Quality Segment
agency
EP 2.6.1, JP 4.06, USP 71
sterility
sterile; γ-irradiated (9-20 kGy)
form
plate
feature
ready-to-use
packaging
pkg of 20 units (triple bagged)
technique(s)
Rapid Sterility Testing: suitable, microbiological culture: suitable
plate capacity
10 mL
application(s)
cosmetics
food and beverages
pharmaceutical
sterility testing
compatibility
for use with Milliflex® Rapid System
storage temp.
2-25°C
suitability
nonselective for
General description
RSTM Cassette is a ready to use media plate specifically designed to aid sterility testing of pharmaceutical product samples. The agar medium is uniquely formulated to reduce microbial incubation period from 14 days to 5 days even for slow growing microorganisms
The complex medium supports the growth of a wide range of aerobic and anaerobic bacteria as well as yeast and molds. by the application of various incubation conditions.
RSTM Cassettes are highly sensitive and can detect microbes in samples containing preservatives like thiomersal at 0.01% and it is compatible with inactivated influenza vaccines and aluminum phosphate or aluminum hydroxide adjuvants of up to 8 mg/l.
The complex medium supports the growth of a wide range of aerobic and anaerobic bacteria as well as yeast and molds. by the application of various incubation conditions.
RSTM Cassettes are highly sensitive and can detect microbes in samples containing preservatives like thiomersal at 0.01% and it is compatible with inactivated influenza vaccines and aluminum phosphate or aluminum hydroxide adjuvants of up to 8 mg/l.
Application
RSTM Cassette is used to detect microorganisms in sterility testing samples.
Features and Benefits
- RSTM Cassettes are triple-bagged and gamma-irradiated in the final packaging at 9-20 kGy to ensure secure use.
- For convenient use in isolators, the innermost bag has a hole in the seal, which is used to suspend the bag during decontamination.
- The RSTM Cassettes are designed to work perfectly with PVDF membranes of the Milliflex Oasis Rapid Funnels to provide optimized results in the final bioluminescence reaction and automated counting.
Legal Information
MILLIFLEX is a registered trademark of Merck KGaA, Darmstadt, Germany
저장 등급
11 - Combustible Solids
wgk
WGK 2
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