Fluid K USP – Screw Cap with Septum

A diluting and rinsing fluid for sterility testing of pharmaceutical products. Fluid K is supplemented with 0.3% beef extract and 0.1% Tween 80 and is suitable for testing samples that contain petrolatum, oils, or oily solutions. Excellent for rinsing pathways of medical devices, and for samples that are “difficult” to filter or dissolve.

Specifications

Container Syrup
Available fill size(s) (ml) 100, 300
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 6.9 +/-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. Fluid K is supplemented with 0.3% beef extract and 0.1% Tween 80 and is suitable for testing samples that contain petrolatum, oils, or oily solutions. Excellent for rinsing pathways of medical devices, and for samples that are “difficult” to filter or dissolve.

SKU: 3305