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USP 60
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Quick understanding about test
USP 60 - Ensuring Safety in Non-Sterile Medical Products
- Burkholderia cepacia Complex
- The test involves enriching the sample in a suitable broth medium to promote Burkholderia cepacia Complex growth, followed by streaking onto selective agar and incubation. The agar plates are then examined for microbial colonies, with confirmation through biochemical or molecular methods.
- Aids regulatory compliance with strict standards.
- Ensures product safety and market readiness.
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Abstract
Manufacturers of pharmaceuticals and medical devices, as key players, have always sought many ways to enhance their capacity to bring out quality products in the market. One component of this initiative is the examination of products for microbial presence especially in the non-sterile products.
The USP provides several standard methods for this purpose, including USP 60, which is focused on the identification of the Burkholderia cepacia Complex (Bcc) in non-sterile medical products. USP 60 describes a method of sample preparation that is useful for the identification of Burkholderia cepacia Complex in nonsterile products.
Burkholderia cepacia Complex (Bcc)
Bcc are a group of gram-negative bacteria that efficiently multiply and persist in moist conditions. Thus, they are a significant threat to non-sterile pharmaceuticals and medical products. They are genotypically distinct, phenotypically similar, and exhibit various metabolic activities, making it challenging to eliminate them once they infect products or surfaces. Bcc can be present in hostile environments that include low nutrient conditions and possesses the ability to produce robust biofilms, thus increasing the need for standardized testing protocols.
USP 60 test
The occurrences of Bcc contamination and related outbreaks highlight the need for proper testing practices to avoid cross-contamination and safeguard patients’ lives. USP60 provides the methodology and testing parameters for detecting Bcc.
Test method
Media and conditions
- Broth medium
The choice of the right broth medium is very important with regard to the enrichment process. This medium should allow the optimum growth of Bcc. Examples of media that can be utilized include tryptic soy broth or other rich media through which bacterial growth is encouraged.
- Agar medium
The choice of agar medium must be selective for Bcc to ensure accurate results. Selective agars such as Burkholderia cepacia selective agar are designed to promote the growth of Bcc.
- Incubation conditions
Proper incubation conditions, including temperature and duration, are essential for the optimal growth of Bcc. Typically, incubation is carried out at 30-35°C for a period of 48-72 hours.
Step-by-step procedure
- Enrichment
The initial step involves enriching the sample in an appropriate broth medium. This step increases the likelihood of detecting any Bcc present by allowing the bacteria to multiply. Enrichment is crucial because it ensures that even low levels of contamination can be detected.
- Streaking
After enrichment, the sample is streaked onto an agar medium and incubated for a specific period.
- Result Interpretation
After incubation, the agar plates are examined for the presence of any microbial colonies. The growth of smooth, shiny, transparent or opaque colonies indicates the presence of Bcc. Biochemical tests or molecular methods such as PCR can be used for further confirmation.
The importance of USP 60 test and preventing Bcc contamination
Health risks
Bcc is an opportunistic pathogen which may cause life-threatening infections in immunocompromised patients. Such infections may be as simple as respiratory infections to more complicated systemic infections. Since Bcc is quite resistant to action in aqueous environments, non-sterile products such as nasal sprays, mouthwashes and liquid medicated products are highly vulnerable to contamination.
Regulatory compliance
To mitigate Bcc contamination, regulatory agencies require strict testing processes and procedures to be adopted. USP 60 is still a recognized procedure that helps manufacturers prove that their products are not contaminated with Bcc to achieve the required quality standards set by the government as well as to protect public health.
Preventative measures
In addition to testing, manufacturers can adopt several preventive measures to reduce the risk of Bcc contamination.
1. Good Manufacturing Practices (GMP)
2. Regular cleaning and disinfection
3. Supplier quality management
4. Employee training
Comprehensive testing solutions at MIS
At Microbe Investigations Switzerland (MIS), we provide all the necessary USP tests for non-sterile products such as USP 60, USP 61 and USP 62. Our team of professionals has extensive experience in developing and implementing test analysis protocols related to industry guidelines and norms.
We understand that the needs of each client are unique. Our experts work closely with clients to understand their specific requirements and expectations. We take full responsibility for delivering reliable and accurate results, ensuring that our clients can confidently release safe products to the market.
MIS is equipped with state-of-the-art laboratory facilities and advanced testing technologies. Our laboratories are designed to handle a wide range of microbial testing needs, from routine quality control to complex problem-solving.
If you need assistance with USP testing services, our team is here to help. Contact our experts to learn more about how we can support your efforts to ensure product safety and regulatory compliance. Our customer service team is available to answer your questions and provide guidance on the best testing solutions for your needs.
Frequently Asked Questions
DR. Martinoz Scholtz
USP 60 specifies microbial analysis methods for the presence or absence of Burkholderia cepacia Complex in non–sterile medical products.
It takes 2-3 weeks to complete the test.
At Microbe Investigations, we test for USP 60 using Burkholderia cepacia Complex.
This test is applicable for assessing non-sterile water-based pharmaceutical products such as liquid oral preparations, ointments, nasal drops, oral and cutaneous solutions, eye preparations, and other products based on water which are easily affected by Burkholderia cepacia complex.
The process of performing the test involves placing the product sample in a liquid medium that fosters the growth of the Burkholderia cepacia complex. This mixture is then streaked onto a selective medium that prevents the growth of bacteria and is incubated under optimal conditions. After incubation, colonies on the selective medium are identified using biochemical tests or molecular methods to confirm the presence of the Bcc.
The acceptance criteria for this test require that no Burkholderia cepacia complex organisms are detected in the product sample. The absence of Bcc confirms that the product meets the microbial quality standards set by the USP.
The frequency of testing varies with the regulatory requirements. Typically it should be done during the product development stage, QA and QC tests, and on the finalized product. It is necessary to mention that constant testing helps to maintain compliance with regulations and product integrity.
This test tests for Burkholderia cepacia complex only, while the other microbial tests, such as USP 61 and USP 62, test for a range of microorganisms. This is why this test offers targeted detection and should be used in products which are at higher risk of Bcc contamination.
A number of regulatory bodies, like the U. S. Food and Drug Administration (FDA), specify this test for non-sterile, aqueous-based pharmaceutical products. Meeting the requirements of this standard ensures that the product is free from microbial contamination, guarantees patient safety, and passes regulatory benchmarks.
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