| Conceptual Design |
Conceptual design and scope definition are among the most challenging aspects of cGMP facility design. An essential prerequisite for any successful facility is concept development to provide the basis for project cost and time schedule.
BiOZEEN starts with clients process and do backward engineering to design the URS (User Requirement Specification) of project. BiOZEEN also assist clients in designing a rational business model. BiOZEEN provides the entire gamut of bioprocess engineering and consulting services that will ensure that your project starts off on the right track.
- Master planning
- Scope definition
- Facility layout (cGMP Manufacturing & Lab Space Planning)
- Feasibility studies
- Site selection
- Basis of design
- Process description
- Process flow diagrams
- Project quality planning
- Equipment layout
- Clean room classification
- AHU and pressure zoning
- Men and material flow
- Human resource planning
- Project budgeting & scheduling
- Project execution planning
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| Process Engineering |
BiOZEEN's consultancy services are process driven. Our team understands clients process and do backward integration to optimise facility and equipment design. The portfolio includes :
- Plant P & ID
- Core plant URS
- Automation proposals
- Cost estimates
- Project quality plan
- Utility design verification
- Identification of critical / non-critical equipment
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| Basic & Detailed Engineering |
BiOZEEN provides design solutions that assure the process integrity, operational efficiency & regulatory compliance to clients facility. BiOZEEN assists in basic and detailed engineering of equipment and facility. Typically, our services are :
- Architectural drawings
- Structural drawings
- Equipment layout
- Lighting & HVAC details
- Room data sheet
- Utility matrix
- Equipment sizing & specifications
- Time Schedule etc.
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| Procurement Assistance |
Project success is linked to good vendor management. At BiOZEEN, we offer project services that support a win-win relationship with your suppliers. BiOZEEN assist in selection of right vendor for your project & quality deliverables within defined time schedule.
Procurement assistance portfolio includes:
- Vendor evaluation
- Development of user requirement specifications
- Process system specifications
- Functional requirement specifications
- Equipment data sheet
- Tender preparation & analysis
- Procurement assistance
- Evaluation of vendor quality plan
- Master time scheduling
- Stage wise inspection
- FAT assistance
- SAT assistance
- Document verification etc.
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| Facility & Equipment Validation |
Validation Master Plan (VMP) will be prepared for the qualification & validation of equipment including facility based on the concept. VMP follows at each & every stage of project execution, implementation and commissioning. Broadly the services relate to:
- Validation master plan
- Risk analysis
- Qualification (DQ / IQ / OQ)
- Preparation of SOP's
- Cleaning & validation
- Software validation
- Maintenance & calibration schedules
- Overall documentation
- Commissioning supervision
- Continuous support - post commissioning etc.
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| Project Delivery |
We partner you in many ways
Project model is tailored to meet your project needs at any stage. The clients have the flexibility to choose our expertise depending on their project life cycle.
Project execution types
Bioprocess & Biopharmaceutical Engineering
Core capability in Biologics / Biopharmaceutical processing, FDA regulatory compliance and cGMP equipment design makes us the first choice to execute the process and equipment engineering for your projects.
cGMP Facility Design
From concept to commissioning, we are well-resourced to provide design solutions that assure the process integrity, operational efficiency and regulatory compliance of your facility.
Process Equipment Delivery
We can provide equipment design, build & support, which involves process design, automation architecture, system specification, equipment procurement, inspection, expediting, commissioning and qualification. If you have an equipment rehabilitation, retrofit or new equipment requirement, involve us.
Owner’s Representative
Project lifecycle methodology is a perfect fit for projects that involve key manufacturing operations, integrated equipment systems and automated process technology. We offer a unique combination of expertise in cGMP design qualification and process equipment sourcing. With BiOZEEN you can be rest assured that your interests are accurately represented to your suppliers.
Small Project Solutions
BiOZEEN has a network of partners that supply mechanical design, architectural and construction management to the biologics & biopharmaceutical industries. Our combined capabilities allow us to offer turnkey design build project services with the right combination of aggressive project management, experienced design professionals and proven performance. |
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