COMMISSIONING AND VALIDATION

BPS provides expertise in the start-up, commissioning and validation of biologics production facilities only. Our projects have ranged from single skids to support of major facilities. BPS staff has the right mix of engineering, operations, technology and regulatory experience to identify and implement the best solutions. We take responsibility and ensure that testing is thorough, appropriately documented and completed on time.

Life Cycle Approach

We employ the common “life-cycle” approach to commissioning, qualification, and validation. This approach defines the requirements for design, procurement, pre-delivery inspections, factory acceptance testing, installation, commissioning, and validation during the earliest project phases to allow for an integrated approach to qualification. We will work with other design, construction, and commissioning teams to ensure that testing activities, such as pre-delivery inspection, factory acceptance testing, site acceptance testing, commissioning, and qualification, are appropriately planned, documented, and completed in sufficient detail and depth to support later life-cycle requirements. The results from each project phase will then support the next phase in the life cycle.

Commissioning

BPS staff has the expertise and the knowledge to ensure your commissioning project starts off and proceeds smoothly to completion using the following basic methods:

• Develop and implement the commissioning plan.
• Plan and coordinate the QA activities of equipment vendors, construction contractors and the client.
• Develop commissioning inspection and test procedures, forms, and protocols per client and project specifications and guidelines.
• Optimally integrate commissioning with the overall project schedule
• Document the inspections, start-up, and initial testing of equipment to streamline the follow-on qualification activities.

Major Commissioning and Validation Services

We provide the following services tailored the project needs:

Commissioning/Start-Up

• Commissioning/Start-Up Plan
• Commissioning Management
• FAT Protocols and Execution
• Equipment Installation Inspections
• SOPs
• Parts Washer Cycle Development
• CIP Cycle Development
• User Requirements Specifications
• SIP Cycle Development
• Punch-list and Maintenance
• Turnover Packages

Validation

• Validation Master Plan
• Quality Assurance Plan
• Protocol Development (IQ/OQ/PQ)
• Design Qualification (DQ)
• Protocol Execution and Final Reports
• Continuing Validation Studies (CIP/SIP

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