In this webinar, Declan O’Shea, Product Manager for Isolators and Containment Systems at ILC Dover, shares his expertise on advanced containment solutions for potent products. He covers strategies for achieving high Occupational Exposure Limits (OEL), meeting stringent SMEAP testing criteria, and developing effective Standard Operating Procedures (SOPs). The session offers valuable insights into balancing equipment capabilities with operator handling to enhance safety and compliance in the pharmaceutical and biopharmaceutical industries.
This webinar provides a comprehensive overview of the latest technologies and methods to handle highly potent compounds, making it an invaluable resource for professionals looking to enhance their processes and maintain industry compliance.
Watch the video or explore the transcript below to learn more.
Transcript
Introduction
[Declan O’Shea] 0:06
Hello, everyone. Thank you for attending today’s ILC Dover webinar. I’m Declan O’Shea, the Product Manager for Isolators and Containment Systems at ILC Dover. I generally get involved with anything related to isolated systems and containing products of most natures within the pharmaceutical and biopharmaceutical fields, particularly handling high-potency products within closed barrier systems and aseptic or sterile manufacturing.
[Declan O’Shea] 0:51
Today, we’ll be discussing solutions for handling nanogram-potent products. This involves looking at the very high levels of OEL (Occupational Exposure Limit) and what we can do to help ourselves pass SMEAP testing criteria, which is used to show or highlight the performance of a piece of equipment and process. We’ll also talk about SOP development and the kind of containment features you want to be looking out for when developing these systems.
Agenda
[Declan O’Shea] 1:32
I always like to give a bit of an overview to see where we’re going today. I’ll start with an overview of ILC Dover for those unfamiliar with the company or who may be interacting with us for the first time. Then, we’ll briefly look at other product offerings from ILC Dover. After that, we’ll discuss the general potency of molecules in the pharma space and how that has increased over the past years, leading to our current path.
[Declan O’Shea] 2:05
We’ll talk about our involvement as containment specialists, how we engage with organizations, and the knowledge base we bring. Following this, we’ll delve into containment testing, including different types of testing, considerations around testing, and the environment and circumstances under which we conduct these tests. We’ll discuss how to set up your operation to ensure good containment system performance.
[Declan O’Shea] 2:29
We will also discuss equipment and SOPs, exploring what’s more important: the equipment side or the operator’s handling of the product. We’ll look at how to combine these elements to achieve the best performance results. Finally, we’ll focus on mechanical controls—what mechanical measures can prevent exposure and how SOP development can bridge the gaps that mechanical controls might not cover.
[Declan O’Shea] 3:49
We’ll wrap up with a summary to highlight the proven benefits of these approaches. We’ve conducted SMEAP testing multiple times on many of our systems and seen excellent performance results. This summary will outline the key considerations you need to keep in mind before choosing your equipment, supplier, or testing provider.
Company Overview
[Declan O’Shea] 4:26
Let’s start with a brief overview of ILC Dover. We’ve grown tremendously over the past few years, acquiring multiple subsidiaries to position ourselves as a turnkey solution provider in the industry. We have numerous locations across North America and Europe and account managers or sales representatives in most regions worldwide. This gives us a global presence, enabling us to assist many clients.
[Declan O’Shea] 5:14
We are primarily a manufacturing company, producing our own products using our proprietary film called ArmorFlex. This capability allows us to maintain high sourcing quality and manufacture our engineered systems. However, we are also an engineering company, providing customized solutions to meet the unique needs of our clients in this evolving industry.
[Declan O’Shea] 5:57
Our products are broadly categorized into pharmaceutical and biopharmaceutical spaces, generally centered around single-use plastic products. We offer powder transfer systems, flexible containment systems (which I’ll discuss today), PPE for both the pharma and biopharma industries, and isolator systems. We also handle media and buffer prep in our EZ BioPac product line and are developing liquid handling solutions.
[Declan O’Shea] 6:46
Beyond the pharmaceutical and biopharmaceutical sectors, we also have significant contracts in the military and government sectors, utilizing our PPE systems, which are trusted across these industries.
Important Molecules
[Declan O’Shea] 8:01
The rise of potent molecules in the pharmaceutical industry has been significant over the past decade or two. This trend is driven by the need for more targeted therapies to address modern diseases and infections. As a result, we’ve seen a shift from one-microgram OEL products to those with nanogram levels of potency. This increase in potency necessitates advanced containment solutions to protect both operators and the environment.
Containment Expertise
[Declan O’Shea] 10:16
Our expertise in containment extends across multiple industries, including life sciences, nuclear, and military sectors. We often start with proven solutions and customize them to meet the specific needs of each client. We handle hundreds of inquiries annually, allowing us to apply lessons learned across different sectors to improve our containment systems continually.
Is Containment Testing Mandatory?
[Declan O’Shea] 13:13
Containment testing is not mandatory by regulatory standards, but it is highly recommended, especially for processes involving high-potency products. The primary benefits include reassuring operators about their safety and ensuring the facility’s functionality and reliability. For contract manufacturers, containment testing can demonstrate the capability to handle potent products safely, which can enhance their market position and attract more business.
