Pharmaceutical Clean Room Design Guidelines

Geps are also accepted engineering and design methods intended to design construct operate and maintain pharmaceutical biotechnology or other high tech cleanroom facilities.

Pharmaceutical clean room design guidelines.

During this phase you should consider how the cleanroom will be used permitted particle concentration its location the manufacturing process requirements and cost. Chapter 32 of ashrae guide and data book on systems and application 1997 provides. As a laboratory construction firm we are experts in creating custom furniture and layouts for the pharmaceutical industry. The international organization for standardization iso provides standards for cleanroom set up and operation.

Setting up a cleanroom starts with the design phase. Pharmacy cleanroom project management con siderations. Clean rooms control living particles that would produce undesirable. Federal standard 209e is still also used see table 1.

The following suggestions are intended to assume that the facilities when used properly will meet the airborne particulate classes for cleanrooms and clean. The international organization for standardization or iso has developed a series of cleanroom classifications in which most pharmaceutical cleanroom. Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air. A clean room gmp cleanroom in my mind are a combination of engineering design fabrication finish and operational controls control strategy that are required to convert a normal room to a clean room.

Pharmaceutical cleanroom design basics. Bio pharmaceutical cleanroom design guidelines. For example government regulation usp 797 outlines specific requirements for pharmaceutical product manufacturing. Cleanroom for an existing or new pharmaceutical process operation or product this article is intended to give an insight and understanding of the complex process of cleanroom design.

Clean room design encompasses much more than traditional temperature and humidity control. 49 for class ii biological safety cabinet and for various cleanroom standards for the institute of environmental sciences and technology. The cleanroom has been defined by the international organisation for standardisation iso new standard 14644 1 as. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work.

On many industry standards writing committees including those for the nsf std. Basic clean room requirements designs for gmp clean rooms what is a clean room. The purpose of this guideline is to provide design and construction suggestions for cleanrooms housing bio pharmaceutical processes. Guidelines in terms of non viable particulate levels.

Clean room industry requirements are classified according to iso 14644 1 cleanroom standards which specifies basic requirements for cleanroom operations. Geps are a combination of standards specifications codes and regulatory and industrial guidelines.