Pharmaceutical Clean Room Design Guidelines

Guidelines in terms of non viable particulate levels.

Pharmaceutical clean room design guidelines.

Pharmaceutical cleanroom design basics. 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. 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.

Basic clean room requirements designs for gmp clean rooms what is a clean room. The international organization for standardization iso provides standards for cleanroom set up and operation. Kastango es demarco s. On many industry standards writing committees including those for the nsf std.

Setting up a cleanroom starts with the design phase. What exactly makes a cleanroom clean. For example government regulation usp 797 outlines specific requirements for pharmaceutical product manufacturing. Bio pharmaceutical cleanroom design guidelines.

Clean room design encompasses much more than traditional temperature and humidity control. Federal standard 209e is still also used see table 1. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work. The cleanroom has been defined by the international organisation for standardisation iso new standard 14644 1 as.

The following suggestions are intended to assume that the facilities when used properly will meet the airborne particulate classes for cleanrooms and clean. The purpose of this guideline is to provide design and construction suggestions for cleanrooms housing bio pharmaceutical processes. 49 for class ii biological safety cabinet and for various cleanroom standards for the institute of environmental sciences and technology. As a laboratory construction firm we are experts in creating custom furniture and layouts for the pharmaceutical industry.

Geps are also accepted engineering and design methods intended to design construct operate and maintain pharmaceutical biotechnology or other high tech cleanroom facilities. Pharmacy cleanroom project management con siderations. Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air. Clean rooms control living particles that would produce undesirable.

Many labs manufacture and create products and pharmaceuticals that require specific environmental conditions during production. The international organization for standardization or iso has developed a series of cleanroom classifications in which most pharmaceutical cleanroom.