Containing potent compounds and sensitizing materials within a containment boundary resolves four major issues for the pharmaceutical industry:
Preventing worker exposure
Isolating waste streams for environmentally safe disposal
Preventing materials migration within manufacturing complexes
Preventing cross contamination
While the usual rationale for any containment is worker protection, the most important from an infrastructure perspective are the quality and environmental aspects, both of which are subject to regulatory oversight. Yet these features of using containment are usually discovered only as a beneficial outcome rather than a project goal. Isolation is the means by which all these issues may be resolved.
The formalization of Risk-MaPP has been a step forward along these lines, allowing companies to both identify and prioritize shortcomings in their facilities, just as they did when the Process Hazard Review regulations came into effect. That flexible containment technology provides for both a rapid and low cost method of solving simple and complex facility retrofit is slowly being recognized. Corporate Engineering services, Architectural and Engineering providers, and building operations are recognizing this approach as the way to achieve fast results without resorting to major capital projects. The introduction of containment to the workforce in a user-friendly manner is an added benefit. Additional benefits of using materials handling isolators and equipment enclosures is the ability to eliminate the major costs and discipline involved with Personal Protective Equipment usage. A small investment with a large return.
If the Quality Organization is on board with introducing any form of process containment or suite isolation using a mix of glove bags, flexible isolators, flexible barriers, and flexible room enclosures, the easier it becomes to dedicate a budget and resources to rapid remediation efforts. Similarly for the Environmental staff dealing with waste distribution and handling. Because costs are minimal it is often possible to introduce flexible containment without resort to top management decisions on resource allocation.
Existing data showing control of materials migration is the most convincing argument for resorting to flexible containment solutions. Because testing has been continuous since the first pharmaceutical industry use of flexible isolation barriers in 1993, potential users are in an informed position when presenting arguments to management. Consultation with peers in the engineering and occupational health disciplines can help in developing management presentations. FabOhio Inc. is another valued resource when introducing flexible containment solutions to a manufacturing site because of our breadth of experience in practical and economical applications and the results that can be achieved.
We realize that many users have neither the time nor resources to conduct monitoring studies in their workplace. We are pleased to help them when making a value based decision on the type of containment needed.
The dilemma many clients face is retrofit of a facility having older equipment not designed to contain. Our experience in this area is vast. We have solved many apparently insurmountable challenges. While flexible barrier solutions are not as cosmetically desirable as stainless steel constructions, they are functional to the same level as equivalent rigid isolators and room enclosures. Data on materials migration has been gathered in support of regulatory agency challenges and met with acceptance. Agency inspectors are slowly becoming accustomed to flexible barrier solutions as a means of complying with their cross contamination control expectations, i.e. avoiding the need for a dedicated facility for some classes of pharmaceuticals. Agencies do expect to see data supporting your claims as well as a show of due diligence.
While providing flexible containment barriers to clients, we have been able to share their data and achieve better functionality in design supported by monitoring feedback. This is an ongoing program. FabOhio, Inc. has provided sampling study support for both the ISPE and the soon to be published American Glovebox Society protocols. The latter provides a strong statistical data set measuring the engineering performance which may then be replicated throughout the usable life of the containment solution, both rigid and flexible.
Testing using Actual Pharmaceutical Ingredients (API) has provided us with a realistic measure of workplace operations during Process Performance Qualification. This differs from qualification processes using surrogate materials. API is usually analyzed by the site Quality Laboratory and is accompanied by a known addition spike sample to assure quantifiable recoveries at lower detection limits than those common for surrogate materials. The advantage is that the particle size and dustiness characteristics are realistic performance measures of the intended operational conditions and typically at lower validated concentrations. Flexible glove bags, flexible isolators, and flexible room enclosures have all shown to be effective containment measures by such testing when properly installed and used.
When you need containment solutions, FabOhio Inc. will be pleased to discuss your project knowing that we can stand behind the performance of our existing solutions.