Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
| Autor: | Joerg Luemkemann, Jakob W. Buecheler, Alexander Streubel, Silke Mohl, Henning Gieseler |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Immunoconjugates
Time Factors Materials science Manufacturing process Pharmaceutical Science 02 engineering and technology 021001 nanoscience & nanotechnology Residual 030226 pharmacology & pharmacy Seal (mechanical) Vial Visual defects Injections 03 medical and health sciences 0302 clinical medicine Pharmaceutical Preparations Technology Pharmaceutical Process control Drug product Composite material Drug Contamination 0210 nano-technology Drug Packaging |
| Zdroj: | PDA Journal of Pharmaceutical Science and Technology. 73:111-120 |
| ISSN: | 1948-2124 1079-7440 |
| DOI: | 10.5731/pdajpst.2018.008870 |
| Popis: | The capping of vials plays a critical role in drug product manufacturing process due to its complex interplay of several adjustable process steps. Seal quality, integrity and assurance of containment is essential for parenteral pharmaceuticals as the vial’s content may be contaminated, or in case of highly potent drugs (e.g. antibody drug conjugates) may bear a risk of contamination. The residual seal force (RSF) method can enable further insight in capping equipment settings independently of the container closure system (CCS) and their resulting seal quality. The present study investigates the accuracy of the RSF method focusing on different force settings, RSF development over time, distance between capping plates and vial neck (roller-axis), time point of flip-off button removal and internal and external vial pressure differences (flight simulation and vials closed under vacuum). Results show that the forces used on a RSF tester should be kept low to minimize deformation of the CCS and a period of stable RSF values after the initial decrease should be implemented between capping and RSF measurement to increase accuracy. Variations in the distance between the capping plates and vial neck (roller-axis) can result in incomplete crimps, or visual defects of the seals. Additionally, the time point of removal of the flip-off button as part of the sample preparation had no significant impact on RSF measurements. Finally, pressure differences between the vial interior and exterior had no significant impact on the RSF data. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|