Controlling the growth of microbes within non-sterile formulations is critical for ensuring product safety and meeting regulatory expectations in both the pharmaceutical and personal care industries. Recent concerns over persistent opportunistic pathogens have highlighted the importance of focusing on the Burkholderia cepacia Complex (BCC). This presentation will provide insights into the unique challenges posed by Burkholderia sp. and the necessary considerations for developing a robust preservative system to mitigate these risks.
The BCC is a group of Gram-negative, rod-shaped bacteria that pose significant health risks, particularly to immune-compromised patients, those using ventilators, or individuals with underlying illnesses. These opportunistic pathogens can establish themselves in water systems and on manufacturing equipment surfaces, making them a persistent threat in both pharmaceutical and personal care product manufacturing environments.
Ensuring an effective preservative system for Burkholderia sp. is crucial not only for drug manufacturers but also for producers of cosmetics and personal care products. The FDA has issued several product recalls due to contamination with persistent opportunistic pathogens, including oral liquid drugs, liquid dietary supplements, saline solutions, and hand sanitizers. This underscores the importance of rigorous microbial control measures.
This presentation will offer a comprehensive overview of the antimicrobial preservative effectiveness test, a key tool for assessing the efficacy of preservative systems against Burkholderia sp. and other opportunistic organisms of concern. Attendees will learn about the methodologies used in these tests and how to apply them to ensure the safety and efficacy of their products.
By understanding the specific challenges posed by Burkholderia sp. and implementing effective preservative strategies, professionals in the pharmaceutical and personal care industries can better safeguard their products and meet regulatory requirements. This knowledge is essential for developing products that are both safe for consumers and compliant with industry standards.