Facility of the Year Awards, An ISPE Program

Pfizer Inc. is the 2016 ISPE Facility of the Year Winner for Equipment Innovation for their Portable, Continuous, Modular, and Miniature (PCMM) Collaboration project located in Groton, Connecticut.

Pfizer is an industry leader in applying science and global resources to bring therapies that extend and significantly improve lives.  To create the next generation of Oral Solid Dosage (OSD) processing technologies and address the rapidly changing requirements of pharmaceutical drug manufacturers, Pfizer, GEA, and GCON Manufacturing formed a consortium to design and build a portable, autonomous manufacturing environment for continuous oral solid dosage production using GEA’s ConsiGma™25 system and G-CON’s modular POD system.

The result — Portable, Continuous, Miniature, and Modular (PCMM) Development and Manufacturing for Solid Oral Dosage forms— is a platform technology utilized in product development and commercial manufacturing.  A key advantage to this innovative technology is being able to use the same equipment throughout the entire product lifecycle.

This continuous processing equipment was designed and fabricated at GEA’s facility in Wommelgem, Belgium and incorporates both Wet Granulation and Direct Compression process capabilities. Both systems convert powder to tablets within minutes using the standardized platform technology.  G-CON designed and fabricated the POD® system at its manufacturing facility in College Station, Texas, USA. Each system was fully assembled and functionally tested prior to shipment to the final assembly site at Pfizer’s Worldwide Research and Development campus in Groton, Connecticut, USA.

The PCMM project and installation represents collaboration between three companies (Pfizer, GEA, and GCON Manufacturing) that:

  • Conceptualized, designed, fabricated, installed, and commercialized a novel facility to continuously manufacture pharmaceutical solid oral dosage forms using a POD-based installation that is portable, miniature, and modular
  • Utilized investments of company resources, talents, and capital from all three entities to create a unique OSD platform technology
  • Created a new paradigm to develop and commercially manufacture solid oral dosage forms that does not use traditional batch pharmaceutical processing
  • Developed and integrated novel in-line vertical continuous powder mixing technology, customized PAT interfaces, and advanced process control systems into this facility
  • Lastly, with the help and support of many diverse scientist and engineers, Pfizer has a working oral solid dosage cGMP continuous tableting operation that produces at rates of 5 to 30 kg per hour inside a former warehouse space

Pfizer Facility POD - 2016 Facility of the Year Award Winner   Pfizer Facility POD - 2016 Facility of the Year Award Winner   Pfizer Facility POD - 2016 Facility of the Year Award Winner   Pfizer Equipment - 2016 Facility of the Year Award Winner   Pfizer Facility Layout Diagram - 2016 Facility of the Year Award Winner

 

The Pfizer Collaboration anticipates the opportunity for significant expansion of the platform in the future, and foresees PCMM becoming the industry platform for OSD manufacturing. The miniaturization of the equipment allows the equipment to fit inside a cGMP enclosure, a POD®, and that POD® can then be placed inside a cost efficient structure. The modular and portability components allow for unit operations to be “plugged-in” when needed. Modularity and portability will also minimize construction issues. Finally, risks associated with stranded assets/facilities are mitigated due to the modularity and portability of these designs.  PCMM truly represents a breakthrough platform for equipment innovation and facilities of the future.

ISPE congratulates the Pfizer team for their achievements and win for Equipment Innovation. Learn more about Portable, Continuous, Modular and Miniature (PCMM) Collaboration project.

Join ISPE and prominent industry leaders as we recognize the 2016 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the FOYA Banquet on the evening of Tuesday, 7 June 2016 in North Bethesda, MD during the ISPE/FDA/PQRI Quality Manufacturing Conference.

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