While the world waits for a vaccine for the Coronavirus, pharmaceutical companies must also look at what will be involved in administering it safely to the public. We spoke with Michael Goehring, Medical Industry Manager at ZwickRoell in North America, about the role of materials testing in the development of a vaccine and the importance of reliable test results.
ZR: What role does materials testing play in the development of a Covid-19 vaccine?
MG: Materials testing plays in important role in vaccines in general and none more important than the Covid-19 vaccine as we must reach 60 - 70% of the global population to be immunized to reach what is considered heard immunity. Vaccines are packaged in a vial, administer by a nurse or nurse practitioner who draws up the dose via a single-use syringe, clears the air from the syringe and administers the dose to the patient. The vial must be sterile; common tests for this are Container Closure Integrity and Residual Seal Force (RSF), the latter of which is typically more efficient. The syringe and the needle must be tested for performance and safety. Finally, the person who administers the vaccine must be protected by personal protective equipment (PPE) that all must have the appropriate materials testing performed.
ZR: Let’s take a closer look at the testing of the vials. Why is a residual seal force test more efficient than testing for container closure integrity?
MG: A CCI test is the standard that must be measured, however the test takes a long time compared to an RSF test. When we think of the sheer volume of vials that will need to be tested (~200M in the US and 4.7B globally) to obtain “heard“ immunity, the time to run a test quickly is of utmost importance to deploy the vaccine rapidly. For this reason, RSF tests are run as they are performed much more quickly than CCI test. For RSF tests to be a valid replacement, there is an initial correlation study that must be performed between CCI and RSF. Once this study has been completed and appropriate bounds set, the testing can be moved to an RSF test. ZwickRoell offers an RSF testing system with testXpert III software for traceable and tamper-proof test result in accordance with FDA 21 CFR Part 11.
ZR: What are the various tests involved in testing needles and syringes? What solutions does ZwickRoell offer for these tests?
MG: A syringe with a needle is a hazardous device that must be tested for safety reasons and to make certain that the correct dose is administered as painlessly as possible. ISO 7886-1 covers the testing requirements of sterile hypodermic syringes for single use. One of the most common tests measures break away and glide force as these criteria impact how “painless” a vaccine can be administered while obtaining the proper effective dose. Once again, this is a standard solution that ZwickRoell can provide.
ZR: And of course, PPE needs to be tested so that healthcare workers are protected. How can ZwickRoell solutions provide reliable testing in this area of the healthcare industry?
MG: The nurses and doctors are our frontline essential workers, this pandemic has shown just how vulnerable they are. Our healthcare workers must be able to easily swap out PPE as needed without failure. Items as simple as gloves, if not test properly, can fail during application. Each piece of PPE must be tested to ensure they do not fail. ZwickRoell provides reliable and traceable testing equipment for gloves, masks, and gowns that ensures that healthcare workers are not put at further risk.