Ready-to-use media
Trypticasein Soy Broth (TSB) EP/ USP/ISO
Highly nutrient liquid medium for general purpose use, formulated according to Pharmacopeial Harmonised Method.
- Cat. No.
- LC-6701
- Category
- Ready-to-use media
- Formats
- 2 formats
- ISO 17025 quality control
- Yes
- Standards
- European PharmacopoeiaISO 10273USP
Liquid culture medium used in Sterility Test, according to European Pharmacopoeia and USP.
Key features
Applications
Selective enrichment of Bacillus cereus; diluent and enrichment (general use).
Industry
Clinical, cosmetics, final product quality control, food, pharmaceutical/veterinary.
Standards
European Pharmacopoeia, ISO 10273, USP.
Description and technique
Description
Use according to expected results, according to type of samples and validated methods.
Technique
All the conditions and data for the validation of aseptic filling process can be consulted in the ISO Standard 13408-1 in the chapters devoted to the methods of preparation of sterile products in several Pharmacopoeias.
Each bag is intended for use with an automatic dispenser in laboratories requiring large volumes of broth media or diluent.
Discard any partially used bag to avoid contamination.
The bag has multiple connection points: 1 penetrable cap (injection port) of latex-free polycarbonate, for any additive injection required, and an injection (vial stopper) to connect to any standard laboratory dosing equipment with a connector.
Once completely empty, the bag can be disposed of along with normal plastic (PVC).
LC-6718, 2 L bags
It can be used in Media Fill in pharmaceutical industries.
Presentation
| Code | Presentation | Filling | Packaging |
|---|---|---|---|
| LC-6701 | 2 prepared bags, 5 L | 5000 ± 15 mL | 1 box with 2 bags of 5 L. PVC plasticizer free sterile bag with 1 vial stopper + 1 penetrable cap. Dimensions: 27 x 40 cm. For use in food testing. |
| LC-6718 | 5 prepared bags, 2 L | 2000 ± 10 mL | 1 box with 5 bags of 2 L. PVC plasticizer free sterile bag with 1 vial stopper + 1 penetrable cap. Dimensions: 18 x 32 cm. For use in food testing. |
Composition
| Ingredient | g/L |
|---|---|
| Peptone from casein | 17.0 |
| Soya peptone | 3.00 |
| Sodium chloride | 5.00 |
| Dipotassium phosphate | 2.50 |
| Dextrose | 2.50 |
Quality control
Physical/chemical control
| Color | Yellowish-brown |
|---|---|
| pH | 7.3 ± 0.2 at 25 °C |
Microbiological control
Prepare tubes - inoculate: practical range 10-100 CFU (productivity) according to harmonized Eur. Pharmacopoeia.
Aerobiosis. Incubation at 30-35 °C. Read after 18-24 h to 72 h for bacteria and 3-5 days for fungi.
| Microorganism | Growth |
|---|---|
| Bacillus subtilisATCC 6633, WDCM 00003 | Good |
| Ps. aeruginosaATCC 9027, WDCM 00026 | Good |
| Escherichia coliATCC 8739, WDCM 00012 | Good |
| Staphylococcus aureusATCC 6538, WDCM 00032 | Good |
| Salmonella typhimuriumATCC 14028, WDCM 00031 | Good |
| Aspergillus brasiliensisATCC 16404 | Good |
| Candida albicansATCC 10231, WDCM 00054 | Good |
LC-6718, 2 L bags: microbiological control
Prepare tubes - inoculate: practical range 10-100 CFU (productivity) according to harmonized Eur. Pharmacopoeia.
Analytical methodology according to ISO 11133:2014/Amd 1:2018; A2:2020.
Aerobic. Incubation at 30-35 °C for 18-72 h (bacteria) and 20-25 °C for 3-5 days (moulds and yeast).
| Microorganism | Growth |
|---|---|
| Bacillus subtilisATCC 6633, WDCM 00003 | Good |
| Ps. aeruginosaATCC 9027, WDCM 00026 | Good |
| Staphylococcus aureusATCC 6538, WDCM 00032 | Good |
| Escherichia coliATCC 8739, WDCM 00012 | Good |
| Salmonella typhimuriumATCC 14028, WDCM 00031 | Good |
| Aspergillus brasiliensisATCC 16404, WDCM 00053 | Good |
| Candida albicansATCC 10231, WDCM 00054 | Good |
Sterility control
Incubation 14 days at 32.5 ± 2 °C: NO GROWTH.
Incubation 14 days at 22.5 ± 2 °C: NO GROWTH.
Bibliography
- ATLAS, R.M. & L.C. PARKS (1993) Handbook of Microbiological Media. CRC Press, Inc. London.
- DOWNES, F.P. & K. ITO (2001) Compendium of Methods for the Microbiological Examination of Food, 4th ed. ASM. Washington. DC.
- EUROPEAN PHARMACOPOEIA 8.0 (2014) 8th ed. § 2.6.13. Microbiological examination of non-sterile products: Test for specified microorganisms. Harmonised Method. EDQM. Council of Europe. Strasbourg. (LC-6701)
- FDA (Food and Drug Administration) (1998) Bacteriological Analytical Manual. 8th ed. Rev. A. AOAC International. Gaithersburg. MD.
- HORWITZ, W. (2000) Official Methods of Analysis of AOAC INTERNATIONAL. 17th ed. Gaithersburg. MD. USA.
- ISO 11133:2014/Amd 1:2018. Microbiology of food, animal feed and water. Preparation, production, storage and performance testing of culture media.
- ISO 9308-1 Standard (2000) Water Quality. Detection and enumeration of E. coli and coliform bacteria. Membrane filtration method.
- PASCUAL ANDERSON, Mª R. (1992) Microbiología Alimentaria. Díaz de Santos S.A., Madrid.
- USP 33 - NF 28 (2011) <62> Microbiological examination of non-sterile products: Test for specified microorganisms. Harmonised Method. USP Corp. Inc. Rockville. MD. USA.
- USP 33 - NF 28 (2011) <71> Sterility Tests. Harmonised Method. USP Corp. Inc. Rockville. MD. USA.
- EUROPEAN PHARMACOPOEIA 10.0 (2020) 10th ed. § 2.6.13. Microbiological examination of non-sterile products: Test for specified microorganisms. Harmonised Method. EDQM. Council of Europe. Strasbourg. (LC-6718)
- EUROPEAN PHARMACOPOEIA 10.0 (2020) 7th ed. § 2.6.1. Sterility. Harmonised Method. EDQM. Council of Europe. Strasbourg. (LC-6718)
- ISO Standard 13408-1:2008/Amd 1:2013. Aseptic processing of health care products - Part 1: General requirements. (LC-6718)
What you receive
The product
Shipped under controlled temperature when the product requires it.
Lot certificate
Every lot comes with its certificate.
Tracked shipment
Follow your shipment live, from our warehouse to your lab.
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Frequently asked questions
Can I ask for formats other than those listed?
Yes: custom formats and OEM packs are available on request. Tell us the quantities you need.
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