Isolators are sealed enclosures that maintain a Grade A (ISO 5) environment using HEPA filtration and unidirectional airflow. Operators manipulate materials through glove ports, preventing direct exposure to the external environment.
Key points to note:
- Fully enclosed, reducing microbial risks.
- Meets FDA, EU GMP Annex 1, and ISO 14644-7 standards.
- Lowers cleanroom classification requirements.
- Uses Vaporized Hydrogen Peroxide (VHP) for decontamination.
Types of Isolators
Aseptic Processing Isolators (Positive Pressure)
- Used in sterile manufacturing to protect products from contamination.
- Operates under positive pressure (higher than surrounding areas) to prevent the ingress of contaminants.
- Used for aseptic filling, sterility testing, and final product preparation.
- Decontamination is typically achieved using Vaporized Hydrogen Peroxide (VHP) or another validated gaseous method.
Containment Isolators (Negative Pressure)
- Used for handling highly potent or hazardous compounds (e.g., cytotoxic drugs, hormones, or highly active APIs).
- Operates under negative pressure (lower than surrounding areas) to prevent hazardous materials from escaping.
- Often used in compounding, weighing, and dispensing operations.
Key Features
- Glove ports allow operators to handle materials without breaking containment.
- Materials are introduced through Rapid Transfer Ports (RTPs) or airlocks to prevent contamination.
- Most isolators use Vaporized Hydrogen Peroxide (VHP) for decontamination.
- Other decontamination methods include chlorine dioxide or peracetic acid, depending on the process.
- Advanced isolators are integrated with automated filling, capping, and sealing equipment to enhance sterility assurance.
Key Considerations
- Leak Testing: Required per ISO 14644-7 using pressure decay or tracer gas (e.g., helium) methods to ensure airtight integrity. ISO 14644-7 and EU GMP Annex 1 require leak testing at defined intervals.
- Bio-Decontamination: Must be validated (typically using VHP).
- Environmental Placement: While isolators reduce the need for high-grade cleanrooms, they should still be placed in at least a Grade C (ISO 7) or better environment for aseptic processing, as per EU GMP Annex 1.
- Material Transfer: Uses Rapid Transfer Ports (RTPs), sealed conveyors, or airlocks to maintain containment.
Read also: Role of Isolators in Pharmaceutical Industry
Resource Person: Paul Joseph