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Dose mapping for documentation of radiation sterilization
Radiation Physics and Chemistry, 1999 The radiation sterilization standards EN 552 and ISO 11137 require that dose mapping in real or simulated product be carried in connection with the process qualification. This paper reviews the recommendations given in the standards and discusses the difficulties and limitations of practical dose mapping.
Miller, A.
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International standard (ISO) of radiation sterilization and issues in the sterilization dose setting
Radiation Physics and Chemistry, 1995Abstract The ISO dose setting method 1 uses bioburden and verification by sublethal sterility test. Current devices produced in clean environment have low bioburden, however, sensitivity of verification test declines at low bioburden. Validation of verification in this region should be further studied.
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Validation of Radiation Sterilization Dose for Lyophilized Amnion and Bone Grafts
Cell and Tissue Banking, 2000A limited number of grafts produced in one batch is the main constrain to validate radiation sterilization dose of amnion and bone grafts according to ISO standard. The validation experiments done were according to ISO 13409 with a slight modification in sampling method.
N, Hilmy, A, Febrida, A, Basril
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Sterilization dose auditing for various types of medical products
Radiation Physics and Chemistry, 2002Abstract Different types of products require a different methodology of processing. The homogenous materials with well-known bioburden do not cause much problems nowadays and radiation processing and the sterilization dose can be easily audited. In this technical note the difficulties associated with the validation of radiation sterilization of ...
Zbigniew Zimek, Iwona Kaluska
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Sterility and use patterns of multiple-dose vials
American Journal of Health-System Pharmacy, 1982The viability of microorganisms in multiple-dose vials (MDVs) and the use and in-use contamination rate of MDVs were investigated. Serial tenfold dilutions of stationary cultures of Escherichia coli and Pseudomonas aeruginosa were injected into 30-ml MDVs containing bacteriostatic agents, and samples were removed at 1, 16, 24, and 48 hours, and at ...
J C, Bawden +4 more
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Radiation Sterilization Dose Establishment for Tissue Grafts — Dose Setting and Dose Validation
2007exaly +2 more sources
Stabilized polyethylene on the sterilization dose range
Polymer Bulletin, 2006This paper presents the effect of gamma irradiation on polyethylene stabilized with two derivatives of carnosic acid. LDPE-stabilized samples were subjected to high energy radiation on three doses (5, 10 and 20 kGy) on the sterilization range of polymers.
T. Zaharescu, S. Jipa, B. Gigante
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The effect of dose distribution on sterility assurance for gamma sterilized medical products
Radiation Physics and Chemistry, 1993Abstract 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
R.D.H. Chu, G.G. Vandyk
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Sterility of Anesthetic Multiple-dose Vials after Opening
Anesthesiology, 1985Despite the widespread use of multiple dose vials (MDV) for anesthetic medications, there is a paucity of data concerning the sterility of in-use MDV. The purpose of this study was to analyze the frequency of bacterial contamination of MDV used in current anesthesia practice.
A, Schubert, K C, Hyams, R N, Longfield
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Low-Dose Gamma Radiation Sterilization for Decellularized Tracheal Grafts
Journal of Visualized Experiments, 2023One of the main key aspects in ensuring that a transplant evolves correctly is the sterility of the medium. Decellularized tracheal transplantation involves implanting an organ that was originally in contact with the environment, thus not being sterile from the outset.
Martinez-Hernandez N +7 more
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