Among all of the containment technology solutions, Flexible Containment is unique in that it has the greatest applicability for the lowest cost. Flexible Containment has been statistically proven to provide repeatable containment performance to the nanogram fugitive release level. The lowest performance measured was <0.04 ng/m³ of Actual Pharmaceutical Ingredient (an oncolytic drug substance) at 98% coefficient of variation during aggressive air sampling around the dispensing Glovebag enclosure skin after an entire work week of dispensing operations using a new Glovebag each day. The results satisfied the EMA inspector that using a shared warehouse and dispensing facility was an acceptable practice for this site.
The limited view of using Glovebags solely for the purpose of replacing Gloveboxes overlooks the many advantages that complete flexibility in design offers, i.e. no restriction on shape, size, placement, and even height, beyond the user’s needs. The ability of Flexible Containment to convert a non-cleanable space into a contained dispensing or tableting suite is unmatched. When coupled with advanced cleaning methods to minimize waste volumes, the user now has an unrivaled, non-constraining approach to comply with regulatory requirements.
The primary goals of any Containment is to minimize:
- Cross Contamination – fugitive emission and ingress control
- Worker exposure
- while imposing the maximum in:
- Worker comfort and acceptance
- Adoption as procedures
- Cost conservation
In this way the needs of Quality, Occupational Health, Environmental, Company, and Facilities Managements are all resolved using a single, disposable, and low cost technology solution that requires minimal cleaning and training.
Based on these goals, omission of flexible enclosures for any, and all, materials handling procedures, regardless of scope or materials potency, becomes difficult to justify. An often overlooked advantage is that isolators in all forms enhance materials security because access is minimized whenever isolation is adopted. The major issues with adopting Flexible Containment are unfamiliarity with time, cost, and benefits from reduced facility cleaning, and failure to consult with the managerial organizations noted above. Any proficiently conducted Risk-MaPP or Process Hazard Review (PHR) should include, at minimum, the aforementioned primary goals. Elimination of cross-contamination and cleaning requirements strongly favors the use of Flexible Containment as a desirable option.
Flexible Containment has none of the serious weaknesses inherent to airflow-controlled containment devices, e.g. downflow booths, laboratory hoods, weighing hoods, biological safety cabinets, and Remote Access Barriers where the optimal user training comes from the provider. The presence of stored materials or user movements within these devices immediately sets up turbulent airflow patterns causing uncontrolled materials movement. The methods for validating such spaces are so variable that the user is often at the mercy of measuring an outcome, such as a worker’s exposure level – regardless of the source (ISPE Guideline and SMEPAC), rather than a statistically robust worst case measure of the engineering performance and capability of an enclosure, which can be consistently repeated throughout the usable life of said enclosure.
In addition to airflow-controlled containment devices, the other serious contender for high containment performance is Rigid Containment, which is usually represented by steel or plastic Gloveboxes. Both deserve a high level of use, especially for routine purposes. The installed cost of a Rigid Glovebox is high, and is accompanied with time consuming design and delivery constraints. Only one glovebox manufacturer can currently comply with turnaround cleaning levels to the parts-per-billion range. Furthermore, traditional glovebox designers will attempt to position your equipment inside their glovebox, whereas flexible barriers can be constructed such that only fugitive release points are contained allowing greater access for operator movement, equipment adjustments, maintenance, and clean-up.
FabOhio Inc. has spent considerable effort in developing and rigorously testing low cost, user friendly, cleaning methods that are so effective that even the overhead spaces are cleaned. This research has resulted in methods that can be rapidly adopted for small, medium, large, and complex enclosures. In a production suite environment, the cleaning method involves a small amount of setup time, after which the cleaning process continues with no operator involvement. All internal surfaces of production multi-use enclosures, small scale enclosures such as pilot plants, and processing suites can be cost effectively cleaned with a minimum of segregated waste volume, lost processing time, and operator involvement. Intermediate size enclosures, e.g. rework booths and other single space enclosures, are rapidly cleaned with a low cost system requiring only high pressure air and purified or distilled water, with operator effort reduced to a minimum. The biggest advantage over other cleaning methods is the fact that the entire enclosure is cleaned while generating <10 gallons of waste volume.
