Single-TemperatureTrailer with A-series units

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.

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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.

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This qualification plan describes the procedure for qualifying a refrigeration trailer body type with similar or better insulation than ATP standards (0.4W/m2.K), and equipped with a refrigerated unit type Thermo King Single-Temperature A400, A500 or A–500e.

The qualification provides the documented proof of the fact that the respective refrigerated equipment (ATP certified body + Thermo King refrigerated unit) fulfils the user requirements (URS), GDP and GMP requirements for the transport of medicines. This document specifies the responsibilities and activities that are to be carried out for the qualification. The specific activities and criteria are described and documented in the various test cases.

The equipment is designed to ensure that pre-temperature-controlled goods maintain an adjustable set temperature both for low and high ambient temperatures (winter -25°C and summer +50°C). It must be possible to operate the equipment within the following temperature ranges:

• Temperature below -20°C

• Temperature between +2°C and +8°C

• Temperature between +15°C and +25 °C

Those equipment-types:

• a trailer body of max 88 m³ with THERMO KING refrigerated unit A400.

have been designed and qualified to meet the specific desired temperature ranges for the transport of pharmaceutical products.

The specific equipment has been installed successfully and was proved to comply with the design qualification and installation qualification of the sample-type equipment.

The specific equipment has been proven to perform according to the sample-type equipment. Operating guidance and planned maintenance schedule has been provided to ensure a correct use of the equipment during its lifetime.

The conditions of the performance test of the sample-type were defined.

A basic Performance qualification was performed on the sample-type equipment. The tests were performed according to the test cases defined in the Operational Qualification in order to simulate most common real life conditions. Tests were performed in accordance with ATP standards and test method FDX 15-140. The tests were successfully completed.

As a result of the test, some recommendations have been provided to ensure an optimal use of the equipment in the different operational modes.

Thermo King did use a sample-type approach for the qualification of transport equipment. The sample-type approach consists of performing an initial full qualification on one equipment using the worst case scenario (including thermal mapping in extreme ambient conditions) and all new or existing equipment of the same design specifications are also qualified once IQ and OQ is completed successfully.

• A basic PQ for one member of each sample-type, selected as the most critical or challenging application in the family. Basic PQs are empty load temperature mapping performed in temperature-controlled chamber to better simulate worst case conditions.

• For each new and existing unit, an IQ and OQ have to be completed successfully at a Thermo King authorized workshop location. The verification is conducted by a Thermo King trained technician. The verification includes, above all, the equipment's design specifications and set point verification, sensor calibration and equipment performance check.

The qualification activities will be organized by the qualification team:

The qualification tests will be performed at the Trane Technologies Equipment Manufacturing Engineering and Technology Centre, Prague, Czech Republic. This organization is an accredited ATP-test-station and has the IATF 16949 and ISO 17025 certifications.

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment:

• A 2 zone IR body (0.4 W/m2.K or better insulation) equipped of a Thermo King refrigerated unit V-300 MAX Spectrum ES150+ES150, V-500 MAX Spectrum ES300+ES300 or V-800 MAX Spectrum. ES400+ES400.

• A 2 zone IN body (0.7 W/m2.K or better insulation) equipped of a Thermo King refrigerated unit V-300 MAX Spectrum ES200+ES100.

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment:

• a refrigeration body type (van/truck) with similar or better insulation than ATP IN standards (0.7W/m². K) and equipped with a refrigerated unit type Thermo King Single-Temperature (V-200 MAX 30/50).

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment:

• a refrigeration trailer body type with similar or better insulation than ATP standards (0.4W/m².K) and equipped with a refrigerated unit type Thermo King A400, A500 or A-500e Single-Temperature.

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment:

• a refrigeration trailer body type with similar or better insulation than ATP-FRC standards (0.4W/m².K), and equipped with a refrigerated unit type Thermo King multi-temperatures unit A-500 Spectrum with S3A remote evaporator

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment, a refrigeration trailer type ATP (FRC) certified (0.4 W/m².K or better insulation) with a refrigerated unit type Thermo King multi-temperature (SLXi Spectrum S3, SLXi Spectrum S6, SLXe Spectrum S3 PTC, SLXe Spectrum S6 PTC, SLXe Spectrum S3, SLX Spectrum ETV S3, SLXe Spectrum S6, SLX Spectrum ETV S6) for the transport of medicinal products.

