BIOPHARMA

Custom Restricted Access Barrier System

Many pharmaceutical applications require localized Restricted Access Barrier Systems (RABS) within the cleanroom. Germfree’s purpose-built RABS units mitigate the risk of contamination to sterile materials, containers, vials or surfaces that may come into contact with the product. This design provides separation between personnel and product and offer many flexible options for aseptic processing when a Pharmaceutical Isolator is not required.

Germfree Pharmaceutical RABS

Germfree’s RABS are custom manufactured for each application with respect to size, process-flow, and requirements for air filtration. Additionally, Germfree offers both Closed and Open RABS.

An integrated entry system or MAL (Material Airlock) allows for aseptic transfer. Interlocking doors are utilized if a rare open-door intervention is required.

  • Fast-track design process; 3D modeling
  • 316L all stainless steel construction
  • Radiused corners and seamless surfaces allow for ease of cleaning and decontamination
  • Open and Closed RABS configurations available
  • Filtration systems to meet the specified ISO class and demands of the process
  • Advanced ergonomics for the individualized requirements of your workflow
  • Integrated aseptic material transfer systems
  • Controlled environments for specified set points including temperature and RH
  • Continuous monitoring controls for critical conditions
  • Decontamination/sterilization systems available
  • IQ/OQ; complete documentation and validation package.

Multiple-chamber Pharmaceutical RABS
Germfree offers multiple-chamber RABS that can also be combined with isolator lines. This allows you to separate your materials, processes and improve workflow. Filtration systems and airflow controls are configured to prevent cross contamination or provide containment between chambers. This facilitates the handling and transfer of materials between barrier systems and allows sterile products to remain under isolation.

Contact Germfree to discuss your specific application and requirements for Pharmaceutical RABS.

Fabrication:
Streamlined Manufacturing ⎯ Germfree Completes your Project Faster We have a proven track record of delivering advanced products. 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.

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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