Glass Technology Services spoke to the manager of the chemistry department, Amy Meysner, about choosing a supplier and the role GTS can play.
Tell us a little about your background and your area of expertise?
Prior to becoming the chemistry manager for Glass Technology Services in 2016, I was a laboratory technician, and I have a degree in forensic bioscience. Recently, I also took on the role of technical quality manager.
I’m a leading expert in chemical durability and elemental migration, specialising in delamination – both in terms of risk assessment and investigative analysis to determine packaging suitability. I’m also an active member of various technical committees, including the ICG Technical Committee TC2 (glass durability and analysis) and the ICG Technical Committee TC12 (pharmaceutical packaging).
Sourcing a new supplier for primary packaging can be a difficult decision. What would you advise pharmaceutical companies to look for?
Ultimately, they are responsible for ensuring the suitability of the container. So there’s a lot to consider, and ongoing support and communication with the glass supplier is essential.
They need to establish clear agreements about the quality of the products. And feel assured that if something should affect the quality, they will be alerted promptly, and steps will be made to rectify the issue quickly.
They should also ensure the supplier’s internal quality control processes include trending and monitoring so they’re staying ahead of developments in the industry. Plus, there should be opportunities to audit them.
In terms of the product itself, consider the manufacturing process, post formation surface treatments, coefficient of thermal expansion, and whether they make their own feedstock or source it elsewhere.
How can we support pharmaceutical companies who are switching suppliers?
We can provide assurances about the product they are buying by carrying out comprehensive testing. Our analysis meets industry quality-standards to ensure the packaging meets international pharmacopoeia regulations.
We are highly skilled in
- delamination screening following guidance in USP <1660>
- pharmacopoeial testing to USP <660> and EP 3.2.9
- extractables/leachables assessment following guidance in USP <1664> and <1663>
- result interpretation
- fracture analysis
- dimensional testing
Importantly, we take the time to understand the client’s specific requirements and create bespoke method protocols, so we offer a service fully catered to their individual needs. We then provide a thorough interpretation of the results, plus ongoing support and recommendations.
What are you looking for when assessing primary packaging?
We analyse the quality of the standalone product, the glass type and composition, and whether it adheres to the client’s specifications and industry standards.
We also test the performance of the vial in contact with the drug product over the intended shelf life, and its performance under stress conditions.
Plus, we conduct comparative analysis to ensure the best container is selected in terms of performance and cost.
What impact do the results of the analysis have?ì
Our analysis validates any results or claims made by a supplier. So, as a pharmaceutical company, you can make informed decisions and have confidence in the product, and therefore in patient safety.
Our testing can also have a huge impact in terms of financial losses which could arise from incorrect product, packaging or storage decisions.
Contact us to find out more
Glass Technology Services can put you in touch with an expert who can advise you about the next steps. Call +44 (0) 114 290 1801 or Email email@example.com.
Find out more about the full range of technical service packages available to the pharmaceutical industry.