Modern BioPharma Podcast

In part 2 of our water series with Brian Hagopian we discuss sampling and monitoring of pure water systems.  Understanding what is and isn't in your pure water system is critical to ensuring the safety and efficacy of your product. Brian has been a part of defining many of these rules over the decades. He was a member of the team that wrote the ISPE Good Practice Guide: Sampling Pharma Water, Steam, and Gas Processes.

Here are some of the things we covered in this episode:

What has sampling and monitoring looked like in pure water treatment over the years? 

What are the major types of constituents we sample and monitor for in a Pure Water system? 

How are these prioritized in a Pharma system? 

Why do we have to sample all over a pharma system? Why can’t we just measure like we do conductivity at supply and/or returns of a loop? 

How do you decided to use an analyzer vs sampling of various constituents?  

Want to watch this episode? Check it out at: https://youtu.be/Zq230CJqCU4

Brian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.

Did you know that standards for Microelectronics water are FAR more stringent than those for the Pharmaceutical industry? By any measure, the water used in manufacturing semi-conductors is superior to what is used in pharmaceutical manufacturing.   

On Part 1 of my discussions with Brian Hagopian from Clear Water Consulting talking water, we discussed some of what makes them different and what we can learn from what they do. Here are some questions we discuss:  

Every industry has different “drivers” for how and why certain water quality is needed. What do you see as the main drivers for water quality in the Pharma market? 

How has the Pharma market progressed over the years in relation to improving water quality? What have been the barriers? 

Can you share how the micro-electronics market is leading the way in water quality technologies? 

What are the drivers in this market and how are they able to make changes more easily/differently than the Pharma market? 

Does the micro-electronics market have the same documentation requirements as the Pharma market? 

How can the Pharma market change moving forward learning from the micro-electronics systems installed around the world? What do you see as the main risks associated with these kinds of changes?  

Want to WATCH this episode? Check it out at: https://youtu.be/hFUGMRA54xo

Brian Hagopian is an industry expert with over 30 years high purity water system design, construction, commissioning, and validation experience delivering a wide range of solutions to premiere pharmaceutical, biotech, semiconductor, research and other high technology clients. A recognized industry leader and active volunteer with numerous professional societies, past president of the Boston Chapter of the International Society for Pharmaceutical Engineering (ISPE) and contributing author and lecturer on topics associated with USP purified water (PW), water for injection (WFI) and semiconductor grade water. As a past executive for several water system companies, Brian brings extensive knowledge related to high purity systems engineering, operations, and piping system design.

On Episode 11 of the Modern BioPharma Podcast we speak with Jeff Wassenaar of Astro Pak for Part 2 of our discussion. This time we talk about Electro Polishing.   

Here are some questions we cover in this episode: 

Talk to me about Surface Finish. Why is it so important in the Pharma space? 

When I visit a Pharma facility, there is a lot of "shiny" stainless steel, where is surface finish important? 

We hear a lot about EP or electropolish? What makes it different from mechanical polishing? Is it really better? 

I’ve heard a lot of people say if something is EP’d it doesn’t need to be “passivated”...is this true? There seems to be many that say an EP finish is the “most” passive. It seems like surface finish would be difficult to maintain. 

How do companies determine when it is worth it to remediate damage to surfaces and how is this done?  

Want to WATCH this episode? Check it out at: https://youtu.be/nHBh6Dxtw7I

Do you have any questions about electro polishing? Let me know what they are and we'll work on getting you some answers.  

You can find Jeff at https://www.linkedin.com/in/jeffwassenaar/. 

You can learn more about AstroPak at https://astropak.com/

On Episode 10 of the Modern Biopharma Podcast, we talk with Jeff Wassenaar from AstroPak about Passivation. 

Some of the questions we discuss: 

How do you feel the overall knowledge of Cleaning/Passivation is in the pharmaceutical industry? 

Can you give me a quick background on what Passivation is and why it is important? 

How is passivation different from “derouging”? or “pickling”? 

What are some of the processes you get involved in from a cleaning/passivation/derouging perspective? 

Why are these processes not just automated if we know they will be necessary? 

With the increasing amount of single use facilities, how is that changing the need for passivation services onsite? 

