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USP 60 – Non-Sterile Product Test For Burkholderia cepacia Complex
USP 60 outlines a test method for the detection of potential opportunistic pathogen Burkholderia cepacia Complex, in non-sterile medical products.
USP 60 has been established to help manufacturers and companies in effectively managing and preventing the control of Burkholderia cepacia Complex contamination in their non-sterile drugs (NSDs).
USP 60 Test Method
- First step involves the enrichment of samples in appropriate broth media.
- After this, enriched sample is streaked onto agar medium and incubated for a specific period of time.
- After the incubation period, agar plates are observed for presence or absence of Burkholderia cepacia Complex.
- If the test sample is not contaminated with microorganisms, there will be no microbial growth on petri plates after incubation.
Importance of USP 60 Test
Burkholderia cepacia Complex is an opportunistic pathogen that can proliferate in aqueous, non-sterile drug products. In past, several Burkholderia cepacia Complex outbreaks have been linked to contaminated medical products. This includes –
- Year 2005 : A multistate outbreak of Burkholderia cepacia complex due to intrinsically contaminated alcohol-free mouthwash (AFM)
- Year 2004 : Burkholderia cepacia Complex infection associated with intrinsically contaminated nasal spray
- Year 2017 : Burkholderia cepacia Complex infections related to liquid docusate sodium contamination
- Year 2018 : Burkholderia cepacia Complex outbreak linked to a no-rinse cleansing foam product
Burkholderia cepacia Complex is also linked to cause nosocomial infections among immunocompromised patients. Therefore, the screening of non sterile medical products is important to ensure public safety and reduce health hazards.
To address this, USP (United States Pharmacopeia) describes standardized and analytical methods like USP 61, USP 62, and USP 60 to assess microbiological quality of non – sterile medical products. USP 60 is particularly designed to check Burkholderia cepacia contamination in product samples.
For the medical and pharmaceutical industries, MIS offers a comprehensive product portfolio of USP testing for non sterile products including USP 61, USP 62, and USP 60.
Our team of experts is adept at designing and conducting test analysis protocols in accordance with relevant industry standards and regulations. Our experts understand the client’s needs and expectations first and take full responsibility to deliver reliable and accurate results.
Need any assistance with USP testing services, contact our experts here.
FAQs
USP 60 specifies microbial analysis method for presence or absence of Burkholderia cepacia Complex in non – sterile medical products.
USP 60 test is applicable for water based, non sterile drug products that are intended for inhalation use, oral, cutaneous, or nasal administration.
The USP 60 test takes 1-2 weeks to complete.
At Microbe Investigations, we test for USP 60 using Burkholderia cepacia Complex. Additional strains can be added on customer’s request.
Contact us for more information
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