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New Requirements Effective May 1, 2012 USP <61>, <62> Microbiological Examination of Nonsterile Products: Are you Ready?

If your substances or products have been validated and/or tested using USP methods other than those provided in USP 35-NF 30 it is essential to re-validate and begin testing using USP 35-NF30 tests. Many of the changes are designed to harmonize with the European Pharmacopeia methods. The new USP methods are now more inclusive of more organisms.

Below are major changes for microbial limits testing. Please be advised to factor these new USP methods into your testing schedules.

The following is a brief summary of the changes to USP <61> and <62>.


  • USP<61> microbial enumeration tests include changes in pass/fail criteria and includes longer incubation durations than in previous editions.
  • The Preparatory Test is replaced by the Method Suitability for product inhibition. The growth promotion organisms and the methodology have been significantly updated to include more types of organisms and different growth media. The performance of the Suitability Test Method ensures that any antimicrobial activity inherent in the sample to be tested does not adversely affect the reliability of the test and that the test procedure to be routinely utilized is otherwise suitable for use with the sample.
  • The tests for specified microorganisms are included in USP <62>, the modifications change many growth media utilized in testing for specific pathogens. Critical changes have also been made to incubation temperatures and duration.
  • More organisms have been specified in USP <62>. Organisms such as Candida albicans, Clostridia species, and bile-tolerant gram negative bacteria may be required to be tested depending on specifications regarding product formulation.

Clients must now specify which microorganisms are required to be absent from their substances or products. This requirement is based on the unique characteristics of the product’s formulation process, raw materials, etc.

Microbiology Service

The Quality from Within. Safety & Efficacy

QCL - Quality Compliance Laboratories Inc. offers a large array of microbiology laboratory testing services. Our specifically built microbiology laboratory is equipped with current technologies to analyze raw materials, active pharmaceutical ingredients, and finished products in accordance with Pharmacopoeial methodologies such as a qualified autoclave, temperature mapped incubators and refrigerators and a HEPA supplied biological safety cabinet. Our experienced staffs are fully versed in USP, EP, and JP Pharmacopoeial methodologies and various clients, specific testing with routine turn around times providing dependable and cost effective testing.

Our Microbiology Testing Capabilities include:

MICROBIAL EXAMINATION OF NON-STERILE PRODUCTS

  • Microbial Limit Test (Enumeration Test) - USP <61>
    • Total Combined Yeasts and Molds Count (TYMC)
    • Total Aerobic Microbial Count (TAMC)
    • Most-Probable-Number (MPN) Method
    • Membrane Filtration (MF)
    • Suitability Test (Preparatory Testing)
  • Test for Specified Microorganisms USP <62>
    • Total Combined Yeasts and Molds Count (TYMC)
    • Bile-Tolerant Gram-Negative Bacterial
    • Escherichia coli (E. coli)
    • Salmonella
    • Pseudomonas aeruginosa (P. aeruginosa)
    • Staphylococcus aureus (S. aureus)
    • Candida albicans (C. albicans)
    • Suitability Test (Preparatory Testing)
  • Microbial Enumeration Tests – Nutritional & Dietary Supplements – USP <2021>
  • Microbiological Procedures for Absence of Specified Microorganisms - Nutritional & Dietary Supplements – USP <2022>
  • Suitability Test (Preparatory Testing)

WATER TESTING USP <1231>

  • Total Plate Count
  • Membrane Filtration (MF)
  • Pathogen Screening

ANTIMICROBIAL EFFECTIVENESS TESTING – USP <51>

  • Validation Test
  • Preservative Effectiveness Testing - USP <51>
  • ANTIBIOTICS – MICROBIAL ASSAY – USP <81>
  • Cylinder-Plate Assay
  • Validation Test

BACTERIAL ENDOTOXIN TEST (BET) / LAL – USP <85>

ENVIRONMENTAL MONITORING

  • Air monitoring (Settling Plate and Air Sampler)
  • Surface monitoring (RODAC Plate)

MEDIA QUALIFICATION

  • Growth Promotion
  • Inhibitory Properties

QUALIFICATION OF AUTOCLAVES

  • Biological indicators; 2 days at 60°C±2.5°C

Our highly experienced and knowledgeable MBL scientist can provide advice on compendial testing.