Barrier (pharmaceutical)
Encyclopedia
A barrier isolator, or simply an isolator, is a device that provides a physical barrier between a laboratory
technician
and a work process. Isolators are routinely found within the pharmaceutical industry, and with the recent implementation of USP 797 ("Pharmaceutical Compounding: Sterile Preparations", a set of sterile compounding
standards issued by the United States Pharmacopeia
), are increasingly used in pharmacy
applications. They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile
or aseptic). Isolators may operate at positive, negative, or ambient differential pressure
. Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic
drug compounding to electronics manufacturing.
Regarding pharmacy applications, because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product. In the mid-1980s, the industry began to employ barrier isolators, and later, in the 1990s, Restricted Access Barrier System
s, or RABS, to separate people from the process. The acronym RABS was coined by Stewart Davenport of Upjohn (now Pfizer
). Since that time, the technology and applications of these systems has developed and broadened significantly.
Major manufacturers of barrier isolators include Envair Limited , Walker Barrier Systems, Howorth Air Technology, Amercare Ltd, The Baker Company, Esco Global, and Thermo-Electron Corporation.
Laboratory
A laboratory is a facility that provides controlled conditions in which scientific research, experiments, and measurement may be performed. The title of laboratory is also used for certain other facilities where the processes or equipment used are similar to those in scientific laboratories...
technician
Technician
A technician is a worker in a field of technology who is proficient in the relevant skills and techniques, with a relatively practical understanding of the theoretical principles. Experienced technicians in a specific tool domain typically have intermediate understanding of theory and expert...
and a work process. Isolators are routinely found within the pharmaceutical industry, and with the recent implementation of USP 797 ("Pharmaceutical Compounding: Sterile Preparations", a set of sterile compounding
Compounding
Compounding is the mixing of drugs by a compounding pharmacist to fit the unique needs of a patient...
standards issued by the United States Pharmacopeia
United States Pharmacopeia
The United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...
), are increasingly used in pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
applications. They are designed to provide an isolation of a process or the maintenance of an internal condition (e.g., sterile
Asepsis
Asepsis is the state of being free from disease-causing contaminants or, preventing contact with microorganisms. The term asepsis often refers to those practices used to promote or induce asepsis in an operative field in surgery or medicine to prevent infection...
or aseptic). Isolators may operate at positive, negative, or ambient differential pressure
Atmospheric pressure
Atmospheric pressure is the force per unit area exerted into a surface by the weight of air above that surface in the atmosphere of Earth . In most circumstances atmospheric pressure is closely approximated by the hydrostatic pressure caused by the weight of air above the measurement point...
. Isolators may provide personnel, product, or environmental protection, or any combination thereof. They are used throughout industry, from orange juice filling lines to cytotoxic
Cytotoxicity
Cytotoxicity is the quality of being toxic to cells. Examples of toxic agents are a chemical substance, an immune cell or some types of venom .-Cell physiology:...
drug compounding to electronics manufacturing.
Regarding pharmacy applications, because people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the efficacy of the final drug product. In the mid-1980s, the industry began to employ barrier isolators, and later, in the 1990s, Restricted Access Barrier System
Restricted Access Barrier System
A Restricted Access Barrier System ' is an installation which is used in many industries, such as pharmaceutical, medical, chemical, electrical engineering where clean air is needed. The RABS provides a physical barrier between workers and production areas....
s, or RABS, to separate people from the process. The acronym RABS was coined by Stewart Davenport of Upjohn (now Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
). Since that time, the technology and applications of these systems has developed and broadened significantly.
Major manufacturers of barrier isolators include Envair Limited , Walker Barrier Systems, Howorth Air Technology, Amercare Ltd, The Baker Company, Esco Global, and Thermo-Electron Corporation.