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

Part of Thermo Fisher Scientific

The ATCC Licensed Derivative® Emblem, the ATCC Licensed

Derivative® word mark, and the ATCC catalog marks are trademarks

of ATCC. Remel Inc. is licensed to use these trademarks and to sell products derived from ATCC® cultures.

* ®

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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