Water systems in pharmaceutical manufacturing processes for non-sterile, water-based drug products are vulnerable to water-borne pathogens. As a result, the Food and Drug Administration is urging manufacturers to adopt measures that both prevent water-borne contaminants from entering pharmaceutical production processes and detect them in drug product components and finished products.
Last year, several manufacturers recalled an oral liquid docusate sodium that was tied to a multi-state outbreak of Burkholderia cepacia complex (B. cepacia). Saline flush syringes also were recalled in a separate incident. B. cepacia survives and multiplies in a variety of non-sterile water-based products because it is resistant to certain preservatives and antimicrobials. People with compromised immune systems or chronic respiratory illnesses are at an increased risk for illnesses caused by B. cepacia contamination.
The FDA reports that water is the most common raw material used in pharmaceutical manufacturing. As such, the FDA advises drug manufacturers to develop protocols for testing and validating various stages of the production cycle, including in-process water. These procedures should:
- Rely on validated testing methods only
- Verify the quality of incoming materials
- Utilize manufacturing equipment that supports a sanitary design and promotes hygienic maintenance and cleaning of equipment
- Include production and storage time limits
- Monitor environmental conditions
Read more about the FDA’s recommendations for preventing water-borne contamination in this announcement. To consult with a Triangle Process Equipment representative about equipment solutions for pharmaceutical applications that will help manufacturers meet the FDA’s recommendations for reducing contamination risks posed by water-borne pathogens, please click here.