Pharmaceutical Applications History and Benefits

Flexible containment has many applications within the Pharmaceutical Industry. The benefits to Corporations still remain largely untapped. Whether installed as glove bags, flexible isolators, flexible barriers, or flexible enclosures, the use of flexible containment is often seen as a solution for a single current challenge. Many users focus on their specific needs, so the most common application is for equipment enclosures. Much of the monitoring data collected to date has been for equipment containment performance.

FabOhio Inc. has been fortunate to work with clients who performed extensive full facility monitoring over a period of years where our flexible containment experience and installations have proven effective. The test case was a facility that was comprehensively monitored from start-up through six years of continuous manufacturing. Multi-storey equipment and operations enclosures were successfully employed in place of planned rigid isolators. Multiple annual turnarounds involving line breakages were monitored showing that with both intentional and unanticipated events, the facility did not experience materials migration. Because of this success, flexible containment technology became the basic containment solution for a subsequent plant design, construction, and operation with the same performance success. In this case even more reliance was made on flexible containment for the basic building design concept.

The advantages of using a low cost, readily disposable flexible isolation system crosses all boundaries of ethical drug interests:

  • Conceptual drug research
  • Laboratory drug preparation
  • Laboratory synthetic route development
  • Clinical trials materials dispensing
  • Clinical trials delivery preparations
  • Dose administration methodology studies
  • Phase 1 clinical trials dosing
  • Mutagenicity studies
  • Laboratory scale materials storage and handling
  • Pharmacy materials handling for dose preparation
  • Clinical dosing studies
  • Biotechnology synthesis and materials handling
  • Nano-technology materials handling
  • Kilo scale process scale-up
  • Large-scale clinical trial materials processing
  • Pilot plant process scale-up
  • Process additions, e.g. seed and catalyst
  • Quality Control (QC) laboratory sample splitting
  • QC laboratory sample preparation and handling
  • Analytical equipment enclosures
  • Laboratory waste handling
  • Full-scale bulk drug manufacture
  • Retrofit of existing bulk manufacturing facilities
  • Process Hazard Review solutions
  • Risk-MaPP solutions
  • Manufacturing suite enclosures
  • Facilities protection
  • Product packaging
  • Dispensing
  • Warehousing
  • Shipping
  • Tablet machinery enclosures
  • Parenteral drug delivery equipment enclosures
  • On-line drug dosage inspections
  • Drug packaging
  • Transportation
  • Retrofit of existing finishing facilities
  • Equipment tear down and inspections
  • Equipment cleaning
  • Equipment maintenance
  • Clean equipment storage
  • On-line process sensor calibration
  • On-line process sensor change-out
  • In-process sampling
  • In-process liquid filter change-out
  • Piping changes – piping flanges, valving, skillets, pluggage cleanout
  • Equipment exhaust filter change-out
  • Utilities operations

Plus a myriad of other daily tasks

FabOhio Inc. has worked with several corporations to provide flexible isolation barriers for infrequent but troublesome tasks such as duct cleaning where the site infrastructure requires personnel to handle potent compounds outside of the dedicated manufacturing suites. There are many areas of waste handling for both solid and liquid waste streams that can be addressed. Flexible containment is durable for long periods in outdoor situations making it ideal for cost effective Process Hazard Review solutions.

The primary reason for selecting flexible containment technology is speed of implementation. From concept to delivery and use, an entire project can be brought up to speed with a minimum of cost and delay – usually weeks, without hurting a project budget. This is an asset when clients are attempting to resolve newly identified issues. The solutions are often cost effective Risk-MaPP solutions. Even design concepts for planned rigid containment can be tried out in the workplace before committing to final design. Architectural and Engineering Departments are beginning to appreciate the advantages of this approach when dealing with a speed to market project. With an exercised design in hand a Purchase Order can be provided to rigid isolator fabricators for bid. With user expectations in hand, hard-wall designs can be expedited and delivered at lower cost and more timely than the conventional approach. The flexible concept can be exercised through several iterations based on operator and engineering feedback before submission, all at a cost low enough to be charged on a credit card.

An unanticipated benefit is the ease of environmentally acceptable disposal. The plastic enclosure itself provides the complete disposal package for waste drumming and incineration. After removal of a minimum of reusable items, usually through bag-out procedures, the enclosure is collapsed by expelling the enclosed air through the built-in HEPA filters, rolling or folding the enclosure flat, and placing in the waste drum for pick-up.

Compare this with the time that an operator in protective personal equipment takes to clean down every used item, and the amount of waste developed, which is then handled by other personnel on-site. The benefit can amount to $thousands for a one-time laboratory scale operation. With ready availability of the workspace in today’s climate, the benefits of flexible containment solutions becomes evident.

With the advent of new approaches in Biotechnology and Nanotechnology, the industry is moving rapidly with few visible solutions to their materials and equipment handling needs. FabOhio, Inc. anticipated the demand for pre-sterilized enclosures. We worked with a nationally recognized laboratory to develop the dosing model for sterilization of our packaged enclosures prior to delivery. Our clients have successfully introduced our systems into practice.

For the last 20 years, FabOhio Inc. pioneered the development of a wide variety of applications for our customers based on the broad concepts of flexible containment technology. Today our user applications number in the thousands in many places across the world. Most are simple plastic enclosures, but handling of potent compounds can require innovative and complex engineering approaches. With our expertise base, we thrive on requests for new applications. While there are a few unique situations where flexible isolators, flexible enclosures, and flexible barriers are not appropriate, we have been able to respond to the majority of requests. Our customers are delighted with our ability to address their needs in a timely and low cost manner.

FabOhio, Inc. as a company prizes itself on doing business in a no-frills straightforward manner. We hold to our first bid price for a finalized design submission. We value our relationships with our clients and look forward to responding to your request. 

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