Microbial Limits Test Harmonization - Oxoid
Transcript of Microbial Limits Test Harmonization - Oxoid
Incubator
Saboraud Dextrose Medium
Saboraud Dextrose Agar
Mossel Enterobacter Enrichment Broth
Violet Red Bile Glucose Agar Medium
MacConkey Broth
MacConkey Agar
Potato Dextrose Agar
Soybean – Casein Digest Agar
Soybean – Casein Digest Broth
Rappaport Vassiliadis Salmonella Enrichment Broth
Reinforced Medium for Clostridia
Columbia Agar Medium
Xylose-Lysine-Deoxycholate (XLD) Agar
Cetrimide Agar Medium
Mannitol Salt Agar Medium
Staphylococcus aureus – ATCC® 6538*
Pseudomonas aeruginosa – ATCC® 9027*
Bacillus subtilis – ATCC® 6633*
Escherichia coli – ATCC® 8739*
Salmonella enterica ssp typhimurium – ATCC® 14028*
Candida albicans – ATCC® 10231*
Aspergillus niger – ATCC® 16404*
Data for growth promotion of all media batches
Data for suitability of enumeration schemes
Data for negative controls
Reviewofproductspecifications
The United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) have been harmonized so that each utilizes identical test methodologies. The most obvious change for the USP is that there are now two chapters dealing with Microbial Limits: USP<61>Microbial Examination of Nonsterile Products: Microbial Enumeration Tests, and USP<62>Microbiological Examination of Nonsterile Products:TestsforSpecifiedOrganisms.
There is a need for all companies utilizing Microbial Limits Testing to revalidate all products and raw materials under the harmonized MLT methods. This requires additional productswithspecificingredientsinitemizedamountsandmethods not seen in previous chapters.
Checklist for Harmonized Microbial Limit Testing
Microbial Limits Test Harmonization
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Harmonized Microbial Limits Test Media
Test Medium Property Product Code Type/Fill
Test for Bile-tolerant Gram-negative Bacteria
Mossel Enterobacter Enrichment Broth
Nutritive for Escherichia coli and Pseudomonas aeruginosa; Selective for Staphylococcus aureus
RE112281RE453332
100 ml Bottle500 g
Violet Red Bile Glucose Agar Nutritive & Indicative for Escherichia coli and Pseudomonas aeruginosa
RE110097 RE455302
15x100 mm Plate 500 g
Test for Escherichia coli
MacConkey Broth Nutritive for Escherichia coli and Selective for Staphylococcus aureus
RE112456RE061336 RE453822
100 ml Bottle5ml Tube500 g
MacConkey Agar Nutritive & Indicative for Escherichia coliRE09542RE01550RE453802
10 ml TubeMonoplate500 g
Test for Salmonella enterica ssp typhimurium
Rappaport Vassiliadis Salmonella Enrichment Broth
Nutritive for Salmonella enterica ssp typhimurium
RE117661RE455432
10 ml Tube 500 g
XLD Agar Nutritive & Indicative for Salmonella enterica ssp typhimurium
RE01980RE459902
Monoplate500 g
Test for Pseudomonas aeruginosa Cetrimide Agar Nutritive for Pseudomonas aeruginosa and
Selective for Escherichia coli
RE112040RE01292RE452802CM0575B
200 ml BottleMonoplate500 g500 g
Test for Staphylococcus aureus
Mannitol Salt Agar Nutritive for Staphylococcus aureus and Selective for Escherichia coli
RE01580RE453902
Monoplate500 g
Test for Clostridia
Reinforced Medium for Clostridia Nutritive for Clostridium sporogenes RE112548
RE455402100 ml Bottle500 g
Columbia Agar Medium Nutritive for Clostridium sporogenes RE110165RE455412
Monoplate500 g
Test for Candida albicans
Sabouraud Dextrose Broth Nutritive for Candida albicans RE112558RE112559
990 ml Bottle90 ml Bottle
Sabouraud Dextrose Agar 5.6 Nutritive & Indicative for Candida albicans
RE112562RE01768RE112551RE454462
100 ml BottleMonoplate500 ml500 g
Harmonized Microbial Limits Test Enumeration AgarsAgar Incubation Parameters Product Code Type/FillSoybean – Casein Digest Agar
30-35°C not more than 3 days
RE112700RE455002
500 ml500 g
Soybean – Casein Digest Broth
30-35°C not more than 3 days
RE112728RE455052
500 ml500 g
Potato Dextrose Agar 20-25°C not more than 5 days
RE112535RE454312
500 ml500 g
Sabouraud Dextrose Agar 5.6
20-25°C not more than 5 days
RE112551RE454462
500 ml500 g
Harmonized Microbial Limits Test Specified MicroorganismsSpecifiedATCC®microorganismstomeetorexceedharmonizedUSPspecifications.
Organism Product Code Type/Fill
Staphylococcus aureus – ATCC® 6538*RE4737016 10 Test/Kit
RE4717016 100 Tests/Kit
Escherichia coli – ATCC® 8739*RE4737085 10 Tests/Kit
RE4717085 100 Tests/Kit
Pseudomonas aeruginosa – ATCC® 9027*RE4735210 10 Tests/Kit
RE4715210 100 Tests/Kit
Salmonella enterica ssp typhimurium – ATCC® 14028*
RE4716000 100 Tests/Kit
Bacillus subtilis – ATCC® 6633*RE4731221 10 Tests/Kit
RE4711221 100 Tests/Kit
Candida albicans – ATCC® 10231*RE4731503 10 Tests/Kit
RE4711503 100 Tests/Kit
Aspergillus niger – ATCC® 16404*RE4731100 10 Tests/Kit
RE4711100 100 Tests/Kit
OxoidandRemelhaveallofthemediayouneedfortheharmonizedMLTmethods. ThemediahasbeenformulatedtomeetorexceedharmonizedUSPspecifications.
©2008 Thermo Fisher Scientific Folio 2346
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