By Daniel R. Matlis
Sterile Manufacturing facilities are often, well sterile. They are typically comprised of drab clean-rooms where the color palette is limited to stainless steel and shades of grey.
For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Dr. Ralf Pfirmann, Managing Director of IDT Biologika’s site in Dessau-Rosslau, Germany. IDT’s new vaccine manufacturing site received the 2008 Facility of the Year Award for Operational Excellence.
IDT new 4.700 m² vaccine production facility is changing the perception of sterile manufacturing. Its innovative use of color and transparency suggests a new way of thinking in designing workplace environments.
Clean-rooms with glass walls, glass doors in material locks, and passageways of glass, allow for clear visibility across the entire building. In addition, the facility uses color to create a better working environment. This trend-setting approach allows IDT to meet the most rigorous hygiene standards for aseptic production conditions.
The IDT vaccine production facility features two contained manufacturing lines that allow segregated operations for preparation of cells, virus propagation and virus purification using highly efficient technical systems such as fermenters and robotic systems. In-process control areas, offices and storage areas complement the manufacturing plant. The building was constructed within 19 months and provides capacities for development and manufacturing of vaccines for clinical trials, Phase I though III, as well as for commercial supply.
Key challenges in building this facility included preventing cross-contamination in the multipurpose structure as well as minimizing expensive lead time between manufacturing campaigns.
To meet these challenges, IDT chose to extensively use disposable technologies, to save time and simplify compliance and validate steps. Pre-sterilized, single use technologies enabled IDT to streamline room sterilization procedures and provide transparency of operations and process flows.
Although counterintuitive, disposable technologies offer environmental benefits, as they reduced the use of sterilization agents and large amounts steam used often used to prevent cross contamination.
Since we are not in real estate, pretty colors and open floor plans don’t, by themselves, provide business value.
So in addition to “brightening the sterile manufacturing facility” here are a few more benefits from IDT’s approach:
1. Clear makes it is easier to keep squeaky clean
Glass is easier, faster and cheaper to keep clean in a sterile environment
2. Create a better working environment
Productivity increases when people are in an appealing and comfortable setting
3. Streamline site inspections and audits
Complete visibility into the sterile suite enables thorough walkthroughs with out the need to gown up
4. Disposing can be cheaper that cleaning
Disposable technologies save time, add flexibility and simplify regulatory compliance
5. Advanced technology can limit human exposure and improve efficiencies
IDT uses automated laser techniques and isolators to open and process incubated eggs without breaking the shell membrane, keeping the egg sterile while opened
As a result of the successes IDT has achieved in the vaccine production facility, the company plans a further investment of 24 million Euros in a new filling plant utilizing similar facility design principles.
IDT is working in cooperation with international organizations, biotechnological as well as pharmaceutical companies, to manufacture vaccines against dangerous infectious diseases, such as Tuberculosis, Malaria, AIDS and Rotavirus.