Medical industries require the use of packaging products and containers manufactured with stricter standards to ensure adequate safety for pharmaceutical applications. Specifically, single use products designed for the production of culture media or the filling of sterile APIs and drug products are subject to additional processes such as sterilization. This is often accomplished with gamma sterilization, the process of bombarding the bioburden that are present on a container with high energy gamma rays, which destroys the covalent bonds in bacterial DNA.
Gamma sterilization provides a number of benefits over other methods. It does not generate heat or moisture in the process of sterilization and will not induce heat stress to a product or leave residual radiation. It provides sterility insurance due to the effective nature of the process.
This process, however, is not without some limitations. Standard polymers, such as lab grade polypropylene, are inadequate on a chemical level to handle high doses of gamma radiation, ultimately leaving such materials brittle and stained yellow. Instead, specialized PP-Gamma polymers are used to manufacture plastic containers that are engineered to withstand the gamma sterilization process.
The material used at LA Container is a USP Class VI, highly clarified random copolymer resin designed specifically for the manufacturing of medical devices suitable for sterilization by high energy radiation. In addition to being radiation sterilizable, containers made with this material are E-beam sterilizable and Ethylene Oxide sterilizable. This sturdy polypropylene material has controlled rheology to maintain its structure long-term.
Radiation resistant polypropylene is compliant with many industry and medical standards including RoHS restrictions on the inclusion of heavy metals such as lead, mercury, cadmium, and hexavalent chromium. This material is REACH compliant and also does not contain flame retardants like PBB, PBDE, or benzofurans. PP-Gamma material is also compliant with FDA regulation 21 CFR 177.1520, making it safe for use with food products. No animal products are used to create this polymer.
Gamma Sterilizable containers are used primarily for medical packaging, healthcare applications, or labware. LA Container features an extensive line of over 200 round and square gamma containers to meet nearly every industry’s needs. In addition to gamma resistant polypropylene, there are other material options available including polyethylene and ESD inhibiting materials. For more information regarding gamma resistant materials, or our container options please visit our site or contact us.