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Monday, December 27, 2010

What is an Isolator in pharmaceutical manufacturing

Isolators in pharma manufacturing.

What is an Isolator- A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). There are two major types of isolators:

Closed isolator systems exclude external contamination from the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations.

Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.

In pharmaceutical industry certain operations in pharma manufacturing or a quality control process , some drugs , some materials are required to be handled very carefully so as to protect them from getting contaminated by microorganisms and particulate matter, or it is required to handle a material separately and carefully if it is highly potent and sensitive to moisture and oxygen , as well as operators are required to be protected from untoward hazardous effects of such drugs or materials on their body, example* are cytotoxic, hormones, and radiopharmaceuticals , such materials are hazardous to surrounding environment and to the operator's health as well.

Such materials* are required to be handled in a system or unit which is completely closed and offer complete isolation of such materials or products from surrounding environment as well as from personals processing such materials. Such units which offer these facilities of isolation of such materials from surrounding environment are called as isolators, Isolators are used to handle such materials with ease, Isolators are widely used in processing of such materials by mechanical isolation, isolator systems are available in variety of form size and shape. One can design a manufacturing process line of isolator system where more than one person can work at a time and can carryout an operation, with the help of multiple glove attachments, hence isolator is also called as glove box.

Isolators are widely used for sterile manipulations in aseptic manufacturing of sterile dosage form or an injectable dosage form, Isolators can be supplied with HEPA filtered air and to maintain its sterility in aseptic processing, as well as they can be integrated inert gas purification system and activated charcoal air filtration for handling of materials sensitive to oxygen, and moisture. Processes like weighing, dispensing, and forming a triturate of sensitive material or to compound them in to final product can be accomplished in to an isolator. An antivibration support assembly can be integrated in a isolator to weigh potent drugs accurately in to them.

Isolators are fabricated with stainless steel 316 with surfaces electropolisehed, joints and corners are rounded so as to facilitate easy cleaning and to prevent accumulation of microorganisms or microbial spors, they can be fitted with glass walls for visual observation of process being carried out, Isolators can be fitted with one or more pairs of gloves , so as to facilitate handling of hazardous materials, material containers which are sterile or highly potent or cytotoxic are opened inside a closed isolator system and after the required process or manipulations and then the container is closed again without exposing it to surrounding environment and affecting surrounding environment ,without affecting sterility of material being handled. Isolator systems can be integrated to an oven to facilitate variety of applications of an oven ranging from sterilization to drying.

Also see -->
Isolator and sterile dosage form injectable dosage form manufacturing using isolators
Aspects of aseptic process isolators in sterile dosage form manufacturing   <----You should not miss this article


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1 comment:

Anonymous said...

Will you please provide such good knowledge on HVAC system

Posted by: Martin

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