Sepha aids biotech company with complex CCIT challenge in radiopharmaceuticals
Synopsis
Challenge
A biotech company faced challenges in bringing a new radiopharmaceutical oncology drug to market due to the FDA's requirement for a deterministic CCIT method. The testing needed to be non-destructive and conducted in a radiation-safe environment, capable of detecting even the smallest leaks to ensure product integrity and safety.
Solution
Sepha provided a tailored solution with their Multi-Q machines using pressure decay testing. This met the biotech company's needs by ensuring a deterministic testing process suitable for a sealed, pressurized environment, with effective leak containment and user-friendly operation.
Benefit
Implementing Sepha's solution enabled the biotech company to achieve regulatory compliance, realise significant cost savings, and improve operational efficiency. This approach enhanced safety for personnel, and product integrity, facilitating the successful market launch of their radiopharmaceutical oncology product.
Developments in radiopharmaceuticals
In the rapidly evolving biotech industry, developments in radiopharmaceuticals represent a significant leap forward in personalised medicines, particularly in oncology. The biotech company in focus is at the forefront of this innovation, creating bespoke, high-value drugs in small batches. Their products, encased in glass vials, are critical in treating cancer patients and have a short half-life, making every unit incredibly valuable.
Nuclear medicines: balancing safety and efficiency
The biotech company encountered several challenges that needed addressing before they could bring their new radiopharmaceutical oncology drug to market. The FDA required a deterministic CCIT method, which had to be highly sensitive to detect even the smallest defects in the vials, ensuring the product’s integrity. However, working with nuclear medicine introduces unique difficulties:
- Controlled Environment
Testing had to take place in a controlled, sealed chamber to prevent radiation leakage, with the room being pressurised to ensure any leakages would exit through exhaust vents. - Non-Destructive Testing
The drug’s high value and limited isotope supply necessitated a non-destructive testing method so that any vials passing the test could be returned to the production line. - Safety and Containment
The CCIT solution needed to fit within an isolated chamber or glovebox with enhanced radiation shielding. Large rubber gloves attached to these gloveboxes would allow for handling of the vials and the machine while maintaining isolation. - Human-Machine Interface (HMI)
The HMI needed to be large enough to be operated with large rubber gloves or compatible with a remote monitor and input device. - Leak Detection Sensitivity
Given the potential risks associated with even minor leaks, the CCIT methods for nuclear medicine needed to be highly sensitive to detect micron defects that could compromise the product’s integrity.
Multi-Q technology
Sepha provided a tailored solution by installing several Multi-Q machines utilising pressure decay test method, with each production line equipped with a dedicated Multi-Q machine. These machines were positioned in containment chambers within a pressurised room, designed to safely exhaust any potential radiation leakage. By opting for pressure decay testing over vacuum decay, the company avoided the pitfalls of vaporising radioactive liquids that risked contamination and health hazards. This approach allowed for a deterministic pass/fail outcome without damaging the vials, thus enabling the safe return of passing products to the production line.
Additionally, the design of the machinery facilitated the rapid containment of leaks, limiting contamination solely to the tooling. Operating within a glovebox environment provided safe handling and operations, even under the constraints of large rubber gloves. The tooling was ergonomically designed for ease of use within the containment unit, ensuring operators could effectively handle the tooling while wearing the gloves. The user-friendly Human-Machine Interface (HMI) also is designed for glove operation, ensuring accuracy and efficiency in operations.
Achieving regulatory success and cost savings
The implementation of Sepha’s Multi-Q machines with pressure decay test methods resulted in significant positive outcomes for the biotech company:
- Regulatory Compliance
The deterministic and non-destructive CCIT method met FDA requirements, enabling the company to proceed with bringing their radiopharmaceutical oncology drugs to market. - Cost Savings
By utilising non-destructive testing, the company avoided the prohibitive costs associated with destructive methods, ensuring that valuable product was not wasted. - Operational Efficiency
The seamless integration of the Multi-Q machines at the production lines ensured minimal disruption and maximised productivity. - Enhanced Safety
The pressure decay method and containment measures provided a safe testing environment, protecting personnel and maintaining product integrity.
Leading the way in radiopharmaceuticals
The partnership between Sepha and the biotech company exemplifies how innovative solutions can overcome complex challenges in the biopharmaceutical industry. By implementing a tailored CCIT solution, Sepha enabled their client to achieve regulatory compliance, enhance operational efficiency, and maintain product integrity—all while ensuring safety and cost-effectiveness.
Looking ahead, the biotech company is well-positioned to continue its pioneering work in radiopharmaceuticals, supported by Sepha’s reliable and robust testing solutions. This collaboration highlights the potential for ongoing innovation and success in addressing the unique demands of the biotech industry.
Ready to see how Sepha can help your business achieve similar success? Book a demo with our team today, get in touch on +44(0)28 9048 4848 to learn more about innovative CCIT solutions.
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