The requirements for a new process are seldom the same. Therefore, we begin each enquiry with a project review based on the individual requirements. Our product portfolio and technology platform is comprehensive and allows us to always offer the best technical approach for each application. We use proven features, proven designs and proven packages wherever appropriate.
Short Timescales — Best Results
The time-span from drug development to market introduction is crucial for commercial success. with our extensive experience and production capabilities, pall can help to keep this time to a minimum. our project teams focus on your requirements and directly interlink with your team over the whole project from specification to commissioning. This approach helps to build each system to your user documentation in the shortest possible time.
Process Automation for Cost Savings
With GMP and documentation requirements increasing, process automation is a good investment to optimize overall production costs: Less operator interference makes processes run smoothly, validation easier and with minimum downtime. Pall’s automation solutions are designed for process integration and interfacing, in compliance with 21 CFR 11, from simple data logging to full batch records with electronic signatures.
Expert Application Knowledge for Our Customers
Pall has a large multi-disciplinary team of engineers and scientists with in-depth knowledge of applications and operating parameters for separation systems in biological, BioPharmaceutical and chemical processes. Operating within the PASS (Pall
Advanced separations Systems) group for projects and within the SLS (Scientific and Laboratory Services) and R&D organizations for longer term development and analysis, they enhance the total package for process development and advanced solutions.
GMP and GAMP Approach
We manage our projects and design our systems in accordance with industry guidelines to ensure customer and regulatory requirements are met.
The GMP requirements on validation and documentation for automated systems in BioPharmaceutical production are defined in Annex 15 of the EC Guide to Good Manufacturing Practice of Drug Products and in other international regulatory guidelines. For the US market, 21 CFR Part 11 further influences the design of electronic recording systems. In addition, the ISPE Forum has published its comprehensive GAMP Guide to create a common project design approach for industry users and vendors, from a formal user requirement specification to system commissioning and ongoing maintenance of a validated system. The ASME Bioprocessing and European (EHEDG) guidelines are also important reference points for specific equipment.