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment, a refrigeration trailer type ATP (FRC) certified (0.4 W/m².K or better insulation) with a refrigerated unit type Thermo King SLX(e) single-temperature (SLXi300, SLXi400; SLXe300, SLXe400; SLX300 and SLX400) for the transport of medicinal products.

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment: 

• a refrigeration body type (truck) with similar or better insulation than ATP standards (0.4W/m².K), and equipped with a refrigerated unit type Thermo King T-series SingleTemperature (T-1000R, T-1200R and  UT-1200).

• a refrigeration body type (truck) with similar or better insulation than ATP standards (0.49W/m².K), and equipped with a refrigerated unit type Thermo King T-series SingleTemperature T-800R.

• a refrigeration body type (container ) with similar or better insulation than ATP standards (0.4W/m².K), and equipped with a refrigerated unit type Thermo King T-series SingleTemperature (T-1200R Intermodal)

Thermo King used the risk reporting matrix (see below figure) to identify and classify potential problems while using the specific transport equipment:

• A 2 zones IR body (0.4 W/m².K or better insulation) equipped of a Thermo King refrigerated unit T-1000R Spectrum S3+S3, T-1200R Spectrum S3+S3 or UT-R Spectrum S3+S3.

• A 2 zones IN body (0.7 W/m².K or better insulation) equipped of a Thermo King refrigerated unit UT-1200 Spectrum S3+S3.

Risk Reporting Matrix

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The scope of the qualification work will be done to the equipment (a refrigerated unit designed and built by Thermo King with an ATP certified body) for the transportation, under temperature restrictions, of medicines.
A standard configuration is defined for each group.

Single and Multi-temperatures temperature Units qualified for pharmaceutical applications under Thermo King protocol are configured with specific Pharma configuration file and parameters loaded during commissioning by your local dealer. Evaporators fans have to run during the Null Cycle.

Regarding the acceptance criteria considered in Thermo King Protocol, the air temperature should remain within the required temperature range. For example, if the requirement is for temperature range +2.0°C to +8.0°C, the minimum air temperature recorded should not be below +2.0°C, and the maximum should not exceed +8.0°C.

The trailer shall be used:

• For transport of pharmaceuticals (in combination with Medical devices)

• To maintain and control air temperature at a set temperature.

• In single-temperature operation (< -20°C, +2°C to +8 °C or +15°C to +25°C)

• In single-temperature operation (< -20°C, between +2°C and +8 °C or between +15°C and +25°C) in ZONE 1 compartment.

• In multi-temperature operation (< -20°C, between +2°C and +8 °C or between +15°C and +25°C) in two compartments with the dividing wall in place.

• At ambient temperatures between -25 °C and +40 °C

• At ambient temperatures between -30 °C and +45 °C

• The vehicle will be used for transportation between temperature controlled loading docks of storage locations.

• According to the driver's instructions supplied by Thermo King on use of Thermo King equipment.

• For transport of pharmaceuticals (in combination with medical devices)

• To maintain and control air temperature at a set temperature.

The objective of this qualification is to successfully qualify the designed use of this equipment.

The Operational Qualification conforms to the requirements of the Design Qualification: GDP-TK-DQ-TRA-ST.

The Operational Qualification conforms to the requirements of the Design Qualification: GDP-TK-DQ-TR-MT_A.

• For transport of pharmaceuticals (in combination with Medical devices)

  Combination of pharmaceuticals and medical devices in one load is approved. Mixing loads of food and chemical substances is not permitted even when the compartments are separated as a Single-temperatures load.

  Combination of pharmaceuticals and medical devices in one load is approved. Mixing loads of food and chemical substances is not permitted even when the compartments are separated as a multi temperatures load.

• The load space should be kept clean at all times and only cleaning agents that will not affect the products should be used.

• To maintain and control air temperature at a set temperature

  The products (pharmaceuticals) will be loaded at the correct temperature because they are leaving a temperature controlled storage location. It is stated that the refrigeration unit and box is used to maintain and not change the temperature of the products. The trailer is not designed for cooling down or warming up pharmaceuticals, and therefore it should not be used for this purpose. However there is reserve capacity to overcome unscheduled temperature changes within the air pocket surrounding the load.

• This equipment is only qualified in a single temperature mode (<-20°C, +2°C to +8 °C or +15°C to +25°C):

• At ambient temperature between -25°C and +40 °C.

