Pharmaceutical Clean Room Design Guidelines

Pharmaceutical cleanroom design basics.

Pharmaceutical clean room design guidelines.

Pharmacy cleanroom project management con siderations. Chapter 32 of ashrae guide and data book on systems and application 1997 provides. Guidelines in terms of non viable particulate levels. 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. On many industry standards writing committees including those for the nsf std. Many labs manufacture and create products and pharmaceuticals that require specific environmental conditions during production. Clean rooms control living particles that would produce undesirable.

During this phase you should consider how the cleanroom will be used permitted particle concentration its location the manufacturing process requirements and cost. Cleanroom design goes beyond simply creating a controlled environment for conducting lab work. Geps are also accepted engineering and design methods intended to design construct operate and maintain pharmaceutical biotechnology or other high tech cleanroom facilities. The cleanroom has been defined by the international organisation for standardisation iso new standard 14644 1 as.

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. Federal standard 209e is still also used see table 1. The purpose of this guideline is to provide design and construction suggestions for cleanrooms housing bio pharmaceutical processes.

Bio pharmaceutical cleanroom design guidelines. Clean room industry requirements are classified according to iso 14644 1 cleanroom standards which specifies basic requirements for cleanroom operations. The international organization for standardization iso provides standards for cleanroom set up and operation. Kastango es demarco s.

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. What exactly makes a cleanroom clean. Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air.

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. For example government regulation usp 797 outlines specific requirements for pharmaceutical product manufacturing.