Additional features include final internal cleaning to ensure low level particulate contamination, and sterilization using Electron Beam Irradiation of an entire shipment including packing box and all overpacks.
Small Flexible Containment enclosures, e.g. Glovebags, are economical enough to be disposed of after use, eliminating the development of validated sampling method and strategy (>$45,000) and cleaning validation (>$120/sample for a minimum set of 6 samples for each cleaning cycle) accompanied by lost time waiting for Quality approval. In laboratories and pilot plants, Flexible Enclosures can be cleaned at little cost, in minimal time, with little waste volume generated, and all within the contained space. Eliminating validation method development, labor costs, and lost processing time often prevails over other alternatives which require operator training or setup complexity. The value is further enhanced by ability to make a few modifications while the Flexible Enclosure is in use, e.g. addition of glove-sleeves, pass-through, etc.
FabOhio Inc. specialty designs are currently used for many applications at all scales of manufacture, from laboratory scale to full scale production. The greatest asset of our Flexible Containment solutions is the ability to install these devices in spaces with limitations (e.g. headspace constraints, floor level and elevated sampling/clean-out access points, rotary valve cleaning, etc.) that would preclude the use of a rigid containment product. Flexible Containment is especially useful for utility spaces, pilot plants, and facility retrofit having sudden need for a safe method to change cartridge or exhaust manifold filters, contain seepage, and enclose large pieces of equipment where access was not pre-planned. A key advantage exploited by users in existing facility retrofits is economical and rapid upgrade as frequently practised by third party manufacturers. Typical turnaround time for conceptual design through product delivery can be as short as 4 weeks.
Since most users requirements are of custom design, FabOhio Inc. works with clients to ensure that the final product is as economical as an off-the-shelf product from other providers.
While the physical applications to date are both too numerous and varied to list, they do fall into a series of categories – which are expanding as new technology demands increase.
Small Utility (local) enclosures with fugitive release locations:
- piping flanges
- skillet change-out
- valve stems
- valve actuators
- process sensors
- process drip points
- utility room leak points
- flashlight enclosures
- worker decontamination pool
- sample bottle overpack for inter-building handling
Small Glovebags (<2 m³ enclosed space) with only a single entry path:
- weighing and dispensing
- sample splitting
- laboratory materials handling – sample prep, shipping, etc.
- isolation of laboratory animals
- pilot plant materials handling
- charging process materials using a tri-clover connection
- isolation of processing ticket
- materials disposition – shipping or waste
- multiple materials transfer in/out
- readily adaptable for multiple uses
- inert atmosphere environments
- low cost storage
- whenever exhaust ventilation is not available
Small Glovebags (<2 m³ enclosed space) with a materials pass-through – airlock(s) or pass-through sleeve(s):
- all of the above categories
- when worker procedural performance is at risk
- pilot plant charging enclosure
- drier/mill sampling and pack-out
- extremely friable materials handling
- materials having a high dustiness index
Inflatable frame Glovebag:
- all of the above categories
- offers the ultimate in convenience
- small enough to be moved with one hand
- an integral base allows the Glovebag floor to become a work surface
- enclosure of any process release location
- special operator needs, e.g extreme flexibility, seated, etc.
- in-process filter canister changeout
- changing large exhaust air filters, e.g. filter dryer manifold
- PQ & PPQ for Quality validation, e.g granulators and mills
- enclosure of an entire machine
- materials rework
- Waste materials containment
Multiple room suites:
- pilot plant upgrade
- strip mall manufacturing facility enclosure
- uni-flow personnel access
- extreme isolation – cascading air pressures suite
The reality is that with few limitations, namely, pressure/vacuum demands (+/- 20 w.g.), elevated temperatures (>180°F), only one common solvent incompatibility (methylene chloride), the use of flexible barriers is fully adaptable to user needs. Few technologies have as much freedom in design and usage; hence, Flexible Containment is the perfect solution.