With our raw materials and manufacturing know-how we can fully characterize our extractables and particles profiles.
With subsequent control of our materials and processes, we guarantee lot-to-lot reproducibility of our extractables and particles profiles.
To make your validation easier than ever, we have created a tool, which uses data obtained from both our in-house protocol and the BioPhorum Standardized Extractables Testing Protocol. As well we relate our extractables data to customer process conditions to create a simulated leachables report.
This ensures consistent compatibility of our single-use materials with your biologics.
We have developed a unique partnership, scientific exchanges and quality agreements with our resin suppliers and film extruder Südpack. That has given us full access to polymer materials and additive packages formulation.
We established relevant resin specifications and extrusion design spaces for critical components, such as films, filters and tubings.
This in-depth knowledge of raw materials, combined with our film and tubing formulation know-how and own manufacturing expertise, enables us to fully characterize our particles and extractables profiles.
Resins are controlled against specifications, while films, filters and tubings are controlled against critical process parameters within established design spaces.
Our production particle prevention program covers improving component cleanliness, manufacturing in ISO7 cleanrooms, applying visual inspection and weekly monitoring of sub-visible and visible particles for all our single-use solutions.
Through our stringent material traceability and process controls we guarantee safe and reproducible levels of extractables and particles. This in turn provides consistent biocompatibility of your single-use process with your biologics.
Applying state-of-the-art procedures and sound scientific methods, we generated extractables data for more than 300 bags, tubings, fittings, connectors, filters and sensors. With this new in-house component approach, we can build integrated solution related extractable packages specific to your single-use solution.
In addition we also generated component extractable data using the BioPhorum Standardized Extractables Testing Protocol.
Our validation team supports your risk assessment and provides extractables data for your specific single-use process via our tool, which uses data obtained with both our in-house protocol and the BioPhorum Standardized Extractables Testing Protocol. This approach creates a simulated leachables report which can be used directly for your risk assessments and toxicological studies.
* The BioPhorum Operations Group (BPOG) is a collection of approximately 50 companies encompassing 80% of the global commercial biopharmaceutical capacity. They published two documents which standardized the conditions under which extractables should be collected and proposed a best practice workflow for performing a leachables risk assessment: “Best Practices Guide for Evaluating Leachables Risk from Polymeric Single-Use Systems Used in Biopharmaceutical Manufacturing” and “Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing
General Considerations and Practical Aspects — A Manufacturer’s Perspective
By Ina Pahl, Samuel Dorey, Isabelle Uettwiller, Christian Hoffmann, Paul Priebe, Roberto Menzel, and Armin Hauk
Accelerate Adoption Into Commercial Production Facilities
By Jean-Marc Cappia
Biomanufacturers must address four key challenges when developing a single-use system: It needs to ensure that the technology does not interact with living cells or biological products, that it is a closed and integral system, that it does not leak, and that its supply is ensured. Finally, such systems must reduce complexity, improve quality, and minimize the burden of change controls through standardization. The solutions to these challenges are interrelated, but they depend on improving control of raw materials, components, and processes within the supply cha
By Dr. Armin Hauk and Katell Mignot
Proposals for “standardized” methods are available to conduct extractables studies in the biopharmaceutical industry. Therefore it is worth to consider the proper use of extractables data, with the aim to obtain meaningful extractables data for single-use solutions of different sizes or combinations and properly assess the risk related to leachables for entire processes. These two aspects can hardly be solved by means of analytics alone and this paper introduces methods and models to overcome these challenges.
By Armin Hauke, Elke Jurkiewicz, Ina Pahl, Thomas Loewe, Roberto Menzel
This publication describes the development of an experimental set-up and testing protocol to test the hypothesis that filters used for sterile filtration can act as scavengers of leachables. The filter materials polyethersulfone (PESU) and cellulose acetate (CA) were tested.