E&L for pre-filled syringes | Exclusive interview with Becton Dickinson

Ahead of her presentation at E&L China 2019 this September, we asked Kathy Huang, R&D Manager at Becton Dickinson, for her insights into future changes in the Chinese E&L industry, challenges faced, as well as a quick preview of her presentation on 'E&L study for pre-filled syringes'.

You will be speaking on E&L study for pre-filled syringes, can you give us a brief insight into what areas you are covering in your speech?

The speech will cover the classification of pre-filled syringes, characters of pre-filled syringes, the procedure of E&L in pre-filled syringes, the typical sample of compatibility study for drug in pre-filled syringes.

In your opinion, what is the #1 takeaway of your presentation?

How to do compatibility study for pre-filled syringes and the most things that need to be paid attention to with this special system.

What do you see as the most significant changes coming up in the E&L regulations in China in the next 12-24 months?

Recently, the Chinese Pharmacopoeia Commission published 18 draft standards related to pharmaceutical packaging materials for comments. General chapters for plastics, rubber will also be added in CHP. The E&L compatibility of pharmaceutical packaging materials is required in that chapters. The changes mean that high level requirement for pharmaceutical packaging materials in regulations in China. 

What are the biggest challenges that you see across the sector?

The biggest challenge is how to design a good E&L project that can meet different requirements in different countries at the same time at low cost.

Why do you feel it’s important for companies to attend E&L China 2019?

Attending E&L China 2019 is very helpful to get news in E&L, have the chance to get coaching from E&L experts, get more resource for service labs and experts, have the chance to communicate with others etc.

Who are you most looking forward to at E&L China 2019?

Meeting E&L experts 


Kathy will be presenting as part of the 'Analytical Challenges in E&L' session, alongside other speakers including CFDA Hangzhou Medical Device Testing Center, Novo Nordisk, Shanghai Food & Drug Packaging Material Control Center and more.

 

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