The Milliflex® Rapid System for Rapid Sterility TestingAn automated system for rapid, accurate detection of microorganisms
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Milliflex® Rapid Filtration FunnelsReady-to-use, sterile Milliflex® Filter Units combine a funnel and a Durapore® Membrane (Polyvinyliden di-Fluoride (PVDF)) membrane filter in one device.
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Milliflex® Plus Pump VHP CompatibleThe compact Milliflex® Plus VHP vacuum pump streamlines filtration steps during testing to accelerate and ease sample preparation
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|Industrial Microbiology > Sterility Testing > Rapid Detection Methods for Sterility|
RSTM (Rapid Sterility Test Medium) Cassettes are designed for rapid sterility testing using the Milliflex® Rapid System. This agar medium is specially formulated to reduce incubation time to just 5 days, while enabling the growth of a great variety of Gram-positive and Gram-negative bacteria, including sporulating aerobic and anaerobic bacteria, as well as yeast and molds.
A faster, more sensitive alternative
In comparative studies, rapid sterility testing using the Milliflex® Rapid System with RSTM Cassettes was shown to have considerable advantages over compendial methods, such as membrane filtration and direct inoculation.
The combination of the Milliflex® Rapid System and RSTM Cassettes reduces incubation time from 14 days (compendia methods) to just 5 days. The Milliflex® Rapid System and RSTM Cassettes enable the successful detection of microorganisms in the presence of the preservative thiomersal at 0.01%. Furthermore, the system is compatible with inactivated influenza vaccines and aluminium phosphate or aluminium hydroxide adjuvants of up to 8 mg/l.
Three layers of protection
RSTM Cassettes are triple-bagged and gamma-irradiated in the final packaging at 9-20 kGy to ensure secure use in clean rooms and isolators. The cassettes may be transferred into grade A clean rooms by removing one bag in each material lock. For convenient use in isolators, the innermost bag has a hole in the seal, which can be used to suspend the bag during decontamination. Unprotected (unwrapped) plates should not be exposed directly to VHP decontamination.
Easy to use
RSTM Cassettes are suitable for testing filterable pharmaceuticals, such as vaccines, with or without thiomersal. To begin the test procedure, the sample preparation is filtered and placed onto RSTM Cassettes. Next, 3 cassettes are incubated in parallel for 5 days as described in Table 1. If no visible growth is observed after incubation, RSTM Cassettes should be processed following the usage instructions of the Milliflex® Rapid System.
|Yeast and Molds||Aerobic Bacteria||Anaerobic Bacteria|
|Aerobic at 20-25°C; 5 days||Aerobic at 30-35°C; 5 days||Anaerobic at 30-35°C; 5 days|
|Table 1: Incubation conditions of RSTM cassettes in rapid sterility testing using the Milliflex® Rapid System|