The FDA is challenging pharmaceutical companies to develop and bring more generic drugs to market. Injectable therapies constitute a sizeable share of the generic drug product market. Additionally, there is a growing number of novel compounds slated for a parenteral format. This combination signals there will be a need for even more testing services for prefilled syringes and other injection devices.
The bulk of the requirements surrounding the physical and mechanical performance of a pre-filled syringe is covered by the ISO 11040 series of standards. Most of the testing that DDL conducts pertains to Parts 4 and 6 of ISO 11040, which govern glass and plastic syringe subassemblies, respectively, and Part 8, which defines the method requirements for fully finished pre-filled syringes.
Another of the key aspects of ISO 11040 for glass Luer syringes is the subject of connectivity. The manufacturing process produces a slippery and slightly irregular Luer taper, which can have issues forming a secure connection with some components. The ISO standard addresses this issue by recommending that certain Luer tests from ISO 80369-7 are conducted in order to demonstrate adequate connectivity to the same components which will be attached to the syringe in the actual use situation. ISO 80369-7 is the replacement for ISO 594. As a side note, the FDA will no longer accept submissions showing conformance to ISO 594 beginning in 2020.
These standards contain the information needed to conduct a technically valid test. When supplemented with information provided by the drug manufacturer, it ensures that the manufacturer, when presented to the regulatory authority, understands all judgments and rationales for the testing data.
Additional testing that accounts for drug / device interactions that will likely need to be performed to bring a pre-filled syringe product to market includes:
- Extractables and Leachables (E&L)
- USP Particulate Matter Identification and Determination.
- USP 1207 Container Closure Integrity (CCIT)
- ISO 11607 Package Validation
- Stability Studies to determine product shelf-life
To learn more about Pre-Filled Syringes and Parental Manufacturing, please read the Special Feature from the May 2019 issue of Drug Development & Delivery: https://drug-dev.com/special-feature-prefilled-syringes-parenteral-manufacturing-flexibility-for-faster-development/
If you have any questions, or need help with an upcoming test, please contact us or call us at (800) 229-4235
