Risk-based approach to E&L studies for single use manufacturing systems within biopharma
Download our white paper to discover how extractables & leachables studies can be used to qualify single-use manufacturing systems within the biopharma industry.
There are likely to be a number of changes to a material or component used in the manufacture or storage of drug products, this is especially true when the manufacturing processes involves single use components.
Material changes occur throughout product lifecycles. They can occur for a number of reasons and can either be in or out of the end user’s control. Reasons include; suppliers making changes to their materials e.g. as part of process improvements , as part of cost reduction exercises, to improve supply chain security, as part of product rationalization and many more.
When a material or component change is required, there is an important question in the qualification of change, Is it safe?
Why download this white paper?
This free white paper covers the following topics:
- Types of material changes and when they can occur
- Definition of risk as it relates to extractable and leachable compounds
- Types of studies which can inform the risk to patient safety from these changes
- Considerations for evaluating available data
For more information about our extractables and leachables studies and consulting services, or to request a quote, contact us today.
Complete the form below to download our white paper
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Extractables & Leachables Studies
Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
Backed by regulatory expertise, extensive experience, and a vast extractables database, our comprehensive E&L solutions ensure the safety of materials used across the healthcare sector.
We deliver tailored studies for pharmaceutical, biologic, medical device, reduced risk, combination products and more, in accordance with regulatory expectations.
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