Non-Product Contact Applications

After building a high containment facility dedicated to potent or sensitizing compound (Actual Drug Ingredient or API) manufacturing, a company would like a degree of comfort that it will work as intended. A few years ago there was little likelihood of operating such a facility without resorting to operators wearing Personal Protective Equipment (PPE).

Mechanical equipment designed to today’s standards still gives rise to occasional product leakage because it has not yet proven possible to charge, sample, and package routinely in a fully contained manner. Now add the need for in-operation maintenance due to line breakage, valve removal and replacement, sensor removal, calibration, and replacement, and many other small but necessary operational needs. Also consider how raw materials are received and final product shipped and transported to the storage warehouse for dispatching. Finally consider turnaround and large scale servicing and maintenance such as piping changes, Clean In Place (CIP), and movement of contaminated equipment through a facility for major tear down, cleaning, and/or maintenance, all of which creates the greatest potential for contaminating hallways, elevators, tools, and inevitably the operators and building visitors.

All of these circumstances can be a nightmare for the Quality, Health and Safety, and Environmental professional trying to do their job of protecting product, operators, building visitors, and the site, while minimizing and managing the copious amounts of waste contaminated with highly potent drug or sensitizing materials, containing both known and unknown entities.

Turnaround and maintenance challenges often get lost when designing a functional processing facility, yet they involve work with opened equipment. Regardless of the amount of cleaning, there are always unanticipated pockets of process materials waiting to be released to contaminate the workplace and be tracked around the facility. Utility areas are rife with potential for leakages. Flexible containment barrier solutions have been implemented to solve many of these challenges. From simple glove sleeves, glove bag and localized plastic enclosures, to full scale process containment using flexible room enclosures, and even containment suites with integrated airlock, gowning and de-gowning airlocks and decontamination airlocks, we have learned that flexible containment applications are only limited by the imagination. Flexible containment technology is at its best during retrofit when space limitations and ergonomic challenges preclude other approaches.

Let’s review the process suite at a bulk-manufacturing site. We have a six-storey building, ostensibly with operations conducted in isolated suites on each floor. Entry to each suite is through a double airlock consisting of a gowning room and decontamination shower. There is a pressure cascade with the access hallway at barometric pressure and the process suite at a reduced pressure of -0.75″ of water gauge (w,g,). The process materials progress from the top to the lowest floor as the materials are:

  • Charged into the process through a closed system
  • Drop into a reaction vessel
  • Reacted contents dropped into a conditioning vessel for seed addition
  • Slurry is filtered using a centrifuge
  • Wet cake is dropped into a dryer
  • Dried API is dropped into a hopper and packaged in a closed system

The entire process is carried out under an inerting atmosphere.

Of necessity, materials handling involves floor penetrations for piping and equipment vessels supported on load cells, dryer, and mills and dryers hanging through floors and ceilings, the storage hopper on load cells, and the discharge pipe to packaging.

Until FabOhio Inc. entered the picture there were no provisions to prevent fugitive emissions from transport both up and down this entire set of contained suites during normal operations. Operators on floors having no evidence of fugitive release were experiencing contaminant build-up on their floors. Every operator on every floor within the containment suites was in PPE as a counter measure.

Merely placing flexible closures around the floor openings did not solve the problem because every time a pressure change occurred on any floor of the containment suites it rapidly travelled to every other floor by disrupting the seals. The pressure acting on the closure also affected load cell response on vessels and hoppers.

FabOhio Inc. solved the problem by engineering an oversize annulus connected between the pipe or vessel and the penetration lip to allow flexure with room pressure. Embedded within it was an array of our implanted HEPA filter cartridges, adequate to allow expansion and airflow passage to absorb the pressure shock waves without creating erroneous load cell readings. Where solvent releases were anticipated the HEPA filters were supplemented with an organic vapor filter. In this way the suites were all isolated from each other and migration prevented between floors without impacting the process.

