Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleResearch

Using Extractables Data of Sterile Filter Components for Scaling Calculations

Ina Pahl, Roberto Menzel, Armin Hauk and Thomas Loewe
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 523-537; DOI: https://doi.org/10.5731/pdajpst.2018.009647
Ina Pahl
Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: ina.pahl@sartorius-stedim.com
Roberto Menzel
Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Armin Hauk
Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Thomas Loewe
Sartorius Stedim Biotech GmbH, August-Spindler-Straße 11, D-37079 Göttingen, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Lopes A. G.
    Single-Use in the Biopharmaceutical Industry: A Review of Current Technology Impact, Challenges and Limitations. Food Bioprod. Process. 2015, 93, 98–114.
    OpenUrl
  2. 2.↵
    1. Shukla A. A.,
    2. Gottschalk U.
    Single-Use Disposable Technologies for Biopharmaceutical Manufacturing. Trends Biotechnol. 2013, 31 (3), 147–154.
    OpenUrlCrossRefPubMed
  3. 3.↵
    1. Whitford W.,
    2. Petrich M. A.
    SUStainability – Concerning Single-Use Systems and the Environment. BioProcess Int. 2018, 16, 1–13.
    OpenUrl
  4. 4.↵
    European Department for the Quality of Medicines. European Pharmacopoeia, 9th ed.; Council of Europe, 2016; Chapter 3.
  5. 5.↵
    U.S. Pharmacopeial Convention. General Chapter <661.1> Plastic Materials of Construction. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 6403–6424.
  6. 6.↵
    U.S. Pharmacopeial Convention. General Chapter <87> Biological Reactivity Tests, In Vitro. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 6017–6020.
  7. 7.↵
    U.S. Pharmacopeial Convention. General Chapter <88> Biological Reactivity Tests, In Vivo. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 6020–6025.
  8. 8.↵
    Indirect Food Additives: Polymers. Code of Federal Regulations, Part 177, Title 21, 2018.
  9. 9.↵
    1. Zweifel H.,
    2. Maier R. D.,
    3. Schiller M.
    Plastics Additives Handbook; Carl Hanser Verlag GmbH & Co. KG: Munich, 2009.
  10. 10.↵
    1. Kröhnke C.,
    2. Werner F.
    Stabilisers for Polyolefins; Rapra Review Reports Report 132; Rapra Technology Ltd, 2001; Vol. 11, No. 12.
  11. 11.↵
    1. Tolinski M.
    Additives for Polyolefins; Elsevier, 2015.
  12. 12.↵
    1. Selke S. E. M.,
    2. Culter J. D.
    Additives and Compounding. In Plastics Packaging; Carl Hanser Verlag GmbH & Co. KG: Munich, 2015; pp 159–184.
  13. 13.↵
    1. Suarez J. C. M.,
    2. da Costa Monteiro E. E.,
    3. Mano E. B.
    Study of the Effect of Gamma Irradiation on Polyolefins—Low-Density Polyethylene. Polym. Degrad. Stab. 2002, 75 (1), 143–151.
    OpenUrl
  14. 14.↵
    1. Medel F. J.,
    2. García-Álvarez F.,
    3. Gómez-Barrena E.,
    4. Puértolas J. A.
    Microstructure Changes of Extruded Ultra High Molecular Weight Polyethylene after Gamma Irradiation and Shelf-Aging. Polym. Degrad. Stab. 2005, 88 (3), 435–443.
    OpenUrl
  15. 15.↵
    1. Komolprasert V.,
    2. Morehouse K. M.
    1. Kawamura Y.
    Effects of Gamma Irradiation on Polyethylene, Polypropylene, and Polystyrene. In Irradiation of Food and Packaging; Komolprasert V., Morehouse K. M., Eds.; ACS Symposium Series 875; American Chemical Society, 2004; pp 262–276, Chapter 16.
  16. 16.↵
    1. Mathlouthi M.
    1. el Makhzoumi Z.
    Effect of Irradiation of Polymeric Packaging Material on the Formation of Volatile Compounds. In Food Packaging and Preservation; Mathlouthi M., Ed.; Springer: Boston, MA, 1994., pp 88–99.
  17. 17.↵
    Section 211.65–Equipment Construction. Code of Federal Regulations, Part 211, Title 21, 2017.
  18. 18.↵
    U.S. Food and Drug Administration. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), 1999.
  19. 19.↵
    European Medicines Agency. Guideline on Plastic Immediate Packaging Materials. EMA: London, 2005.
  20. 20.↵
    Union Guidance on Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food as Regards Information in the Supply Chain. European Commission: Brussels, 2013.
  21. 21.↵
    European Commission. EudraLex–EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. European Commission: Brussels, 2010.
  22. 22.↵
    1. Gouveia B. G.,
    2. Rijo P.,
    3. Gonçalo T. S.,
    4. Reis C. P.
    Good Manufacturing Practices for Medicinal Products for Human Use. J. Pharm. BioAllied Sci. 2015, 7, 87–96.
    OpenUrl
  23. 23.↵
    1. Li K.,
    2. Rogers G.,
    3. Nashad-Samuel Y.,
    4. Lee H.,
    5. Mire-Sluis A,
    6. Cherney B.,
    7. Forster R.,
    8. Yeh P.,
    9. Markovic I.
    Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products. PDA J. Pharm. Sci. Technol. 2015, 69(5), 590–619.
    OpenUrlAbstract/FREE Full Text
  24. 24.↵
    U.S. Pharmacopeial Convention. General Chapter <665> Polymeric Components and Systems Used in in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products (Draft), USP: Rockville: MD, 2019.
  25. 25.↵
    1. Ding W.,
    2. Madsen G.,
