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USP <61>/<62> Microbial Limits Testing (Total Count & Pathogen Screening)
Microbial limits testing per USP <61> and <62>, including Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), and screening for specified organisms such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis.
Price per sample:
$160
Additional information
| Turnaround Time | 2 weeks |
|---|---|
| Sample Size | 50 grams |
Microbial Limits Testing (USP <61>/<62>) – TAMC, TYMC & Specified Organisms
Pentyl Labs offers comprehensive microbial limits testing in accordance with USP <61> and USP <62> to evaluate the microbiological quality and safety of cosmetic, personal care, and consumer product formulations.
This testing combines quantitative microbial enumeration (USP <61>) with specified organism screening (USP <62>) to provide a complete assessment of microbial contamination and potential pathogen presence.
What This Test Covers
USP <61> – Microbial Enumeration (Quantitative Testing):
Determination of:
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mold Count (TYMC)
These results provide an overall measure of microbial load within the product and are commonly used to assess product hygiene, manufacturing quality, and stability over time.
USP <62> – Test for Specified Microorganisms (Qualitative Screening):
Detection of objectionable or pathogenic organisms, including:
- Escherichia coli
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Candida albicans
- Aspergillus brasiliensis
These organisms are selected based on their relevance to product safety, potential health risks, and regulatory expectations.
Why This Testing Is Important
Microbial limits testing is critical for:
- Verifying product safety prior to market release
- Supporting toxicological risk assessments (TRA)
- Meeting retailer, regulatory, and internal quality requirements
- Evaluating the effectiveness of preservation systems (in conjunction with PET/ISO 11930)
- Monitoring batch-to-batch consistency and manufacturing hygiene
While USP <61>/<62> does not define universal pass/fail criteria, results are typically evaluated against:
- Internal specifications
- Industry guidelines
- Retailer requirements
- Toxicologist recommendations
Sample Requirements
- Typical sample size: 20–50 grams or mL
- Product should be submitted in final packaged form when possible
- Directions for use (e.g., leave-on, rinse-off) should be provided
Turnaround Time
- Standard turnaround: 5–7 business days from sample receipt
Reporting
A formal Pentyl Labs report is issued upon completion, including:
- TAMC and TYMC results (CFU/g or CFU/mL)
- Presence/absence of specified organisms
- Method references (USP <61>/<62>)
- Clear sample identification and test conditions
Results apply only to the sample(s) tested as received.
Additional Notes
- Testing may be performed in-house and/or through qualified partner laboratories, depending on project scope
- Suitable for cosmetics, personal care products, raw materials, and certain consumer goods
- Can be paired with Preservative Effectiveness Testing (ISO 11930) for a complete microbiological evaluation strategy
Description
Microbial Limits Testing (USP <61>/<62>) – TAMC, TYMC & Specified Organisms
Pentyl Labs offers comprehensive microbial limits testing in accordance with USP <61> and USP <62> to evaluate the microbiological quality and safety of cosmetic, personal care, and consumer product formulations.
This testing combines quantitative microbial enumeration (USP <61>) with specified organism screening (USP <62>) to provide a complete assessment of microbial contamination and potential pathogen presence.
What This Test Covers
USP <61> – Microbial Enumeration (Quantitative Testing):
Determination of:
- Total Aerobic Microbial Count (TAMC)
- Total Yeast and Mold Count (TYMC)
These results provide an overall measure of microbial load within the product and are commonly used to assess product hygiene, manufacturing quality, and stability over time.
USP <62> – Test for Specified Microorganisms (Qualitative Screening):
Detection of objectionable or pathogenic organisms, including:
- Escherichia coli
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Candida albicans
- Aspergillus brasiliensis
These organisms are selected based on their relevance to product safety, potential health risks, and regulatory expectations.
Why This Testing Is Important
Microbial limits testing is critical for:
- Verifying product safety prior to market release
- Supporting toxicological risk assessments (TRA)
- Meeting retailer, regulatory, and internal quality requirements
- Evaluating the effectiveness of preservation systems (in conjunction with PET/ISO 11930)
- Monitoring batch-to-batch consistency and manufacturing hygiene
While USP <61>/<62> does not define universal pass/fail criteria, results are typically evaluated against:
- Internal specifications
- Industry guidelines
- Retailer requirements
- Toxicologist recommendations
Sample Requirements
- Typical sample size: 20–50 grams or mL
- Product should be submitted in final packaged form when possible
- Directions for use (e.g., leave-on, rinse-off) should be provided
Turnaround Time
- Standard turnaround: 5–7 business days from sample receipt
Reporting
A formal Pentyl Labs report is issued upon completion, including:
- TAMC and TYMC results (CFU/g or CFU/mL)
- Presence/absence of specified organisms
- Method references (USP <61>/<62>)
- Clear sample identification and test conditions
Results apply only to the sample(s) tested as received.
Additional Notes
- Testing may be performed in-house and/or through qualified partner laboratories, depending on project scope
- Suitable for cosmetics, personal care products, raw materials, and certain consumer goods
- Can be paired with Preservative Effectiveness Testing (ISO 11930) for a complete microbiological evaluation strategy