Localized flexible containment solutions were developed to capture releases from valves and piping flanges. PolyTetraFluoroEthylene (PTFE or Teflon) lined pipe is used on the premise that it is non-reactive, corrosion resistant, and leak-proof. It is micro-porous and used for generating primary standard calibration devices for vapors because it exhibits constant vapor permeation rates. It is also susceptible to spontaneous leaks due to pinhole formation when in service. Before a pinhole leak becomes apparent there is a slow but steady degradation with small amounts of process materials escaping into the outer lining. Properly installed PTFE lined piping has breather holes in the casing or a gasketed joint that permits vapor leakage. This prevents pressure build-up between the casing and the lining but also allows process solutions to escape. Early stages of leakage allow materials to escape from the process and enter the workplace long before it becomes visible. FabOhio Inc. developed a containment method that allows even early leakage to be contained to prevent materials migration. A containment sleeve around the flange or valve with a combination organic vapor/HEPA filter cartridge for venting was developed. A sorbent pad was placed inside the sleeve. Any escaping process solution droplets dripping onto the pad leave a visible stain even after the solvent has evaporated. The system has been used successfully for several years. Any stain provides early warning allowing the operators to anticipate potential problems and take remedial actions before suite contamination occurs. Continuous building monitoring has shown no fugitive releases within the suites in which these devices were installed, even when visible signs of leakage were present on the sorbent pads.

Use of flexible containment is commonplace where rigid containment would be an ergonomic nightmare. Examples of frequent uses of flexible glove bags are:

  •     to enclose, or in place of, fixed sampling devices
  •     in-process maintenance such as cleaning out rotary valves between manufacturing lots
  •     in-process changing of filters in solvent and process lines
  •     in-process liquid sampling
  •     in-process adjustments, and cleanup of tableting equipment between lots resulting in localized collection of waste materials for ease of contained disposal.

The adaptability of flexible containment is compatible with the demands of a functioning facility. Many of the application needs could not have been solved economically in other ways. It also places a low cost burden on operations. In fact the use of flexible containment devices reduces the cost of otherwise necessary procedures such as suite cleanup after a contained release event. Manufacturing rig availability improves dramatically whenever fugitive emissions are eliminated.

These simple but necessary installations saved customers countless hours looking for sources of leakage. By identifying leaks before room contamination and migration occurred, they eliminated many hours spent in cleaning, and even more in convincing Quality and Occupational Health professionals that clean up was effective. The savings in laboratory support during cleaning numbers in the millions of dollars.

FabOhio Inc. learned our lessons long ago on what to do, and not to do, such as attempting to achieve closure around an angular corner. For extreme performance improvements, the simplest and most effective way is to increase the number of pass-through airlocks. Training operators to use the J-clamp closure technique when performing any bag-in/bag-out combines containment performance with product integrity while minimizing the need for special tools.  

The administrative costs of having a PPE program are often overlooked. Pro-active planning and installation of localized containment measures have allowed our customers to operate shirt-sleeve manufacturing in their bulk and finishing operations. Any minor inconveniences and training requirements are a welcome alternative to operator use of PPE throughout their facilities.

As the earliest proponents of flexible containment solutions for the Pharmaceutical Industry, FabOhio Inc. and our customers established credibility for flexible barrier development. Based on a program of conducting well-designed statistical monitoring studies during routine operator use of our installations, our clients established a strong database of performance, reliability, speed-to-market solutions, cost savings, and cost efficiency for a wide variety of our flexible containment devices.

Presentation of performance results and innovations were made to the community at ISPE and Pharmaceutical Safety Group (PSG) meetings from 1993 onward. They were often accompanied with discussions of the difficulties experienced in cleaning room surfaces and steel finish studies.

During these early years, many devices were developed in support of client needs to operate potent compound processing in both dedicated and shared manufacturing facilities. Many of the devices FabOhio Inc. developed have become common practice within the industry. Other vendors now deliver products based on our pioneering work. The existence of vendors supplying flexible containment of any type is a direct result of the groundbreaking work that FabOhio Inc. and our customers did in the early 1990’s. FabOhio Inc. customers benefit from our experience base that far exceeds the experience and supporting data of newer providers. FabOhio Inc. was the first and is still the best provider of flexible containment solutions to the Pharmaceutical, Biotechnology, and Nanotechnology industries.

We are proud of our history of innovation as we increase our product offerings through development at minimal, or often no cost, to our customers. FabOhio Inc. also remains the most consistently economical provider. Our products are all fabricated at our manufacturing site in Uhrichsville, Ohio. Our site is subject to routine inspection by Federal Agencies and Primary Pharmaceuticals Manufacturing Quality Organizations with whom we do business.

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