Safety Follow up. As mentioned in previous sections, safety rules apply to each sub-component; these rules may differ following the laboratory where the equipment is installed, adding complexity to the activity. In parallel with the design and manufacture, it is essential to look at the systems' safety and perform various risk analyses to grant the compliance of the systems with applicable rules. Identifying the owner of every component will be required to facilitate the discussion about compliance with Safety Rules. Safety regulations must be followed as the anti-cryostat changes the boundary of the existing cryostats. Required documentation and certification for pressure vessels may differ between the two laboratories (UPPSALA following European safety standards and CERN following internal safety rules that are inspired (but not identical) to E.U. regulations. The pressurized anti-cryostat will have to follow the safety rules for pressure vessels and be in electrical compliance. As this equipment is expected to be used at CERN (SM18), the equipment has to respect the CERN safety Rules (e.g., case GSI-M-4 and may require the application of the PED Directive 2014/68/E.U.). Similarly, the motorized shaft and the rotating coil should follow the machinery directive 2006/42/E.C.: it is required that both laboratories inquire about the applicable rules, as specified early in this document. The anti-cryostat lifting tool has to be C.E. certified as lifting equipment. Due to the complexity of the regulatory framework for this project, it is recommended to appoint reference persons for safety at CERN and at FREIA in order to facilitate exchanges about safety all along the project.
Safety Follow up. As mentioned in previous sections, safety rules apply to each sub-component; these rules may differ following the laboratory where the equipment is installed, adding complexity to the activity. In parallel with the design and manufacture, it is essential to look at the systems' safety and perform various risk analyses to grant the compliance of the systems with applicable rules. Identifying the owner of every component will be required to facilitate the discussion about compliance with Safety Rules. Safety regulations must be followed as the anti-cryostat changes the boundary of the existing cryostats. Required documentation and certification for pressure vessels may differ between the two laboratories (UPPSALA following European safety standards and CERN following internal safety rules that are inspired (but not identical) to E.U. regulations. The pressurized anti-cryostat will have to follow the safety rules for pressure vessels and be in electrical compliance. As this equipment is expected to be used at CERN (SM18), the equipment has to respect the CERN safety Rules (e.g., case GSI-M-4 and may require the application of the PED Directive 2014/68/E.U.). Similarly, the motorized shaft and the rotating coil should follow the machinery directive 2006/42/E.C.: it is required that both laboratories inquire about the applicable rules, as specified early in this document. The anti-cryostat lifting tool has to be C.E. certified as lifting equipment. Due to the complexity of the regulatory framework for this project, it is recommended to appoint reference persons for safety at CERN and at FREIA in order to facilitate exchanges about safety all along the project. All the documentation shall be stored in EDMS. The collaborators shall plan, establish, implement, and adhere to a documented quality assurance program that fulfills all the requirements described in this technical specification and shall be submitted in electronic format: Drawings in CATIA® or AUTOCAD® Text documents in Microsoft Word® and/or PDF format Cost breakdowns and equipment list in Microsoft Excel® format Schedule in Microsoft Project® format List of tests (TBD): Assurance of the correct functioning of all operation and safety aspects. Acceptance testing before shipment by checking the static and dynamic behavior with laser tracker systems. Leak test for the anti-cryostat Pressure test for the anti-cryostat Electrical test for the heater on the anti-cryostat Magnetic measurements
Safety Follow up. A safety follow-up visit will occur 30 days (+14 days) after last dose of study drug. In some cases, nonserious AE observations may continue beyond the safety visit. All ocular AEs will be followed until resolution, stabilization, or return to baseline. In these instances, additional information may be requested by ImmunoGen to adequately categorize the nature of the toxicity. All serious adverse events will be followed until they resolve, stabilize or return to baseline, regardless of time from last dose or last visit.
