Interview with Waters

Ahead of the upcoming E&L China 2020 conference, we caught up with Baiba Cabovska, Principal Product Manager at Waters, who will be presenting at this December's E&L China.

Current Industry Focus:

Q. As consumers continuously demand safer solutions, what do you believe is one of the biggest concerns in the areas of Extractables and Leachables today?
  • The requirements for safer products will keep increasing not just in the pharma world, but also across other industries which utilize plastic or elastomeric materials. The concern is always around exposing customer and or patients to unnecessary risk - especially if they take a drug or use a medical device for a prolonged period of time. In addition, while there is plenty of toxicological information on individual extractables, there are significant challenges in more precisely evaluating risks where multiple extractables may be migrating from the same product and how their combination may  impact patient health in the long term.
Q. What are some of the biggest opportunities gaining attention within the Extractables and Leachables field and how has Waters chosen to react or adapt with evolving industry trends?
  • The industry has been looking to regulatory authorities in setting clear expectations for quite some time with many arguing that changes to the current regulations are well overdue. The general sentiment across the industry implies that any clarification in testing requirements will be well received across the world. Recent updates to regulations and guidances such as those suggested through the EU Medical Device Regulations (EUMDR) or USP chapters will help streamline required E&L testing. Of critical importance is how organizations will update their processes to ensure compliance with new regulatory requirements in order to move their products to market as quickly as possible. Through its partnerships and collaborations throughout the industry, Waters maintains a thorough understanding and offer support in understanding how regulatory changes will impact its customers. In addition, Waters actively leverages customer challenges and emerging regulatory requirements in enhancing its portfolio to help the industry meet even the most stringent analytical testing challenges.

Future Focus:

Q. What industry topics are currently getting the most attention and how are they influencing the future of pharmaceutical packaging and medical device materials?
  • Sustainability seems to be among the hottest and most promising topics - especially for manufacturers of packaging and other materials used in medical devices. Currently, it is a challenge to include recycled materials into medical devices and pharmaceutical packaging. If there were well characterized approaches to understand all the potential migrants from variety of materials, it would be less challenging.
Q. What does your company/organization hope to achieve over the next 5 years with regards to the future of pharmaceutical packaging and medical devices?
  • For Waters, our primary goal is to continue supporting our customers with their analytical challenges in E&L applications, and help them to offer end users the most reliable and safest products possible. In parallel, Waters highly collaborative approach allows us to work with our customers closely in finding ways to streamline testing, ensure consistency across multiple labs and technologies, and enable an environment for accelerated innovation.
Q. What opportunities are there for harmonization of pharmaceutical packaging and medical devices in the Asia Pacific region?
  • In the increasingly global marketplace, both drug products and medical devices are being manufactured and sold all across borders. Through harmonization of regulations, both manufacturers as well as the end users will benefit from a consistent set of regulations aimed at meeting an enhanced level of safety regardless of where in the world the product is manufactured. With a majority of products and components typically manufactured across Asia Pacific, the region  has the potential to set a great example by creating harmonized safety standards for extractable and leachable testing.
Q. What do you expect the future regulatory landscape for Extractables and Leachables look like in China?
  • I expect the regulations in China to evolve and deliver clear directions for local manufacturers as well as international suppliers relevant to the  Chinese market. It’s really all about making the products as safe as they are effective for patients across all countries.

Conference Related:

Q. Which presentations or what session topic are you most looking forward to hearing about at E&L China? 
  • My favorite talks are usually around case studies, especially when the speakers describe a challenging situation and how it was ultimately solved. The presentations on the local regulations in China will definitely be on my list as well.