Extractables information

Simplifying extractables and leachables risk assessments through standardization

 

Implementation of Quality by Design (QbD) processes for bioprocessing equipment begins with well-understood and well-characterized components. Standards and industry-aligned guidelines such as USP <665> and the BioPhorum extractables protocol support this QbD approach, and in many cases can minimize cost and simplify the overall impurities risk assessment. To this end, Cytiva has launched a dedicated program to address the new USP <665> extractable testing requirements. This program includes rigorous testing and collaboration with our supplier network, prioritizing single-use and filtration bioprocess components intended for critical applications that are closest to patients.

 

Cytiva’s approach to extractables and leachables testing

 

Cytiva has extensive experience in generating extractables and leachables data to support product and process risk assessments. This includes data from USP <665> and BioPhorum datasets, process-specific simulation studies, and leachables studies. To streamline and accelerate adoption of single-use, filtration, and multi-use technologies, Cytiva has prioritized testing on newly introduced bioprocess components, and components intended for use in higher risk applications (e.g., final sterilizing-grade filtration, aseptic transfer, filling sets, tubing, storage, etc.). In addition to the large number of reports currently available, ongoing efforts continue to map the extensive portfolio of historical bioprocess part numbers to materials of construction families and to generate or verify that available data cover all the part numbers within each family. The list of part numbers fully bracketed by a component extractables study is generally provided as part of the report. However, given the breadth and diversity of components in bioprocessing, some part numbers that have not yet been verified as part of a material family may not yet be included.Further information on assembly families may also be found in product Validation Guides.

 

Here are a few ways we are contributing:

• Publishing comprehensive extractables information on our products.
• Aligning current testing with USP <665> and BioPhorum extractables protocols.
• Providing process-specific risk assessments, extractables simulation studies, and leachables testing. For information, please refer to Extractables & Leachables Services.

Comprehensive extractables information

In our view, bioprocess technology manufacturers should be responsible for extractables testing of their components. We therefore offer extractables information for our products.

By logging in to the regulatory support application, you can access relevant extractables data for use in your own risk assessments.

Access extractables

For information in identifying and accessing available extractable studies by product type, download the Extractables Data Guide Table further below. Portal access to the reports can be found via the links in the far right column of the table. Please note two separate portals are used for sharing depending on the specific report.

Updated: June 2024
How to access the data:
i. Navigate to cytiva.com/rsf
ii. Choose either Access Regulatory Support (Reg. Sup.) or the Accelerator Documentation Center (ADC) as noted in the Report portal column below.
iii. Log in to the portal. A confidentiality agreement will need to be accepted and approved before access to reports is provided.
Document USTR 3437 is now part of this data guide

Printable version of Extractables Data Guide Table