What is the uses of isolator technology ?

• Isolator  technology used since the mid-1980s.
• In recent years, isolator technology has found a broad acceptance in healthcare manufacturing.
• Isolators are very useful in sterile manufacturing where microbial contamination and cross contamination is a major problem.
• Contaminated drugs have caused grave (Ex. permanent injury, death ) consequence for the consumer.
• Isolator system protect during handling direct contact between the analyst and test articles.
• Isolator are constructed of flexible plastics (Such as polyvinyl chloride) rigid plastics, glass or stainless steel.
• Aseptic manipulations within the isolator are made with half-suits or gloves and sleeves.
• Pharmaceutical industry compounding isolator are used for maintaining sterility of the product.
• Isolators are routinely found with the pharmaceutical industry and are widely used in aseptic compounding applications.
• Air velocity and changes are far less important in isolator or closed RABs than in clean rooms because personnel are more carefully separated from the product, product containers and closures.
• Total particulate counting in an isolator is likely to provide an immediate of changes in contamination levels.
• Isoloaters provide a working space that is detached from the surrounding environment.
•  Positive pressure isolator is most common, negative pressure isolator used in  handle of toxic product.
  
• Enclosed isolator are always positively pressurized units with High Efficiency Particulate Air (HEPA) filters that do supply ISO 5 airflow in a unidirectional or turbulent manner to the interior.
• Air is generally re-circulated and cleaning may be automated or manual.
• Isolator are designed to provide continuous and complete isolation of the inside of the isolator from the external  room environment, only installed gloves or robotic arms are used to manipulate the product.
• This ensures that the environment is maintained as contamination-free to safeguard patients who will later be administrated the drug. 
• Isolator system microbial monitoring is much less important in establishing their efficiency in elimination bio burden. 
• As per USP general chapter 1116  RABs, clean rooms aseptic air sampling frequency each operational shift, but isolator air sampling frequency once per day.
• Bio-decomposition occurs via an automated cycle that generally utilizes Vaporized Hydrogen Peroxide (H2O2).
• The interior of the isolator is treated with sporicidial chemicals that result in the elimination of all viable bio burden on exposed surfaces.
• Isolator work operation not required to wear sterilized clean room gown.
• A pair of sterile gloves is frequently worn under the isolator gloves.
• A second glove worn under isolater, can provide an additional level of safety against glove leaks or can act as a hygienic measure.
• Isolator technology should be significantly, lower sill and can be expected to be <0.1% on the basis of published monitoring results.
• One isolator to another isolator material transfer purpose Rapid transfer port (RTP's) are available.
• RTP gaskets disinfectant frequently and changed at the recommended frequency and periodically checked for damage.

Related : Isolator Decontamination cycle verification

Sterility Test Isolator:

• Sterility test isolator, which are generally a range of two glove and four glove isolator.
• They are specifically built for sterility testing and are designed for sterility testing in pharmaceutical products.
• Sterility isolator mainly used for avoid the cross contamination of product testing.
• Sterility isolator give the results  most accurate.

Two types of Isolaters available.

1. Closed isolators: Which are systems with no direct opening to the external environment, are normally used for maintained the sterility of the product.
2. Opened isolators: Which allow the egress of material through a defined openings that precludes the entry of contamination by means of air over pressure may be used.

• Closed isolators and opened isolators both are maintained positive pressure relative to the surrounding environment, and over pressure of 20 Pa or more are typical.
• The user should never exceed the maximum pressure recommended by the isolator manufacturer. 

Related : Isolator Integrity test or Isolator chamber leak test

Different stages used in Isolator technology:

1. Sterility testing isolator
2. Isolator for API dispensing and Aseptic operation
3. Isolator for Dispensing & Weighing 
4. Six stage research and development isolator
5. Isolator for Dispensing & milling
6. Isolator for Compact mixer -Granulation dryer 
7. Isolator for Deduster and metal check
8. Bottle filling and vial filling machine isolator
9. Isolator for cytotoxic manipulation.