Evolution of Flexible Containment in the Pharmaceutical Industry

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Evolution of Flexible Containment in the Pharmaceutical Industry and the role that FabOhio Inc. played.

Before 1993 there was one publicly disclosed use of flexible barriers in pharmaceutical manufacturing. An iconic European supplier of rigid isolators had installed an entire flexible enclosure barrier around a client’s product finishing line, This radical approach included roll-around modules having docking abilities. Sadly, little is now known of this experience, or the lessons learned.

In the early 1990’s, a mid-western pharmaceutical company was successfully using a continuous liner system made of virgin polyethylene for bulk materials packaging.

In the early 1990’s, potent drug development really blossomed. The traditional approach to worker protection had been the use of Personal Protective Equipment, for which FabOhio Inc, already had manufacturing experience. However, this only protected the worker. Prior experiences with sensitizing drug manufacture had shown the weakness of this approach. Materials migration was a quality issue yet to become the major concern that it is today

With guidance from their consulting Architectural and Engineering (A & E) firms and in-house engineering staff, the pharmaceutical industry slowly adopted rigid isolators for enclosing their manufacturing equipment. These solutions were traditional because of the industries perception that sanitary finish stainless steel was an acceptable cleanable surface for use in the workplace. It looked cleanable!

While the nuclear industry had developed usage of both rigid and flexible isolators, the pharmaceutical industry consultants were not yet aware of the capabilities of flexible barrier isolation. As a consequence the cosmetic appeal of polished stainless steel prevailed. The limitations of this approach have left a legacy of manufacturing equipment placed inside rigid steel or fiberglass enclosures with extensive demands on validation, the infrastructure for the required decontamination and utilities, and never ending operating challenges.

FabOhio Inc. has provided flexible isolators to Government facilities and heavy industry since we started business in 1963.

Our first opportunity to support the pharmaceutical industry was early in 1993 when a major pharmaceutical company provided a sketch of a dispensing glovebag and asked us to make a prototype. At that time PVC was the material selected because of their experience with flexible room barriers made of a conductive painted PVC film. PVC was later replaced with polyurethane films having inherent conductance which did not suffer mechanical damage when shipped at sub-zero temperatures. This early adoption of polyurethane also circumvented more recent environmental demands for a clean-burn waste stream.

This was the beginning of a fruitful relationship for both the pharmaceutical company, and indeed the entire industry, as well as ourselves. FabOhio Inc. was able to provide a fast, economical response to their requests for design changes as they were testing new configurations of flexible isolators. FabOhio Inc. also gained through the engineering developments needed to support their fast track program of designing a new ground-up facility to manufacture Bulk Active Pharmaceutical Ingredients.

With an established budget, but limited containment expertise, they were willing to try new containment approaches. They realized early in design that A & E firms would bill for many hours of design and testing for rigid isolators costing major capitol dollars for unknown performance capability. The infrastructure demands and costs to support such systems were only loosely identified at that time.

Braving the image concerns, a site operator and an engineer had begun trials to test home-made flexible isolators inside an unused freezer, i.e. a confined space. In the absence of existing sampling strategies they adopted statistically robust techniques for clearance monitoring as used in abatement practices, which EPA had garnered from the extensive experience of Health Physicists in the nuclear industry. With no ventilation to dilute the outcome they ran worst-case trials handling a high dustiness index powder.

After some successes they realized they needed flexible isolators of higher mechanical integrity than they were able to make using polyethylene sheeting, modified asbestos removal glovebags, and duct tape. FabOhio Inc. provided that capability. In satisfying their needs we established a highly effective partnership. With each new iteration and cumulative learning experience, company management slowly came to appreciate the value of flexible containment in replacing planned designs for rigid containment and more important – the ability to address otherwise impossible challenges. Within two years, their engineers had introduced the use of flexible isolators and other flexible barrier solutions across their global manufacturing, laboratory facilities, and other support services. By the end of 1994, FabOhio Inc. was making and shipping over 140 different flexible containment products to US, European, and South American locations for this client.

With this accumulated experience within the pharmaceutical industry, imagine how we could assist in your future destiny. We have made friends with Operations, Engineering, Health and Safety, Quality Control, Environmental Control, Project Management, and even Accounting and Budgeting Departments – and know how to address their concerns. Why not contact us at (740) 922-4233, Fax us at (740) 922-4785, or e-mail to fabohio@tusco.net.

Look for our next information releases where we will provide more details about performance methodology, performance outcomes, cleaning issues, utilities requirements, and product contact concerns. You will not find this information in any existing educational courses. We will endeavor to provide information that makes you, the person on the performance end, aware of the pitfalls and successes of all forms of containment practices. Also visit our web site at fabohio.com to see pictures of installed flexible containment solutions at client facilities.

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