Radiological protection stakes and improvement in the radiopharmaceutical industry and transport: The example of Cis Bio International in France

The company CIS BIO International is located on the site of the nuclear research centre of Saclay and is the only company in France producing radioisotopes for medical use. Since January 2002 CIS BIO International became a subsidiary of the SCHERING group (100% of the share holdings). CIS BIO International has two nuclear facilities. the main one is making conception, manufacturing, packaging and trading of radioactive materials for medical (radiopharmaceutical) or industrial use. Regarding the huge amount of radioactive material circulating and being manipulated in the dispatching room, the workers in charge of packaging and the drives in charge of loading those packages into their vehicles are the most exposed to radiation hazards. Them the highest individual dose recorded by dosimeters film, over 12 months in the row, for workers in charge of jobs in the dispatching room, increased from 10.5 mSv in 2000 to 12,7 mSv in January 2002. In the new decree related to radiological protection of workers, in application of the 1996 Euratom directive, the whole body dose limit should decrease. In that context and regarding the dosimetric stakes, an ALARA study has been carried out in the dispatching room. This ALARA study is aimed to reach an optima value of the exposure of the workers in the dispatching room and, indirectly of the exposure of the drivers. In order to take into account all external constraints towards activities carried out in the dispatching room and to insure coherency and an exhaustive list of improvement options related to exposure, a description of all the input/output processes was realised, in addition to those concerning the dispatching room. As a matter of fact, those constraints due to the specific nature of the company are various. They are on the one hand related to regulations applied to the nuclear facilities, to the radioactive materials transportation in countries of transit and in the recipient countries and on the other hand, related to regulation about goods manufacturing practises for medical drugs. At these constraints are also added those related to quality management system and to trading practises. These constraints having been in constant evolution, the company had to adjust with them. The requisite adjustments have been usually carried out one after the other, according to the constraint at a given time. So, the dosimetric constraint often leaded to set up additional biological protection shield in the dispatching room. These practices are limited in the way they just focus on a dosimetric objective. If setting up an ALARA approach allows a through investigation of means aimed to reach an optimal value of the exposure it has not to be restricted to the activities of the group under study, otherwise the choice of the radiological protection options would be limited. This is why investigation has also been carried out on upstream downstream activities of the dispatching room, which brought up additional radiological protection options related to these activities. Then, the knowledge of these activities allows checking the coherency of radiological protection options related to the whole processes linked to the dispatching room. (Author)