WORK PACKAGE 2 – ON-BOARDING. MANUFACTURING SPACE QUALIFICATION Catapult will perform an Operation Qualification (OQ) of the Manufacturing Space (as-built) prior to the Actual Occupation Date. Catapult will define the minimum requirements for the at-rest OQ (Operation Qualification) and room PQ (Performance Qualification). Catapult will provide a template for the ‘at rest’ room OQ and room PQ protocols and reports for use by COLLABORATOR. Should COLLABORATOR elect not to use the Catapult templates, any templates proposed by COLLABORATOR must be approved in advance by Catapult. Catapult will perform all analysis of the environmental monitoring outputs produced by COLLABORATOR according to the agreed study design, including specification if required. Catapult will provide a final report of the environmental monitoring analysis. The executed ‘et rest’ room OQ and room PQ reports will be approved by both COLLABORATOR and Catapult. Catapult will provide all environmental monitoring consumables and 3 mobile volumetric air samplers and non-viable particle counters for use by COLLABORATOR for the initial manufacturing space qualification. Catapult will train COLLABORATOR in the relevant environmental monitoring sampling methods. COLLABORATOR is responsible for the execution of the ‘at rest’ OQ and PQ of its Module, in accordance with Catapult’s defined minimum requirements. This protocol will include environmental sampling within the Module and also a subcontracted Cleanroom Performance Study incorporating air pattern assessment employing smoke visualisation techniques, room clean-up rate assessment and non-viable particle analysis. COLLABORATOR will perform the ‘at rest’ OQ and room PQ, the environmental monitoring sampling outputs being transferred to the Catapult for analysis. Cleanroom Performance testing will be performed by Clean Air Technology (CAT). Contributions (as set out in paragraph 6 below) are based on a standard study design, with a single performance of the OQ and PQ (incorporating a minimum of three separate sampling events). Study designs involving additional analysis or repetitions will incur additional Contributions to those set out in paragraph 6 below. Contributions Include no operator monitoring.
