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Design characteristics of clinical supply laboratories relating to HVAC systems.

Author(s) : BOSSERT K. A., MCGINLEY S. M.

Summary

The manufacture of clinical supplies in compliance with current good manufacturing practice regulations represents a unique challenge to the pharmaceutical industry in combining the technical and regulatory requirements of a production facility with the novel scientific challenges of a research and development environment. Drug products for investigational use can be manufactured in many different environments, from the laboratory setting to commercial manufacturing facilities. The paper describes general characteristics of a clinical supply laboratory while discussing specific criteria for HVAC systems in key manufacturing areas within the facility.

Details

  • Original title: Design characteristics of clinical supply laboratories relating to HVAC systems.
  • Record ID : 1995-2491
  • Languages: English
  • Source: ASHRAE Transactions 1994.
  • Publication date: 1994
  • Document available for consultation in the library of the IIR headquarters only.

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