Want to WATCH this episode? Check it out at: https://youtu.be/FNEDa-4411g

You can find Jeff at https://www.linkedin.com/in/jeffwassenaar/. 

You can learn more about AstroPak at https://astropak.com/

The Youtube video at https://youtu.be/FNEDa-4411g includes some graphics discussed during the episode.

On Episode 9 of the Modern BioPharma Podcast we have Merrilee Whitney from MilliporeSigma on to discuss the launch of the BioContinuum Platform.  

The current paradigm shift and digital transformation in biomanufacturing will result in a facility of the future that is truly an ecosystem of intensified, connected & continuous processing seamlessly coupled with uninterrupted data acquisition and analysis. Together, this will make real-time lot release and lights-out manufacturing achievable to the ultimate benefit of patients around the globe, expanding access to affordable life-saving and life-enhancing biotherapeutics.  Merrilee Whitney is the Head of the BioContinuum Platform at MilliporeSigma. 

This episode is also available on YouTube at: https://youtu.be/ehVnDIDCLio

You can find Merrilee on LinkedIn at: https://www.linkedin.com/in/merrilee-whitney-02aa939/

Want to learn more?  Check out their site at https://www.emdmillipore.com/US/en/20180329_155610

COVID-19 has had an immediate and drastic effect on the Global Economy. Particular attention has been placed on some critical industries to include the BioPharma industry and its ability to continue full scale production with the limitations placed on the Global Supply Chain.  

On today's episode, James Zwiefel from Burns & McDonnell discusses the state of our existing global supply chain and how we move forward with the "new normal" with how companies and policy makers look to balance priorities to include the risk of a scenario like a worldwide lockdown in mind. 

What does this look like? What about maintaining a more significant reserve? How much of API production should be domestic vs international? 

This conversation is just beginning. What do you think? How has this impacted your business life?  

Want to WATCH this episode? Check it out at: https://youtu.be/XKYvQUSFWmA

Connect with James at: https://www.linkedin.com/in/jameszwiefel/

Or visit Burns and McDonnell at https://www.burnsmcd.com/

Brian Duffy is the Director of Process Engineering at IPS in Chelmsford MA. His career has seen him in various positions at some of the big BioPharma companies in the Boston area. 

We cover his time in the industry, the changes in the industry modular cleanrooms have introduced,  and some of the amazing changes happening in the cell and gene therapy arena.  

Say hi to Brian on LinkedIn at: https://www.linkedin.com/in/brian-duffy-9a23387/

If you have someone you think we should interview, please reach out to me directly on my LinkedIn page at: https://www.linkedin.com/in/jesse-mclaughlin-4bb1668/

The Do's and Don'ts of commissioning a #RABS. That's one of the many things that Erich and Herman Bozenhardt have written about in their informative articles published at bioprocessonline.com. They share their experiences of helping customers through engineering and process challenges regularly in articles and their own podcast, Bioprocess with the Bozenhardts, hosted by #bioprocessonline.

The original article can be found here:

https://www.bioprocessonline.com/doc/what-you-call-that-a-rabs-real-life-aseptic-filling-blunders-to-avoid-0001

Connect with Erich here: https://www.linkedin.com/in/erich-bozenhardt-pe-a405b518/

Connect with Jesse here: https://www.linkedin.com/in/jesse-mclaughlin-4bb1668/

If you have a guest you think we should interview, or if you'd like to be interviewed, please reach out to me on LinkedIn or Twitter

Rick Pierro is an institution in the New England area Biopharma space. He has been leading his company, Superior Controls, for many years and been active in organizations like the ISPE Boston Area Chapter for as long.

Michael Rodionov is a Principal Engineer for MMR Consulting based out off the Toronto area with specialties in Clean Utilities, Sterile Fill & Finish, Washing & Sterilization, cGMP Facilities Design and both Upstream & Downstream processes.  

We had a great discussion about the Biopharma industry with a particular focus on how he and his team approach critical utilities in a plant. We also had a good conversation about project delivery models and why he thinks the small to midsize engineering firms can help their clients build a "dream team" for better project execution in the end.  

Listen in our conversation!