Regulatory Compliance
Tested and Qualified: Single Use Systems Testing Directly After Pre-Concept Phase
As soon as single-use technology selection has been made, our project teams will help you evaluate the extractable data package for film and components. For toxicological assessment you can then perform an extrapolation evaluation on the possible quantity of extractables in the intermediate API or drug product. We can provide full support for process risk analysis and for validation of single-use systems including leachable studies through our Confidence® validation service. A test for leachables should be done under real contact conditions. Our SME’s are there to support.
Delivery of Your Biomanufacturing Process
Conceptual Design to Site Acceptance
Our Integrated Solutions project team employs a six step process from conceptual design to final on-site acceptance. Upon completion of your specific design and detailed engineering of your process, our experienced qualification team will assemble the full bioprocess equipment to execute comprehensive hardware, wetware (single-use systems) and software testing in our facility.
The IQ/OQ as well as the PQ is mandatory to prove functionality and performance. The test plan is defined jointly and leads to the milestone “Approval for FAT”. In order to be fast and efficient, you are invited to participate in these tests on our premises. All required tests will be done during SAT after shipment and commissioning.
Regulatory Compliance from Process Development to Commercial
New standards for single-use technologies
To ensure that technologies we implement in early phase processes meet future regulatory requirements, we carefully track evolving industry regulatory requirements, our experts are actively involved in standards organisations ( ASTM, ASME BPE, USP...) working towards developing future standards for disposable technologies. Current standards for disposables that are already in draft format with the standards organisations include extractables, particulates, integrity testing and cell growth.
Commissioning & Qualification of a Hybrid Production Plant in Single-Use and Multi-Use Design for Biopharmaceuticals
The particularity of this project for the commissioning and qualification was the design of the production line as a so-called hybrid system. This is a combination of classic stainless steel equipment, here referred to as multi-use (MU), and equipment of the young single-use (SU) technology. Both technologies are subjected to the same formal cGMP verification rules.
