Manage risk during pharmaceutical transport
Maintaining the quality and integrity of medical and biological products during transport is critical for pharmaceutical manufacturers and suppliers, and most importantly for public health and patient safety.
Since most medical and biological products require a temperature-controlled environment at all stages of production and distribution, controlling storage and transport temperatures is critical to maintaining the quality and effectiveness of drugs.
Pursuant to the Regulation of the Minister of Health, pharmaceutical distributors are required to comply with the strict European Union guidelines on Good Distribution Practice (GDP) for medicinal products, ensuring that a high level of product quality is maintained throughout the entire supply chain.
TK PharmaSolutions is a comprehensive and dedicated expert assistance that responds to the specific needs of the pharmaceutical industry, providing know-how in the field of applications and a full spectrum of services.
All Thermo King devices have been tested* zgodnie z wytycznymi GDP:
- In the temperature range from +15°C to +25°C; +2°C to +8°C; and temperatures below -20°C.
- In extreme ambient temperatures from -30°C to +40°C to ensure load safety in extreme climatic conditions.
- Door opening test, emergency mode as reference for customer risk management analysis.
To confirm that the refrigeration equipment performs to specifications, tests were carried out in a temperature-controlled chamber of the industry-certified ETC (Engineering and Technology Center Prague) in Prague. The research and development facility is ISO 9001:2000 certified; ISO 14001 and ISO 18000 and authorized to ATP certification.
* Tests designed and conducted taking into account "worst case" conditions.
PharmaSolutions recommends the use of remote monitoring systems such as TracKing™ to reduce the risk of damage, loss of quality and waste of high-value medical and biological products.
TracKing™ is a telematics solution that uses GPRS and GPS technologies to track loads in real time.
- Remotely monitor and control temperature setpoint, return and discharge air temperatures, and load temperature to prevent deviations beyond manufacturer specifications.
- Pre-journey reports and scheduled pre-cooling to ensure shipping containers are ready for loading.
- Transport temperature data logging is also available through Thermo King data loggers that comply with European standards EN12830.
- TracKing™ enables manufacturers, shippers and fleet operators to ensure product integrity and on-time delivery.
To ensure compliance in the distribution chain, we conduct training on GDP guidelines, high risk areas for product quality, pre-trip procedures, including pre-cooling the vehicle to minimize temperature fluctuations.