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STBMRFA12DP

Fluid A, Double packed

Name: Fluid A, Double packed
Brand: MM

double packed of, ready-to-use, bottle volume 100 mL , filling volume

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Synonym(s):

Rinse Fluid, Washing Fluid

eCl@ss:

32014001

NACRES:

NA.74

Agency

in accordance with EP 2.6.1
in accordance with JP 4.06
in accordance with USP 71

Quality Level

400

description

For rinsing and dilution

sterility

sterile; ethylene oxide treated

form

liquid

feature

closure type screw cap with septum
ready-to-use

packaging

double packed of

bottle capacity

125 mL

bottle volume

100 mL , filling volume

input

sample type pharmaceutical(s)

pH

7.1

application(s)

pharmaceutical
sterility testing

compatibility

for use with Steritest^® Symbio FLEX Pump Kit, 2 media (SYMBFLE01)
for use with Steritest^® Symbio ISL Pump Kit, 2 media (SYMBISL01)
for use with Steritest^® Symbio LFH Pump Kit (SYMBLFH01)
for use with Steritest^®

shipped in

ambient

storage temp.

2-30°C

suitability

nonselective for

Related Categories

Sterility Testing Consumables, Media & Instruments

General description

Fluid A is a general rinse buffer in compliance with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06. The sterilized double Tyvek^® packaging increases the test method reliability, allowing to streamline the cleaning procedures, minimize the risk of cross-contamination in laminar flow hoods and secure an efficient decontamination of isolator chambers. The product is a clear colorless liquid with a pH of 7.1 ± 0.2 at 25°C. It can be stored at 2-25°C (protected from light) for 12 months. A single box contains 12 bottles of 100ml of fluid, each bottle with a screw cap with septum closure that reduces the risk of cross-contamination and optimizes the disinfection procedures.

Application

Fluid A is used to rinse aqueous solutions during sterility testing by membrane filtration. It is also used to dilute soluble solids for the same application. This product is recommended as a rinsing fluid for membrane filtration of non-sterile products. It is excellent for dissolving or diluting samples, reconstituting commercial microorganisms, or as a transport medium for microorganisms.

Sterility testing
Bioburden testing

Components

Screw cap with septum

Culture Medium

Fluid A

Legal Information

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

Tyvek is a registered trademark of E. I. du Pont de Nemours and Company

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Storage Class Code

12 - Non Combustible Liquids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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