- 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
Pharmaceutical Isolator Types Include:
Dispensing Isolators
Transfer Isolators
Sub-division and Weighing Isolators
Cell Therapy – Cell Culture Isolators
R&D Isolators and Class III Biosafety Cabinets
Reactor and Charging Isolators
Off-Loading Isolators
Cytotoxic Compounding Containment Units
Micronizing/Milling & Blending Isolators
Pharmaceutical Isolators – Rigorous Engineering Standards and Features:
Filtration systems to meet the required ISO class, biosafety or specialized levels of containment
Units for Routine Aseptic Processes and Emerging Biopharmaceuticals
Germfree’s cGMP-compliant systems provide the required combinations of functionality and protection. Our engineering specialists work with you to determine the optimal configuration:
H-API Isolators – Safely handle highly potent, small molecule active pharmaceutical ingredients
Custom Aseptic Process Isolators – Aseptic conditions for working with sterile products
Biocontainment Isolators – Safely handle pathogens/biological risk agents
Streamlined Manufacturing – Germfree Completes your Project Faster
Our leading-edge fabrication technology, engineering team and subject-matter experts are all located on-site, in our US factory. We provide an efficient and collaborative design process and coordinate all logistics. From concept to completion, we deliver advanced solutions in an accelerated timeline.
