The effect of dose distribution on sterility assurance for gamma sterilized medical products

✍ Scribed by R.D.H. Chu; G.G. Vandyk

• Publisher: Elsevier Science
• Year: 1993
• Tongue: English
• Weight: 320 KB
• Volume: 42
• Category: Article
• ISSN: 0969-806X
• DOI: 10.1016/0969-806x(93)90329-s

✦ Synopsis

Medical products sterilized in a gamma processing facility are given an absorbed dose greater than or equal to a specified minimum dose chosen to achieve a required sterility assurance level. Because of the dose variation in the product volume, most of the product receives a dose greater than the minimum value. The actual sterility assurance level achieved will depend on the dose distribution in the product volume, the microbial bioburden, and the radiation resistance of the microbial population.

Calculations were performed for typical product densities for two gamma irradiator designs to determine the fraction of the product receiving different doses. Assuming the microbial resistance distribution used in AAMI Method 1, the actual sterility assurance levels obtained were calculated and compared with the specified sterility assurance levels.