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.