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Key Documents

1.46053

Millipore

RSTM Cassette

For sterility testing with Milliflex® Rapid System

Synonym(s):

Rapid Sterility Test Medium

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About This Item

UNSPSC Code:
41106217

Agency

EP 2.6.1
JP 4.06
USP 71

Quality Level

400

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

Related Categories

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.

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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