In this webinar, ILC Dover Technical Sales Manager Declan O’Shea explores how drug manufacturers, contract manufacturing teams, and R&D groups can control oxygen and humidity within flexible film isolator systems. With the correct engineering controls, sub 1% relative humidity and PPM oxygen levels are possible.
What is possible with single-use isolated technology in life sciences? Gain insight to see where you can take your new product or current processes in the future with an in-depth review of how to leverage this technology for the safe handling of products sensitive to oxygen and humidity.
WATCH: Safe Handling of Oxygen & Humidity Sensitive Products with Single Use Containment Technology
Transcript
[Declan O’Shea] 0:04
Hello, everybody. Good morning, afternoon, evening. My name is Declan O’Shea. I’m the Product Manager for Isolators and Containment Systems here at ILC Dover. Thank you very much for attending our webinar on controlled environments: safe handling of oxygen and humidity-sensitive products within single-use containment technology.
Summary
0:27
If you are familiar with our webinar series, we provide insights into certain parts of the containment industry and containment applications that may be useful to drug manufacturers, contract manufacturing, and research and development groups. We aim to help you understand what is possible within single-use isolator technology and the general scope of life sciences, offering insights on how you could take your new product or process forward.
1:06
Here’s a summary of today’s agenda:
- Overview of ILC Dover and its product offerings.
- Creating the right environment for your process.
- Our expertise as containment specialists.
- Process considerations for maintaining your desired environment.
- Discussing four different operations with varying levels of control and complexity.
- Summary of proven benefits that the system can offer for your processes.
ILC Dover Overview
3:27
As a company, ILC Dover primarily focuses on manufacturing and engineering solutions for customer requests and problems. Starting pre-World War II with latex products, we have evolved to making spacesuits for NASA missions and various pharmaceutical products. Our offerings include single-use bag systems for powder transfer and containment, biologic space liquid bags, fluid transfer assemblies, and isolator systems. We have a global presence with recent expansion in Asia.
ILC Dover Products
4:50
In life sciences, we work in the pharmaceutical and biopharmaceutical industries. Our products include flexible IBCs, powder bags, flexible containment systems, PPE, single-use powder applications, media and buffer handling, sterile manufacturing isolators, and 2D liquid bags. Today’s focus will be on the crossover between pharmaceutical and biopharmaceutical applications requiring low humidity and low oxygen environments.
Creating the Right Environment
5:50
Creating the right environment means ensuring that your product is handled in a way that prevents cross-contamination and protects both the product and the operator. This involves considering air flow, containment, and the specific environment needed for different applications, such as anaerobic environments for cell banking or low humidity for dry powder inhalation.
Our Involvement as Containment Specialists
8:00
Our experience as containment specialists comes from handling a wide range of applications across various industries, including nuclear and atomic. We see thousands of inquiries each year, and while we may not convert all of them, we gain valuable experience. We use this knowledge to develop innovative products that cater to multiple markets, ensuring sensitive environments for protecting products under low humidity and low oxygen conditions.
Process Considerations
10:08
Before starting your process, consider what is needed to maintain the desired environment. The best gases to use, such as nitrogen or argon, will depend on the required oxygen levels. For extremely low levels, pure inert gases may be necessary. For low humidity, compressed dry air can be a cost-effective solution. Safety considerations are crucial when handling inert gases, ensuring proper ventilation and sensor systems to prevent accidents.
Basic Operation – Manual Gas Saturation
15:00
For basic operations, a simple containment system with manual gas control may suffice. This setup includes a nitrogen inlet and a ventilated sleeve for exhausting air. Manual systems can achieve desired oxygen levels quickly but require constant monitoring. This low-cost solution is suitable for basic experiments or development processes.
Expanded Operation – Gas Mixing and Flow Control
17:51
For more controlled environments, consider a system with a gassing tower that allows for automated gas mixing and flow control. This setup includes a feedback loop to maintain negative pressure and consistent air saturation. It’s a step up from manual systems, providing more accuracy and repeatability for development operations.
Complex Operation – Purge and Recycle
20:56
For processes requiring higher control and flexibility, a more comprehensive system with multiple chambers and data recording capabilities is ideal. This setup allows for precise control of oxygen levels and the ability to run different processes with varying requirements. Safety features and alarms ensure reliable operation.
Unique Operation – Purge and Catalyst Control
23:16
Our most unique and recent development involves creating an environment with 10 ppm oxygen levels for anaerobic cell banking. This system uses radio frequency welding, gas-tight zippers, and palladium catalysts to maintain extremely low oxygen levels. It’s suitable for long-term processes requiring consistent anaerobic conditions.
Demanding Processes – What is Possible?
29:32
For more demanding processes requiring multiple environments, we can combine different systems to meet your needs. Examples include low oxygen and sterile environments, low humidity with high airflow, high containment with low oxygen, and specific humidity control. Our experience across industries allows us to create tailored solutions for complex processes.
Proven Benefits
35:37
Key takeaways include ensuring the right gas and equipment for your environment, conducting thorough risk assessments, and choosing a system that fits your process needs. Mechanical controls should be prioritized over operator controls for safety and process assurance. Consider scalability and upgrading systems as needed.
39:08
That’s it for today’s presentation. I hope you found it informative. If you have any questions or need further information, please feel free to reach out via chat, email, or phone. Thank you for your attention, and enjoy the rest of your week.
