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Humidity Control is an Essential Part of Pharmaceutical Manufacturing

Humidity control factors heavily into pharmaceutical manufacturing, quality control, and product storage. If medications and supplements are not handled and stored properly, this can result in damaged goods that do not meet consumer safety standards. 

In turn, the moisture-damaged products will place a burden on your business’s bottom line when it comes time to manufacture replacement batches. However, with proactive measures, the risk of humidity exposure can be curbed during these phases of the product lifecycle from manufacturing to transporting, storing, retailing, and consumer use.

Why Make Humidity Control a Priority? 

As we previously mentioned, humidity control can help prevent damage to your products. Presumably, your business is not interested in regularly manufacturing goods that do not meet industry quality standards. 

Here are some of the ways that prioritizing humidity control will benefit your business: 

Cost Efficiency

Preventing humidity damage to your products also prevents your business from sinking operating capital into replacing and recalling defective batches. This does not benefit bottom-line goals and will create additional operating expenses. 

Adopting and implementing the proper humidity control measures at your facility should precede the manufacturing, storage, and transporting phases of your business operations. With these best practices in place, the chances of moisture-related damage occurring at your workplace will plummet. 

Greater Trust

If you are a contract manufacturer that implements high humidity control standards at your facility, you will have greater trust with your clients that are paying you to produce their pharmaceutical and nutraceutical products. These standards should permeate every aspect of your business, from manufacturing to storage and transportation. 

Corporations that manufacture in-house should also adopt strong humidity control measures to ensure better product quality. Less defective batches and recalls result in stronger trust with distributors, retailers, and consumers. 

Human Safety

Thirdly, and most importantly, facility climate control can help preserve product integrity and prevent defective vitamins, supplements, and medications from reaching consumers. This will protect their safety and ensure that the products you manufacture are making a real difference in peoples’ lives. 

How Can Humidity Damage Pharmaceutical Products? 

Lack of proper humidity control can lead to multiple scenarios where products are damaged. In most cases, the end result poses a threat to product quality and/or consumer safety. Considering this, businesses should prioritize climate-controlling all manufacturing and storage environments in accordance with industry best practices. 

Excess humidity exposure can damage medications in the following ways: 

  • Desterilization leading to microbial growth and contamination 
  • Destabilization of formulas that may not be reversible 
  • Unintended chemical reactions between affected ingredients 
  • Product degradation 
  • In some cases, may cause product toxicity 

For the safety of medical professionals and consumers alike, controlling humidity levels in pharmaceutical products should never be overlooked. Operators need to prioritize maintaining an ideal environment inside manufacturing facilities throughout the entire duration of the manufacturing process. 

Beyond best practices, the U.S. Food and Drug Administration requires pharmaceutical storage facilities to maintain appropriate environmental conditions and that qualified employees continuously monitor conditions with trackable recording devices. 

Additionally, the World Health Organization (WHO) insists that pharmaceutical facilities implement automated monitoring systems for both temperature and humidity control within storage rooms. Using these solutions can allow facilities to recognize and quickly resolve any humidity issues before any damage to products can occur. 

What is the Ideal Environment for Humidity Control? 

According to WHO guidelines, the ideal environment for storage room humidity control should include: 

  • Calibrated temperature control sensors accurate to +/- 5 degrees Celsius and monitoring systems positioned away from the door. 
  • Calibrated humidity control sensors accurate to +/- 5% relative humidity  and monitoring systems positioned away from the door. 
  • Calibrated temperature and humidity alarms

Each of these solutions should be calibrated to defined air temperature profile standards relative to individual storage rooms. Refer to the previous link provided to learn more details about properly calibrating these devices. 

Areas in your storage room not ideal for storing products near also include: 

  • Doors
  • Lights and lamps 
  • Air vents/other air sources
  • Loading docks/bays 
  • Sources of moisture, warm air, and cool air 
  • Windows 

Additionally, the WHO also advises that facility maintenance implement and maintain a cleaning and decontamination program for all controlled spaces. The guidelines include: 

  • Ensure the entire floor area is fully accessible for cleaning. All stored goods should not be stored directly on the floor. 
  • Do not store non-pharmaceutical products in the room except for those like ice packs, gel packs, and others relevant to proper transport. 
  • Prevent the accumulation of dust, dirt, and waste. Do not allow packaging waste to remain in the storage room. 
  • Enact precautions against spilling, breaking, and cross-contamination of substances. 
  • Prevent the accumulation of frost and ice in the storage rooms. 
  • All waste should be collected in designated, closed containers that can be safely disposed of frequently. 
  • Refrigerators in storage rooms should also be routinely cleaned as well, and all facilities should have a contingency plan in place to move frozen-stored products to another safe area should any cooling equipment need repair. 

For further guidance on humidity control during product transport, please refer to the same WHO document. These separate guidelines also ensure that transportation providers can meet the standards that you set for your own facilities. 

Humidity Control and Quality Assurance 

During the quality control phases of the production cycle, you must check your products  for excess moisture. Doing so can prevent damage to the product as well as protect consumer safety. 

Some quality control equipment that we offer to help you with that include: 

Mettler Toledo H353 Moisture Analyzer 

The H353 Mettler Toledo Moisture Analyzer offers quality control operators a comprehensive solution in a compact device. It comes complete with a progress indicator, 50~160 degree C drying temperature 0.01%MC (1mg) readability along with aluminum sample pans and glass fiber filters. This system grants you a full view of product moisture conditions so that you can resolve any issues you identify during your analysis. 

ISMA Instant Softgel Moisture Analyzer

Designed specifically for softgel moisture control applications, the ISMA is a handheld device that you can use to quickly determine the relative moisture of a softgel capsule shell. This is accomplished by measuring electrical resistance through the shell and allows for nondestructive testing within a few seconds. It measures moisture content from 5% to 20% within 5 seconds and can hold approximately fifty (50) individual #10 oval softgels. 

CapPlus Water Activity Meter (WAM) 

Excess water in consumer pharmaceuticals, nutritional supplements, and food can create a risk of microbial growth and water migration. This leads to unwanted outcomes like product clumping, consistency changes, shorter shelf life, and more. Improper water levels can also affect gummy production and result in a product that is too wet or too dry. 

Operators can use the CapPlus Water Activity Meter (WAM) as a critical component of the quality control process to determine when the water level within a product has declined enough to the point where it is suitable for packaging. This will be when the vapor pressure has dissipated enough to the point where it no longer poses a threat to the quality of packaged final products. 

Some features of the WAM include:

  • Easy portability – lighter in weight than a mobile phone 
  • Fast results – measure water activity within 5 minutes
  • Easy-to-understand data – Clear display of all findings on screen 
  • Convenience – Automatic shutdown, manual shutdown, and undervoltage alarm features 
  • Connectivity – Connect to a PC with a USB cable to analyze your data in greater detail 
  • Bluetooth – Further connectivity via Bluetooth for wireless data output 

For more information, please view our Water Activity Meter brochure

Looking to Improve Your Water Activity Monitoring Capabilities? Let Us Help

CapPlus specializes in connecting pharmaceutical, vitamin, and nutritional manufacturers with the best equipment for their specific facilities and operations. To support this mission, we offer a variety of quality control equipment, including industry-leading water activity meter solutions. To learn more about how we can help you improve your water activity monitoring capabilities, contact us.

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