Using extractables data of sterile filter components for scaling calculations

I Pahl, R Menzel, A Hauk, T Loewe - PDA Journal of Pharmaceutical …, 2019 - journal.pda.org
Users of single-use (SU) components need extractables data to demonstrate material safety
for regulatory bodies before incorporation in the biopharmaceutical process. In this context …

Extractables and Leachables Evaluations for Filters

RH Colton, DG Bestwick - Filtration and Purification in the …, 2007 - api.taylorfrancis.com
Sterile filtration is one example of a process using a polymeric component for
whichextractables and leachables are a concern. Ideally sterile filtration removes …

Filtration membranes-Scavengers for leachables?

A Hauk, E Jurkiewicz, I Pahl, T Loewe… - European Journal of …, 2018 - Elsevier
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 …

Comparative extractables study of autoclavable polyethersulfone filter cartridges for sterile filtration

R Menzel, I Pahl, T Loewe, A Hauk - PDA Journal of Pharmaceutical …, 2018 - journal.pda.org
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Because such
filters are in direct contact with the process fluid, profiling of the extractables is of utmost …

[PDF][PDF] Quantifying and qualifying extractable substances from components of disposable assemblies

T Jiang, S Kang, J Chartier - BioProcess International, 2007 - eu-assets.contentstack.com
Biopharmaceutical companies are using disposable assemblies at a rapidly increasing rate.
Single-use technologies are becoming available for a range of applications and process …

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

A Hauk, I Pahl, S Dorey, R Menzel - European Journal of Pharmaceutical …, 2021 - Elsevier
Quantitative information on process equipment-related leachables (PERLs) is required for
process qualification and within a safety assessment. Extractables data for single-use …

Qualitative assessment of extractables from single-use components and the impact of reference standard selection

MA Jordi, S Khera, K Roland, L Jiang… - … of Pharmaceutical and …, 2018 - Elsevier
The advent of single-use bioprocess systems used for the delivery, storage or manufacture
of biopharmaceuticals has introduced a new potential source for extractables and …

Extractables from filter components in model solvent streams for pharmaceutical filtration processes

T Jiang, M Phelan - PDA Journal of Pharmaceutical Science and …, 2003 - journal.pda.org
Drug manufacturers use filters widely in their manufacturing processes for bioburden
reduction and sterility assurance. In implementing a pharmaceutical filtration, it is essential …

Extractables analysis of single-use flexible plastic biocontainers

L Marghitoiu, J Liu, H Lee, L Perez… - PDA Journal of …, 2015 - journal.pda.org
Studies of the extractable profiles of bioprocessing components have become an integral
part of drug development efforts to minimize possible compromise in process performance …

Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review

N Sharma, Y Brahmankar, D Babar, T Bhogle… - Journal of Packaging …, 2023 - Springer
In recent years, the pharmaceutical industry has been adversely affected by an upsurge in
the recall instances of pharmaceutical products. This is due to the leaching of the chemical …