CHROMID™ B CEPACIA

Enhanced Detection for Effective Prevention

Chromogenic medium that detects the presence of Burkholderia cepacia microorganisms from total aerobic microbial counts.

Overview

The U.S. CGMP regulations 21 CFR 211.113 Control of Microbiological Contamination require that objectionable microorganisms be excluded from non-sterile drug products. An industry survey of non-sterile drug product recalls for microbial contamination between 2004 and 2011 highlighted that 34% of the recalls were for Burkholderia cepacia1. FDA microbiologists responded by publishing an article expressing their concern with this opportunistic bacterial pathogen due to its ability to survive in disinfectants, sanitizing agents and preserved, aqueous non-sterile drug products. Therefore, the FDA has recommended that microbiological testing methods be capable of screening for Burkholderia cepacia2.

As the compendial tests described in USP <61> and <62> do not contain a specific test for the absence of Burkholderia cepacia, bioMérieux developed an innovative proprietary chromogenic solid medium suitable for both the Total Aerobic Microbial Count and the screening for the Gram-negative bacteria Pseudomonas aeruginosa and Burkholderia cepacia in non-sterile drug products.

Downloads

>> Poster: A New Chromogenic Culture Medium for Screening for Burkholderia cepacia in Non-sterile Pharmaceutical Products

>> CHROMID B CEPACIA Brochure

>> BIOBALL® B CEPACIA Brochure


References

1. Memorandum of the Department Of Health And Human Services - Public Health Service - Food and Drug Administration - Center For Drug Evaluation And Research - 2013 - Reference ID: 3417530 and 3317977 - Erika Pfeiler, John Metcalfe.
2. Torbeck, L., Raccasi, D., Guilfoyle, D. E., Friedman, R. L., & Hussong, D. (2011). Burkholderia cepacia: This Decision Is Overdue. PDA Journal of Pharmaceutical Science and Technology, 65(5), 535-543. doi:10.5731/pdajpst.2011.00793

Features & Specs

CHROMID B. cepacia Agar is a general purpose medium used for total aerobic microbial counts (TAMC) with an additional chromogenic substrate that enables detection of Pseudomonas aeruginosa and Burkholderia species.

  • Greater than 97% recovery of a library of pharmacopeia strains, aerobic and anaerobic bacteria, yeast and molds
  • Color change visible within 3 days of incubation at 30-35⁰C and full color expression at 5 days of incubation at 30-35⁰C
  • Chromogenic substrate tested with over 100 species of B. cepacia for detection and coloration intensity
B. cepacia colonies after 3 days incubation showing a lighter pink coloration while looking through the plate bottom B. cepacia colonies after 5 days incubation showing a darker pink coloration on the media surface Mixed population dispersed with B. cepacia at 5 days incubation showing a halo like color formation on the media surface The same Mixed population dispersed with B. cepacia at 5 days while looking through the plate bottom P. aeruginosa colonies at 3 days incubation showing a dark purple coloration on the media surface

 

Uses

CHROMID B cepacia medium allows the detection of specifice Burkholderia cepacia complex (BCC) and Pseudomonas aeruginosa strains for the conrol of different non-sterile drugs. This new medium brings and efficient and effective solution to the pharmaceutical industry with the following characteristics:

  • Equivalent performance to Tryptic Soy Agar for Total Aerobic Microbial Count control
  • Specific and rapid detection of Burkholderia cepacia complex directly on an agar plate suitable for microbial counts
  • Compatibility with test methods described in USP <61> and <62>

Pioneering Diagnostics