When our flexible barriers are installed correctly they perform as effectively as a rigid containment and far better than an airflow barrier system.
Until ca. 2000 the best analytical sensitivity for testing rigid and flexible isolators using surrogate challenges was 0.2 micrograms/cu.m. Testing of our flexible isolators showed measurements below the analytical detection limit, which approximates to a Containment Factor of >3,000.
With improvements in analytical sensitivity, isolator performance has become quantifiable at the analytical detection limit of 0.2 nano-grams/cu.m. for a full period measurement of a procedure, corresponding with a Containment Factor of >1,000,000. When properly installed and used, our flexible isolators typically achieve non-detectable performance.
Under worst conditions, a client recently demonstrated <0.04 ng/m3 for an Active Pharmaceutical Ingredient, documenting an in-use Containment Factor of >15,000,000.
Studies conducted by an independent laboratory confirm the efficacy of the radiation dosages we have established. The biological efficiency exceeds a kill factor of 1,000,000 for a standard battery of organisms.
Selection of e-Beam sterilization precludes the formation of pinholes in the film structure. The integrity of our flexible barriers was maintained through levels up to 10 times the established conditioning dosage.
Clients are provided with a confirming Certificate of Irradiation with their shipment. Dosage tags remain on the conditioned shipping container.
Installation and Training
FabOhio Inc. stands ready to assist clients requesting the installation of flexible barriers and operator training. A cost proposal will be provided for this service. We strongly encourage clients to establish a lead person responsible for working with FabOhio Inc. who can learn to install flexible barriers and conduct training sessions for their users.
We will also conduct performance testing of either a test set-up or an installed flexible isolator if requested.
FabOhio stands firmly behind our flexible isolators designed to the conditions specified by our clients. The versatility of flexible containment applications that we support covers the entire life cycle of Pharmaceutical products, from discovery through to product packaging.
Our expertise in flexible isolation barrier concepts ranges across research, development, pilot plant, full scale, shipping, storage, dispensing, formulation, finishing, inspection, and final product packaging, as well as the many service operations, e.g. maintenance, on-line instrument installation and calibration, on-line filter changing, dispensing and formulations, in-process equipment adjustments, exhaust filter change-out, and waste handling.
The nature of the Pharmaceutical Industry requires batch operations rather than continuous processing. This is the primary reason why our flexible containment solutions are used so frequently. The ease of cleanup without the need for isolator or room cleaning validation adds to the overall cost benefit of a one time use, disposable, flexible barrier allowing for fast turnaround time without environmental legacies. The added benefit of being user friendly cannot be overstated.
It is commonplace to find our flexible glovebags used for simple applications such as flange and valve enclosures, materials additions, product rework, rotary valve clean-out, and process sampling. In the finishing world they are seen surrounding formulation, filter changeout, granulation, milling, drying, dosing, lyophilizing, tabletting, inspection, and final packaging operations.
Laboratory bench scale, kilo lab, pilot plant, and full scale batch and continuous operations for both formulation and bulk API manufacture rely on our flexible isolator products for every day operation. Flexible barrier containment solutions for R & D and Quality Laboratories, routine plant operations, routine maintenance and turnaround, and even outdoor waste handling needs are all successfully supported.
Our clients are starting to use our economical continuous liners for packaging of intermediates without the expense of costly engineered closed packaging and charging systems and their associated operating costs. Continuous liners are available in many diameters and lengths suitable for standard bag-in/bag-out applications from laboratory through to production scale.
With the endorsement of Risk-MaPP, we have been able to respond rapidly to assist clients in upgrading their processing performance to acceptable levels. Our inventory of flexible containment solutions is proving to be their greatest asset in addressing their need to resolve issues in a timely and cost effective manner.
We are especially adept at addressing unusual operating environments such as:
1) Low (<4%) oxygen levels during materials handling
2) Inert atmospheres
3) Static dissipative needs
4) API and chemical contact
5) Retrofit for older equipment and processing suites
6) Limited accessibility
as well as the ever present need to address operator beliefs and techniques.
FabOhio Inc. relies on a strong partner relationship and the common understanding developed with the client. From the onset of a project through final execution, the client is of paramount importance.
Once performance criteria are established, FabOhio Inc. will review related projects for compatibility and learning points. This results in both rapid response and cost savings for the client. We are experienced at developing new concepts, however many new projects show familiarity with prior products.
Most changes required amount to simple adjustments of connection points, support systems, and clearance requirements. Closure techniques for glovebags, flexible isolators, and even flexible enclosures are common with installed location being the major variable.
While we retain confidentiality with our clients we are in a position to share non-proprietary concepts. This eliminates the steep learning curve and costs often involved in developing new concepts with a client.
No Hidden Costs
FabOhio Inc. strives to manufacture and deliver quality products at the lowest feasible cost to the client. We always present our best quote up front. This applies to our manufactured goods – glovebags, flexible isolators, flexible enclosures, flexible barriers, and all of their permutations, as well as services.