Burkholderia cepacia Selective Agar Base USP

Burkholderia cepacia complex (Bcc) is a group of 17 closely related bacterial species. Bcc are Gram-negative aerobic bacteria that can be found in water and soil. Water is the most common raw material used in pharmaceutical formulations, so Bcc can contaminate these preparations.

The USP recommends this medium to ensure the absence of Bcc in regulated products. 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.

The possible presence of Bcc is indicated by the growth of greenish-brown colonies with yellow halos, or white colonies surrounded by a pink-red zone on BCSA. Any growth on BCSA is confirmed by identification tests.

Typical formula in g/L, adjusted and/or supplemented as required to meet performance criteria.

Preparation

Suspend 25.3 g of the medium in 500 mL of distilled water. Mix well and dissolve by heating with frequent agitation. Boil for one minute until complete dissolution. Sterilize in autoclave at 121 °C for 15 minutes. Cool to 45-50 °C and aseptically add one vial of Burkholderia cepacia Selective Supplement (LC-6089). Homogenize gently and dispense into Petri dishes.

Instructions for use

Testing of products:

1. Prepare the sample using 1 g or 1 mL of the product to be examined in 10 mL of TSB.
2. Mix and incubate at 30-35 °C for 48-72 h.
3. Subculture by streaking on a plate of Burkholderia Cepacia Selective Agar (BCSA), and incubate at 30-35 °C for 48-72 h.
4. Confirm by identification tests.

• USP 60. Microbiological examination of non-sterile products - Test for Burkholderia cepacia complex (Bcc).
• Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, et al. Burkholderia cepacia: This Decision Is Overdue. PDA J Pharm Sci and Tech 2011.