- Non-GMP Pharmaceutical Development
- Early Stage Development
- Scale Up and Late Stage Development
- Clinical Trial Manufacture
- Contained Development & Manufacture
- Analytical Services
Contained Development & Manufacture
From our state-of-the-art pharmaceutical development facilities, we can develop and manufacture batches of drug product containing potent API.
Our Operator Exposure Level (OEL) bands are aligned with those of SafeBridge Consultants, Inc. which is a reference point commonly used in the industry.
Processing compounds with an Operator Exposure Level (OEL) in the range of 0.03 – 10μg/m3, we have the capability to manufacture batch sizes ranging from approximately mg of API to 100kg of bulk blend.
Containment Capabilities and Rationale
Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses, we have successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in our Pharmaceutical Development facility.
We have applied engineering solutions that employ rigid & flexible film Isolator technology around the processing zones of equipment to contain airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate that we can process compounds with an OEL as low as 30 ng per m3.
We have the capability to process batch sizes up to 100kg using a wide variety of processing techniques, including:
- Dry Granulation
- Wet Granulation / Fluid Bed Drying
- Tablet Coating