In the early 1990’s FabOhio, Inc. collaborated with one of the top 7 Pharmaceutical Manufacturers as they launched their first highly potent compounds. The learning curve was steep because the company had several 1970’s era existing facilities needing retrofit upgrades and were in the design stage of a new ‘contained’ facility. Each iteration of a flexible isolator was thoroughly performance tested before adoption for manufacturing.
The outcome was major savings in PPE programs in several facilities because operators were now working more comfortably in shirtsleeve environments. By incorporating instrument qualifications (DQ, IQ, OQ, PQ, & PPQ) and hazmat documentation the total picture was addressed. This culture change also resulted in prevention of material migration across an entire site and globally. By involving quality, maintenance, emergency responders, and the many other operators accessing facility and site wide services, management were able to solve previously insurmountable challenges and achieve reductions in operating costs because of total spill and waste control measures.
The facility developed over 140 flexible isolator designs to solve operational challenges beyond processing equipment control. Preventative contamination ideas designed with flexible isolators included:
- Laboratory sample preparation and handling
- In-process sensor calibration carts
- In-process sampling of solids and liquids
- Process line flange covers
- Filter change enclosures for liquids
- Filter change enclosures for air handlers
- Warehouse piecing of solids and liquids
- Warehouse storage
- All process line breakage procedures
- Drum lid bonnets
- Isolators for large equipment containment maintenance
- Multiple stores isolators
- Equipment and procedure enclosures for performance testing
- Utility room containment for piping
- Complete multi-room manufacturing suites
- Supplemental airlocks and access points
- Robing/disrobing/decontamination assemblies with waste control
- Procedure specialty carts and enclosures
- Isolation of charging and packaging
- In process sector valve cleaning
- In process valve seal replacement
- Equipment overpack for transport
- Cleaning rooms prototype
With over 50-man years of hands-on experience in R&D, scale-up and optimization, registration, and full-scale manufacture of highly potent and sensitizer compounds, FabOhio, Inc. is well positioned to advise you in operational flexible isolation.
Written by Brian Ward, PhD, CSci, CChem, FRSC