Something driving this growth is the additional knowledge being obtained for existing compounds that were previously not considered to be HPAPIs. As new toxicity data are generated, some of these compounds are being reclassified as HPAPIs. This is coupled with rising cancer rates, which are creating an increasing demand for more effective, better targeted medications using potent compounds.
Establishing an effective containment infrastructure is key to any production involving HPAPIs. Employee safety is paramount; however, regulatory compliance is also critical. To that end, managing the manufacture of new and reclassified HPAPIs is placing increasing pressure on existing manufacturing facilities.
Performance validation testing
Performance testing is critical for effective containment assurance in the pharmaceutical manufacturing environment. Manufacturers generally assess every new control device according to the International Society for Pharmaceutical Engineering’s (ISPE) SMEPAC (Standardised Measurement of Equipment Particulate Airborne Concentration) guideline to evaluate its particulate containment performance before it can be implemented within their process.
It is the industry standard guide for containment performance testing and it forms a basis for users to perform analyses and compare different technologies. It is also used to directly influence the selection process of containment devices and has been adopted by containment equipment manufacturers to evaluate and benchmark the performance of their equipment capabilities.
However, it is important to understand that SMEPAC is a guideline; and, although it is ideal for testing equipment within a laboratory environment and offers a good indication of performance within these conditions, variables need to be taken into consideration when testing within a production environment.
Disposable and wireless technology
The smart monitoring of containment solutions is now enabling users to understand the health status of the technology used and ensure efficiencies. Confirming all containment technologies are functioning correctly is vital for keeping employees safe, maintaining compliance with regulations and making production as efficient as possible.
There are several approaches available to monitor containment system performance and usage levels, including traditional modelling, manual checking and fully integrated automated assessment systems. However, wireless monitoring is one solution that can deliver real-time information at lower costs.
For example, split butterfly valves (SBVs) provide an effective way to transfer material into a process while ensuring containment.
Wireless monitoring technology can communicate critical usage data from multiple valve installations to health and safety, compliance and maintenance teams.
Recording usage data, such as how many times the valve has been opened and closed, allows manufacturers to understand the health status of their transfer device. It is a continuous and automatic process that facilitates maintenance planning and can avoid costly downtime.
Furthermore, manufacturers are increasingly looking at low-cost alternatives to traditional containment equipment, including single-use technology. Some of the main benefits of doing so include reduced operator contamination and washing and cleaning validation activities.
The utilisation of disposable SBV technology is now possible within the manufacturing environment; however, the achievable performance must be equal to its reusable equivalent and the selection of single-use technology must not just be based on its commercial merits.
Final thought
Integrating different technologies by different suppliers into a contained production line is highly challenging. However, using valve-based engineering controls to create common interfaces between different technologies can provide a cost-efficient and flexible means of establishing a contained environment.
In addition, using smart technologies to monitor device usage, manufacturers can better control risk and ensure consistent system integrity. For manufacturers using HPAPIs, these innovative techniques can help them meet their high potency handling requirements and ensure the safety of their employees. It’s a win-win.
