BS ISO 21709:2020 Biotechnology一Biobanking 一Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

BS ISO 21709:2020 Biotechnology一Biobanking 一Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines. 4.3 Facilities 4.3.1 General ISO 20387:2018. 6.3 shall be followed. The processing facility shall be constructed and operated to minimize the introduction, generation, and retention of particles and microorganisms. The biobank shall define a protocol to test the quality of the biobanking environment(s). Where appropriate, test methods proposed in the ISO 14644 series can he considered. 4.3.2 Cell culture facility The biobank culturing and preserving cell lines shall establish a cell culture facility. The biobank shall assess the biological safety level of the cell lines that will be handled. The biobank shall assess the risk of asphyxiation based on the number and condition of liquid nitrogen tanks and storage methods and install an oxygen monitor accordingly. The biobank shall meet biological safety and security requirements for its facilities to minimize the risk to personnel and surroundings from handling the cell lines. The biobank shall take necessary measures to control airflow. The biobank should make efforts to secure a separate space for storage of duplicated cell lines in order to prevent the loss of collections in emergency situations. If the biobank cannot secure a separate alternate space for storage, the biobank should duplicate cell lines and store them in separate liquid nitrogen tanks. If the biobank cannot duplicate all stored cell lines, the biobank should make duplicates of the relevant cell lines or those that can be required by contractual agreements. The biobank shall designate a separate area for handling deposited cell lines and/or tissues until they are determined to be free of microbial contamination. 4.4 Equipment 4.4.1 General ISO 20387:20 18. 6.5 shall be followed. Equipment used in biobanking should be selected under quality specific criteria defined by the biobank, and for managing risks that can affect or impact performed assays, tests or their validity. All incubators used, for working in accordance with this document, shall be monitored. The biobank shall be furnished with or have controlled access to the following equipment as minimum requirements for cell culturing and ensure quality and safety requirements regarding the equipment. a) Biological safety cabinet (Class II, Class Ill): physical structure protecting cell cultures from contaminants and personnel from potentially harmful biological substances. The cabinet can require appropriate biosafety measures, depending upon the biosafety level of the biological materials being handled. b) Cell counting equipment: an automated...