The United States Pharmacopeia (USP) has published a new general chapter, the USP <60> which will become official on December 1, 2019. The chapter specifies tests to determine the presence or absence of Burkholderia cepacia complex (Bcc), a bacterial species of rising importance in the pharmaceutical, OTC and cosmetic industries in recent years. Any source of water in a manufacturing process can harbor Bcc. So Bcc can easily contaminate non-sterile and aqueous pharmaceutical, OTC and cosmetic products. Pacific BioLabs (PBL) is actively working with its clients to validate methods to test their products according to the new USP <60> requirements.
What is Burkholderia cepacia?
The Burkholderia cepacia complex (Bcc) is a group of 17 closely related bacteria species. Bcc are gram negative aerobic bacteria found in soil and water. They can be transmitted through direct skin contact or through sweat. Importantly, these bacteria can stay viable under harsh conditions for many months and are resistant to many antibiotics.
Risk to patients
Bcc are opportunistic pathogens and can pose serious medical risks to populations susceptible to infections such as elderly people and children, as well as to immunocompromised populations such as those with cystic fibrosis, cancer and AIDS. Cystic Fibrosis patients have been found to be especially at risk from Bcc.
Impact of Burkholderia cepacia on pharmaceuticals
Water is the most common raw material used in pharmaceutical formulations and Bcc is widely distributed in water. Hence any source of water in a pharmaceutical’s manufacturing process can hold B. cepacia. Bcc can contaminate aqueous preparations of oral, oromucosal, nasal and cutaneous products, and cosmetics even in the presence of one of more antimicrobial preservatives. It can also form highly resistant biofilm. Non-sterile products are at higher risk of contamination than sterile products. However even sterile products have been recalled due to the presence of Burkholderia cepacia.
New USP <60> chapter
Due to increasing scrutiny about Bcc and its risk to patients, the United States Pharmacopeia has created a new chapter with guidelines to ensure the absence of Bcc in regulated products. USP <60> specifies the test strains for growth promotion, suitability methods and selective media needed. This new chapter complements the existing USP <61> on enumeration of microorganisms and <62> on screening of specific organisms. With the creation of the USP<60>, the pharmaceutical industry has taken a definitive step towards addressing the public health risks posed by B. cepacia.
PBL Initiatives
The microbiology department at Pacific BioLabs is working with clients to validate test methods for their products in conformance with the new USP <60>. PBL strives to serve clients by providing quality testing services that meet the highest industry and regulatory expectations. You can learn more about our pharmaceutical microbiology services here.
References
- USP <60> Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex
- Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, et al. Burkholderia cepacia: This Decision Is Overdue. PDA J Pharm Sci and Tech 2011