Testing Methods
[Declan O’Shea] 17:45
There are various methods for containment testing, with some being more stringent than others. The EN 689 directive, for example, is a rigorous standard that requires diverse operators and multiple test runs to ensure accurate results. We recommend this method, particularly for handling highly potent products, as it provides a comprehensive assessment of the containment system’s performance.
Testing Considerations
[Declan O’Shea] 20:27
When conducting containment tests, it’s crucial to simulate real-life conditions as closely as possible. This includes replicating the testing environment, operator interactions, and sampling methods. Both air and surface sampling are important, depending on the specific product and process. A thorough risk assessment can help identify key testing locations and strategies, ensuring the most accurate and meaningful results.
Risk Assessments
[Declan O’Shea] 25:00
Risk assessments are essential for identifying and addressing the highest levels of risk in your containment system. These assessments should inform the development of SOPs and mechanical controls to mitigate identified risks. Accurate sampling and a detailed analysis of test results are crucial for understanding and improving containment performance. Prioritize testing in high-risk areas identified through these assessments to ensure the system’s overall effectiveness.
Mechanical Controls
[Declan O’Shea] 29:38
Mechanical controls, such as airlocks, anti-chambers, and comprehensive filtration systems, are critical for preventing exposure and ensuring effective containment. Proper waste removal methods and regular integrity testing are also vital components of a robust containment system. For instance, heat-sealing waste in continuous liners has proven to be an effective method for maintaining containment integrity, especially in systems designed for nanogram-level containment.
SOP Development
[Declan O’Shea] 41:13
When mechanical controls are insufficient, SOP development becomes crucial. SOPs should be clear, detailed, and adaptable to future changes. They must account for human error and be designed to be understandable and executable by all operators, regardless of their experience level. Including visual aids and consulting with equipment providers can enhance SOP effectiveness, ensuring operators can follow procedures accurately and consistently.
Summary
[Declan O’Shea] 45:28
In summary, it’s important to work with trusted partners, have a thorough understanding of your process, and be honest about the risks involved. The combination of mechanical controls and well-developed SOPs is key to minimizing risk and achieving optimal containment performance. A balanced approach, which respects the potency of compounds and integrates both mechanical and procedural controls, is crucial for maintaining safety and compliance.
Questions
50:51
That’s the end of the presentation. If you have any questions, please feel free to ask now, or you can reach out to me via email or phone for further discussion.
[Question] 51:41
Is it necessary to protect employees with such high-level PPE while using containment systems?
[Declan O’Shea] 52:02
It’s a great question. While containment systems are designed to minimize the need for PPE, the level of PPE required depends on the specific containment performance and the risk assessment of the process. In many cases, high-level PPE can be reduced once the containment system’s effectiveness is proven through rigorous testing. However, some organizations choose to maintain PPE as an extra precaution, especially during initial stages or with particularly hazardous substances.
[Question] 53:56
Can you show some characteristics of nanogram per meter cubed isolators?
[Declan O’Shea] 54:08
Certainly. Our nanogram-level isolators are designed with advanced features such as gas-tight seals, HEPA filtration, and controlled airflows to maintain extremely low OELs. We also incorporate features like automated glove leak testing and continuous monitoring systems to ensure the integrity of the containment. If you’re interested, I can provide detailed specifications and data sheets after the webinar.
[Question] 55:50
What are the differences between using lactose and naproxen sodium as surrogates for containment testing?
[Declan O’Shea] 56:02
Lactose and naproxen sodium are commonly used surrogates in containment testing. Lactose is less costly and provides sufficient data for many standard applications. However, naproxen sodium has a much lower detection limit, making it suitable for testing systems designed for extremely low OELs. Naproxen sodium is more sensitive and can provide more precise data, especially in systems where we aim to detect contaminants at nanogram levels. It is, however, more challenging to clean and manage, requiring careful handling and disposal procedures.
[Question] 57:10
How does your team ensure that SOPs are practical and applicable across different operator experience levels?
[Declan O’Shea] 57:22
We emphasize clarity and simplicity in SOPs to ensure they are accessible to operators of all experience levels. This includes using straightforward language, providing visual aids, and incorporating step-by-step instructions. We also conduct regular training and workshops to ensure that all operators are comfortable with the procedures. Additionally, we review and update SOPs regularly based on feedback and any changes in the process or equipment.
[Question] 58:15
Can you discuss the importance of mechanical controls in the context of potential human error?
[Declan O’Shea] 58:26
Mechanical controls are crucial because they significantly reduce the reliance on human intervention, thereby minimizing the risk of human error. Automated systems, such as automated glove leak testing or integrated airlocks, ensure consistency and reliability in operations. Where mechanical controls are not feasible, we support them with robust SOPs and thorough training to mitigate potential errors. Our goal is always to create a balanced system where mechanical and procedural controls work together to ensure safety and efficiency.
Declan O’Shea 59:15
Thank you for your questions. If there are any more questions or if you need detailed information on specific topics, please feel free
