STBMRFA12DP

Fluid A

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

• Synonym(s): Fluid A, Double packed, Rinse Fluid, Washing Fluid
• UNSPSC Code: 41106214
• eCl@ss: 32014001
• NACRES: NA.74

Properties

• 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

Description

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

Safety Information

• Storage Class Code: 12 - Non Combustible Liquids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable