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Name/Message content:
Rune Johansson (male)
2010-09-27 18:29:56
Email：
rj@blomdahl.com
Message topic:
Dose-mapping process
Message content:
ATT: Quality Manager Dear sirs, Through corespondance with Lights Medical we understand that you are claiming that dose-mapping must be performed on our products (OQ). We have tried to explain to Lights Medical why there is no need to remake the dose distribution test: “when changing the Cobalt source, JPY has to do several tests including dose-distribution studies on reference loads, but that has nothing to do with the dose-distribution studies the customers have done as a part of the customer process qualification. It is the responsibility of the sterilizing company to ensure that their facility is operating under given and constant conditions. We therefore withhold our position that we do not have to perform any additional dose-mapping.” In Table A.1 in ISO 11137-1:2006 there is detailed guidance on how to act after different types of changes to a gamma irradiator, including, in line one, “addition, removal or reconfiguration of/to radionuclide”. All actions listed in the table involve installation and operational qualification – which does not involve actual products. The dose mapping during operational qualification shall be performed on dummy material on at least the highest and the lowest density processed in the facility (ISO 11137-3:2006). It is unacceptable to require that customers shall repeat dose-mapping twice per year in order for their products to be processed under a sterilization contract. Looking forward to a quick response. Best regards, Rune Johansson Blomdahl Medical AB Sweden
John (male)
2007-11-12 22:54:25
Email：
jwalshVP@aol.com
Message topic:
Gamma Sterilization capabilities
Message content:
I like to know if you can perform Cobalt 60 Gamma Sterilization process validation on stimulating electrodes. Thanks, John
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