Verein Deutscher Ingenieure

Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
 N VDI 6300 BLATT 1

Annotation

The standard describes the state of the art as regards checking safety measures and also sampling as well as analysis for the safe operation of genetic engineering facilities.

The standard applies to genetic engineering laboratories of safety level 1 to safety level 3 and makes reference to the corresponding requirements of the Genetic Engineering Act (GenTG) and of the Genetic Engineering Safety Ordinance (GenTSV), in particular Annex IIIA, as well as to a number of relevant codes of practice (see Table 1 in Section 4.1 and Bibliography). It thus represents an orientational aid for operators, project managers and BSOs in planning and implementing safe operation of genetic engineering facilities. It supports the operators of genetic engineering facilities and their agents (for example, servicing companies, manufacturers, testing laboratories) in meeting and documenting requirements under genetic engineering law as regards the technical and analytic testing of safety-related parameters.

The legislation permits the possibility of deviation in individual cases from the safety measures listed in GenTSV. Due to the special nature of genetic engineering operations or facilities it may even be appropriate to deviate from the measures described here. For this reason, before implementing the measures specified it is advisable for operators and the responsible public authorities to consult together.

This standard does not apply to

• S4 facilities,

• animal facilities,

• greenhouses and

• production areas.