Contamination is a killer and the world of finished drug products is complex and challenging. Aseptic handling is essential for the integrity of all pharmaceutical products and devices.
Sterile and Aseptic processing in complex, both in terms of technology and regulatory requirements.IPS can help you identify the best solution, taking into account all relevant aspects.
Aseptic handling also adds a layer of complexity to the pharmaceutical production processes from formulation and preparation until the product is filled in its final container. Traditionally this has been done in a conventional cleanroom, but today a number of technologies are available (isolator, RABS (restricted access barrier systems), single-use systems and sterile transfer of materials) to ensure a high sterility assurance level.
Other steps in the process, including labeling and packaging, are also undergoing rapid developments. Fuelled by counterfeit complaints, labeling and traceability requirements are on the rise. And the implementation of efficient logistics systems, including automated guided vehicles and automated warehouses, present new challenges for the integrated operation of facilities and the use of technology.
At Integrated Project Services (IPS), we have deep insight into aseptic and sterile fill and finish processes. This includes our first-hand experience operating in these environments, extensive knowledge of regulatory developments, practical experience integrating the different technologies and awareness of the industry’s most recent developments. We can advise you on the mix of technologies that makes the most sense financially for your company. IPS can also help you balance your investment costs, operational costs, regulatory requirements and risks.