    3. Mahajan E.,
    4. O'Connor S.,
    5. Wong K. M.
    Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing. Pharm. Eng. 2014, 34 (6), 1–11.
    OpenUrl
  26. 26.↵
    U.S. Pharmacopeial Convention. General Chapter <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products (Draft), USP: Rockville: MD, 2019.
  27. 27.↵
    1. Jenke D.,
    2. Chess E. K.,
    3. Jakubowski G.
    Modeling of the Leachables Impact on the Engineering of Parenteral Product Container Systems. Int. J. Pharm. 1994, 108 (1), 1–9.
    OpenUrl
  28. 28.↵
    1. Jenke D.,
    2. Rabinow B. E.
    Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions. PDA J. Pharm. Sci. Technol. 2017, 71 (3), 225–233.
    OpenUrlAbstract/FREE Full Text
  29. 29.↵
    1. Hauk A.,
    2. Pahl I.,
    3. Menzel R.,
    4. Dorey S.,
    5. Uettwiller I.
    On the “Fate of Leachables” in Biopharmaceutical Up-Stream and Down-Stream Processes. In Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications, Proceedings of Biopoly II, Tomar, Portugal, May 7–10, 2017.
  30. 30.↵
    1. Piringer O. G.,
    2. Baner A. L.
    Plastic Packaging: Interactions with Food and Pharmaceuticals; Wiley‐VCH, 2008.
  31. 31.↵
    U.S. Pharmacopeial Convention. General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 41–NF 36; USP: Rockville, MD, 2018; pp 7910–7924.
  32. 32.↵
    1. Jenke D.
    A General Assessment of the Physiochemical Factors That Influence Leachables Accumulation in Pharmaceutical Drug Products and Related Solutions. PDA J. Pharm. Sci. Technol. 2011, 65 (2), 166–176.
    OpenUrlAbstract/FREE Full Text
  33. 33.↵
    1. Pahl I,
    2. et al
    . Development of a Standardized Extractables Approach for Single-Use Components - General Considerations and Practical Aspects. BioProcess Int. 2018, 16.
  34. 34.↵
    1. Crank J.
    The Mathematics of Diffusion; Oxford University Press, 1979.
  35. 35.↵
    1. Menzel R.,
    2. Pahl I.,
    3. Loewe T.,
    4. Hauk A.
    Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration. PDA J. Pharm. Sci. Technol. 2018, 72 (3), 298–316.
    OpenUrlAbstract/FREE Full Text
  36. 36.↵
    1. Pahl I.,
    2. Dorey S.,
    3. Barbaroux M.,
    4. Lagrange B.,
    5. Frankl H.
    Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 456–471.
    OpenUrlAbstract/FREE Full Text
  37. 37.↵
    1. Wampfler B.,
    2. Affolter S.,
    3. Ritter A.,
    4. Schmid M.
    Messunsicherheit in der Kunststoffanalytik Ermittlung mit Ringversuchsdaten, Carl Hanser Verlag GmbH & Co. KG, 2017.
  38. 38.↵
    1. Jenke D.,
    2. Couch T. R.,
    3. Robinson S. J.,
    4. Volz T. J.,
    5. Colton R. H.
    The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete. PDA J. Pharm. Sci. Technol. 2014, 68 (3), 256–270.
    OpenUrlAbstract/FREE Full Text
  39. 39.↵
    PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. Submitted to the PQRI Drug Product Technical Committee, PQRI Steering Committee, and U.S. Food and Drug Administration; PQRI Extractables Working Group, 2006.
  40. 40.↵
    1. Jenke D.,
    2. Carlson T.
    A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 407–455.
    OpenUrlAbstract/FREE Full Text
  41. 41.↵
    1. Ash M.,
    2. Ash I.
    Handbook of Plastic and Rubber Additives; Synapse Information Resources, Inc, 2004.
  42. 42.↵
    1. Maddah H. A.
    Polypropylene as a Promising Plastic: A Review. Am. J. Polym. Sci. 2016, 6 (1), 1–11.
    OpenUrl
  43. 43.↵
    1. Flick E. W.
    Plastics Additives, 1st ed.; Elsevier Ltd, 2001; Vol. 1.
  44. 44.↵
    1. Besnoin J.-M.,
    2. Choi K. Y.
    Identification and Characterization of Reaction Byproducts in the Polymerization of Polyethylene Terephthalate. J. Macromol. Sci. Part C 1989, 29 (1), 55–81.
    OpenUrl
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Using Extractables Data of Sterile Filter Components for Scaling Calculations
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
4 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Using Extractables Data of Sterile Filter Components for Scaling Calculations
Ina Pahl, Roberto Menzel, Armin Hauk, Thomas Loewe
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 523-537; DOI: 10.5731/pdajpst.2018.009647

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Using Extractables Data of Sterile Filter Components for Scaling Calculations
Ina Pahl, Roberto Menzel, Armin Hauk, Thomas Loewe
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 523-537; DOI: 10.5731/pdajpst.2018.009647
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Theoretical Considerations
    • 3. Analytical Measurement Considerations
    • 4. Experimental Procedures
    • 5. Results and Discussion
    • 6. Conclusion
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

Keywords

  • Filter cartridges
  • Filter family
  • Component approach
  • Extractables profile
  • UPLC-HRMS (QTOF)
  • Diffusion and partition coefficient
  • Effective filtration area

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire