BIOPHARMA

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.

  • 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.
Germfree Pharmaceutical Isolator

Germfree is known for constructing robust equipment with the finest stainless steel for easy cleaning.

Past Germfree Projects

Germfree consistently delivers exceptional cGMP compliant products around the globe. Browse the grid below to see a selection of relevant past projects:

Mobile Hospital Compounding Pharmacy
Mobile
The remodeling of an I.V. pharmacy presents a range of potentially difficult or costly challenges. During building renovations it is imperative that compounding operations are not interrupted or otherwise negatively impacted
USA
Microbiome Research Modular Cleanroom
Biopharma Projects
This BSL 2+ cGMP Modular Biocontainment Cleanroom Facility is made up of five (5) prefabricated modules (2,000 ft2 / 184 m2 gross area) and is housed within a renovated warehouse structure. The cleanroom is designed to comply with FDA and EU cGMP standards and utilizes a unidirectional process flow.
Alachua, FL
Mobile Viral Vector Production Facility
Biopharma Projects
This Mobile BSL-3 Viral Vector Production Facility is based on quantity 2 semi-trailer chassis (840 ft2 / 79 m2 gross area) and functions as a mobile cGMP cleanroom to facilitate Viral Vector Manufacturing (VVM).
Maryland, USA

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It is the dedication of the Germfree team that enables rapid deployment of critical infrastructure both to cutting edge research facilities and the front lines of global health security

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