Sterilization Services: What flavor does your flexible film containment need to be?

FabOhio Inc. Glovebags can offer sterilization services by a business partner using none-destructive e-beam technology.  The e-beam treatment has been tested by a certified independent laboratory to deliver a specific dose to a standard size Glovebag shipment. Our calculated dose is guaranteed to kill an inoculation array of a standard mixture of 12 organisms. The laboratory data established the standard set-up criterion for an organism kill rate in excess of 1,000,000. This has created our target set-up of the irradiating beam for all terminal sterile shipments.

Flexible film isolator users are not aware of the condition of blow-films as they are delivered to the flexible film fabricator. Excluding cast film which is a rarity in the industry, films are created by drawing a thin film from a molten pool of mother liquor. The production rate is established by the length and time with which it is drawn from the melt. The composition of the film is determined by the additives in the melt, e.g. antistatic additive. Film annealing is controlled by the length and time of the vertical draw and the air temperature both inside and outside the film before it meets the cutting blade and is finally rolled onto a support core.

The volumes of air used for annealing and room conditioning in intimate contact with the inside and outside of the film ‘balloon’ precludes air filtration and cooling. Particulate material in the airflow is prone to deposition on both sides of the film until it is secured onto the support core. This is the condition of the film when stored, shipped, and received by the fabrication shop.

Conventional use of Flexible Film Isolators is no different to processing in a normal ventilated room. Many configurations of properly installed isolators have been tested to meet isolation requirements demanded for worker protection (emission control) and materials migration (cross contamination control), i.e. Occupational Health and Engineering criteria.

Significant surface demands only come into play when Quality enters the picture. Clean Room and Sterile Room operations create different criterion from the workers and the production space perspective, i.e. gowning procedures, surface cleaning practices (as part of the production ticket), airflow quality, volume, and envelope pressure demands. In a typical walled facility this requires the processing ticket to include surety that all factors affecting maintenance of room condition are measured and recorded. This in turn requires instrumentation which is installed, validated, and documented throughout processing. Using a properly conditioned Isolator for processing may reduce this burden. This may require an assembled and leak tested Isolator to be internal surface cleaned using approved isopropyl alcohol swabs to create the ‘clean room’ environment, and a finished, overpacked, and packaged for shipment Isolator to be terminally sterilized using irradiation.

When ordering a FabOhio, Inc. Glovebag for cleanroom and sterile processing for an isolator to meet quality criteria, the purchase order needs to be specific to obtain the many virtues gained by these practices.  Please note that sterile processing is not included in our standard practices however can be provided as an incremental service offering.  Contact us at FabOhio, Inc. with any questions, we would be more than happy to discuss sterilization details for your business’ custom containment systems. 

Written by Brian Ward, PhD, CSci, CChem, FRSC

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