Films for Large Volume Parenterals - M312, M312A, M312C

Did you know that up to 20% of IV bags produced can be lost in production and transit due to their material types. Not all plastics are equal when it comes to meeting the demands of large volume parenteral drug manufacturing and delivery. Contact us at medicalpackaging@sealedair.com

Applications

 Our studies show that some films made of lower-grade resins can be harder to set up and use in manufacturing. This is because of their inherent stiffness (Young’s modulus) and higher Tg or Glass transition temperature, which is where a material changes from a fully flexible state into one where it is stiffer and somewhat brittle under stress. Attempting to process and safely reach their destination can be problematic for these materials, particularly in cold climates.

Nurses have also complained about stiffer IV bag materials actually cutting their fingers as they prepare to administer the IV drip.

Sealed Air uses polyethylene as its primary material for its M312 family of IV films. Once extruded, the modulus ranges from 830 to 1,350 kg/cm2 (11,805-19,201 psi) depending on the grade of film. In contrast 3-ply polypropylene films, a frequent choice for standard saline, have a Young’s modulus ranging from 3,130 up to 5,040 kg/cm2 (44,500-71,700 psi). In other words they are 4 times stiffer. See how our films drape easily around the ports during bag production here.

For the M312 family, the Tg is -120°C while for polypropylene, this happens around -20°C. For storage, production and distribution in cold climates, this can lead to poor seals, leaking bags and bags breaking if dropped while our products are drop tested from a height of 2 metres on each corner and do not break or leak.
 

  • Primary packaging for intravenous pharmaceutical solutions
  • Large volume parenterals, dialysis, irrigation, specialty drugs

Specs

  • USP, EP and JP compliant and registered under US FDA DMF #9705
  • Extremely low extractables and leachables
  • Manufactured under quality system ISO 15378 in ISO 7 cleanrooms to give very low levels of particulate
  • Steam sterilizable up to 121°C while also providing excellent low temperature abuse resistance
  • Multilayered coextrusion combines material strength with the widest sealing window in the market for ease of use
  • Reject rate for pre and post-sterilization bags made from M312 to be consistently less than 1% under correct production conditions
  • 40°C sealing window allows for equipment and climatic variation
  • M312 and M312A are USP, EP and JP compliant
  • M312C is approved by the China NMPA and available only in China