Transforming success rates with our unique GDP Protocol
TK 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.
Thermo King developed a GDP protocol covering the four stages outlined in the European Commission’s Good Distributions Practice Guidelines (GDP guidelines) of Medicinal Products for Human Use and the annex 15 to the EU guide of Good Manufacturing Practice to include:
- — Design Qualification (DQ)
- — Installation Qualification (IQ)
- — Operations Qualification (OQ)
- — Performance Qualification (PQ)
Thermo King GDP validation protocol has been supervised and validated by an independent pharmaceutical company. This independent pharmaceutical company specialises in regulatory affairs to the health care industry, with qualified GDP experts and pharmacists highly-experienced in the design and implementation of pharmaceutical related quality systems.
GDP
Thermo King, TK dealers & end customers
1 Design Qualification (DQ)
System configurations and options
2 Installation Qualification (IQ)
System configurations and options
3 Operations Qualification (OQ)
Confirmation of DQ service contract
4 Performance Qualification (PQ)
Thermal mapping
Thermo King GDP qualified and validated equipment
TK PharmaSolutions offers a range of equipment for temperature-controlled transportation, for trailer, truck and vehicle powered units, as well as ColdCube™ Thermo King containers. All equipment has been tested* following Thermo King GDP validation protocol in line with the GDP guidelines:
- — At temperature ranges +15°C to +25°C; +2°C to +8°C; and temperatures below -20°C.
- — 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.
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. The research and development facility is certified ISO 9001: 2000; ISO 14001 and ISO 18000 and authorised for ATP certification.
*Tests developed and performed to include “worst case” conditions
Zone 1 setpoint: +20°C
Zone 2 setpoint: +6°C
Ambient temperature= +40°C Stability duration: 2.5h
Guaranteeing the safe storage and distribution of your pharma shipments
The scale, critically, and quality of pharma shipments presents a unique challenge.
Supporting dynamic rollouts and delivering confidence in the integrity of each shipment are critical for pharmaceutical manufacturers and logistics providers for public health and patient safety. It is also vital to be able to demonstrate how each shipment – from production to patient – is managed with precise temperature controls. A precision that needs to be maintained over the entire cold chain, from the long haul to the last mile, across land, sea, and air.
In response, Thermo King offers the connected end-to-end active temperature-controlled transport and temporary storage solutions needed to guarantee product integrity and manage risk.
What’s more, it’s our promise to every pharma manufacturer that they can trust our technologies to protect their products with the temperatures required – from -70°C to +30°C.
Multiple options for multiple temperature requirements
Delivering billions of time- and temperature-sensitive products to the global community presents a hugely complex logistical challenge. Success will come to those with the capacity to ensure products are being handled, transported, stored, and monitored effectively – while consistently maintaining precise temperature control.
To support this endeavor, Thermo King has expanded its TK PharmaSolutions range to deliver complete coverage for every product on the move and at rest, covering temperature requirements from +30°C to -70°C.
These are solutions that help guarantee the integrity of every product shipped, thereby minimizing any product wastage and ensuring faster deliveries worldwide without compromising the health and well-being of patients.
With Thermo King, pharma manufacturers really can think globally and act locally, confident that product quality will never be compromised.
Transforming success rates in pharma distribution
25%
of all vaccines produced globally are compromised by incorrect shipping.
>50%
WHO estimates suggest more than 50% of vaccines are wasted every year because of temperature control, logistics, and shipment-related issues.
-35$ Billion
The biopharma industry loses approximately $35 billion a year due to failures in temperature-controlled logistics.
