Together with you, the consulting company should prepare a clearly defined Business Case including project cost estimates substantiated with “Net Present Value” analysis and Capital Expenditure Proposals detailing high level information such as expenditure schedules.

The company must also have the capability to draft and implement Project Execution Plans detailing strategic information such as key stakeholder roles and responsibilities, budget reporting systems, key milestone achievements and exit strategies.

A company embarking on this type of project should also reference the real-life experience credentials of the of the design team as this is a vital element in successful conceptual design.

Business Biotics Group success is founded on using a blend of experienced manufacturing specialists and process engineers together with the use of appropriate tried-and-proven design and review methods.

Our Conceptual Design is based on the following criteria:

• GMP Personnel flow
• GMP Product flow
• Product throughput capacity
• Validation requirements
• Product storage and quarantine areas
• Room design and capacity suitability
• Equipment design and capacity suitability
• Room classification suitability
• Facility air pressure differential regimes
• Personnel and equipment air lock functionality
• Waste flow and management
• Future production capacity requirements
• Automation control systems

The design methodology is based on a combination of the ISPE based “Direct Impact” system which is enhanced with the inclusion of a second independent risk analysis assessment. This combination guarantees that the balance between regulatory and technical requirements is fully considered.

Our design process has a number of checks and balances to ensure that the client’s comments and concerns are documented and formally considered throughout the design process.

Design conflicts are managed using a scientifically based risk analysis method. The credibility of a proposed change will be determined by the outcome of the risk analysis.

Our approach encourages active participation by the client at all stages of the design process. Business Biotics Group design process is an open and transparent process with a number of inbuilt key “Go/No Go” decision points for safeguarding the client’s investment. This ensures the client’s strategic managerial control and ownership of the project. We believe that the client’s ownership is a fundamental hallmark for success.

With more than 40 years of manufacturing and cleanroom operational experience we can offer superior strategic guidance and design capabilities that meet the most demanding challenges.

No matter whether the application is pilot scale for the production of Phase I/II clinical trial product or large scale pharmaceutical manufacturing, we offer the critical strategic planning advice and design capabilities to deliver a facility design that will function with maximum technical efficiency and regulatory compliance.