Radiation Sterilization: sometimes the best choice

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

2. 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

3. 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

4. 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

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

6. Radiation Sterilization: sometimes the best choice

7. Radiation Sterilization: sometimes the best choice

8. 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

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

10. 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

11. 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

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

13. Radiation Sterilization: sometimes the best choice

14. 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

15. 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.