Pharmaceutical Clean Room Design Guidelines

What exactly makes a cleanroom clean.

Pharmaceutical clean room design guidelines.

Federal standard 209e is still also used see table 1. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work. 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. For example government regulation usp 797 outlines specific requirements for pharmaceutical product manufacturing.

The purpose of this guideline is to provide design and construction suggestions for cleanrooms housing bio pharmaceutical processes. Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air. Clean room design encompasses much more than traditional temperature and humidity control. 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 rooms control living particles that would produce undesirable. Geps are also accepted engineering and design methods intended to design construct operate and maintain pharmaceutical biotechnology or other high tech cleanroom facilities. Chapter 32 of ashrae guide and data book on systems and application 1997 provides. 49 for class ii biological safety cabinet and for various cleanroom standards for the institute of environmental sciences and technology.

Kastango es demarco s. Basic clean room requirements designs for gmp clean rooms what is a clean room. On many industry standards writing committees including those for the nsf std. Setting up a cleanroom starts with the design phase.

Many labs manufacture and create products and pharmaceuticals that require specific environmental conditions during production. Clean room industry requirements are classified according to iso 14644 1 cleanroom standards which specifies basic requirements for cleanroom operations. Pharmacy cleanroom project management con siderations. Geps are a combination of standards specifications codes and regulatory and industrial guidelines.

Pharmaceutical cleanroom design basics. Bio pharmaceutical cleanroom design guidelines. As a laboratory construction firm we are experts in creating custom furniture and layouts for the pharmaceutical industry. During this phase you should consider how the cleanroom will be used permitted particle concentration its location the manufacturing process requirements and cost.

The international organization for standardization iso provides standards for cleanroom set up and operation. The following suggestions are intended to assume that the facilities when used properly will meet the airborne particulate classes for cleanrooms and clean.