Burkholderia cepacia: how to comply with USP <60>

Burkholderia cepacia how to comply with USP 60 | Medical Supply Company

MSC offers a full range of media and QC strains to ensure you conform to USP <60>. Learn about the importance of testing for Burkholderia cepacia contamination in non-sterile pharmaceuticals.

Burkholderia cepacia complex is a group of Gram-negative opportunistic pathogens commonly found in soil and water. Although Burkholderia cepacia is generally considered to be a harmless environmental microorganism, it can cause serious infections in certain populations, such as individuals with cystic fibrosis or other underlying medical conditions. In recent years, there have been concerns about the presence of Burkholderia cepacia in non-sterile, water-based pharmaceutical products. Burkholderia cepacia can survive and sometimes multiply in these formulations thanks to its resistance to certain preservatives and antimicrobial agents. If not properly controlled, Burkholderia cepacia contamination can lead to product recalls, adverse health effects for patients, and damage to a company’s reputation.

Examples of product recalls linked to Burkholderia cepacia:

  • Rugby Diocto (docusate sodium) oral liquid (2017)
  • Paroex® Chlorhexidine Gluconate Oral Rinse (2020)
  • Regenecare HA Hydrogel (2020)
  • Eco Gel 200 MediChoice M500812 ultrasound gel (2021)

In response to several Burkholderia cepacia contamination incidents, the USP published <60> Microbiological examination of non-sterile products – Tests for Burkholderia Cepacia Complex, which became effective in December 2019. This chapter specifies the test strains for growth promotion, suitability methods and selective media recommended to ensure the absence of Burkholderia cepacia strains.

MSC offer a range of products to help you comply with USP <60> from culture media to QC microorganisms.

Burkholderia cepacia selective agar

Burkholderia Cepacia Selective Agar USP, a selective medium for the isolation of Burkholderia cepacia with the formulation specified in USP <60>. BCSA pre-prepared media contains nutritional components and energy sources that support Burkholderia cepacia growth, and a mixture of antibiotics designed to prevent the growth of non-fermenters not belonging to Burkholderia cepacia complex and typical environmental isolates such as Pseudomonas and Staphylococcus species.

EZ-Accu Shot for Growth Promotion Testing

EZ-Accu Shot kits provides a fast, convenient and reliable solution for Growth Promotion Testing, Media Challenge Testing and more. Each instant-dissolve microorganism pellet is designed to deliver 10-100 CFU per inoculum and provides 8 hours of stability after rehydration, so you can meet Pharmacopeia guidelines with ease.

  • All Burkholderia cepacia strains recommended in USP <60>
  • Delivers 10-100 CFU per 0.1 ml
  • Instant dissolve, no pre-incubation needed
  • Traceability to reference culture ensures authenticity
  • Easy & economical 2-8°C storage

Epower for Suitability Testing

Ideal for media QC and presence/absence testing to enumeration testing, water testing, and disinfectant testing. Each quantitative microorganism pellet delivers a specific range of CFU, so you can easily manipulate Epower to deliver virtually any concentration. Use a single strain or combine multiple strains for a mixed population.

  • Delivers 1 x 107 – 9.9 x 107 CFU per pellet
  • Ready-to-use format to save you time and money
  • Traceability to reference culture ensures authenticity
  • Easy & economical 2-8°C storage

In conclusion, Burkholderia cepacia is a potential threat to pharmaceutical laboratories and patient safety. However, with the implementation of effective quality control measures, pharmaceutical companies can minimize the risk of contamination and ensure that their products meet the highest standards of quality and safety.

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