Meeting the Regulatory and Manufacturing Challenges of Modern Sterile Product Packaging

In the realm of drug manufacturing, sterile products continue to pose challenges. With process failures identified nearly every year, improvement is a continual goal. This has led to exciting innovations such as barrier systems, innovative seals, ready to use components, stoppers, isolators, closed vial filling and cap overseals.

In the manufacturing process, there are also robotics and automation, more accurate control metrics, statistical process capability, better risk assessment and management procedures, improved sterilization techniques, and rapid as well as real-time microbiological testing. However, while these innovations are all helpful, sterility, aseptic process control and processing risks are still a concern.

Sterility Assurance Still an Issue

The production of sterile drug products remains among the most challenging components of drug manufacturing. Around 80 percent of drug recalls are due to issues with sterility including lack of assurance.

Part of the problem is that a number of companies use outdated methods, despite all of the innovations available. However, many risks can be offset with hazard detection so that no harm comes to patients. The key is mitigating risk with extra vigilance in high severity areas that have a higher chance of occurrence. This is best accomplished by employing focused, ideal detection methods. High-risk, commonly occurring breaches of sterility should be the priority.

While quantifying risk during sterile product manufacturing is challenging, it all starts with an understanding of the common events and conditions that pose the biggest risks. While human error is sometimes the cause, a less than optimal process is also a major problem. These two factors can also overlap: variables like inadequate personnel training, fatigue and stressful working conditions can also cause breaches.

Striving for Continual Improvements in Process Design

Lapses in sterility can have grave health consequences. Addressing aseptic processing risks through higher quality products can help to avoid detection issues and human error.

Because the human factor is so hard to quantify, the best way to address sterility concerns is through continued improvement in process design. The best designs can actually minimize or eliminate human variables, taking aseptic process control to new levels of reliability in a range of industries.

While periodic assessment of system performance, equipment, staff training, supplier qualifications, ergonomics and human factors can be useful, improvements in packaging are of primary importance. Effective quality metrics can help, too, but continued innovation is key. The fine tuning of sterile processes and packaging in drug manufacturing continues to be the path to increased safety.