Section 1.  Overview

1.1    Purpose

Hibernicor intends to develop a master plan for a multi-story multipurpose building designed with the primary objective of medical device manufacturing in a urban area with access to an international airport and multiple commuting options.  The building shall have a total floor area not to exceed 100,000 square feet with an emphasis on providing employees with plenty of natural lighting in all possible areas.

Basic outline of possible floor configuration is as follows:

  • Roof Top: Terrace with Small Garden, Roof top bar, Generators, Water supply
  • Floor : Gym, Mens/Womens Locker Rms & Showers, Hotel rooms, Child care
  • Floor: Kitchen & Dining Room, Terrrace
  • Floor: Offices, Meeting Rms
  • Floor: Offices, Dry and Wet Lab, Operating Rm
  • Floor: Clean Room, IT
  • Floor: Quarantine, Storage, and Production Assembly Areas
  • Ground Floor: Lobby & Conference/Presentation Room, Security, Reception, Coffee Bar
  • Basement: Shipping Receiving, Storage & Parking, and Mechanical

1.2    Business Context

Hibernicor is medical device manufacturing company sponsoring the development of the Asporto device and software.  Hibernicor’s mission is to provide the standard of care for increasing the quality and quantity of donor hearts available for heart transplantation. Asporto software is an integral part of the business operation which will provide: 1) a safe and reliable means to controlling pump operation, organ perfusion, and monitoring during transportation of the donor heart; 2) controlling the usage of the individual heart containers (for sales purposes); and 3) providing clinical data for auditing each donor heart transport.

1.3    Scope

The purpose of creating the building master plan for a non-site-specific building project for capital fundraising. The master plan needs to be adaptable for site-specific requirement in a subsequent project phase.

The project consultant should provide planning services for all the functions for the building allowing for adequate area and layout requirements based upon user input. The layout requirements and technical data should be incorporated into the master plan.

1.4    Limitations

The following services are not requested:

  • Process development or process assessment for laboratory or production functions
  • Site specific planning (site preparation, local regulations, etc.)
  • Project control (estimates, activity breakdown, change control, progress monitoring, reporting, project documentation, or execution).
  • Contract formulation

Section 2.  Building Concept

This section describes the base requirements for the building including:

  • Project organizational chart describing authority and reporting structure
  • Building functionalities
  • Economic boundaries, overall budget estimation, budgeting milestones
  • Project timeframe as an execution plan including: an estimated overall project duration, phasing for different functions, expansion options.
  • Operational boundaries; maximum number of staff, material flow for specific process requirements
  • Establishment of an initial building design with functional areas and fixed points such as structural walls stairs, windows, and installed services.
  • Definition of based personnel and material flow through the building.
  • Contracting strategy based upon optimal resource allocation and risk mitigation.

The consultant should prepare deliverables of 3D CAD drawings, functional layouts, and building sections specifying the building concept.

2.1  Manufacturing Program

Hibernicor will provide the manufacturing program as well as the block flow diagrams including all manufacturing process steps within the clean room area, laboratory, electronic assembly, and the packaging areas.  The block diagrams will function as a basis for further details to be determined for dimensioning of manufacturing, storage, and logistical areas.

2.2    Manufacturing and Lab Equipment

Hibernicor will provide the consultant with a list of all manufacturing equipment.  From this list the consultant will determine the energy, space and media requirement.

2.3    Material Flow and Logistics

A logistics concept will be developed to integrate the following aspects:

  • Storage demands (temperature, quarantine, hazardous substances, etc.)
  • Material flow including staging and zoning concepts
  • Space needs for storage and staging
  • Waste logistics (solid, liquid, and gas)

The logistics concept should serve as the basis for the physical layout.

2.4    Personnel and Material Flow Clean Room Concepts

The consultant should develop and overall concept for personnel and material airlock process for a clean room including a pictographic drawings, and material airlock processes in a tabular format.

2.5    Layout

The total area demands for all functions will be determined and summarized in an area program to form the general building concept. These conceptual interior block architectural layouts (at 1:200 scale) should have a maximum of three different options.

The block layout should include the basic information:

  • Main equipment setup
  • Personnel flow (manufacturing, lab, and common areas)
  • Material and waste flow
  • Hygiene zones
  • Pressure zones

Laboratories should be classified by wet and dry and zoned for 100% outside air supply.

Wet labs require chemical resistant work surfaces and cabinets that are liquid tight to contain spillage. Chemical and glassware storage and fume hoods are significant factors in space planning and furniture selection.

Dry analytical labs typically require a lot of large shelving to support instrumentation. Height-adjustable work surfaces may be required to allow large counter-mounted equipment to be placed at a comfortable operating height or be completely removed to provide instant space for the addition of floor mounted equipment.

Laboratory should be zoned by a designated spaces:

Options for laboratory types should be considered for optimal workflow.

  1. A) A single corridor lab design with labs & offices adjacent to each other
  2. B) A single corridor with office clustered at the end or in the middle.
  3. C) A single corridor with office clusters directly accessing the main labs

2.6    Utilities

The utility concept, written description, and schematic sketches for the new building will be defined to include:

  • Heating, ventilation, cooling, and air conditioning (HVAC)
  • Clean air
  • Pressurized air
  • Technical gases
  • Drinking water, de-ionized water, and wasted water.
  • Electrical utilities, building automation, security, and communication
  • Clean media (WFI, clean steam, clean gases)

The consultant should prepare a media systems description to define the space requirements for the technical and mechanical areas to be integrated into the building layout.

