Vaccine Delivery Device and Packaging Testing

Solution

• Software-controlled tensile and compression testers.
• Precision torque testing systems with software control.
• Customised grips and fixtures matched to component geometry.

Benefits

• Intuitive software enables bespoke procedures or international standard compliance.
• Grips and fixtures can be changed to test with a number of different things.
• Automated routines are used to simplify the QC checks during the manufacturing stage.
• Comprehensive reporting provides audit-ready documents.

Requirement

The complexity of the COVID-19 vaccines' development and production processes, along with the urgent necessity to introduce them into practice, put high importance on the intensive testing of the vaccine delivery devices and containers. Vaccines can be given orally, intramuscularly (IM), subcutaneously (SC), intradermally (ID), or intranasally (ID). Both of the administration techniques also depend on the use of a medical machine, which should satisfy high safety and regulation requirements.

FDA 21 CFR Part 11 compliance guarantees the integrity of the electronic records and reliability, as well as secure storage of data and complete audit trails. To ensure compliance with regulations, testing software should be able to support the requirements.

Solution

In injecting vaccines (SC, IM, ID), sterile needle-like machinery is employed, with the needle size being customized to suit the demographics of the patients. The force testing ensures that there is smooth operation of the plunger, which reduces the stiction that would lead to painful insertion of the needle. Consumption of puncture-resistant tests is used to check the sharpness of needles, whereas axial loads and torque tests of Luer connectors to ISO 80369 verify secure fixation.

Special hereditary measures, like intranasal multi-dose spray pumps, should also be taken into consideration. The nozzle, the spring, the actuator, and the valve should be able to work under frequent operation. Force and torque tests guarantee the variability of operation, accurate dosing, and durability of devices in the long term.

Vaccine packaging is vital because it helps in keeping sterility and safeguarding delicate biological substances. Vial, ampoule, bottle, and closure tests are used to determine container closure integrity (CCI), performance of elastomeric stoppers, and resistance to peeling, tearing, or deforming under storage and transportation environments. Previously plotted temperature extremes like dry ice storage, can have an influence on CCI, which causes loss of elasticity of the stopper. To maintain the seal integrity, it is important to apply appropriate capping and crimping of the seals.

Force and torque testing systems are used to evaluate the following:

• Tensile performance of elastomeric closures.
• Peel and tear properties of flexible and rigid packaging.
• Torque requirements for maintaining CCI.
• ISO 11607-1, EN 868-5, and ASTM F88 standards.

Presto Stantest has a history of more than four decades of competitive experience in providing stable and affordable testing solutions to the medical device and packaging industry. We have experience in IQ/OQ/PQ guidelines and FDA 21 CFR Part 11, which makes our materials, force, and torque testing-related problems present with accurate and repeatable results.

Test Equipment

• Compression, tensile, and force testers.
• Precision torque testing systems.
• Standard and custom-fit grips and fixtures
• 3D-printed bespoke fixtures to match complex component geometries.