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USP 1111
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USP 1111 - Microbiological Examination of Non sterile products
The USP 1111 outlines the microbiological examination and acceptance criteria for nonsterile pharmaceutical products.
- Provides clear criteria for quality control in manufacturing and distribution.
- Supports compliance with pharmacopeial and GMP guidelines.
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Abstract
USP 1111 provides crucial guidelines to guarantee the microbiological safety of non-sterile
pharmaceutical products. It defines specific limits for acceptable microbial levels to ensure they do not reduce the therapeutic effectiveness of the product or adversely affect patient health. The document details specific acceptance criteria based on the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC).
Microbial enumeration of nonsterile medical products is conducted through following the methods – Microbial Enumeration Tests (USP 61) and Tests for Specified Microorganisms (USP 62). USP 61 gives estimation of total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) in given tested products. While, USP 62 helps to determine the presence of specified microorganisms in non-sterile products.
The values for acceptance criteria for TAMC and TYMC are provided in Table 1 and Table 2, respectively. Acceptable count values are interpreted as –
10 1 cfu: maximum acceptable count = 20
10 2 cfu: maximum acceptable count = 200
10 3 cfu: maximum acceptable count = 2000; and so forth.
Compliance with these given microbial limits helps to maintain product safety, stability, and efficacy.
USP 1111 โ Acceptance Criteria for Non-Sterile Pharmaceutical Products
Table 1 : Acceptance Criteria for Microbiological Quality of Nonsterile Dosage Forms
Route of Administration | Total Aerobic Microbial Count (cfu/g or cfu/mL) | Total Combined Yeasts/Molds (cfu/g or cfu/mL) | Specified Microorganism(s) |
Nonaqueous preparations for oral use | 10 3 | 10 2 | Absence of Escherichia coli (1 g or 1 mL) |
Aqueous preparations for oral use | 10 2 | 10 1 | Absence of Escherichia coli (1 g or 1 mL) |
Rectal use | 10 3 | 10 2 | โ |
Oromucosal use | 10 2 | 10 1 | Absence of Staphylococcus aureus (1 g or 1 mL)
Absence of Pseudomonas aeruginosa (1 g or 1 mL) |
Gingival use | |||
Cutaneous use | |||
Nasal use | |||
Auricular use | |||
Vaginal use | 10 2 | 10 1 | Absence of Pseudomonas aeruginosa (1 g or 1 mL)
Absence of Staphylococcus aureus (1 g or 1 mL)
Absence of Candida albicans (1 g or 1 mL) |
Transdermal patches (limits for one patch including adhesive layer and backing) | 10 2 | 10 1 | Absence of Staphylococcus aureus (1 patch)
Absence of Pseudomonas aeruginosa(1 patch) |
Inhalation use (special requirements apply to liquid preparations for nebulization | 10 2 | 10 1 | Absence of Staphylococcus aureus (1 g or 1 mL)
Absence of Pseudomonas aeruginosa (1 g or 1 mL)
Absence of bile tolerant Gram Negative bacteria (1 g or 1 mL) |
Table 2. Acceptance Criteria for Microbiological Quality of Nonsterile Substances
Total Aerobic Microbial Count (cfu/g or cfu/mL) | Total Combined Yeasts/Molds Count (cfu/g or cfu/mL) | |
Substances for pharmaceutical use | 10 3 | 10 2 |
Any other microorganisms that are not outlined in table 1 need to be evaluated based on following factors to assess their potential impact. These factors include –
- The route of administration of the product – Different routes of administration, such as oral, topical, or injection, may pose different risks associated with specific microorganisms.
- The method of product application – The method of applying the product should be taken into consideration when evaluating microbiological quality of products.
- Growth potential of product – This helps to determine whether products support microbial growth or have antimicrobial preservation action.
- The intended recipients – Factors like age and existing health conditions (disease, wounds, or organ damage) of the intended patient population should be taken into consideration. Additionally, the use of Immunosuppressive agents or corticosteroids by patients can compromise the immune system and increase the vulnerability to microbial infections.
Importance of USP 1111
Safety Assurance: By setting specific microbial limits for nonsterile pharmaceuticals, USP 1111 helps ensure that these products are safe for consumer use. The presence of excessive microorganisms can compromise product safety and effectiveness, potentially leading to adverse health effects.
Quality Control: By setting specific acceptance criteria, USP 1111 helps manufacturers maintain consistent quality in their products. It ensures that the microbial bioburden is kept at a low level, which is essential for the stability and efficacy of the product.
Regulatory Compliance: Adhering to USP 1111 is mandatory for pharmaceutical manufacturers to meet regulatory requirements. Compliance helps avoid legal issues and product recalls, which can be costly and damage a companyโs reputation.
Risk Mitigation: By implementing the standards set forth in USP 1111, manufacturers can significantly reduce the risk of contamination. This proactive approach is beneficial for preventing complications associated with microbial contamination, such as infections or product inefficacy.
Compliance and Industry Standards for USP 1111
Key aspects include :
Risk-Based Quality Management: Manufacturers must conduct microbial risk assessments, considering factors such as product type, patient population, and manufacturing processes.
GMP: GMP practices should be used to minimize the risk of contamination during production and handling.
Monitoring and Testing: On a regular basis, raw materials, in-process samples, and finished products shall be periodically inspected to ensure continued compliance with USP.
Training on Personnel: Training shall be conducted to interpret the test results.
Regulatory Audits: Compliance audits are performed by regulatory authorities to ensure that manufacturers are always in compliance with this standard .
Conclusion
At MIS, we offer an extensive portfolio of USP testing services globally. Our testing capabilities include USP 61, USP 62, and USP 60. With our extensive expertise in the field of microbiology, we are committed to delivering accurate and reliable results for each test conducted.
We specialize in offering customized testing services tailored to specific needs of clients. Our microbiology experts meticulously design protocols that align with your requirements and USP guidelines.
Need any assistance with USP testing services, contact our experts here.
Frequently Asked Questions
DR. Martinoz Scholtz
USP 1111 outlines the acceptance criteria for nonsterile pharmaceutical products through microbial enumeration tests.
USP 1111 test is applicable for non-sterile products such as topical products, inhalation products, parenteral products, eye and ear preparations, etc.
This test is crucial in pharmaceutical manufacturing as it ensures the microbiological safety and quality of non-sterile products, protecting patient health and maintaining compliance with regulatory standards.
Regulatory bodies like the FDA, EMA, and WHO recognize USP 1111 standards for ensuring pharmaceutical product safety and quality.
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