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
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
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
Preparation Note
Fluid A
Other Notes
Screw cap with septum
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
