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13th August 2024  Content supplied by: Southern Group Laboratory

High Quality Sterilty Testing Media & Rinsing Fluids from SGL


SGL supplies a high-quality range of Sterility Testing Media & Rinsing Fluids to suit a wide variety of sterility testing applications.

Manufactured in controlled environments, these products have been formulated and tested to meet harmonized Pharmacopoeia requirements.

Each lot undergoes stringent quality control, including pH, sterility, and growth promotion tests according to USP, EP, and JP methods.

  • Available from stock in a range of formats to suit a wide range of testing applications.
  • Long Shelf Life
  • QR code on each bottle linking to Certificate of Analysis
  • QC Release tested by SGL’s own ISO17025 Laboratory using Pharmacopoeia-compliant tests.

 

Sterility Media:

  • Tryptone Soya Broth (TSB) / Soybean-Casein Digest Medium SGL has worked with customers to develop a range of container types, caps, and fill volumes to suit a variety of testing applications and sample types. Whether testing by membrane filtration, direct inoculation, sample addition, or as a pre-enrichment for non-sterile products. SGL has a format to suit your requirements.
  • Fluid Thioglycollate Medium (FTM) is primarily intended for the detection of anaerobic bacteria; the medium is recommended by the Harmonized Pharmacopoeia for sterility testing and conforms to USP/EP/JP performance specifications. Available from stock in a range of formats.
  • Clear Thioglycollate Medium has the same growth promotion properties as the standard FTM and is compliant to the USP, EP and JP. This alternative formulation brings extra visual clarity versus the FTM which has a slight turbidity or haze. Available from stock.

 

Rinsing Fluids as described in the USP <71>

  • Fluid A is suitable as a general dilution and/or rinse buffer. Excellent for dissolving or diluting aqueous and soluble samples, reconstituting microorganisms, or as a transport medium.
  • Fluid D is a diluting and rinsing fluid for sterility testing of pharmaceutical products. Fluid D is supplemented with 0.1% Polysorbate (Tween®) 80. Excellent for rinsing sterile pathways of devices, and typically used for rinse method testing of medical devices and testing aerosol products.
  • Fluid K contains additional peptone (peptic digest of animal tissue), 0.3% beef extract and 0.1% Polysorbate (Tween®) 80 and is suitable for testing samples that contain oils or oily solutions.

 

SGL also supply a large number of other diluent and rinsing solutions such as buffered sodium chloride peptone broth. All liquid media can be supplied in 10ml to 5000ml fill volumes in a range of formats.

Click here for further information on Sterility Test Media & Rinse Fluids.

Contact your local SGL representative now using the "Request Information" button below.


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Date Published: 13th August 2024

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