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GDP qualification of equipment with temperature-controlled units for the transport of pharmaceutical products This document is only valid in conjunction with the GDP validated equipment certificate and on completion of the qualification process |
Thermo Assistance is a multi-lingual communication tool designed to put you in direct contact with an authorized Thermo King dealer.
Thermo Assistance should only be contacted for breakdown and repair assistance.
To use this system, you need the following information before you call: (phone charges will apply)
Contact Phone Number
Unit Type
Thermostat Temperature Setting
Ambient temperature
Present Load Temperature
Probable Cause of Fault
Warranty Details of the Unit
Payment Details for the Repair
Leave your name and contact number and a Thermo Assistance Operator will call you back. At this point you can give details of the service required and the repair will be organized.
No payment at point of repair for customers with a ThermoKare service contract or with a guaranty of payment from their Thermo King or FRIGOBLOCK home-dealer
Please note that Thermo Assistance cannot guarantee payments and the service is designed for the exclusive use of refrigerated transporters with products manufactured by Thermo King Corporation.
| Revision A | (02/22) New format |
| Revision B | (04/24) Added A-500e |
| Temperature controlled units covered: | ||
| Single-Temperature Trailer units | ||
| A400 | ||
| A500 | ||
| A–500e | ||
| Kit PharmaSolutions TR-ST | 706806 | |
| For further information, refer to: | ||
| A-series Operator Manual | ||
| A-series Single-Temperature Systems Installation Manual | ||
| The information in this manual is provided to assist owners, operators and service people in the proper upkeep and maintenance of Thermo King units. | ||
At Thermo King®, we recognize the need to preserve the environment and limit the potential harm to the ozone layer that can result from allowing refrigerant to escape into the atmosphere.
We strictly adhere to a policy that promotes the recovery and limits the loss of refrigerant into the atmosphere.
When working on transport temperature control systems, a recovery process that prevents or minimizes refrigerant loss to the atmosphere is required by law. In addition, service personnel must be aware of the applicable European Union, National, Federal, State, and/or Local regulations governing the use of refrigerants and certification of technicians. For additional information on regulations and technician programs, contact your local THERMO KING dealer.
Service Tools - Use the proper service tools. Gauge manifold sets should include appropriate shutoff valves or disconnects near the end of each service line.
Recovery Equipment - Recovery equipment must be used. Proper recovering, storing and recycling of refrigerants is an important part of all service work.
Service Procedures - Recommended procedures must be used to minimize refrigerant loss.
Components may be isolated by closing service valves and performing system pump-downs.
Components unable to be isolated for service must be repaired only after refrigerant is properly recovered.
The information in this manual is provided to assist owners, operators and service people for GDP qualification of equipment with temperature controlled unit for the transport of pharmaceutical products.
This GDP Qualification Documentation is in line with the EU guideline of Good Distribution Practices of medical products for human usage (GDP) and annex 15 “Qualification and Validation” of the Good Manufacturing Practice for Medicinal products for Human and Veterinary Use (GMP).
Units covered in this manual are Thermo King Single-Temperature A400, A500 and A–500e.
Units covered in this manual are: Thermo King Trailer Multi-Temperature Units: A-500 Spectrum and S3A remote evaporator in ZONE 2.
GDP Qualification Documentation
This manual is organized into the following chapters:
| Chapter | Purpose |
|---|---|
| Certificate of the equipment qualified GDP compliant | Validation of the Installation Qualification for specific equipment.
Note(To be inserted in pouch provided at the front of this
Manual.)
|
| GDP Approval letter by Independent pharmaceutical company |
Note(To be inserted in pouch provided at the front
of this Manual.)
|
| Qualification Plan | Summarizes the minimum information that is included in this qualification report, Purpose, User Requirements Specifications, stages of qualification, qualification method, and responsibilities. |
| Risk Assessment | Identifies sensible measures to control the risks during the transport of pharmaceutical products with temperature controlled equipment. |
| Design Qualification | Lists equipment specifications and provides a documented verification that the proposed design of the equipment is suitable for the intended purpose. |
| Installation Qualification | Confirms that the equipment is installed and conforms to the approved design qualification and the manufacturer's recommendations. |
| Operational Qualification | Confirms that the equipment performs as intended throughout the anticipated operating ranges and provides operating guidance. |
| Performance Qualification | Provides temperature mapping test results that prove that the equipment can perform effectively and reproducibly, based on the approved process method and product specification. |
| Certification | Certificate of Approval of Trane Technologies Quality Management system. |
Before you call Thermo King Service, have the following information on hand (for exact data see serial plate on your unit):
Unit Type (commonly typed on serial plate after code DESC)
System or Model number (commonly coded on serial plate after Barcode)
All advancer models are covered under model/system number TKTRLA + 8 digits)
Serial Number
Who to call: Your Thermo King Dealer Representative or Thermo King Service Center.
This manual may contain blank pages at the end of chapters. This is normal. There is no information missing from the manual.
Roadside/Curbside terminology: These terms can be confusing because of differences between North America and Europe. Please note:
| Curbside: | The side of the truck to the driver’s right when the driver is in his seat and facing forward. |
| Roadside: | The side of the truck to the driver’s left when the driver is in his seat and facing forward. |
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Last Updated : 04/03/2024