Cost-effective sterilization method

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

Several methods are used to sterilize medical devices including ethylene oxide, steam under pressure, dry heat, and gamma irradiation. In recent years. E-beam sterilization has become an increasingly popular method for the sterilization of medical plastics. E-beam sterilization offers a lower cost alternative to the more common gamma and ETO sterilization techniques. In selecting a thermoplastic resin for use in medical devices it is important to consider the effects of the sterilization method on the physical and optical properties of the material. Previously a smdy was performed to determine the effects of gamma sterilization on thermoplastic resins used in medical devices In the present work, a similar study was performed after E-beam sterilization. 

All three niethod.s of sterilization or bacterial reduction offer both benefits and disadvantages. Irradiation Ls the most effective means of bacterial reduction, however, there are consumer concents about the safety of the product, Ethylene oxide b a proven method that has been in use for years but has recently come under the scrutiny of FDA and the Environmental Protection Agency (EPA). The wet steam process is not quite as effective as irradiation and the cost is slightly liigher, however, it is regarded as a safe method. I he dry steam method is highly effective and the newest method available. It Is more expensive than irradiation but less expensive a process than both ethylene oxide and wet steam. No one method is perfect. The selection of the method to be used is up to the individually processor and must meet the needs of the customer. 

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