• Sterilization process alternatives include irradiation (including Cobalt 60 and electron-beam), ethylene oxide (EtO), steam autoclave, and vaporized hydrogen peroxide. The decision of which process to use is usually driven by the type of medical device. Consider the material and drug compatibility with the sterilization process, as well as cost issues.
• International challenge: The color of a pouch can be an issue in certain regions.
• Biocompatibility issues to consider include how sterilization and the package itself could affect the product. Stockdale recommended ISO 10993 (10 parts), "Biological evaluation of medical devices," to help select necessary tests. Toxicity, carcinogenicity, and irritation are among the evaluations.
• EtO considerations: Gas has to penetrate the entire package and have a pathway to the medical device; gas is lethal to microorganisms and people; there are regulatory or market concerns. Primary package requires a porous membrane such as Tyvek or paper. Although paper allows EtO penetration, it also absorbs the gas and can affect the sterilization cycle. Validation includes cycle development, determination of most difficult gas pathway, production process validation, palletized load characteristics, and large-scale aeration. Stockdale said there's a need to shorten the process cycle from 9 to 14 days down to 2 to 3 days. Shipping products to Europe requires multiple-language printing. Four-chamber EtO sterilization equipment costs around $1,000, and few people are needed to load in packaged product and monitor the process.
• Irradiation considerations: The process produces fast turnaround but requires a large investment, and bioburdens become an issue. Dose meters should be added intermittently in the package to determine product exposure. Production bioburden should be sampled to confirm validation. E-beam is not as invasive and can be done with small units on the packaging line. Packaging container thickness can affect the e-beam process.
• Steam autoclave: Not usually used for medical devices, this process uses dense steam at temperatures above 121°C. Medical companies need to pack devices prior to autoclaving. Hospitals may reprocess devices.
For protocols and summary reports, Stockdale suggests they be written with a Food and Drug Administration reviewer in mind. They require a quality unit signature, and you should report all deviations and resolutions. Treat these as legal documents, and have them support regulatory approvals. For more information, contact Doug Stockdale at 949/888-9488, or visit www.stockdale-inc.com.
--By Jim Butschli, Editor
• International challenge: The color of a pouch can be an issue in certain regions.
• Biocompatibility issues to consider include how sterilization and the package itself could affect the product. Stockdale recommended ISO 10993 (10 parts), "Biological evaluation of medical devices," to help select necessary tests. Toxicity, carcinogenicity, and irritation are among the evaluations.
• EtO considerations: Gas has to penetrate the entire package and have a pathway to the medical device; gas is lethal to microorganisms and people; there are regulatory or market concerns. Primary package requires a porous membrane such as Tyvek or paper. Although paper allows EtO penetration, it also absorbs the gas and can affect the sterilization cycle. Validation includes cycle development, determination of most difficult gas pathway, production process validation, palletized load characteristics, and large-scale aeration. Stockdale said there's a need to shorten the process cycle from 9 to 14 days down to 2 to 3 days. Shipping products to Europe requires multiple-language printing. Four-chamber EtO sterilization equipment costs around $1,000, and few people are needed to load in packaged product and monitor the process.
• Irradiation considerations: The process produces fast turnaround but requires a large investment, and bioburdens become an issue. Dose meters should be added intermittently in the package to determine product exposure. Production bioburden should be sampled to confirm validation. E-beam is not as invasive and can be done with small units on the packaging line. Packaging container thickness can affect the e-beam process.
• Steam autoclave: Not usually used for medical devices, this process uses dense steam at temperatures above 121°C. Medical companies need to pack devices prior to autoclaving. Hospitals may reprocess devices.
For protocols and summary reports, Stockdale suggests they be written with a Food and Drug Administration reviewer in mind. They require a quality unit signature, and you should report all deviations and resolutions. Treat these as legal documents, and have them support regulatory approvals. For more information, contact Doug Stockdale at 949/888-9488, or visit www.stockdale-inc.com.
--By Jim Butschli, Editor
