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
Key Projects
Equipment & Facility Engineering
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
Feasibility and implementation of new filling and closing equipment enclosed in a new aseptic isolator, integrated to the existing lyophylizer and depyrogenation oven
Compliance & Validation
Process
Filling Suite layout for the filling and closing machines enclosed by an aseptic isolator, with an integrated vial washing and depyrogenation tunnel
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
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