However they were achieved, risk assessments have been the basis of decision-making around containment of potent compounds and segregation of products, e.g.sensitizers and oncolytics, since the 1980’s. This has driven the pharmaceutical industry to great lengths and cost to prevent product migration, and document cross-contamination control. These drivers were the foundation for adoption of all four types of containment control:
Rigid isolation barriers
Flexible isolation barriers
as well as improvements in cleaning practices.
The ISPE guideline on Risk-MaPP formalized risk assessments, documenting capability and creating a roadmap for facility improvements. Capital expenses for improvements by major players also benefit from a cost effective facilities improvement plan.
The methods used for both Risk-MaPP and Process Hazard Reviews (PHR) amount to in-depth process, utilities, and facilities analysis. The end result is typically an engineering search for cost effective Risk-MaPP solutions, and can be carried over to PHR interventions, by evaluating the merits of process control, and adoption of control methods listed above.
Risk-MaPP solutions and PHR interventions can be achieved speedily and cost effectively. It is a simple matter to resort to flexible containment technology for the majority of equipment closures to address both needs. Flexible barriers are usually the most cost effective solution since they place no demand on facilities infrastructure. Without expending development money, you can rely on existing expertise from technical resources e.g. FabOhio Inc. who have a vast amount of experience in solving one-off problems. In our 50 years of flexible barrier development, including the last 20 years for pharmaceutical applications, you are probably not the first client with a specific problem but like most customers your environment may still be unique. Don’t be lured into funding a development project when a simple existing design modification will suffice.
Your manufacturing hardware can only tolerate a minimum of modification followed by re-validation. The simplest solution for preventing product migration is an enclosure. Flexible enclosures can be designed, fabricated, installed and performance tested within mere weeks of commitment. Costs for such an approach can typically be covered using a company credit card instead of having your purchasing department issue a PO. There is no limit on size. Solutions ranging from a simple piping flange to multistory equipment enclosures have all been tested over the past 20 years.
Flexible isolators can act as effective prototypes for simulation of rigid isolator use. The learning can be translated into a better original design, shortened delivery time, and minimized engineering costs for projected rigid solutions. Flexible containment also places less demand on utilities, consequently engineering, maintenance, and on-site fabrication departments don’t become bottlenecks.. Additional benefits are the early introduction of operations into a project with operator buy-in through their feedback on design modifications.
It is hard to justify modification of a validated glovebox (following a formal re-documentation of Design, Operational, Installation, Performance, and Process Performance Qualifications – DQ, OQ, IQ, PQ, and PPQ). By contrast, it is a matter of a few days for a fabricator to deliver a second generation flexible isolator at reasonable cost. The added bonus is simplification of your waste problems and minimizing space requirements through elimination of:
Liquid waste handling
Automated flushing systems
Cleaning software validation
Rigid Isolator Storage.
The end product is typically a collapsed plastic enclosure containing disposable utensils ready for drumming and incineration by a certified vendor. Proper film selection means that you will meet all regulatory constraints.
There are many documented cases of equivalent containment performance for both rigid and flexible containment systems. Non-robotic gloveboxes rely on flexible closures (glove sleeves and bag-in/bag-out connections), consequently durability of flexible systems has been an established fact for >65 years.
Risk-MaPP solutions and PHR interventions have become a value added way of improving your operations while documenting control for regulatory agencies. Our web site at www.fabohio.com provides examples of some of the thousands of installations that our customers have made. With our extensive client experience we can help with economical solutions for many of your Risk-MaPP and PHR outcomes.
Contact us at our manufacturing site (740) 922 4233.
For technical support call Don Coy at (317) 797 4540