Tuesday, June 1, 2021

Annual Decontamination of Pharmaceutical Production Facilities

Microbial contamination can be a difficult challenge for all sectors of the pharmaceutical industry. The presence of dangerous organisms in pharmaceutical facilities can lead to costly product recalls, which result in loss of revenue, customers, and brand reputation. By taking greater preventive measures, risk of microbial issues can be minimized or eliminated. Measures such as annual preventive decontaminations will help to eliminate the presence of any harmful organisms that would cause such issues. Performing an annual “deep clean” of your facility by decontaminating it with chlorine dioxide gas allows for a true reset to zero pathogens.

Chlorine dioxide gas provides a sterilization level fumigation of any enclosed space with minimal equipment and minimal downtime. True gases such as chlorine dioxide (CD) are the only truly effective agents for the decontamination of buildings, rooms, isolators, and biological safety cabinets as gases offer many benefits over other agents. It fills the space it is contained within completely and evenly, ensuring that no matter how large the target space is, no surface is left untouched including crevices and harbor locations. Chlorine dioxide is safe on materials and leaves no post treatment residuals. CD gas has successfully treated many pharmaceutical facilities to eliminate viruses, bacteria, mold, and beta lactams establishing sterility prior to production starting up as well as re-establishing sterility between batches or studies.

Case Study: Annual Shutdown Decontamination

The Bausch + Lomb Vision Care production facility in Greenville, South Carolina manufactures contact lens solutions in sterile processing areas within a clean environment. Each year, the facility closes for planned maintenance shutdowns. Though necessary, these shutdowns create unsterile environments because foreign equipment, tools, and people enter the clean areas. Therefore, the environment must be cleaned and disinfected before normal production resumes. Previously, this 300,000 ft3 facility underwent three cycles of detergent cleaning and water rinse followed by three treatments with Spor-Klenz. This required over a dozen personnel with mops and buckets over multiple shifts and a minimum of a week’s worth of time. The process was costly (consumables alone cost approximately $100,000) and had inherent failures in the process since it was a laborious manual process. The facility switched to chlorine dioxide gas decontamination. The result was a decontamination cost of under $100,000, a time savings cost of three days, and efficacy improved to a complete 6-log sporidical kill.

To learn more about the benefits of an annual decon, join our webinar on June 24 at 1pm Eastern.