Modern, world class GMP facility. Modular design, with vessel size range, 200 L to 5000 L. Hastelloy hydrogenators, cryogenics, high-temp. Clean rooms for API production. OEB3/4 capable in large trains, and OEB/5 capable isolator. Kilo-Lab, including GMP small scale trains.
Quality lies at the heart of our manufacturing organization, and we have developed a quality systems that meets the high standards set by our clients and international regulators. Our Dayawan site is built to meet global GMP standards.
Safety is paramount. Our manufacturing processes, operations, and practices all hold safety as a core principle.
Our process safety program ensures that all stages delivered from the labs are safe to operate. ARC/ARSST and DSC testing is carried out as a matter of course before executing a process above 5L reaction volume. This removes the risk of an unsafe process being brought into the manufacturing environment.
Operating instructions, and engineering configurations are all reviewed by safety panels together with development chemists and operational representatives, to ensure safety.
We maintain a high level of containment during materials handling. From the use of Downflow booths with HEPA filters for materials dispensing through to split butterfly valves and contained solids transfer systems for charging and enclosed sampling loops and offloading and packing areas.
In addition to the extensive preventative measures taken, we also have engineering controls in place such as the use of nitrogen in all processing equipment including filters and driers. Bursting disks and emergency venting space.