• This trailer is qualified in multi-temperature and single-temperature modes based on the details below:

  When operating the equipment in multi-temperatures mode, the splitting of the compartment zones should be as stated below:

  • For the A-500 Spectrum unit with a S3A remote evaporator, ZONE 2 maximum split should be 1/3 of the total load space. If a larger ZONE 2 compartment is required, consult with your Thermo King Dealer.

  • For customers who want to use the mentioned equipment as a single-temperature load, the dividing door must be stowed in such a way that it does not interrupt the airflow from the main ZONE 1 host unit evaporator.

    • Zone 2 must be switched off.

• Unit can operate at ambient temperature between -30°C and +45 °C.

• This GDP qualification is performed for use in the ambient temperatures as tested. To provide qualification for the expected ambient temperatures in these regions the qualification test temperatures will be performed in the following manner, minimum to be set at -25°C (to simulate average winter temperatures in Northern Europe) and maximum +40 °C (to simulate average high summer temperatures in the South of Europe).

• This GDP qualification is performed for use in the ambient temperatures as tested. To provide qualification for the expected ambient temperatures in these regions the qualification test temperatures will be performed in the following manner, minimum to be set at -30°C (to simulate average winter temperatures in Northern Europe) and maximum +45 °C (to simulate average high summer temperatures in the South of Europe).

• The vehicle will be used for transportation between temperature controlled loading docks of storage locations.

  • Door openings can have a major effect on the temperature inside the trailer, depending on the difference in ambient temperature and temperature inside the trailer. To minimize this effect, this is recommended to open doors of the trailer only at loading and unloading at temperature controlled warehouse. In these warehouses the product and the environment is temperature controlled.

  • If the vehicle is to be used with multiple door openings in a non-controlled environment, based on the results of a risk analysis a complementary Performance Qualification may have to be performed by the customer.

• The equipment has to be used according to the drivers instructions supplied by Thermo King on use of Thermo King refrigerated Equipment. These driver instructions can be found in multiple languages via a QR code decal located at the unit’s controller.

• The equipment must be run and checked to ensure that all elements are functioning correctly.

• The load space considerations indicated below must also be considered.

• The load space should be kept clean at all times and only cleaning agents that will not affect the products should be used.

• The flow of temperature controlled air in the load space has to reach all parts of the load space:

  • An adequate clearance must be provided in front of the evaporator air outlet and a minimal distance of 300mm must be maintained between the top of the load and the ceiling even with double stack loading as defined in GDP-TK-DQ-TRA-ST. When possible the gap between ceiling and cargo is identified by a red line on the side walls.

    Trailer lay out

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• If double stack system with individual beams is used there should be allowance for air to be correctly distributed around the cargo on both levels. When not used, the beams must be stored in the trailer in a way that doesn't restrict the airflow and/or block the air circulation in the air distribution system/air channel.

• The loading pattern must not obstruct the air circulation around and under the cargo. A recommended air gap of 50mm between the load and the walls should be maintained at all times:

  • If the load is positioned tightly against the body internal walls satisfactory air circulation and temperature management will not be achieved.

  • To minimise risk and for correct air circulation it is not recommended to place any products directly below or beside the evaporator.

The objective of this GDP qualification is to successfully qualify the designed configuration of the equipment mentioned in the Design Qualification: GDP-TK-DQ-TRA-ST.

The objective of this GDP qualification is to successfully qualify the designed configuration of the equipment mentioned in the Design Qualification: GDP-TK-DQ-TR-MT_A.

For this qualification three issues are important:

• The flow of temperature controlled air in the load space has to reach all parts of the load space.

• The flow of temperature-controlled air in the load space must reach all parts of the load space. Therefore, a fixed return air system is essential.

  • Return air bulkhead panel to be of solid fixed type allowing a minimum return air gap of 52 mm from the evaporator panels and the top should be closed to conform to Thermo King recommended minimum standards.

• The capacity of the unit that is used to manage the temperature within the load space has to be sufficient to maintain the products at the set temperature range recommended by the manufacturer of the product (pharmaceutical company). Therefore, the base colour white plus allowable 20% decal coverage is set to the DQ. Other darker colours would decrease the cooling capacity of the Advancer trailer.

• The temperature logging equipment used for the calibration process must in itself be calibrated to each temperature range. This will be checked and confirmed during the OQ (Operational Qualification) process.

The equipment must comply with the three requirements as laid out above and should be measured with calibrated temperature data-loggers and must be registered as such. This will be checked and confirmed during the OQ process.

