The pharmaceutical industry is one of the top five industries in the world, valued at more than $86 billion dollars back in 2015. In an industry comprised of various sectors, strict regulations have been put in place by the World Health Organization (WHO) to ensure safety and quality on a global scale. The list is long, but one of the most important factors that could turn lifesaving materials into hazardous materials is climate control.
General Storage Conditions
Temperature and humidity exposure are two main concerns that could cause products to become useless. Although facilities must tailor conditions around their product, the typical storage conditions for pharmaceuticals should be kept between 15 °C – 25 °C (59 °F – 77 °F) or up to 30 °C with no more than 60% relative humidity, depending on the climate in a given region.
Creating and maintaining a properly functioning HVAC system for pharmaceutical supplies is no easy task. Companies must not only prepare to make a sizable investment, but also brace for the ongoing maintenance costs.
If the HVAC system were to fail, temperature sensitive products could spoil, costing the facility thousands of dollars. The slightest deviation in temperature or humidity can cause products such as vaccines, pills and ointments to become ineffective or even cause harm to patients.
Here are the WHO’s recommended storage conditions:
- Frozen Storage: -20 °C (4 °F)
- Refrigerated Storage: 8 °C – 15 °C (45 °F – 59 °F)
- Room Temperature Storage: 15 °C – 25 °C (59 °F -77 °F)
Data Loss Prevention
The WHO has strict requirements for environmental monitoring devices. Wireless systems that continuously monitor ambient, refrigerated or frozen storage conditions must be able to record data during the event of a power outage or network failure.
MadgeTech wireless data loggers go above and beyond industry standards by offering customizable features, remote access to data, as well as total confidence in the accuracy and reliability of measurements.
In case of a power outage or network disruption, the data logger will record data to the internal memory of the device. Configurable alarms and notifications allow users to receive a text or email if specified thresholds are breached, and data can be viewed from any smart device connected to a Wi-Fi network with MadgeTech Cloud Services platform.
Maintenance of Monitoring Devices
The WHO also requires that environmental monitoring devices come with an ISO/IEC 17025 or a NIST calibration certificate to confirm measurement standards and instrument traceability. Every MadgeTech data loggers comes with either an ISO 17025 or standard certificate direct from its in-house calibration laboratory.
MadgeTech offers a wide variety of data loggers for pharmaceutical needs, including devices with wireless capabilities, and ultra-low or high temperature sensors. MadgeTech 4 Secure Software simplifies compliance with 21 CFR Part II requirements and includes IQ/OQ/PQ protocols to validate the data logging system is operating correctly.
To view all of the data loggers for pharmaceutical applications, click here.