FICHE TECHNIQUE
Transcription
FICHE TECHNIQUE
TECHNICAL DATA SHEET TRYPTO-CASEIN SOY BROTH (TSB) BK046HA BK046GC BM00908 NUTRIENT MEDIUM 1 BM03008 BM16608 BM17908 INTENDED USE Trypto-casein soy broth (TSB) is a universal nutrient medium suitable for a wide range of uses. In light of its excellent nutritive value, it favors the growth of most fastidious microorganisms. It is used in the pharmaceutical industry to satisfy sterility tests and its formula is that listed in the United States Pharmacopoeia and European Pharmacopoeia. 2 PRINCIPLES The combination of Tryptone and papaic digest of soybean meal leads to a synergy between the protein supply of casein and the carbohydrate supply of soybeans. This leads to the optimal growth of a large number of species, both fastidious or not. Glucose is an energy source. Sodium chloride maintains osmotic balance. Dipotassium phosphate acts as a buffer to maintain a constant pH. 3 PREPARATION Preparation of dehydrated medium : Dissolve 30.0 g of dehydrated medium (BK046) in 1 liter of distilled or deionized water. Reconstitution : 30.0 g/L Sterilization : 15 min at 121 °C Stir slowly until complete dissolution. Dispense in tubes or flasks. Sterilize in an autoclave at 121 °C for 15 minutes. 4 INSTRUCTIONS FOR USE Harmonized chapters of the Pharmacopoeia - Detection of specified microorganism : Inoculate the medium prepared as above, or the ready-to-use media (BM009, BM030 or BM179) with the sample to test. Incubate at 32.5 ± 2.5 °C for 18 to 24 h. - Test for bile-resistant gram-negative bacteria : Inoculate the medium prepared as above, or the ready-to-use media (BM009, BM030 or BM179) with the sample to test. Incubate at 20-25 °C for 2 hours (a time sufficient to resuscitate the bacteria but not sufficient to encourage multiplication of the microorganisms). Incubation must not exceed 5 hours. Animal Health (U 47-107; U 47-108) Inoculate the medium prepared as above, or the ready-to-use media (BM009, BM030 or BM179) with the sample to test. Incubate for 3 to 5 hours at 37 ± 2 °C. Note : For other uses, follow the current reference method. Rue des Quarante Mines – ZAC de Ther – Allonne – B.P. 10245 – 60002 Beauvais Cedex – France Tél : + 33 (0)3 44 14 33 33 – Fax : + 33 (0)3 44 14 33 34 – www.biokar-diagnostics.com Page 1 of 3 5 RESULTS Growth results in turbidity of the medium. Subcultures are prepared in order to purify strains to be identified. 6 TYPICAL COMPOSITION The typical composition can be adjusted to obtain optimal performance. For 1 liter of medium : - Tryptone .................................................................................................................... 17.0 g - Papaic digest soybean meal ...................................................................................... 3.0 g - Glucose ....................................................................................................................... 2.5 g - Dipotassium phosphate ............................................................................................... 2.5 g - Sodium chloride .......................................................................................................... 5.0 g pH of the ready-to-use medium at 25 °C : 7.3 ± 0.2. 7 QUALITY CONTROL Dehydrated medium : cream-white powder, free-flowing and homogeneous. Prepared medium : amber solution, limpid. Typical culture response (inoculum 2 10 microorganisms, in duplicate) : Microorganisms 1 Staphylococcus aureus Bacillus subtilis 1 Pseudomonas aeruginosa 2 Candida albicans 2 Aspergillus brasiliensis (1) 48 hours of incubation at 32.5 °C (2) 5 days of incubation at 20-25 °C 1 8 Growth WDCM 00032 WDCM 00003 WDCM 00026 WDCM 00054 WDCM 00053 Positive Positive Positive Positive Positive STORAGE Dehydrated medium : 2-30 °C. Prepared media in vials or tubes (benchmark value*) : 6 months at 2-25 °C. Ready-to-use medium in tubes, in vials and in flexible bags : 2-5 °C, shielded from light. The expiration dates are indicated on the labels. 9 PRESENTATION Ready-to-use media in tubes : 50 x 10 mL tubes ................................................................................................................................................. BM03008 Ready-to-use media in vials : 10 x 100 mL vials ................................................................................................................................................. BM00908 10 x 90 mL vials .................................................................................................................................................. BM17908 Ready-to-use media in flexible bags : 2 x 5 liters flexible bags........................................................................................................................................ BM16608 Dehydrated medium : 500 g bottle .......................................................................................................................................................... BK046HA 5 kg drum .............................................................................................................................................................BK046GC 10 BIBLIOGRAPHY Ministère de l’Agriculture. Cosmétologie. Commission XXX. Recherche de Pseudomonas aeruginosa dans les produits cosmétiques. Rue des Quarante Mines – ZAC de Ther – Allonne – B.P. 10245 – 60002 Beauvais Cedex – France Tél : + 33 (0)3 44 14 33 33 – Fax : + 33 (0)3 44 14 33 34 – www.biokar-diagnostics.com Page 2 of 3 Journal Officiel du 25 octobre 1978. Essai de stérilité, 8233-8237. FIL provisoire 181. Décembre 1998. Produits laitiers secs. Dénombrement de Bacillus cereus. Technique du nombre le plus probable. NF U 47-106. December 2004. Animal health analysis methods. In vitro determination of the susceptibility of bacterial to antimicrobial agents using the agar dilution method. NF U 47-107. December 2004. Animal health analysis methods. Guide de réalisation des antibiogrammes par la méthode de diffusion en milieu gélosé. NF EN ISO 20645 (G 39-014). August 2005. Textiles fabrics. Determination of the antibacterial activity. Agar diffusion plate test. NF EN ISO 21871 (V 08-063). July 2006. Microbiology of food and animal feeding stuffs. Horizontal method for the enumeration of low numbers of presumptive Bacillus cereus. Most probable number technique and detection method. NF EN 12353 (T 72-145). September 2006. Chemical disinfectants and antiseptics. Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sproricidal and fungicidal activity. NF EN ISO 18416 (T 75-607). September 2009. Cosmetics. Microbiology. Detection of Candida albicans. United States Pharmacopeia. Microbiological Tests / Microbial Limit Tests. Buffer Solution and Media. 84-86. Microbiological Tests / Microbiological Examination. Recommended Solutions and Culture Media. Microbiological Tests / Sterility Tests. Media. European Pharmacopoeia. 2.6. Biological tests. 2.6.1. Sterility. 2.6.1. Culture media and incubation temperatures. European Pharmacopoeia. 2.6.13. Microbiological examination of non-sterile products test for specified microorganisms. Recommended solution and culture media. 11 ADDITIONAL INFORMATIONS *Benchmark value refers to the expected shelf life when prepared under standard laboratory conditions following manufacturer’s instructions. It is provided as a guide only and no warranty, implied or otherwise is associated with this information. The information provided on the package take precedence over the formulations or instructions described in this document and are susceptible to modification at any time, without warning. Document code Creation date Update Grounds for revision : : : : BK046/A/2003-01 : 11. 2003-01 2013-03 General revision (Denomination; §4 : Instructions for use ; §9 : Presentation) Rue des Quarante Mines – ZAC de Ther – Allonne – B.P. 10245 – 60002 Beauvais Cedex – France Tél : + 33 (0)3 44 14 33 33 – Fax : + 33 (0)3 44 14 33 34 – www.biokar-diagnostics.com Page 3 of 3
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