2.7    Key Site Features

The building concept should also encompass multiple functions for a modern medical device manufacturing workplace including:

  • Receiving area
  • Secure quarantine room
  • Electrical component subassembly
  • Information Technology room
  • Device assembly and storage
  • Clean room
  • Packaging area
  • Wet bench lab and dry chemistry lab.
  • Offices and meeting rooms
  • Gym, Day Care, Kitchen and Dining Rooms
  • Lobby or reception area
  • Large multifunction conference room
  • Shipping area
  • Parking

2.7    Building Surface Visualization

The consultant should prepare a minimum of 5 different building concept sketches 3D hand drawings with elevations and sections.  One concept will be finalized as surface rendering in CAD.

2.8    Common Design Mistakes

Several mistakes that are common in laboratory planning occur from a lack of knowledge, insufficient planning or down grading in the wrong areas to reduce costs.  Design mistakes should be avoided by adhering to GMP design guidelines.

Common mistakes are:

  • No allowances made in the structure for adding new drains or fume hood exhausts in the future
  • Lab modules are too shallow; not enough space
  • No way to expand the facility in the future
  • Critical systems and equipment are not connected to a continual power source or an emergency power system
  • Inadequate distribution system for data cables; no cable trays
  • HVAC is not sufficient to maintain adequate temperature levels or supply makeup air for fume hoods
  • Electrical system lacks sufficient power, appropriate distribution or enough outlets
  • Too little space provided for using and servicing equipment
  • Location of fume hoods is too close to primary exits
  • Not all lab areas have adequate access to primary exits

Section 3.  Project Timeline and Methodology

The consultant will compile a conceptual project timeline for planning and realization of the major milestones based upon practical and theoretical experience.  Options based upon budget, schedule, cash flow, project complexity, risk mitigation, team composition, and project goals should be used to determine a rank order for possible project delivery methods.

  • Design-Bid-Build
  • Construction Management
  • Engineer-Procurement-Construct

3.1    Success Criteria and Metrics

The consultant should identify and define metrics to provide priority and goal setting for the project conceptual design based upon external benchmarks and sources of information.  Value engineering concepts should be utilized to design in optimal value for the initial and long term investment.

3.2    GMP Compliance

The building should be of suitable size, constructed, and located to facilitate cleaning, maintenance and operations. The building layout shall be designed to allow production and components to flow through the building to prevent contamination or mix-ups.

The consultant should define which standards comprise GMP compliance for this building plan.  The standards should be provided in tabular list form with title and publication date, they should be appropriately referenced in the plan.

3.3    Validation Planning

Because the processes described in the building master plan are used to create the actual layout of the facility, the design should be consistent with industry standards and regulations that can be validated following construction.  During designing, experts in different disciplines must coordinate efforts so that the individual design elements align to produce a facility the meets GMP.

3.4    Constructability

The design of the building should be constructible and should have be defined by its constructability; that is the ease and efficiency with which the structure should be built. The design documents should be easy to understand and interpret.  Experienced construction knowledge should go into the conceptual planning and design.  Ideally the building master plan would be independently reviewed by an executive with a minimum of 10 years of experience in pharmaceutical and/or hospital project management and construction.

3.5    Construction Logistics

The overall project development plan preliminary schedule should provide a time frame that has milestones that have a clear timeline and tasks which is understandable from an expert in construction; thus having steps which are logically oriented to prevent unnecessary significant delays or cost overruns in the execution of the project.

3.6    Cost Estimate

The cost estimate should be delivered with an accuracy of +/-30%.

Section 4.  Documentation

The project language will be in English. All documents will be prepared and delivered in English language without typos, grammatical, or spelling errors.  All decision making processes and planning results will be documented and structured in a traceable form with dates and a versioning scheme.

4.1    Documentation File Formats

All intermediate documentation will be an electronic format. Final documents will be provide in both soft and color printed hard copy with blue ink signatures.

Soft Copy:

Microsoft Office 2007, compatible with 2003.

Adobe Portable Document Format (unlocked, Version 1.5, Acrobat 6.x)

Computer Aided Design (CAD) vendor neutral vector format (.step)

4.2    Documentation Coordination

The consultant should provide a plan for optimal design coordination including recommendations for:

  • CAD platform and version
  • CAD standards, procedures, and conventions
  • Drawing numbering standards
  • Deliverables: 2D schematics, piping and instrumentation diagrams, isometrics, orthographs, etc.
  • Project closeout requirements – drawing turnover to construction.

4.3    Document List

The consultant should provide a final plan including the documents meet the sections outlined in this document.

Section 5. Project Organization

People complete projects.  The project organization structure and the selection of the right project team members and their activities are the two most important tasks for this building plan.  The formal leader for this project is Hibernicor’s President (Dr. Andrew Rivard).

It is important that all members of the project team understand the overall goals and objectives of the project, the roles and responsibilities of the team members, project milestones, and measurements for success, and approach for project execution.

The consultant should define a roles and responsibilities matrix using a spreadsheet to define the team members contributions.

5.1    Timeline

The final building master plan should be completed in 10-12 weeks.  A kick-off meeting may be used as well as workshops as needed.

5.2    Travel Expenses

The proposal should not include any travel expenses for the consultant team.

5.3    Acceptance of Services

The individual plan should be divided into parts which have clear deliverables and time frame for payment.

Additional work beyond the scope of this request for proposal needs to be agreed upon with a signed written agreement prior to commencement of such activities.  Work completed beyond the scope of the proposal without prior approval will not be reimbursed.