PharmaSolutions, a dedicated expertise platform from Thermo King, addresses the complex needs of the pharmaceutical industry by delivering a broad spectrum of services
If the quality of pharmaceutical product shipments is compromised, the risk is more than the loss of cargo – it can compromise the health of patients.
Industry statistics indicate that 25% of vaccines reach their destination in a degraded state because of incorrect shipping, and approximately 30% of scrapped sales at pharmaceutical companies can be attributed to logistics issues – Thermo King has been working to decrease these percentages to ensure top quality medical products for patients worldwide.
PharmaSolutions, a comprehensive and dedicated expertise platform from Thermo King, addresses the precise needs of the pharmaceutical industry by delivering applications, advice and a broad spectrum of services.
This solutions package purposefully covers the four stages outlined in the European Commission’s Good Distributions Practice Guidelines (GDP Guidelines) of Medicinal Products for Human Use to include:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operations Qualification (OQ)
- Performance Qualification (PQ)
Design and installation qualification
PharmaSolutions offers a range of equipment for temperature-controlled transportation, from trailer to pulley-motor truck, as well as ColdCube Thermo King containers. All equipment has been tested to conform with GDP guidelines:
- At temperatures of +15°C to +25°C; +2°C to +8°C; at -20°C to suit different cargo, as well as an annual three-temperature calibration check.
- Under extreme ambient temperatures from -30°C to +40°C to assure you of your cargo’s safety in extremes of climate.
- Test of door openings, failure mode as a reference for customer’s risk management analysis.
The validation protocol has been supervised and validated by an independent pharmaceutical company specialised in regulatory affairs of the healthcare industry, with qualified responsible personnel and pharmacists highly-experienced in the design and implementation of pharmaceutical related Quality Systems (e.g. ISO13485, GDP and GMP).
To confirm that the refrigerated equipment is performing to specification, tests have been conducted in a temperature-controlled chamber of the industry-certified Ingersoll Rand Engineering and Technology Centre (IRETC) in Prague. This R&D facility is certified ISO 9001: 2000; ISO 14001 and ISO 18000 and authorised for ATP certification.
Operations and performance qualification
The PharmaSolutions service range can be delivered as a complete package, individually, or as a selection of services combined into a PharmaAssist service contract.
The service range includes:
- Product application expertise and training services
- 24/7 fleet monitoring services
- Real-time tracking and monitoring
- Full service history and proactive maintenance
- Product application expertise and training services
PharmaSolutions delivers product application expertise covering refrigeration system set-up, risk mitigation and operating guidelines that are critical to know for any transportation partner. Pharmaceutical transporters can rely on the extensive Thermo King Dealer Network for guidance on installation and use of refrigeration systems. Customised training services can also be offered based on the customer’s operations and needs in relationship to the new requirements of the GDP guidelines.
24/7 fleet monitoring services
PharmaSolutions offers 24/7 fleet monitoring services for end-to-end management of any refrigerated vehicle fleet. It is a powerful tool to improve operational efficiency of the pharmaceutical supply chain and enable connectivity to manufacturers’ goals.
Thanks to a strong dealer network, PharmaSolutions helps you to minimise the risk of load-loss in case of breakage, with about 2,000 Europe-wide technicians highly trained to ThermoKing standards as well as to GDP standards. The Dealer Locator App can help you identify the nearest service points when evaluating the points of risk along the delivery route.
Real-time tracking and monitoring
With regard to transportation temperatures, the GDP guidelines say that medicines requiring controlled temperature storage should be transported by appropriately specialised means. PharmaSolutions recommends the use of remote monitoring systems such as Thermo King’s TracKing to reduce the risk of damage, loss of quality and wastage of high value medical and biological products.
Full service history and proactive maintenance
This PharmaSolution can offer the option of storing a full service history over the complete life of your refrigerated vehicles, with an online database recording of all your repairs, maintenance and calibration activities conducted on your equipment to ensure data management for audit and inspection. A planned maintenance schedule for your equipment that proactively notifies you when you need a service is also an option.
www.thermoking.com
