The Compliance Officer Will See You Now: Chemical Storage in Pharmaceuticals

Pharmaceutical manufacturers are no strangers to chemical storage. Where are the opportunities for improved compliance practices and what are the benefits?

When Pfizer developed its COVID-19 vaccine in 2020, at least one ingredient had to be kept within a certain temperature range to maintain its effectiveness. At the time, we worked closely with one factory manufacturing the vaccine in question to supply specialist storage solutions that ensured they achieved this. Many modern medicines operate similarly, requiring careful temperature control on the part of the manufacturer, distributor, and all to keep the ingredients from becoming compromised and the medicines viable for patient use.

• Ingredients stored outside of their temperature thresholds can lose their effectiveness as a result of poor temperature control.  
• Sometimes, poor temperature control can lead to changes in the physical properties of certain ingredients that cause them to become toxic.
• It can also compromise their stability and shelf life, reducing their potency and effectiveness over time — something the patient would be unable to account for.

Lots of cosmetics also fall under this umbrella, with those containing flammable chemicals introducing additional hazards into the equation. How do you measure the importance of temperature control across your pharmaceutical operations and what steps can you take to keep your site’s compliance standards in the best possible health?

The right degree of temperature control

When the chemicals you’re storing are sensitive and would be adversely affected by fluctuations in temperature, it’s important that the storage location is a controlled environment. It’s the sensitivity of these substances to temperature fluctuations that makes some solutions more effective than others. When even a slight temperature variation can lead to chemical deterioration, compromising the quality and effectiveness of the product, you have to be able to rely on your temperature-control solution to keep conditions steady.

This can be achieved with the use of insulated and, where appropriate, temperature-controlled, fully bunded stores, which can also be supported by individual heated “jackets” that provide temperature control when the drum/IBC is being taken to the production area. By providing a controlled environment with stable temperatures, insulated units offer many benefits that contribute to preserving the integrity and safety of pharmaceutical ingredients.

Temperature stability

Insulated units are designed to maintain consistent temperatures within a specified range, creating a stable environment that protects their contents from temperature fluctuations.

Thermal protection

The insulation material used in insulated units acts as a barrier against external temperature influences, providing thermal protection for any ingredients (pharmaceutical or other) stored inside.

Humidity control

Some insulated units may incorporate features for controlling humidity levels, further enhancing the reliability of the storage conditions. By maintaining optimal humidity levels, an insulated unit helps control the environment by preventing moisture-related issues such as condensation, mould, or chemical instability, ensuring the stability of the ingredients.

Monitoring capabilities

Advanced insulated units can sometimes be equipped with monitoring systems that continuously track and record temperature and humidity levels inside the unit. These systems provide real-time data and alerts, allowing you to promptly identify and address any deviations from the desired storage conditions before the contents are compromised.

“When the liquids you’re storing are sensitive and would be adversely affected by fluctuations in temperature it’s important that the location where they are stored is a controlled environment.”

Cosmetic fire risks

It’s not uncommon for cosmetics to contain chemicals that are actually flammable. Hairsprays are a good example of this. Volatile chemicals sometimes have a low auto-ignition temperature, which means they will automatically ignite at a certain temperature. These ingredients require extra attention because the guidance and regulations surrounding them will directly impact the health and safety of your people. Fire-rated units are one way compliance officers are keeping a lid on this risk.

Fire containment

Fire-rated units are built with fire-resistant materials and structural components that can withstand exposure to fire and high temperatures. In the event of a fire within the unit (or around it), the fire-rated construction helps contain the flames, preventing them from spreading to other areas of the facility or igniting the product within the container. This feature limits the damage and reduces the risk of injury or property loss.

Fire suppression

Some fire-rated units may be equipped with built-in fire suppression systems, such as sprinklers or more advanced fire extinguishers. These systems are designed to detect and extinguish fires automatically or manually, depending on the level of threat.

Regulatory compliance

Compliance officers across industrial manufacturing regularly rely on fire-rated units to meet regulatory requirements and industry standards for storing flammable chemicals safely. By implementing these kinds of solutions, you’re demonstrating your commitment to adhering to applicable regulations and safeguarding against fire risks in your manufacturing facility.

“Volatile chemicals sometimes have a low auto-ignition temperature, which means they will automatically ignite at a certain temperature.”

How healthy is your compliance?

I’ve been helping manufacturers solve these kinds of challenges for years, and Emtez (formerly Empteezy) has been doing the same for even longer still. Not so long ago, we delivered fire-rated units to the British Library in London to help them with the safe storage of hand gels on site, which are alcohol-based and therefore flammable. Based on their risk assessment, these were the solutions that provided the safety and reliability they needed.

The pandemic is behind us, but pharmaceutical manufacturing never ramps down. How could an insulated or fire-rated unit help you to keep your compliance status healthy?

If you’re unsure about the regulations or guidance with which you should be complying, or you’d like advice around an insulated/fire-rated storage solution, get in touch today.