A sterile facility becomes compromised during annual maintenance shutdowns since outside equipment, tools and people enter the clean areas. Bausch + Lomb Vision Care has a production facility in Greenville, South Carolina where all contact solutions are manufactured in sterile processing areas. These solutions must be sterile since the drops will clean lenses or be placed directly in the eye. Therefore, it is critical that containers be filled and sealed in an extremely high-quality environment. To maintain sterility of the product, the environment is cleaned and then disinfected prior to resuming normal production following their annual shutdown.
This cleaning procedure in the past required over seventy-five personnel with mops and buckets and a minimum 3 days’ worth of time followed by a disinfection process utilizing multiple applications of a high-level disinfectant solution. This process is a costly (time and materials) method that uses over $100,000 of consumable cost to fully decontaminate the entire sterile processing facility and still had inherent failures since it was a laborious manual process. To reduce the failures and potentially reduce the costs, chlorine dioxide gas decontamination was investigated.
The gross cleaning and fine cleaning are still done prior to any gassing. Afterwards, the ClorDiSys decontamination team of five people arrived on-site early afternoon to unload the crates of equipment, setup manual chlorine dioxide gas generators, and begin sealing. After setup was complete, gassing began the next day around 4:30pm. The decontamination cycle was fulfilled, and the team was cleaned up and heading out by 1:30am. Resulting ppm-hours achieved from the decontamination cycle were adequate to provide a 6-log sporicidal reduction on the biological indicators after 36 hours of incubation. It was also a success from an economic point of view. The costs of gassing or fumigating were slightly less than the traditional spray and wipe approach With this cost savings, shorter down time, and better coverage of the decontamination agent, chlorine dioxide gas was selected as the company’s decontamination agent.
Read more about this application and comparison in Jennifer Longstaff's Pharmaceutical Engineering article. To start planning your complete decontamination during annual shutdown, contact us here.