Barrier Technology for Aseptic and Containment
SAGE provides comprehensive, end-to-end expertise in barrier technology, guiding your projects from initial concept through to commercial operation. Our knowledge is built on extensive, hands-on experience specifying, integrating, and validating Isolators and Restricted Access Barrier Systems (RABS) for complex processes. We routinely manage vendor assessments, execute critical barrier mock-ups to optimize material flow and interventions, and lead comprehensive aseptic process simulation studies (media fills) to ensure absolute sterility and compliance.
We excel at developing tailored containment solutions that seamlessly integrate new technology with existing infrastructure. Our teams have successfully executed complex line layouts, including the integration of new filling and closing machines within aseptic isolators linked directly to existing lyophilizes and dehydrogenation ovens.
Beyond sterile filling, we apply our deep aseptic knowledge to high-potency and Oral Solid Dose (OSD) containment, providing innovative solutions to actively reduce the spread of potent compounds and ensure strict facility segregation for specialized oncology products.
Our expertise extends deeply into the highly specialized radiopharmaceutical sector, where safe containment is critical. We provide comprehensive user specifications, vendor management, and validation oversight—including the execution of critical smoke studies—for complex radioactive environments. From qualifying new isotope transfer isolators to validating Grade C synthesis hot cells and Grade A dispensing hot cells, we ensure your barrier systems provide the highest levels of both product sterility and operator radiation safety.
Key Projects
Facilities
- Oncology products filling suite with closed/active Restricted-Access Barrier System (RABS) constructed in a new building expansion with facility segregation
Solution
- Provision of innovative containment solutions for existing Oral Solid Dose (OSD) processes and equipment to reduce the spread of potent compounds
Equipment & Facility Engineering
Equipment
- Feasibility and implementation of new filling and closing equipment enclosed in a new aseptic isolator, integrated to the existing lyophylizer and depyrogenation oven
Equipment & Facility Engineering
Equipment
- Feasibility and implementation of new filling and closing equipment enclosed in a new aseptic isolator, integrated to the existing lyophylizer and depyrogenation oven
Key Projects
Facilities
- Facilities
- Oncology products filling suite with closed/active Restricted-Access Barrier System (RABS) constructed in a new building expansion with facility segregation
Equipment & Facility Engineering
- Solution
- Provision of innovative containment solutions for existing Oral Solid Dose (OSD) processes and equipment to reduce the spread of potent compounds
Equipment & Facility Engineering
- Equipment
- Feasibility and implementation of new filling and closing equipment enclosed in a new aseptic isolator, integrated to the existing lyophylizer and depyrogenation oven
Process
- Filling Suite layout for the filling and closing machines enclosed by an aseptic isolator, with an integrated vial washing and depyrogenation tunnel
Compliance & Validation
Containment
- User specification, vendor management and execution of smoke studies to validate new isotope transfer isolator, Grade C synthesis hot cell and Grade A dispensing hot cell
Project Management
Line Layout
- Project management and oversight for demolition, structural and construction work required. Sourced potential contractors for the work and coordinated the tender package
Project Management
CMO Management
- Project management and technical leadership for the fill/finish activities of a COVID-19 therapeutic at 4 CMOs to supply finished product for 30,000+ patient treatments
Barrier Technology for Aseptic and Containment
SAGE’s knowledge of barrier technology has been built on first hand experience of specifying Isolators and Restricted Access Barrier Systems (RABS) for production machines and freeze driers, vendor assessments, barrier mock-ups incorporating material flow and process setup/interventions, line installation and start-up with vendors, equipment and environmental qualifications, and aseptic process simulation studies (media fill). We bring projects from concept through to commercial operation. We have also taken our aseptic containment knowledge and expanded it to hi-potency containment, designing unique containment solutions for clients.
A core business offering since the company’s inception, SAGE provides project services including:
- Forecast analysis
- Specifications
- Impartial equipment tendering and procurement
- Vendor management
- FAT, installation, SAT management
- Commissioning of process and facility related equipment
