Commissioning and Decommissioning
We provide a full range of start-up, commissioning and decommissioning services (in addition to qualification, validation services, maintenance programs, training, operational procedures, and other regulatory compliance services focusing on facilities, processes, and manufacturing in the Pharmaceutical, Biotechnology, and Medical Device industries.
- Overall Project review and setting of milestones for Completions, Pre-Commissioning, commissioning, and Start-up
- Commissioning, qualification and validation of processes, facilities and utility systems to ensure compliance and approval to meet design specification.
- Planning, coordination and liaison for project between the owner, design, commissioning, start-up, validation, and the various owner groups (e.g. manufacturing engineering, maintenance, and quality).
- Development and Execution of Commissioning Documentation
- Full decommissioning documentation service
- Coordination and Management of Vendors
- FEMA, Hazard and Risk assessments
- Control Plans for Completions, Pre-Commissioning and Commissioning
- Budget Cost Estimates for commissioning / decommissioning activities
- From a single item of equipment to complete facilities
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Why choose Blue Hatch for Commissioning and Decommissioning?
- We are familiar with regulatory requirements (e.g. FDA, EMEA, WHO, etc.), ISPE commissioning and qualification guidelines, ASTM E2500 Verification, EPCV, the “V-model”, and traditional validation approaches
- We have over 40 years’ of technical and managerial experience specific to commissioning, validation & decommissioning.
- Can provide a full turnkey service from URS creation, through specification, FAT, commissioning and qualification.
- Full lifecycle management including maintenance schedules, end of life validation and decommissioning
- Our validation, engineering and technical experts work together to provide you with a holistic service.
- We can work within your own engineering and validation teams, or can provide a stand-alone project team.
- Can act as Subject Matter Experts for you for audits and regulatory inspections.