic flow-type processing systems and packaged into small medical device plastic trays such as those used for contact lenses. SterilFlex™ can also be placed inside thermowells to monitor Sterilization in Place (SIP) of product transport lines and filling machines.
SteriFlex™ contains Geobacillus stearothermophilus spores and is to be incubated at 55-60°C for a validated reduced incubation time of 48 hours (per FDA protocol). A positive (non-sterile) test will turn from purple to yellow due to the pH color indicator within the growth medium of the unit.
SterilFlex™ is manufactured by Mesa Labs at its Bozeman Manufacturing Facility and comes with an expiration of 12 months from date of manufacture.
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