The environment inside a pharmacy and pharmaceutical storage areas must be optimal and constant to ensure the effectiveness of the medications within them. The implications of humidity for pharmaceutical are numerous as moisture causes de-sterilization, irreversible destabilization and oxidative degradation because the proteins found in many drugs are sensitive. In extreme cases, temperature fluctuations and humidity may result in harmful toxic degradation that isn’t easily detectable. Temporary climate control solutions are the best way to ensure the ideal environment for stored pharmaceuticals and maintain their safety and effectiveness for patients.
Ideal Environment and Humidity for Pharmaceuticals
In Title 21 of the Code of Federal Regulations, the U.S. Food and Drug Administration mandates that pharmaceutical storage rooms maintain optimal environmental levels and that the appropriate employees monitor the conditions using continuous recording equipment that’s traceable.
The World Health Organization states that optimal conditions include:
- Temperatures indicated by a manufacturer (General storage temperatures range between 15° and 25°C; different drugs have different recommended storage conditions)
- Relative humidity levels of 60 percent or lower
- Good ventilation
- Odor-free environment
- Keeping drugs away from light
- Clean facility and storage room
- An alternative power supply in the event of power losses
Before a pharmaceutical company monitors its storage environment, it must identify areas that are not ideal for drug storage, such as those near:
- Doors
- Lamps
- Windows
- Ventilation outlets
- Loading bays
- Dead corners
- Sources of moisture
- Sources of warm or cool air
A pharmaceutical company should also take into account temperature differences between the storage areas furthest away from ventilation units, as well as different tiers on shelves.
The Benefits of Monitoring Storage Conditions
Monitoring conditions is important to the success of pharmaceutical distribution because it ensures compliance with standards and regulations and the safety and effectiveness of drugs. Tracking humidity for pharmaceuticals allows for precision and security and keeps drugs stable through their expiration dates. Other advantages of monitoring include:
- Accurate measurement of data
- Access to real-time data
- Automatic data logging
- Intelligent alarms and the ability to receive alerts when storage conditions aren’t optimal
- Knowing exactly when to use temporary climate and humidity control solutions
- Streamlining the manufacturing process
- Improved productivity
- Brand quality maintenance
- The ability to access and produce historical data
- Flexible data access
- Simple implementation
- Data security
Incorrect temperatures and high relative humidity levels in pharmaceutical storage areas are catastrophic. Polygon’s temporary climate control solutions help guarantee product stability and the maintenance of optimal environmental conditions throughout the year. Pairing these solutions with remote monitoring technologies ensures regulatory compliance and aid in risk management to align with an organization’s moisture management plan. Talk to a Polygon representative today to learn more about the custom climate control and monitoring solutions available for the pharmaceutical industry.
[Photo from Rennett Stowe via CC License 2.0]
