Custom Pharmaceutical Aseptic Isolator Containment Systems
Isolators are a core component to the pharmaceutical industry critical for a range of processes. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment.
Germfree manufactures advanced cGMP-compliant isolators to protect sterile products, personnel and the working environment. Germfree’s Aseptic Isolators are customized to meet the rigorous demands of your specific application and operate under negative pressure. Biopharmaceutical production often requires working with potent chemical APIs and hazardous biological agents. Germfree Provides Containment Solutions for All Types of Hazards – Chemical, Biological, Radiological and Volatile Compounds.
Custom Pharmaceutical Aseptic Isolators
Stringent aseptic conditions are essential to maintain quality control and meet FDA cGMP and other regulatory demands. Our Pharmaceutical Aseptic Isolators provide a complete barrier that separates and protects your product from personnel, other processes and the work environment.
Features
- Fast-track design process; 3D modeling
- 316L all stainless steel construction
- Radiused corners and seamless surfaces allow for ease of cleaning and decontamination
- Advanced ergonomics for the individualized requirements of your workflow
- Integrated aseptic material transfer systems
- On-board decontamination/sterilization
- Controlled environments for specified set points including temperature and RH
- System for continuous monitoring of critical conditions
- IQ/OQ; complete documentation and validation package
- Factory Acceptance Testing
- Units meet or exceed all cGMP and other relevant standards and guidelines including: ISO classes, USP, GAMP 5, BSL and FDA CFR Title 21 Parts 210 & 211