Custom & Aseptic Containment Isolators,Germfree Laboratories Inc._specification/price/image

Product Detail
Company Profile

Custom & Aseptic Containment Isolators

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

General
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

Applications

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.

Germfree Laboratories Inc. creates environments that serve life science innovation and advance global health. The company, founded in 1962, designs, engineers and manufactures flexible cGMP-compliant cleanroom facilities and mobile units, as well as high containment laboratories, which are process-ready, upon deployment. www.germfree.com