When Highly Potent Active Pharmaceutical Ingredients (HPAPI’s) became the focus for disease control in the 1990s a new generation of processing criteria had to be adopted to mitigate personnel contact and cross contamination control. The industry resorted to control methods developed in the heavily regulated Nuclear Industry. Rigid Glass and Steel Gloveboxes were viewed as the future engineering controls compatible with existing and new processing equipment. While appropriate where heavy load bearing such as IBC connections were required, the rigid geometry of Gloveboxes created more of an impediment than a solution.
Since 1963, FabOhio Inc. had already developed Flexible Barrier Containment solutions and the discipline needed for support of government nuclear programs. Consequently, we were well prepared when approached in 1993 by a major pharmaceutical company to develop flexible isolation/containment barriers for HPAPI development and manufacturing. The company had a fast-track project aimed at completing the last phases of Toxicity and Clinical Trials and NDA submission while creating an inventory of launch materials.
Working while their patent clock was ticking and with a 1970s era pilot plant and simultaneously the design of a new HPAPI Drier Addition plus a Complete 3-Rig HPAPI facility forced rapid deployment of flexible containment to achieve their goals. The site management allowed the Hygienist and Engineers to adopt flexible barrier technology under the constraint that containment performance be measured and documented for each phase of the project.
Companies tackling setting performance targets for HPAPI’s found the cost for specific molecule Occupational Exposure Limits (OEL’s) extremely burdensome. The solution was exposure banding as a general classification methodology. As the longest established providers of flexible containment to the Pharmaceutical Industry, FabOhio Inc. contributed to the deliberations with a baseline of tested validation protocols and data capable of achieving picogram/cu.m performance for personnel and environmental releases covering the most extreme banding target to date.
Client Consulting Expectations
To ensure your project will have the desired outcome, key questions need to be answered:
- Can your consultant bring decades of proven experience meeting performance bands in the nanogram/cu.m range?
- Will they support you with a variety of tested installation methods to satisfy your unique requirements?
- Are they conversant with regulatory constraints and capable of responding to quality challenges regarding materials isolation?
- Will they address operator education and training sufficiently to achieve processing ticket conformity?
FabOhio Inc. Project Stepping Stones
- FabOhio supports containment projects at a wide variety of phases, from early strategy planning to hand-off of the final design
- Arrangements for FabOhio can be made to visit onsite, however if interested in keeping costs lean, we will be able to work with your business through alternative communication channels and provided with the following key project requirements
- Containment drawing are shared with client stakeholders for review and feedback
- Once final drawing is approved, production can begin
- Our vast inventory of validated designs is a valuable resource allowing FabOhio Inc. to respond rapidly and economically to a client’s needs
- All transactions and designs are maintained in confidence between FabOhio Inc. and our clients
- Our manufacturing site is subject to routine Quality Assurance audits and acceptance by Government Agencies and commercial clients
To expedite your project, be prepared to share:
- Measurements/dimensions and images of existing table, equipment, frame, etc. (pictures are always helpful for full context for our team)
- Necessary frames and/or support required for installation
- Material specifications
- Enhancements requirements such as zippers, continuous liners, HEPA filters, tool pouches, and cable ports
Written by Brian Ward, PhD, CSci, CChem, FRSC