Peter Wieczkowski

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Peter Wieczkowski
Associate, Pharmaceutical Services
Email Peter
P: 816-822-4260
F: 816-822-3416

Medical Device Production Facility

Location: Pennsylvania

Client: Confidential client

Completion Date: April 2009

Burns & McDonnell conducted an architectural program for a ready-to-fill syringes (RTFS) production facility with an output of 84 million units per year. A key requirement was to facilitate current Good Manufacturing Practice (cGMP) standards for medical devices as acceptable by U.S., European and Japanese pharmaceutical manufacturers and regulators. The facility will house primary production of syringes within classified modular clean rooms as well as associated support functions.

The architectural programming study evaluated the existing 48,000-square-foot building and its potential to accommodate all necessary functions. The study team concluded that the existing building is not sufficient to house all of the production lines envisioned and does not lend itself to the required segregation of products and proper cGMP flow of materials and personnel. An additional 40,000 square feet are required to achieve cGMP standards. In the study, Burns & McDonnell provided an example of how to organize this additional space to accomplish RTFS production in a cGMP manner.

  • Feasibility study
  • Architectural program
  • Cost estimate

The client manufactures syringes for the medical and pharmaceutical community and provides the final sterile assembly of the components in a facility regulated by the Food and Drug Administration. Its business has seen rapid growth in single-use syringes and, more recently, the pilot development of 1 milliliter (mL) RTFS units. It expects continued rapid growth into full production of the 1 mL RTFS with further expansion into 3 mL RTFS and 5 mL RTFS units.

The facility has grown into its existing space with little ability to control layout efficiency. Predicting rapid growth in its existing facility, the client must determine how to sustain current production, expand the company product line, maintain high quality cGMP processing and increase layout efficiency within budgetary constraints. A primary goal is to segregate material flow (individual product lines as well as component and finished assemblies) in order to meet cGMP requirements.   

Study deliverables included:

  • Material and personnel flow diagrams
  • Adjacency diagrams
  • Review of clean rooms
  • Space requirements programming
  • Schematic layouts (multiple options)
  • Conceptual cost estimates
  • Responded to the client’s desire to demonstrate manufacturing scale-up to that of a major international pharmaceutical company
  • Allowed for cGMP segregation of material, personnel and equipment flows
  • Integrated architectural, process utility and process needs