There is no information in GDP guideline as to location of or how many thermo couplings for temperature measurement should be inserted into the load space during the qualification test. Air and load temperature measurements are made with thermo-sensors of type Pt 100. Accuracy is within limits ± 0.3 °C. Thermo-sensors are calibrated based on procedure of Czech Metrologic Institute. Sensors were placed according to FDX 15-140. Temperature data is measured and recorded by equipment independent of the refrigeration unit. Placement of the thermo-sensors (thermocouples) for individual compartment is shown in figure below. All sensors except sensors mounted at front solid return air bulkhead and rear doors are located 15 cm from the relevant walls, ceiling or floor. Those exceptional two sensors are placed 5 cm from the relevant surface.

Thermocouples Ti1 to Ti4, Ti16 to Ti19, Ti21 to Ti24 and Ti9 to Ti12 are located 150mm away from any wall/door.

Thermocouples Ti13, Ti20, Ti25 and Ti15 are located in the centre.

For each individual equipment (vehicle + refrigerated unit) a specific TK PharmaSolutions - IQOQ Check-MUL document has to be completed by the Thermo King official dealer. The latest valid revision of this document has to be used and is available from Thermo King EMEA InfoCentral intranet.
This document confirms that:

• Installation is conducted as per GDP-TK-IQ-VP-MT.

  Installation is conducted as per GDP-TK-IQ-TRA-ST.

  Installation is conducted as per GDP-TK-DQ-TR-MT_A.

  Installation is conducted as per GDP-TK-DQ-TR-MT.

  Installation is conducted as per GDP-TK-IQ-VPU-ST.

• A calibration check has been performed in an empty body for each qualified range. This calibration check is performed for the controlling sensors and the datalogger sensors and the results are attached to this document. The results are available on request in electronic format.

  A 3-temperature calibration check has been performed and the results attached to this document. The results are also available on request in electronic format.

• All required risk management and due diligence protocols are in place and comply with the GDP requirements. This protocol's minimum requirements should be:

  • Scheduled Maintenance

  • Breakdown repairs

  • Annual 3-temperatures calibration check

  • Availability of Service History

  • Asset Management

Thermo King designs and builds temperature-controlled transport equipment.

These types of equipment can be validated for a specific desired temperature range for the transport of pharmaceutical products.

Due to the fact that several test were performed on the different units in time, not all the tests are performed under the same circumstances.

This protocol defines the qualification of the equipment (a refrigerated unit designed and built by Thermo King with an ATP certified body) for the transportation, under temperature restrictions, of medicines.

The qualification is based on the following documents: GDP-TK-VMP, GDP-TK-DQ-TRA-ST, GDP-TK-IQ-TRA-ST and GDP-TK-OQ-TRA-ST.

The qualification is based on the following documents: GDP-TK-VMP, GDP-TK-DQ-TR-MT_A, GDP-TK-IQ-TR-MT_A and DP-TK-OQ-TR-MT_A.

The scope of the qualification work will be done to the equipment: a refrigerated unit designed and built by Thermo King with an ATP certified body.

A standard configuration is defined for each group.

For Single-temperatures Advancer trailer the specifications are as per the Design Qualification GDP-TK-DQ-TRA-ST.

For the multi-temperature trailer the specifications are as per the Design Qualification GDP-TK-DQ-TR-MT_A.

As an indicator to support Risk Analysis of the customer the following Hot and Cold spots have been identified in an empty body. Refer to GDP-TK-OQ-TRA-ST figure 2 for locations.

During COOLING cycle

• Hotspot is Ti04.

• Coldspot is Ti16.

During HEATING cycle

• Hotspot is Ti16.

• Coldspot is Ti03.

Temperature mapping results of the qualification are presented in a separate PQ report and are available on request following the signing of an NDA (Non-Disclosure Agreement).

The report number for A400 is: ZZ-1274-20 from 09-2020 also named GDP-TK-PQ-TRA-ST.

• To maintain the best temperature management within the load-space it is recommended to operate with the following set-point temperatures in the following ranges.

  • +20 °C Set-Point for temperature range +15 °C to +25 °C

  • +5 °C Set-Point for temperature range +2 °C to +8 °C

  • -25 °C Set-Point for temperature below -20 °C

• For optimum temperature management and air distribution, the refrigeration unit's continuous operation mode should be used for all temperature ranges.

• Efficient loading practices and operating procedures have to be followed to ensure optimum air circulation and temperature management.