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USP 1111 – Acceptance Criteria for Non-Sterile Pharmaceutical Products
USP 111 specifies acceptance criteria for nonsterile pharmaceutical products based on the following microbial enumeration tests – aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC).
Microbial enumeration of nonsterile medical products is conducted through following methods –
USP 61 (Microbiological Examination of Nonsterile Products) and USP 62 (Tests for Specified Microorganisms). 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.
Products that can be tested with USP 1111
USP 1111 test provides bioburden limits for following non-sterile products –
- Aqueous/ non aqueous oral preparations
- Topical products (creams, ointments, gels)
- Parenteral products (injectables)
- Inhalation products (aerosols, inhalers)
- Eye and ear preparations (drops, ointments)
- Nasal sprays
- Vaginal products
- Rectal products
- Transdermal patches
| 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 | — |
| 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) |
| 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 Test
Microorganisms can contaminate medical products during manufacturing, storage, or handling processes. This contamination can lead to compromised product quality and potential risks to patient safety. Likelihood of microbial contamination of products increases during manufacturing, storage, and handling processes.
Therefore, it is a prerequisite for manufacturers to ensure acceptable microbial limits (a low bioburden) of finished dosage/substances. United States Pharmacopeia (USP) has developed USP 1111 method to provide acceptance criteria for specific types of nonsterile products.
At MIS, we offer an extensive portfolio of microbiology 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.
FAQs
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.
USP 1111 test takes 5-6 weeks to complete.
At Microbe Investigations, we test for USP 1111 using the following microbial strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), and Candida Albicans (MTCC 3017). Additional strains can be added on customer’s request.
Contact us for more information
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