2-modular_constThe father of shipping containers, Malcolm McLean, not only launched the process of importing and exporting into a new age, he inspired a new direction in pharmaceutical manufacturing. The abundance in global supply and manufacturing opportunities are proving today’s pharmaceutical stakeholders need a competitive advantage.  Growing out of its novelty status, modular construction (prefabricated and remotely constructed facilities) has become a solid solution to present day manufacturing challenges.  Industry developments have proven the days of slow start-ups and deep capital commitment have transformed to severed timelines and languished financial wagers.

Competition is vigorous and the trends of modular and disposable manufacturing are fulfilling stakeholder needs for timely and quality production without endangering a company’s capital or reputation.  The modular “competitive edge” solution fits in a shipping container, is standardized for rapid validation, provides simulations for efficient staff start-up, and reduces financial and time risks of traditional stainless steel facilities.  Equipment vendors are working parallel to align new technologies and facility engineers meet challenges with innovative methods which provide flexibility and agility in a company’s present and future needs.  The pharmaceutical industry as a whole is embracing the paradigm shift and working together to be a part of a new industry standard in manufacturing.

Success in modular facility construction is dependent on modularization and pre-fabrication.  Modularization is based on an off-site modular build concept consistent in quality and manufacturing dependability without the vulnerability of unforeseen on-site variables.  Each building requirement is fundamentally analyzed for necessary components and converted into a building block design.  Each building block is established into a sub-unit for pre-manufacture and incorporated into the overall facility. Pre-fabrication takes place under a controlled atmosphere removing weather hazards and third party uncertainties which guarantee timeline adherences and successful validation predictability.

Why modular construction:

  • Low risk for emerging markets
  • Tight quality control
  • Prospect of replication
  • Remote assembly opening timelines for parallel construction off- and on-site
  • Tangible construction methodology during planning phase
  • Standardized for consistent training between sites
  • Flexible scaling

ISPE has acknowledged the trend in modular construction since 2007 with honors for manufacturing innovation as part of the Facility of the Year Awards. Here’s what the judges had to say over the years:

2007 – Facility Integration

Cook Pharmica, LLC: Project Phoenix

“Modular cleanroom construction helped moved the project forward with speed, even during inclement weather conditions and significantly reduced waste and construction materials.”

 2011 – Facility Integration

Merck & Co., Inc.: Global Clinical Supplies Manufacturing, Packaging, and Warehouse Expansion

“By pre-casting the piers, a smaller, 300 ton crane was able to move throughout the modular building footprint enabling the pre-cast piers to be moved into place and bolted down as needed.  Installation of the building modules continued uninterrupted and in a very cost-effective approach.”

2010 – Project Execution

Genetech: ECP-1 Bacterial Manufacturing Facility

“Nearly all acceptance testing and qualification work was executed before module shipment to the Singapore site, thus reducing the time to start up once the modules were installed at the ECP-1 site”

2012 – Facility Integration

Merck & Co., Inc.: Vaccine Bulk Manufacturing Facility (VBF) Program of Projects

“By moving 270,000 craft work hours off-site and decoupling significant critical path activities, the modular construction strategy proved to be a paradigm shift; the project could not have been completed with traditional methods in the established timeframe and budget.”

Go here for illustrated examples of prefabricated modules such as process and facility modules, clean room panels and pipe racks streamlined for on-site installation as a nearly completed facility.