Containment is defined as the action of confining within a defined space a microbiological agent or other entity that is being cultured, stored, manipulated, transported or destroyed to prevent or limit its contact with people and/or the environment. Methods to achieve containment include both physical and biological barriers as well as inactivation using physical or chemical means. In short,containment is used to prevent any negative impacts (contamination) being transferred from one area to another and vice versa.

Driven by the development of more potent active ingredients and a stronger focus on health and safety by the regulatory authorities, the last 20 years have seen a significant increase in the need for contained handling and processing in the pharmaceutical manufacturing industry. So, why are drug producers interested in containment? For two reasons: minimizing operator exposure to toxic materials that cause adverse health effects and the prevention or elimination of cross-contamination.

In today’s pharmaceutical industry, despite the many safety precautions in place, hidden dangers still exist for operators involved in oral solid dosage production.Did you know, for instance, that although manufacturers take stringent steps to ensure that their production systems are as safe as possible, a fully gowned operator can still create as many 150,000 particles per minute? As such, drug manufacturing is never a completely hazard-free process.What’s more, failure to adopt appropriate measures could have disastrous consequences, from non-compliance issues to product recalls, and from legal and financial implications. Most importantly, however, it could alsonegatively impact the health and wellnessof keypersonnel.

And, given that more than 60% of pharmaceutical products are produced as tablets,capsules, lozenges or similar solids — with many of them comprising increasingly more potent active pharmaceutical ingredients (APIs) — the focus on employee well-being has never been more acute. In some markets, the segment for highly potent APIs (HPAPIs) is growing in the double-digit range, especially driven by oncology medication. In fact,the global HPAPI market is expected to grow at a CAGR of 10.3% to reach a value of $34.8 billion by 2025.

Established standards and practices in western countries are now being adopted in emerging geographies as mandatory procedures migrate from using PPE (personal protection equipment) to maintain operator safety to practicing containment at the source. The message has never been clearer: it is the first duty of the employer to protect the health of their workforce. 

In addition, it is becoming increasingly apparent to manufacturers that the implementation of seamless containment solutions offers considerable housekeeping benefits, such as

• faster changeover times owing to reduced (room) cleaning
• significantly decreased cross-contamination risks
• substantial savings (air filters, air suits, contaminated cleaning fluid, for example).

Keeping the real operating conditions of the final installation in mind, GEA can determine what level of containment is required where, optimizing the manufacturing process and making it efficient, safe and cost-effective.

Digital Canary protects your people

Navigating the maze of available hardware components and the huge variety of currently available containment solutions has made it progressively more difficult to select the most appropriate equipment for the specified task. Even for experienced people, making the right choice has become   increasingly difficult.

Help is at hand, though; GEA has a long history of expertise in this field. We not only offer a comprehensive range of robust and compliant products, our experts benefit from a thorough understanding of containment risk analysis. And, always looking to do more — and better — the latest addition to the organization’s ever-expanding portfolio is a continuous real-time monitoring system for manufacturing processes that’s completely unique.

Before getting into the details, though, let’s turn the clock back to the late 1890s when John Scott Haldane suggested that small animals — such as canaries— could be used by miners to identify dangerous levels of toxic gases (such as carbon monoxide) underground. With a faster metabolism, they reacted more quickly to the harmful effects of poisonous conditions and acted as an early detection system to the workers before the situation became critical.

Around 1911, miners started carrying canaries into mines with them … and they quickly became a metaphor for warning signs. When the canary became unconscious, it was time to evacuate and head for the surface before you become the next victim! Using songbirds in a good manufacturing practice (GMP)-compliant production environment to monitor potential hazards is, of course, not allowed. Which is why GEA has introduced its Digital Canary to enable the early detection of powders being released into the local atmosphere from production equipment.

Designed for today and the future

The 21st century equivalent of a coal-mine canary from GEA Pharma & Healthcare has been designed to detect breaches in contained pharmaceutical production lines. By providing an additional level of monitoring, the Digital Canary reduces the need for routine occupational health checks. The patented innovation comprises a sensor that provides a constant reading (compared with a baseline) of any product exposure at the sampling point. Adjustable to suit a specific particle size distribution if required, the information is relayed to a control system that initiates an alarm or corrective action if out-of-specification data is received.

Modern pharmaceutical equipment is designed to operate in a completely dust-tight manner; but, it’s absolutely critical to be fully prepared for worst-case scenarios, such as an unexpected containment breach. As the level of potentially dangerous airborne particles is often far below what can be seen with the naked eye, the Digital Canary is designed to be a fully integrated and reassuring part of modern production lines.

When the sensor detects powder levels that are above the allowed limit, a warning is sent to the operators. This enables them to leave the contaminated area as soon as possible. Once the concentration of airborne particles has returned to an acceptable level, the system will inform the operators.