Radiation Sterilization: sometimes the best choice Dr. Vijai Kumar Sharma Hollister Medical India Private Limited Bawal, Haryana, INDIA

Radiation Sterilization: sometimes the best choice Modern plastics: versatile unmatchable properties for devices & healthcare products biocompatibility easy manufacturability for mass production durability barrier properties light weight

Radiation Sterilization: sometimes the best choice Plastics cannot withstand the high temperatures of heat / steam sterilization. Their sterilization requires 'cold' processes. Two options: Radiation sterilization (gamma, electron beam, X ray) Ethylene oxide sterilization

Radiation Sterilization: sometimes the best choice Radiation sterilization should be the first choice High penetration power Limited temperature increase No need for permeable packaging materials Validation relatively easy Routine control easy Parametric (dosimetric) release Product immediately available after sterilization No toxic residues

Radiation Sterilization: sometimes the best choice Products that our company sterilizes by irradiation:

Radiation Sterilization: sometimes the best choice

Radiation Sterilization: sometimes the best choice

Radiation Sterilization: sometimes the best choice Unfortunately irradiation has undesirable effects on common materials such as PP or PVC Darkening or yellowing Undesirable odors Brittleness Ethylene oxide is then the only choice

Radiation Sterilization: sometimes the best choice Advantages of Ethylene oxide sterilization: Allows using ANY materials Allows using INEXPENSIVE materials

Radiation Sterilization: sometimes the best choice Drawbacks of Ethylene oxide sterilization: Pressure & temperature variations stress packaging High humidity required Leaves toxic chemical residues Validation complicated Effect on environment if no proper gas disposal

Radiation Sterilization: sometimes the best choice Ethylene oxide made progress in the recent past: Optimization of cycles with lower gas concentrations All-in-one chambers with process that includes pre-conditioning, sterilisation and degassing Reduced quarantine times Fast incubation tests for Biological Indicators Depollution systems for ethylene oxide facilities Lower residues limits

Radiation Sterilization: sometimes the best choice Products that Hollister Medical sterilizes by ethylene oxide

Radiation Sterilization: sometimes the best choice

Radiation Sterilization: sometimes the best choice Best method is the method best suited for a specific product Sterility achieved Quality and functionality retained Cost acceptable Availability of sterilization method

Radiation Sterilization: sometimes the best choice Medical device manufacturers tend to be process neutral. Both, Radiation & Ethylene oxide sterilization are necessary. Both methods will be used for many more years.