ISOLATOR
A pharmaceutical isolator is a sealed, controlled environment used in drug manufacturingand research to maintain sterility and protect operators from hazardous substances.It ensures aseptic processing by using HEPA or ULPA filtration, glove ports, and controlledairflow. Isolators are commonly used for handling cytotoxic drugs, sterile compounding,and microbiological testing.
What is an Isolator?As a physical principle, isolation means the separation of a process – e.g. raw materials,a product or a laboratory experiment - from its environment.Reasons for this: to eliminate contamination from the environment to the isolated object,or vice-versa. Type of Isolators:- Positive / Negative Flexible / Rigid
Where is it Used?1. Pharmaceutical Industry – Sterile drug manufacturing, compounding, and filling.
2. Biotechnology & Laboratories – Handling sensitive biological samples.3. Electronics & Semiconductor – Assembling microelectronic components.4. Food & Beverage – Maintaining hygienic processing of food ingredients.
How Does It Work?
1. Operators insert their hands into the integrated gloves for handling materials.
2. Airflow and filtration systems maintain a controlled, contamination-free environment.
3. The sealed chamber prevents external pollutants from entering.
4. After the process, decontamination cycles ensure sterility.
Specifications1. Material: SS 304 / SS 316L with seamless welding.
2. Filtration: HEPA/ULPA filters (99.99% efficiency at 0.3 microns).
3. Pressure Control: Positive or negative pressure operation.
4. Integrated Gloves: Highly flexible and chemical-resistant gloves.
5. Sterilization System: VHP (Vaporized Hydrogen Peroxide) compatible.
6. Control System: Touchscreen PLC-based monitoring & alarm system.
Features
1. High containment and sterility assurance.
2. Ergonomic design for operator comfort.
3. Easy to clean with smooth, rounded corners.
4. Real-time monitoring with digital control panels.
5. Optional integrated glove leak test system.
Compliance & StandardscGMP, ISO 14644, EU-GMP, WHO-GMP
Containment isolator – design criteria
1. Generally operated under negative pressure to ensure max. operator safety.2. Typically classified as ISO 7 (Class 10,000 Grade C) at rest condition.3. The exhaust air must not exchange with the surrounding environment,except double HEPA filters.4. Operate under pressure of -80 to -120 Pa, with electronically controlled.
5. Design to allow the processing of highly effective category OEB 6(Occupational Exposure Band) products – Multi product use.6. Equipped with nitrogen supply, if required.7. Interlocked isolator door after start of operation.8. Visual display indicates permanent status of the isolator.9. All materials exiting the isolator must be cleaned or contained. 10. Designed in compliance with international cGMP standards.11. Designed to achieve Class 3 Containment level, as per ISO 10648-2.12. Integrated rapid transfer ports (RTP) for loading and discharging withoutcompromising the surrounding.13. Fully automated isolator / glove leak test cycle before each process.14. Glove test prior to production “push –push” system for exhaust air filters.15. To be designed for operation in a intrinsically safe area.16. Full traceability compliant to FDA 21 CFR part 11.17. FDA-approved pressure-tight seals.
