Pharmaceutical Clean Room Design Guidelines

Pharmaceutical cleanroom design basics.

Pharmaceutical clean room design guidelines. What exactly makes a cleanroom clean. Pharmacy cleanroom project management con siderations. Clean room design encompasses much more than traditional temperature and humidity control. The international organization for standardization or iso has developed a series of cleanroom classifications in which most pharmaceutical cleanroom.

Setting up a cleanroom starts with the design phase. 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. As a laboratory construction firm we are experts in creating custom furniture and layouts for the pharmaceutical industry. On many industry standards writing committees including those for the nsf std.

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. Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air. The following suggestions are intended to assume that the facilities when used properly will meet the airborne particulate classes for cleanrooms and clean.

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. Guidelines in terms of non viable particulate levels. Clean rooms control living particles that would produce undesirable. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work.

Chapter 32 of ashrae guide and data book on systems and application 1997 provides. The purpose of this guideline is to provide design and construction suggestions for cleanrooms housing bio pharmaceutical processes. Geps are a combination of standards specifications codes and regulatory and industrial guidelines. Kastango es demarco s.

Basic clean room requirements designs for gmp clean rooms what is a clean room. The cleanroom has been defined by the international organisation for standardisation iso new standard 14644 1 as. 49 for class ii biological safety cabinet and for various cleanroom standards for the institute of environmental sciences and technology. Many labs manufacture and create products and pharmaceuticals that require specific environmental conditions during production.

Geps are also accepted engineering and design methods intended to design construct operate and maintain pharmaceutical biotechnology or other high tech cleanroom facilities. Federal standard 209e is still also used see table 1.