CEN/TC 233/WG 2 - Large-scale process and production

This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.

This European Standard gives guidance on the assessment and the selection of procedures for treatment of waste process microorganisms from biotechnological plant to ensure the safety of people and environment. This European Standard applies to wastes and effluents (solid, liquid and gaseous) emitted from biotechnological processes which include traditional processes such as brewing or food processing, fermentation of pharmaceutical and chemical products as well as biotechnological processes for environmental and agricultural application.

This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes. In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of microorganisms in plant building of containment levels 1, 2, 3 and 4. This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals.

This European Standard describes the principles for the assessment and selection of fermentation and downstream operations so that they are carried out in a manner which ensures the safety of personnel and the environment and quality and safety of the product. It is intended for use by those designing and/or operating processes, by regulatory bodies and auditors, and by other interested parties. Unit operations are not described in detail and individual production processes can require specific equipment or unit operations which are not described here.

This European standard gives guidance on control procedures for raw materials u used in the biotechnological processes. This European standard does not list individual materials, but provides criteria against which raw materials used in industrial biotechnology processes can be checked. This European standard is applicable to all materials used during production of products by means of a biotechnological process. It is not applicable to equipment.

This European Standard specifies general requirements for management and organization of procedures for conservation of microorganisms used for large-scale process and production. It is intended to secure safe handling and also to ensure that reproducible results are obtained in biotechnology processes.

This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms and the product itself if it presents a biohazard. Note 1: When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.