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Merck
CN

STBMRFA12DP

Fluid A - Ready-to-use Rinse Fluid

bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Black screw cap with septum and protector, double packed of 12 bottles

Synonym(s):

Fluid A, Double packed, Rinse Fluid, Washing Fluid

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About This Item

UNSPSC Code:
41106214
NACRES:
NA.74
eCl@ss:
32014001

Key Documents

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Product Name

Fluid A - Ready-to-use Rinse Fluid, bottle capacity 125 mL, bottle filling volume 100 mL, closure type, Black screw cap with septum and protector, double packed of 12 bottles

agency

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

sterility

sterile; ethylene oxide treated

form

liquid

feature

closure type Black screw cap with septum and protector
ready-to-use

packaging

double packed of 12 bottles

bottle capacity

125 mL

bottle filling volume

100 mL

input

sample type pharmaceutical(s)

pH

7.1

Quality Level

400

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

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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

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.

Other Notes

Screw cap with septum

Preparation Note

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

Storage Class

12 - Non Combustible Liquids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

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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