Product Contact

Examples of FabOhio Inc. material data sheets for our commonly used materials of construction for product packaging and flexible isolator items are attached. Data sheets are available for custom materials that we provide. This information can assist in film selection but is no substitute for prudent practice on the part of the user.

In spite of documentation on the part of FabOhio Inc., the Agencies require the user to establish their product contact performance data for both short term accelerated and long term storage under appropriate storage conditions. Virgin Linear Low Density Polyethylene (LLDPE) remains the reference standard for product contact packaging evaluations.

Virgin LLDPE formulation incorporates the polymerization catalyst but is devoid of additives such as anti-stat agents, lubricants, etc. Modified films of Polyethylene, PVC, and polyurethane, etc may create problems due to additive migration out of the film into adjacent product. As well as product contamination, loss of film integrity may also occur especially over time. This is especially true whenever there is potential for residual solvent in the packaged product. It is critical that stability testing be performed with materials newly sampled from the process, since stock materials may show different stability performance. It is in the users best interests to test the film compatibility with the process solvent as both a liquid and a vapor.

While the requirements for product intermediates made prior to the Critical Step are less stringent, we strongly advise that users check film compatibility with all intended materials packaging. Process outcomes can be affected when a leached film additive passes through your process without early detection, even if chemically changed. The analytical complexity of identifying and tracking such contaminants can be an overwhelming task.

.LLDPE presents the lowest potential risk for adverse outcomes. FabOhio Inc. LLDPE individual and continuous liners are readily available in many diameters and lengths. Other film materials are available upon request.