ISOLATOR – A Definition :
A sealed enclosure used in pharmaceutical and related applications in which critical operations can be performed. A variety of constructional and aerodynamic means are used to enclose a controlled workspace with qualities validated to comply with the requirements of the work.
• To protect the product from the operator and the environment
• To protect the operator from the product
• To protect both the product and the operator
• Nuclear Engineering
• Pharmaceuticals/ Chemicals
• Radioactive Hazard Containment
• Animal Laboratories
• Microbiological Safety
Pharmaceutical Application :
• API/Formulation Applications : All standard processes
• Research & Development Processes : Handling materials with unknown & limited safety data
• Bulk Solids Handling
• Sterility Test Isolators : Aseptic environments to remove the chance of human contamination
• Sterile Processing : Advantages in quality, safety and cost by replacing traditional clean-rooms with micro production environments based on isolators.
• Afford the Greatest Operator and Product Protection With Minimum Reliance on SOP’s
• Maintain cGMP practices during operations
• Eliminate Cross Contamination between products
• To provide a desired environment to suit the product & process.
• Localize Contamination to the Immediate Processing Area in Order to Reduce Cleanup and Product Change Over Requirements
Isolators -ve pressurised to protect the operator from the product "SAFETY"
Isolators +ve pressurised to protect the product from the operator "STERILITY ASSURANCE"
Product & Process Protection
• Micro-organisms/Particles/Water vapour/Oxygen/Cross-contamination
• An isolator with or without an air moving system will prevent contamination of a process from the outside environment. Where an isolator has its own air handling system the air entering and leaving the device will be pre and HEPA filtered. The arrangement and type of fans, filters and control system will determine the isolator pressure, number of air changes and classification.
• Toxic chemicals (solid, liquid or gas)/Pathogenic micro-organisms/genetically engineered material.
• By the creation of an effective physical and environmental barrier between the process and the operator then the hazards can be effectively contained as an alternative approach to providing personal protective equipment for the operator. The disadvantage is in getting the ergonomics right as the operating circumstances become less flexible.
Operator and Product & Process Protection
The isolator is an ideal system for achieving these dual and normally opposing objectives. Depending on the greater of the two demands positive or negative pressurisation used.
The OEL (Operator Exposure Limit) of the Product :
• The OEL limit set for exposure to a chemical expressed in micro-grams per cubic meter of air factored over an 8 hour period. Compliance checked using air samplers located near the operators breathing zone during operation.
• Number of methods for setting these limits.
• OELs for the protection of workers around since 1939.
• Adhering to OELs effective and proven way to protect workers from the effects of chemicals if appropriately determined and periodically monitored for in the workplace air.
• If set with too high a safety margin then resources wasted if too low then health & safety compromised.