How to Maintain a Safe Transportation for Drugs?
Sensing Temperature in Cold Chain Logistics
A drug can take a variety of paths from the manufacturer to the patient. Most often, the product leaves the manufacturer’s direct control and enters a complex system of handoffs. Distribution systems that deliver pharmaceutical products require special handling based on the conditions clearly indicated in the labeling for the product. The Prescription Drug Marketing Act of 1987 and the ensuing regulations in 21 CFR Part 203, Prescription Drug Marketing, and Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, provide the necessary regulations and guidance for several legs of the distribution chain for the prescription drug.
Manufacturers are obligated to include distribution as part of their overall quality system and should be continuously monitored and updated to adhere to industry best practices. Current Good Distribution Practices for the pharmaceutical supply chain have been divided into seven different categories (Stability, Distribution Control Management, Performance Management, Supply Chain Partner Management, Qualification / Validation, Continuous Improvement, and Import / Export Compliance) in PDA Technical Report #52.
Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps. The allowable time and temperature exposure to ranges outside of the long-term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines.
One of the biggest risks to drug product in a controlled-logistics network is the freezing of final drug product. Even the temporary storage of a thermal packaging system into forced-air refrigeration cooler within its qualification time period will most likely cause low temperature exposures and potential freezing. Proper testing of drug products in freeze-thaw conditions for distribution is critical. Most freeze-thaw stability testing does not consider the effect of ‘supercooling’ on solutions.
The suppression of the freeze point or ‘supercooling’ and subsequent ‘flash’ freezing in current freeze-thaw stability testing guarantees a homogenous solid is formed. In the distribution environment, the vibration and shock events inherent in the logistics network practically guarantees freezing of a solution at its freezing point. The frozen solution is rarely homogenous and can be observed as slurry of frozen and liquid solutions. These conditions are detrimental to proteins in solutions because of the risk of increased protein concentration, and how it can cause protein denaturation, aggregation, degradation or inactivation. These conditions are not properly tested by current static stability studies.
The transport of final drug products is one the most difficult tasks in the pharmaceutical supply chain because of the sensitive nature of the product and the complexity in a modern logistics network. An integrated process management and product characterization approach using dynamic stability testing for distribution is required to minimize risks to drug product quality during transport.
Sensor Solutions for Data Logging
STS32 Temperature Sensor
Based on the versatile STS3x platform, the STS32 is a digital, I2Cc-based temperature sensor. It features a GDP adapted accuracy specification and an included three-point calibration certificate provided by Sensirion’s new ISO/IEC 17025:2017 accredited calibration laboraty. The calibration set points are T = -30°C, 5°C, and 70°C. All values are provided in a machine readable XML file format and can be associated to the respecitve sensor by its unique, non-changeable Serial number. Metrological traceability of the calibration is conforming to ch.6.5 of ISO/IEC 17025:2017, commonly referred to NIST traceability or traceability to other national metrology institutes, according to the CIPM Mutual Recognition Arrangement (CIPM MRA).
- 3-point-calibration data for each sensor provided
- Sensor-specific calibration certificate according to ISO 17025:2017, true NIST-traceability
- Linearized digital output, I2C Interface with communication speeds up to 1 MHz and two user selectable addresses
- Wide supply voltage range, from 2.15 V to 5.5 V
- Accuracy of up to 0.4 °C
- Tiny 8-pin DFN package
- CMOSens® Technology enables high-volume applications due to unprecedented price-performance ratio
- Proven quality thanks to many years of experience in mass production for the automotive and medical industry
- Robust and shock-resistant design ensures no sensor drift during transport
- Ultra-low power consumption enables longer battery life and cost savings
- Easy to integrate in portable devices due to small chip-sized package
- Fully calibrated digital output with I2C interface guarantees an easy hassle-free Integration
- Cost-effective SMD assembly