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USP 61/62

USP 61/62

USP <61> provides an evaluation of the microbial content of a product also known as bioburden testing. USP <62> is the method described for the screening of objectionable organisms or pathogens. The USP <61> and <62> test system requires validation/suitability testing and provides a rugged process for the detection of objectionable organisms. Product specific objectionable organisms can be determined based on the product type, optimizing the testing process.

This test method has defined procedures for the detection of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species and fungal organisms, and a quantitative for bile-tolerant Gram negative bacteria. USP <61/62> testing is recommended on all pharmaceutical raw materials, non-sterile products (such as liquids and powders), transdermal patches and dietary supplements.

The advantage of using Nelson Laboratories is our rugged validation method for the test process, combined with a professional team of experts who provide individualized consultation. We’ll help you design the appropriate test plan for determining the objectionable organisms in your product.

Applicable Standards

  • USP 61
  • USP 62

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
MEP110 USP 62: Suitability test, per organism 0 Add
MEP115 USP 61: Suitability test 0 Add
MEP215 USP 61/62: Transdermal patches 14 Add
MEP250 USP 61: TAMC and TYMC 14 Add
MEP265 USP 61: TAMC or TYMC (one method only) 14 Add
MEP310 USP 61/62: TAMC, TYMC, 1 org. screen 14 Add
MEP320 USP 61/62: TAMC, TYMC, 2 org. screen 14 Add
MEP330 USP 61/62: TAMC, TYMC, 3 org. screen 14 Add
MEP340 USP 61/62: TAMC, TYMC, 4 org. screen 14 Add
MEP350 USP 61/62: TAMC, TYMC, 5 org. screen 14 Add
MEP360 USP 61/62: TAMC, TYMC, 6 org. screen 14 Add
MEP370 USP 61/62: TAMC, TYMC, 7 org. screen 14 Add
MEP110 - USP 62: Suitability test, per organism
0 days
MEP115 - USP 61: Suitability test
0 days
MEP215 - USP 61/62: Transdermal patches
14 days
MEP250 - USP 61: TAMC and TYMC
14 days
MEP265 - USP 61: TAMC or TYMC (one method only)
14 days
MEP310 - USP 61/62: TAMC, TYMC, 1 org. screen
14 days
MEP320 - USP 61/62: TAMC, TYMC, 2 org. screen
14 days
MEP330 - USP 61/62: TAMC, TYMC, 3 org. screen
14 days
MEP340 - USP 61/62: TAMC, TYMC, 4 org. screen
14 days
MEP350 - USP 61/62: TAMC, TYMC, 5 org. screen
14 days
MEP360 - USP 61/62: TAMC, TYMC, 6 org. screen
14 days
MEP370 - USP 61/62: TAMC, TYMC, 7 org. screen
14 days

Sample Specifications

MEP110: The USP requires 10 grams/mL/patches/doses for the initial preparation, unless the batch is less than 1 L/kg. The Salmonella screen also requires 10 grams/mL of sample. It is recommended to supply 30-
MEP115: The USP requires 10 grams/mL/patches/doses for the initial preparation, unless the batch is less than 1 L/kg. It is recommended to supply 30-40 grams/mL/patches/doses for the USP <61> and <62> suitabi
MEP215: The USP requires 10 patches for the initial preparation, unless the batch is less than 1 L/kg. It is recommended to supply 20-30 patches for the testing.
MEP250: The USP requires 10 grams/mL/patches/doses for the initial preparation unless the batch is less than 1 L/kg. It is recommended to supply 20-30 grams/mL/patches/doses for the testing.
MEP265: 20 grams or 10 mL

Study Outline

The USP <61/62> test system uses the compendia method, as set forth by USP, for the testing of non-sterile pharmaceutical products and other non-sterile articles for bacterial load and pathogenic organisms. USP <61> testing includes an enumeration plate count and suitability testing, which validates the plate count.  USP 62 testing evaluates the presence or absence of specific organisms.

The suitability test verifies the validity of the testing method by demonstrating that any antimicrobial properties of the product do not inhibit possible recovery of growth. The suitability is performed with inoculation of the product with <100 colony-forming units (CFU) of the defined organisms.

USP <61> describes the validation of the plate count preparation and plating method by demonstrating recovery of Staphylococcus aureus, Pseudomonas aeruginosa,  Bacillus subtilis, Candida albicans and Aspergillus brasiliensis on the appropriate media. The testing is performed to determine the total aerobic microbial counts and total yeasts and molds counts. The plating of the sample can be performed by membrane filtration, pour plating or the spread plate method. The sample is diluted, plated for the total aerobic microbial count and total yeasts and molds count, and incubated.

USP <62> analysis is performed to determine the presence of specified microorganisms: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant Gram-negative bacteria, Clostridia species, Salmonella species and/or Candida albicans. The test involves an initial enrichment of the sample and then streaking the enriched sample onto selective agars for determination of the presence of the defined objectionable organisms.