Material Data Sheets

Material data sheets for commonly used flexible containment materials.

Reference Material Data Sheets to Assist in Film Selection

Access material data sheets for our commonly used materials of construction for product packaging and flexible isolator items below. This information can assist in film selection but is no substitute for prudent practice on the part of the user.

10mil Clear Polyurethane Film

Polymer:
Thermoplastic polyurethane, aromatic polyether – blown film

Key Attributes:

  • Very tough, abrasion resistant
  • Excellent chemical resistance
  • Good low-temperature-flex properties

10mil Clear Anti-Static Polyurethane Film

Polymer:
Static dissipative thermoplastic polyurethane, aromatic polyether – blown film

Key Attributes:

  • Very tough, abrasion resistant
  • Excellent chemical resistance
  • Good low-temperature-flex properties

8mil Frosty Polyurethane Film

Polymer:
Thermoplastic polyurethane, aromatic polyether – extruded film

Key Attributes:

  • Very tough, abrasion resistant
  • Excellent chemical resistance
  • Good low-temperature-flex properties

8mil Frosty Anti-Static Polyurethane Film

Polymer:
Static dissipative thermoplastic polyurethane, aromatic polyether – blown film

Key Attributes:

  • Very tough, abrasion resistant
  • Excellent chemical resistance
  • Good low-temperature-flex properties

Industrial Nitrile Gloves

Key Attributes:

  • Cotton flocking, reducing sweat for the wearer
  • Sandpatch finish giving the glove a smooth surface that decreases
    Indirect costs, thanks to fewer rejects of fragile parts
  • Fully reusable, with an unequaled abrasion resistance
  • Provides superb comfort for the wearer
  • Complies with FDA food handling requirements

Large Tooth Zipper

View material specifications, dimensions, physical properties, and more.

O-Rings

View material specifications, dimensions, physical properties, and more.

Testing Film Compatibility and Stability

Agencies require users 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.

This 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 products. LLDPE presents the lowest potential risk for adverse outcomes.

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.

 

Additional Specs and Certifications

 

Continuous Liner Certification

June 21, 2022

FabOhio, Inc. certifies that 4 mil thick Low Density Polyethylene (LDPE) film is the material of construction used to make continuous liners. The manufacturer of the LDPE film has certified that it meets the specifications of the United States Federal Food, Drug, and Cosmetic Act, and as more particularly described in 21 C.F.R. 177.1520 (c), […]

E-Beam Sterile Conditioning of FabOhio Inc. Glovebag

June 21, 2022

The study was performed at an E-Beam facility in Ohio. A certified testing laboratory in Cleveland prepared multiple test strips inoculated with known concentrations of 12 organism recognised as suitable candidates. FabOhio Inc. had provided a large glovebag folded ready for shipment with 2 over pack layers all in a standard sealed shipping box. The […]

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

September 17, 2021

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 […]

Case Study: OEL Performance

September 17, 2021

During a site compliance visit, an EMA team observed that our client’s central facility was storing, dispensing, and dispersing a potent API globally which was averse to their expectations. Without supporting data showing potent compound isolation, this was an unacceptable procedure. The client’s Quality Laboratory in partnership with their Occupational Health colleagues developed a sampling […]

Closure Methods for Glovebags

September 16, 2021

In spite of a tried and true method for safely detaching glovebag sleeves which has been in use by the Nuclear Industry since the 1950’s and the Pharmaceutical Industry since the early 1990’s, questions often arise challenging the efficacy of the procedure. The issue commonly arises due the lack of consideration of materials compatibility. The […]

Film Cleanliness and Composition

September 16, 2021

Quality organizations in the Pharmaceutical Industry are rightly concerned with any issues that may affect product integrity. Any solids, liquids, or vapors that may be released in close proximity to a product are suspect. The presence of any of these places additional burden on Quality laboratories. Film Cleanliness There is considerable confusion about what can […]