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. Additional information and illustrations of our solutions can be found on our web site at fabohio.com.

You can contact our main office at:     (740) 922-4233
International:                                          001 740 922 4233
Technical support                                  (317) 797-4540
International:                                           001 317 797 4540
e-mail:                                                    kshelley@fabohio.com