Good Manufacturing Practices: Complexities in Clean Room Standards

The United States and European Union both attempt to control the safe testing and manufacture of medical devices and pharmaceutical products through Good Manufacturing Practices or GMPs. In general, these practices adhere to two primary ideas:

  • Manufacturing processes should be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications that the manufacturer has developed for the product.
  • Manufacturing processes are controlled, and any changes to the process are evaluated before they are changed. Changes that have an impact on the quality of the product (the drug, or medical device) are carefully evaluated.

However, these GMPs are not nearly as helpful or as straightforward as they seem.

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The Importance of Developing A Building Program

The core design work for most of SPEC projects involves manufacturing process engineering. The first and most important step is establishing the client’s manufacturing scope.  The space that houses the manufacturing process is only one of the many spaces required in any manufacturing facility.  Space must be planned for utility rooms, laboratories, warehousing, shipping, offices, meeting spaces and corridors.  This planning begins with the building program. 

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How SPEC develops Design/Build Projects (Part 3 of 3)

Detailed Design and Construction

Detailed design is simply be an extension of the design work done in the Design/Build Package.  Both architectural and engineering drawings will be completed to level of detail required for construction.   Detailed specifications will be written to supplement the drawings.  Our licensed engineers will stamp the required engineering and architectural drawings for permit submission.

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How SPEC develops Design/Build Projects (Part 2 of 3)

Design/Build Package

After SPEC has completed the Scope Study, and the client has reviewed and approved the package, work can proceed immediately on the Design/Build Package.

This involves the development of a comprehensive design package covering all aspects of the project.   This design package provides enough definition to accurately budget the full project and is bid to subcontractors and vendors.  SPEC then compiles the bids to develop a contract price for the entire project.  The end result is a comprehensive set of design documents covering the process and facility components of the project.    

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How SPEC develops Design/Build Projects (Part 1 of 3)

Part I
SPEC’s approach to Design/Build projects is unique, even within the design/build community.  Since we are frequently asked to clarify what our approach encompasses, we thought the topic was worth further explanation here.

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Storing & Handling Flammable and Combustible Substances

SPEC frequently works with clients that store some amount of flammable and/or combustible substances.  Obvious substances like gasoline and diesel fuel are flammable and combustible but even common products, such as polishes, waxes, adhesives, paints, cleaners, solvents, and thinners can pose a threat.  Ensuring that such products are properly stored, especially in an industrial workplace, can protect against serious fire or injury.  The NFPA and state and local building codes provide regulations and standards to employers for the handling and storage of flammable and combustible liquids.

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