Fluid D USP – Universal Vial

A diluting and rinsing fluid for sterility testing of pharmaceutical products according to the membrane filtration method. Fluid D is supplemented with 0.1% Tween 80, is suitable for testing samples that contain lecithin or oil, and is compatible with most antibiotics. Excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices.

Specifications

Container Universal
Available fill size(s) (ml) 10
Neck width (mm) 24
Caps PP, Perf, Metal
Shelf life 12 months
Storage Temp 2-25oC
Appearance Clear, pale straw-coloured liquid
Recommended Incubation 20 - 37oC
pH 7.1 +/-0.2

Quality Control

Organisms Ref. No Result
Aspergillus brasiliensis NCPF 2275 ATCC16404 Equivalent recovery rate after 45 minutes (± 50% of initial count)
Bacillus subtilis ATCC 6633 NCTC 10400 Equivalent recovery rate after 45 minutes (± 50% of initial count)
Candida albicans ATCC 10231 NCPF 3179 Equivalent recovery rate after 45 minutes (± 50% of initial count)
Clostridium sporogenes ATCC 19404 NCTC 532 Equivalent recovery rate after 45 minutes (± 50% of initial count)
Pseudomonas aeruginosa ATCC 9027 NCIMB 8626 Equivalent recovery rate after 45 minutes (± 50% of initial count)
Staphylococcus aureus ATCC 6538 NCTC 10788 Equivalent recovery rate after 45 minutes (± 50% of initial count)

Supporting Documents

MSDS Download
TECHNICAL DATASHEET (TDS) Download

Description

A diluting and rinsing fluid for sterility testing of pharmaceutical products according to the membrane filtration method. Fluid D is supplemented with 0.1% Tween 80, is suitable for testing samples that contain lecithin or oil, and is compatible with most antibiotics. Excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices.

SKU: 4824