Using extractables data from single-use components for extrapolation to process equipment-related leachables: The...

Area of Science:

• Pharmaceutical Manufacturing
• Analytical Chemistry
• Chemical Engineering

Background:

• Quantitative data on process equipment-related leachables (PERLs) is crucial for process qualification and safety assessments.
• Extractables data from single-use equipment (SUE) can be applied if study conditions match or bracket expected use.
• Extrapolation of extractables data is necessary when in-use conditions exceed tested parameters.

Purpose of the Study:

• To develop and describe quantitative methods for extrapolating extractables data from single-use equipment.
• To enable the prediction of process equipment-related leachables (PERLs) under diverse operational conditions.
• To provide a scientifically sound basis for safety assessments and process qualification.

Main Methods:

• Scaling extractables data for devices of varying sizes to relevant process volumes.
• Extrapolating data to different temperatures, solvent compositions, and contact times.
• Combining extractables data from individual components to assess entire assemblies.

Main Results:

• Developed methods provide quantitative predictions of PERLs, simulating a full extractables study.
• Methods are derived from fundamental physicochemical principles and validated against experimental data.
• The study discusses the applicability and justification of these calculation methods.

Conclusions:

• The presented extrapolation methods offer a robust approach to determine PERLs from extractables data.
• These methods are essential for bridging the gap between extractables testing and real-world process conditions.
• This work supports the safe and efficient use of single-use equipment in pharmaceutical manufacturing.