Microbiology TestingPharmaceutical Industries Laboratory Services
- USP <61>, For Pharmaceutical Industry Testing
- USP <61>, Total Yeast and Mold Count, TYMC
- USP <62>, Microbial Examination Tests for Specified Microorganisms
- USP <51>, Antimicrobial Effectiveness Testing (Preservative Effectiveness)
- USP <1111>, Criteria Acceptance for Pharmaceutical OTC Product Testing
USP <61>, Total Aerobic Microbial Count, TAMC
- TAMC USP <61> provides very specific guidance for assessing total aerobic bioburden present in products.
- TAMC determines the total number of aerobic bacteria per mL (gram) of the cosmetic, personal care or pharmaceutical product.
- TAMC method requires 48 to 72 hours incubation testing.
- TAMC is a mandatory mirobiological test for every lot personal care products before sale to consumer.
USP <61>, Total Yeast and Mold Count, TYMC- TYMC USP <61> uses Aspergillus brasiliensis (ATCC 16404-mold) and Candida albicans (ATCC 10231-yeast) as positive control.
- TYMC determines the total number of yeast and fungi per gram of the product.
- TYMC method requires a minimum of five to seven days of incubation testing.
Note: USP <61> and <62> methods of microbiological testing must include a positive control microbe and a negative control of diluents.
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USP <62>, Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms
USP <62> allows for the determination of the absence of, or limited occurrence of, specified microorganisms.
Test Microorganisms Used
Microorganism Name Identification Codes
Staphylococcus aureus
ATCC 6538, NCIMB 9518, CIP 4.83, NBRC 13276
Pseudomonas aeruginosa
ATCC 9027, NCIMB 8626, CIP 82.118, NBRC 14275
Escherichia coli
ATCC 8739, NCIMB 8545, CIP 53.126, NBRC 3972
Salmonella enteric
ATCC 14028, NBRC 100797, NCTC 6017, CIP 80.39
Candida albicans
ATCC 10231, NCPF 3179, IP 48.72, NBRC 1594
Clostridium sporogenes
ATCC 11437, NBRC 14293, NCIMB 12343, CIP 100651
Clostridium sporogenes
ATCC 19404, NCTC 532, CIP 79.3
A listing of tests for specified organisms is as follows:
- Bile-Tolerant Gram-Negative Bacteria: The presence of gram-negative bacteria is indicated by red precipitate around the colonies in Violet Red Glucose Agar. The product complies with the test if there is no growth of colonies.
Incubation Time: 3 Days
- Salmonella: The possible presence of Salmonella is indicated by the growth of well-developed, red colonies, with or without black centers in Xylose Lysine Deoxycholate Agar. The product complies with the test if colonies of the types described are not present.
Incubation Time: 3 Days
- Pseudomonas aeruginosa: Growth of yellow-green to blue colonies in Centridmide Agar indicates the possible presence of P. aeruginosa.
Incubation Time: 3 Days
- Staphylococcus aureus: Presence of S. aureus is indicated by the growth of yellow or white colonies surrounded by a yellow zone in Mannitol Salt Agar.
Incubation Time: 3 Days
- Clostridia: An occurrence of fluorescent orange to bright red colonies in Columbia Agar indicates the presence of Clostridia.
Incubation Time: 3 Days
- Candida albicans: Growth of white colonies in Sabouraud Dextrose Agar may indicate the presence of C. albicans.
Incubation Time: 5 DaysUSP <51>, Antimicrobial Effectiveness Testing
The antimicrobial efficacy test as defined in USP <51> evaluates the effectiveness of an antimicrobial preservative in the health, beauty, personal care, or cosmetic product. The test is carried out in such a way that the product is challenged with the known strains of the microorganisms. Personal care and cosmetic testing samples are tested at different intervals to determine the survival of the organisms. The test demonstrates the efficacy of the product to stop the growth of pathogenic organisms like staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. The microorganism survival is monitored for the duration of 28 days and analyses are made on the 7th, 14th and 28th day.
Criteria for Antimicrobial Effectiveness
The requirements for antimicrobial effectiveness are met if the criteria specified under the following table are met. The term ‘no increase’ is defined as not more than 0.5 log10 unit higher than the previous value measured.
Criteria for Tested Microorganisms
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Injections, parentals including emulsions, otic products and sterile nasal products. Bacteria:
Not less than 1.0 log reduction from the initial calculated count at 7 days, not less than 3.0 log reduction from the initial count at 14 days, and no increase from the 14 days count at 28 days.
Yeast and Molds:
No increase from the initial calculated count at 7, 14, and 28 days.
Topically used products, nonsterile nasal products and emulsions.
Bacteria:
Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days.
Yeast and Molds:
No increase from the initial calculated count at 14 and 28 days.
Oral products other than antacids.
Bacteria:
Not less than 1.0 log reduction from the initial count at 14 days, and no increase from the 14 days count at 28 days.
Yeast and Molds:
No increase from the initial calculated count at 14 and 28 days.
Antacids.
Bacteria, Yeast,
and Molds:No increase from the initial calculated count at 14 and 28 days.
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USP <1111>, Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
Manufacturers must ensure a low bioburden of finished dosage forms by implementing current guidelines on Good Manufacturing Practice during the manufacture, storage, and distribution of pharmaceutical preparations.
Microbial examination and analysis of nonsterile products is performed according to USP <61> and <62>. The following tables list the criteria for both pharmaceutical preparations and substances for pharmaceutical use:
Acceptable Criteria for Pharmaceutical Products
Route of Administration Category
Total Aerobic Microbial Count (cfu/g or cfu/mL)
Total Yeasts and Molds Count (cfu/g or cfu/mL)
Specified Microorganism(s)
Nonaqueous preparations for oral use
3
103
102
Absence of Escherichia coli
Aqueous preparations for oral use
3
102
101
Absence of Escherichia coli
Cutaneous Use
2
102
101
Absence of Staphylococcus aureus
Nasal Use
2
102
101
Absence of Staphylococcus aureus
Please note that this list is not necessarily exhaustive, and for a given preparation it may be necessary to test for other microorganisms depending on the nature of the starting materials and the manufacturing processes involved.
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