List of our Microbiological Services

  • Aerobic Plate Count--USP<61>, USP<2021> and AOAC 990.12
  • Yeast and Mold Count--USP<61>, USP<2021>, AOAC 997.02 and AOAC 2014.05
  • Escherichia Coli--USP<62>, USP<2022> and AOAC 991.14
  • Coliform--FDA BAM and AOAC 991.14
  • Bile tolerant Gram-Negative Bacteria--USP<62>, USP<2022> and AOAC 2003.01
  • Pseudomonas aeruginosa--USP<62>
  • Staphylococcus aureus--USP<62>, USP<2022> and AOAC 2003.01
  • Salmonella--USP<62>, USP<2022> and PCR
  • Candida albicans--USP<62>
  • Burkholderia Cepacia—USP <60>
  • Preservative Efficacy Testing (PET)—USP<51>, ISO11930, PCPC, EP/BP and JP
  • Micro Suitability Testing
  • Time Kill Testing
A more detailed list of the microbiological method according to USP can be found below.


Effective May 2009, the USP <61> and <62> provide harmonization to the existing European Pharmacopeia method for testing non-sterile pharmaceuticals. This includes over-the-counter (OTC) and personal care products.


The original total microbial limits USP <61> underwent significant changes and split into two-part new parts, USP <61> and <62>.


In addition, the chapter USP <60> was published at the end of 2019. This chapter specifies tests to determine the presence or absence of Burkholderia cepacia.

  • USP <61> Microbial Enumeration Tests such as total aerobic microbial count (TAMC), and total yeast and mold count (TYMC).

    The Microbial Enumeration Tests’ changes include new pass/fail criteria, longer incubation durations, and the disallowing of retests. A negative control is now required every time that the product is tested. Organism validation in TSA plates have changed to Staphylococcus, Pseudomonas, and Bacillus subtilis.

  • USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms.

    The modifications on microbiological media for specific pathogens like Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Clostridia, bile–tolerant Gram-negative bacteria, and Candida albicans. Critical changes have been made to enrichment broth, incubation temperatures, and incubation duration. Organisms such as Candida albicans, Clostridia species, and bile-tolerant Gram-negative bacteria may be required to be tested depending on product type per FDA and USP monograph. Negative control is required every time that the product is tested.

  • USP <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia Cepacia Complex.

    This is a gram-negative aerobic bacteria commonly found in soil and water. It is an opportunistic pathogen that has the ability to remain viable under harsh conditions as it is resistant to preservatives and antimicrobial agents. Any source of water in a manufacturing process can potentially contain BCC leading to possible contamination of non-sterile and aqueous pharmaceutical, OTC, and cosmetic products. Contaminated products can possibly cause serious medical risks to populations susceptible to infections such as elderly people and children, as well as to immunocompromised populations such as those with cystic fibrosis, cancer and AIDS.  Cystic Fibrosis patients have been found to be especially at risk from BCC.

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