High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 1. Method Development and Validation

References

1. 1.↵
   Department of Health and Human Services. Container Closure Systems for Packaging Human Drugs and Biologics, CMC Documentation, Guidance for Industry. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER): Rockville, MD, 1999.

   Google Scholar
2. 2.↵
   Department of Health and Human Services. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. Guidance for Industry. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM): Rockville, MD, 2008.

   Google Scholar
3. 3.↵
   Department of Health and Human Services. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Guidance for Industry. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Office of Regulatory Affairs (ORA): Rockville, MD, 2004.

   Google Scholar
4. 4.↵
   EudraLex. The Rules Governing Medicinal Products in the European Union, Volume 4. EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 1 Manufacture of Sterile Medicinal Products. Brussels, Belgium: European Union, European Commission, DG Enterprise and Industry - Pharmaceuticals Unit, November 25, 2008 (rev.).

   Google Scholar
5. 5.↵
   ASTM F2338–09 (2013) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method. ASTM International: West Conshohocken, PA.

   Google Scholar
6. 6.↵
   1. Möll F.,
   2. Doyle D.,
   3. Haerer M.,
   4. Guazzo D.

   Validation of a high voltage leak detector to use with pharmaceutical blow-fill-seal containers—a practical approach. PDA J. Pharm. Sci. Technol. 1998, 52 (5), 215–227.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
7. 7.↵
   Lenox Laser, 12530 Manor Road, Glen Arm, MD 21057 (www.lenoxlaser.com).

   Google Scholar
8. 8.↵
   Nikka Densok USA, Inc., 610 Garrison Street, Suite D, Lakewood, CO 80215 (www.nikkadensok.com).

   Google Scholar
9. 9.↵
   TellTech Service Corp., 333 Rockledge Road, Mahopac, NY 10541 (www.telltechusa.com).

   Google Scholar