What actually applies to walls in genetic engineering facilities?

Dr. Petra Kauch

The wording for wall properties is different for S1 and S2 systems in the GenTSV. Does this also result in practical differences?

The GenTSV initially distinguishes between laboratory areas and production areas (Annex 2) as well as greenhouses (Annex 3) and animal rooms (Annex 4). Annex 2 (to Section 14) sets out safety measures for the Laboratory area security level 1 is it [called:
"Work surfaces and the surfaces adjacent to them, in particular walls, floors and furniture, should be easy to clean and must be resistant to the substances used as well as to cleaning and disinfection agents." (AI a. No. 2). Annex 2 (to Section 14) contains safety measures for the Production area security level 1 is it [called:
"Work surfaces and the surfaces adjacent to the work surfaces, in particular wall surfaces, floors and inventory, should be easy to clean and must be durable. (BI a. No. 2). There are no corresponding provisions for wall surfaces in greenhouses and animal rooms. Via Section 15 Paragraph 2 and Section 16 Paragraph 2 GenTSV, the requirements of Annex 2 for the laboratory area also apply to greenhouses and animal rooms, provided that work is carried out in these with genetically modified microorganisms. In contrast, for the Laboratory area safety level 2 : "Surfaces in the workrooms (e.g. work surfaces, walls, floors and furniture surfaces) must be easy to clean and resistant to the substances used as well as to cleaning and disinfection agents. The work surfaces, adjacent wall surfaces and the floor as well as the wall-floor connection must be liquid-tight." (A. II. a. No. 3). In Annex 2 (to Section 14) safety measures for the Production area security level 2 is it [called:
"Surfaces in the workrooms (e.g., work surfaces, walls, floors, and inventory surfaces) must be easy to clean and resistant to the substances used, as well as to cleaning and disinfecting agents. The work surfaces, adjacent wall surfaces, the floor, and the wall-floor connection must be liquid-tight." (B. II. a. No. 3). There are also no corresponding provisions regarding wall surfaces in greenhouses and animal rooms. Via Section 15, Paragraph 2 and Section 16, Paragraph 2 of the GenTSV, the requirements of Annex 2 for laboratory areas also apply to greenhouses and animal rooms, provided that work is carried out with genetically modified microorganisms. Thus, the following can be stated for the S 1 area: 1. The wording in S 1 area are the same for laboratories and production. 2. What? The requirements for cleaning and durability in the laboratory area only apply to furniture, whereas in the production area the entire inventory, not just the furniture, is subject to this requirement. The term "inventory" is broader and also includes smaller equipment. 3. How? The distinction between cleanability (should) and durability (must) is marginal, since the term "should" also describes a standard, from which, however, in contrast to "must" with regard to durability, deviations are still possible in individual cases with good reason. Since the amendment to the GenTSV in 2019, the obligation for durability applies not only to cleaning and disinfection agents but also to the substances used. Liquid-tight wall and wall-floor connections are not yet required.

For the S 2 area The following applies: 1. The wording in the S 2 area is the same for laboratories and production. 2. What? Regarding the extension of the requirements to furniture in the laboratory area and inventory in the production area, the provisions for the S 1 area apply. 3. How? A strict requirement applies overall to the cleanability and durability, as well as the liquid-tightness of wall surfaces and wall-floor connections. This applies—as in the S 1 area—to the materials used, including cleaning agents and disinfectants.

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