In the $1.3-trillion biopharma industry, consistency and quality are crucial and go hand in hand. Pharmaceuticals are subject to extensive regulations, best practices, and industry guidelines that pharma companies must follow down assiduously. Among those regulations and best practices is ensuring the appropriate production, storage, and transport environments of their products. It’s essential that they continuously measure and monitor a range of environmental conditions that include relative humidity levels.
Traditional HVAC (heating, ventilation, and air conditioning) systems were designed with people in mind, providing them with a comfortable working environment. With a typical HVAC system, you can expect relative humidity to hover around 40-60% and ambient temperatures to range between 18ºC and 23ºC.
Our bodies enjoy optimal comfort in this temperature and humidity range, as we don’t feel either too cold or too hot. However, pharma research, manufacturing, storage, and distribution environments call for both humidity and temperature to be controlled at tighter limits. Even a deviation of 1% in relative humidity can have serious consequences for the integrity and quality of pharmaceutical products and equipment.
Moreover, relative humidity depends on various factors, many outside the control of management, that include:
- Manufacturing procedures, cleaning cycles, and plant operator behaviors
- The climate, geographical location, airflow control, building insulation, and capacity of the manufacturing or storage space itself
- Materials in use and their humidity-sensitivity properties like hygroscopicity
- Specific good manufacturing practices (GMP) that you’ve put in place
Clearly, relative humidity levels in pharma settings must be measured and monitored consistently and regularly to ensure product quality and consistency. However, this is far from the only reason pharma companies must track humidity levels.
1. Ensuring Pharmaceutical Product Quality
Whether you’re on the last phase of a clinical trial, transporting consumer-ready drugs, or reviewing Covid-19 vaccines storage conditions, consistent quality is non-negotiable for pharma companies. Subjecting products to poor environmental controls, especially when it comes to humidity levels, can cause a variety of effects on the pharma supply chain.
For example, relative humidity levels lower than 45% are known to enable an undeterred buildup of static charges in a manufacturing line. As if that isn’t terrible enough, an accumulation of static charges can cause pharmaceutical products like tablets to stick to one another, potentially leading to quality, packing, and marketing nightmares. And, if solvents play any role in the manufacturing process, you can expect the products to dry out, impacting their efficacy and quality.
On the flip side, high levels of relative humidity can result in the degradation of some antibiotic tablets, reducing their efficacy. It can also cause pharmaceuticals to take up more moisture during manufacturing and packaging phases. Don’t forget that packaging under high humidity conditions can degrade moisture-sensitive products over the long haul.
The need for humidity monitoring doesn’t just protect the products; it can also make a vast difference within the production equipment. For instance, coating tablets using aqueous solutions requires tight restrictions on humidity to ensure the coating dries at the right rate of time. In some cases, relative humidity must be maintained in the 95-98% range to make sure the ink doesn’t dry out entirely during the coating process.
For these reasons, pharma companies must provide the control and monitoring of relative humidity to protect product quality and ensure optimum productivity. This is precisely where thermal or humidity data loggers come into the picture. According to Dickson, humidity monitors in the pharma industry can be used both for monitoring ambient environments (such as where final products are stored) and in processing units, such as reactors and ovens.
2. Gaining a Competitive Advantage
When it comes to pharmaceutical R&D, having the necessary environmental controls can influence the speed and efficiency of bringing a new drug or vaccine to market. For example, during production, manufacturing yields are usually low until temperature and humidity (aka thermal conditions) are precisely controlled. A pharma company cannot effectively ramp up production until they find the humidity sweet spot for coating new tablets.
The control of temperature and humidity has been shown to play a critical role in this. Poor humidity control can leave tablets with non-uniform coatings, and the whole batch may end up being wasted. Discarding products that are imperfect and do not meet regulatory standards can have financial implications, too.
Putting in place a robust environmental monitoring system is perfect for tracking humidity levels and can provide pharma companies with the much-needed edge over their competitors.
3. Realizing Long-Term Return on Investment (ROI)
Upgrading to web-based data logging solutions for humidity control and monitoring can save pharma companies money in the long term. After all, these state-of-the-state control systems that measure, monitor, and record humidity levels automatically reduce the odds of human error. To cap it off, the data loggers can alert the appropriate personnel to excursions in safe environmental conditions to aid in restoring appropriate conditions and safeguarding product.
Continuous reading of humidity levels frees up staff to take care of other tasks and prevents costly loss of assets and falling out of regulatory compliance. At the end of the day, the long-term savings and automation offered by humidity control systems can help pharma firms realize substantial ROI in both the short-term and long haul.
4. Ensuring Regulatory Compliance
Having an environmental control system at play to monitor humidity levels is advantageous to everyone down the pharma supply chain. However, it’s especially beneficial to distributors and manufacturers because it helps them easily meet regulatory requirements pertaining to both quality and safety. Moreover, data logging devices can help pharma companies stay in compliance and pass audits by providing verifiable environmental data.
5. Maintaining Optimal Pharma Storage and Warehousing Conditions
Exposure to uncontrolled humidity and temperature is the most common cause of the degradation of pharma products and loss of efficacy. That’s why pharma companies must consider controlled exposure of their products to humidity throughout the whole cold supply chain.
Any excursions in humidity and temperature conditions must be controlled, minimized, and documented in warehousing and storage. Data loggers can help ensure those “just right” conditions, as well as compliance with best practices..
Conclusion
Once the target controls for relative humidity have been established, pharma companies must use data loggers to maintain those setpoints for consistency and quality in the supply chain. Putting in place an actionable humidity control strategy at every point in the pharma supply chain will improve product quality, ensure consumer safety, and guarantee GMP compliance.
Salman is a prolific environmental writer, and has authored more than 500 articles in reputed journals, magazines and websites. He is proactively engaged in creating mass awareness on renewable energy, waste management, sustainability and conservation all over the world.
Salman can be reached on salman@cleantechloops.com
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