Investigation of Air–Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents

References

1. 1.↵
   1. Sharnez R.,
   2. Monk M.

   Strategies for Enhancing the Performance of Cleaning Processes–Part I: A Framework for Assessing Performance. J. Validation Technol. 2011, 17 (1), 36–39.

   OpenUrlGoogle Scholar
2. 2.↵
   Guide to Inspection of Validation of Cleaning Processes; U.S. Food and Drug Administration: Rockville, MD, 1993; pp 1–6.

   Google Scholar
3. 3.
   1. Cordoba-Rodriguez R.

   Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations. PDA J. Pharm. Sci. Technol. 2010, 64 (5), 445–450.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
4. 4.
   1. Chalk S.

   Raw material variability: The Biopharmaceutical Industry Is Developing a New Approach to Controlling Variability in Raw Materials. Biopharm. Int. 2014, 127 (4), 38–39.

   OpenUrlGoogle Scholar
5. 5.
   USP. First Supplement to USP 38-NF 33, Reference Tables/Description and Solubility, United States Pharmacopeial Convention: Rockville, MD, 2015; p 7219.

   Google Scholar
6. 6.↵
   1. Pahl I.,
   2. Dorey S.,
   3. Barbaroux M.,
   4. Lagrange B.

   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 TextGoogle Scholar
7. 7.↵
   1. Ding W.

   Determination of Extractables and Leachables from Single-Use Systems. Chemie Ingenieur Technik 2013, 85 (1-2), 186–196.

   OpenUrlGoogle Scholar
8. 8.↵
   1. Hammond M.,
   2. Nunn H.,
   3. Rogers G.,
   4. Marghitoiu A. L.,
   5. Nashed-Samuel Y.,
   6. Anderson C.,
   7. Vandiver M.,
   8. Kline S.

   Identification of a Leachable Compound Eetrimental to Cell Growth in Single-Use Bioprocess Containers. PDA J. Pharm. Sci. Technol. 2013, 67 (2), 123–134.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
9. 9.↵
   1. Jurkiewicz E.,
   2. Husemann U.,
   3. Greller G.,
   4. Barbaroux M.,
   5. Fenge C.

   Verification of a New Biocompatible Single-Use Film Formulation with Optimized Additive Content for Multiple Bioprocess Applications. Biotechnol. Prog. 2014, 30 (5), 1171–1176.

   OpenUrlGoogle Scholar
10. 10.↵
    1. Pritchard G.

    Plastics Additives: An A–Z Reference. Springer Science+Business Media BV: Dordecht, Netherlands, 1998.

    Google Scholar
11. 11.↵
    1. Wypych G.

    Handbook of Antiblocking, Release, and Slip Additives; ChemTec Publishing: Toronto, Ontario, Canada, 2005.

    Google Scholar
12. 12.↵
    1. McDonald G. R.,
    2. Hudson A. L.,
    3. Dunn S. M.,
    4. You H.,
    5. Baker G. B.,
    6. Whittal R. M.,
    7. Martin J. W.,
    8. Jha A.,
    9. Edmondson D E.,
    10. Holt A.

    Bioactive Contaminants Leach from Disposable Laboratory Plasticware. Science 2008, 322 (5903), 917–917.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
13. 13.↵
    1. Haider S. I.,
    2. Asif S. E.

    Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries; CRC Press: Boca Raton, FL, 2010.

    Google Scholar
14. 14.↵
    1. Ebnesajjad S.,
    2. Ebnesajjad C.

    Surface Treatment of Materials for Adhesive Bonding, 2nd ed.; Elsevier Science: Waltham, MA, 2014.

    Google Scholar