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Key Documents

STBMRFD34

Millipore

Fluid D

ready-to-use, bottle volume 300 mL , filling volume

Synonym(s):

Rinse Fluid, Washing Fluid

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About This Item

UNSPSC Code:
41106214
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

description

For rinsing of solutions containing oil or lecithin

sterility

sterile; autoclaved

form

liquid

shelf life

17 mo.

feature

closure type screw cap with septum
ready-to-use

packaging

bottle of

bottle volume

300 mL , filling volume
500 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 D is suitable for testing samples that contain lecithin or oil, and compatible with most antibiotics. Composition of this fluid comply with the European Pharmacopeia (EP) 2.6.1, United States Pharmacopeia (USP) 71 and Japanese Pharmacopeia (JP) 4.06. This is a clear colorless fluid and the pH of the product is 7.1 ± 0.2 at 25°C. It can be stored at 2-25°C (protected from light) for 17 months. One box of product contains 4 bottles of 300 mL of fluid. Each bottle has a screw cap with a septum to minimize the risks of cross-contamination and optimize the disinfection procedures.

Application

Fluid D can be used in combination with the STERITEST® sterility testing system for the rinsing of solutions containing oil or lecithin during sterility testing by membrane filtration. It can also be used for the removal of antimicrobial activity by membrane filtration for non-sterile products. The fluid is also excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices.
Sterility testing
Bioburden testing

Culture Medium

Fluid D

Legal Information

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

related product

Product No.
Description
Pricing

Storage Class Code

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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