Sense Biodetection Ltd (SBL)

Brief:

Sense Biodetection Ltd (SBL) were planning to develop commercial gene diagnostic products in a new testing and R&D facility. The design was to comply with current Good Manufacturing Practice (cGMP), with approvals by MHRA and UKAS accreditation to ISO15189 & ISO22870.

The proposal will cover the scope detailed below given to GMPG by SBL, as well the process flow diagram, facility URS and concept design.

What we did: 

The initial work carried out by GMPG was to assist the client in the selection of the building within which the new process and support areas would be located.  

From the initial discussions between SBL, we developed process flow diagrams and the facilities User Requirement Specification, which led to the production of a Front-End Engineering Design (FEED). 

The FEED was developed to enable the detailed design and construction of the facility, utilities, equipment installation, commissioning, qualification, validation, and start-up of the new testing and R&D facility.

 A typical FEED package would include: 

• Facility & Process Layout
• Equipment layout drawings
• Room relationship drawings based on the process
• Facilities layout drawings showing locations of equipment and plan
• Flow diagrams demonstrating
  • Efficient and safe operation of equipment and processes.
  • cGMP compliance for

• Personnel
• Raw Materials
• Work in Progress
• Packaging Components
• Finished Products
• Equipment
• Samples
• Waste
• HVAC, Environmental Control Systems
• Environmental classification zones will be defined
• HVAC design strategy and spatial requirements
• Mechanical & Plumbing (M & P) infrastructure compatibility and extension
• Input to the User Requirements Specification (URS) with regards HVAC, M&P services
• Outline specifications which should have sufficient information to allow cost planning by detailed engineering contractor
• Working with Project Team to achieve fully coordinated design.
• Siting of equipment to ensure finalised positions are agreed (such as vessels, freezers etc)
• Desk Top Survey of proposed building, plant, and external utilities to determine how they may be incorporated into the new proposals

Process & Black Utilities Systems 

• Total utilities load for the process and the facilities
• Generation of steam / LPHW
• Chilled water
• Process utilities: clean steam, Purified water, Compressed air, Compressed gases
• Domestic utilities
• Site electrical supply / switch room / transformer
• Stand-by electrical generation
• Liquid biowaste strategy
• Process / domestic drainage

Cost & Planning

• Report with order of magnitude cost and implementation schedule
• Design Team meetings

From the FEED, GMPG were able to produce a Validation Master Plan which was fully resourced to ensure budgeting was defined going forward.

Results:

GMPG and SBL were able to source a building within the area required and the lease was signed. 

GMPG produced the FEED document which has since been developed by the clients D&B contractor and the facility is in full production and fully accredited.