Controlling the growth of microbes within non-sterile formulations is critical to meet regulatory expectations and to provide a safe and effective product.
Rising concerns over persistent opportunistic pathogens is calling attention to the Burkholderia cepacia complex (Bcc). The Bcc has proven to be a significant health risk to patients who are immunocompromised, relying on ventilators, or suffering from underlying illnesses. This Gram-negative, rod-shaped bacterium is an opportunistic pathogen that can establish itself in water systems and surfaces of manufacturing equipment.
Assuring an effective preservative system for Burkholderia spp. is not just for drug manufactures; it is also for cosmetics and personal-care products. The FDA has issued several product recalls that have included oral liquid drugs, liquid dietary supplements, saline solutions, and hand sanitizers, which were all associated with persistent opportunistic pathogens.
In this webinar the presenter, Aaron Zahne, provides a general overview of the antimicrobial-preservative-effectiveness test and its use to mitigate risk. He also addresses questions related to the preservative system’s effectiveness on other opportunistic organisms of concern.
Watch this webinar to learn the following, among other things:
- Study design
- Importance of suitability testing
- Interpreting the results
This webinar offers considerations for both the pharmaceutical and personal-care industries.