62125-2

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

• 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

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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Your feedback will help improve our manuals. The survey is accessible through any internet-connected device with a web browser.

Scan the Quick Response (QR) code or click Technical Publications EMEA Feedback to complete the survey.

This qualification plan describes the procedure for qualifying 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 A-500 Spectrum and S3A remote evaporator..

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

Equipment, a trailer body of 13.6 m x 2.5 m x 2.7 m (L x W x H) and K-factor of 0.4 W/m². K or better equipped with a Thermo King refrigerated unit A-500 Spectrum and S3A remote evaporator has 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 NFX 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 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

for the transport of medicinal products.

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.

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.

⁽¹⁾ at +30°C ambient temperature under ATP conditions
⁽²⁾ Maximum recommended dimensions: these are guidelines based on airflow and air velocity requirements. For each application, a heat load calculation must be performed. All calculations are based upon the following assumptions: Trailer wall k value = 0.4W/m²K, internal trailer length up to 13.5 m, height up to 2.5 m, width up to 2.5 m, zero heat load from produce carried.

Spectrum S3A - Remote zone up to 1/3 of total body length

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, 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-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 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 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 -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 must be always kept clean and only cleaning agents that will not affect the products should be used.

• If an air chute is installed and extends the full length of the box provision should be made to allow for the dividing door to be closed. Therefore, a system is required that facilitates the air chute to open to allow correct air distribution from the chute.

• A compartment moveable dividing wall is used in multi-temperatures applications to separate the compartments to allow them to operate at different temperatures. The dividing door must not be positioned any less than 1300 mm from the air outlet of the remote ZONE 2 S3A evaporator and any less than 2500 mm from the air outlet of the host ZONE 1 evaporator.

• If a small load is carried at one temperature, ZONE 1 should be utilised, and the dividing wall should be used to reduce the compartment size. The dividing wall must not be positioned any less than 2500 mm from the air outlet of the host ZONE 1 evaporator. This will provide better air/temperature management and help reduce fuel consumption.

• A minimum of 100 mm clearance must be provided between the top of the load and the air intake of a remote ZONE 2 S3A evaporator.

• An air gap of minimum 50 mm should be always maintained between the load and the walls.

• If the dividing wall is positioned tightly against the load, satisfactory air circulation and temperature management will not be achieved.

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

• If the unit is to be used as a single temperature mode, the dividing door should be stowed in such a way that it does not interrupt the airflow from the main host ZONE 1 unit evaporator. The recommended position of the stowed bulkhead is shown below; this will aid airflow when operating in single temperature mode.

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 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 the GDP guideline as to the location of or how many thermo couplings for temperature measurement should be inserted into the load space during the qualification test. Therefore, the locations of the thermocouples are referred to as in standard NFX 15-140. This means 20- 25 thermocouples locations are utilised in the box during the qualification test. These thermocouples are calibrated, and the calibration documents are available under request.

• EAIT_1 Return air sensor Zone 1

• EAOT_1 Supply air sensor Zone 1

• EAIT_2 Return air sensor Zone 2

• EAOT_2 Supply air sensor Zone 2

Thermocouples Ti1_01, Ti1_06, Ti1_11, Ti2_01, Ti2_06 and Ti2_11 are located at Top right corner 150 mm away from any wall/door.

Thermocouples Ti1_02, Ti1_07, Ti1_12, Ti2_02, Ti2_07 and Ti2_12 are located at Right bottom corner between boxes and wall.

Thermocouples Ti1_03, Ti1_08, Ti1_13, Ti2_03, Ti2_08 and Ti2_13 are located at Left bottom corner between boxes and wall.

Thermocouples Ti1_04, Ti1_09, Ti1_14, Ti2_04, Ti2_09 and Ti2_14 are located at Top left corner 150 mm away from any wall/door.

Thermocouples Ti1_05, Ti1_10, Ti1_15, Ti2_05, Ti2_10 and Ti2_15 are located in the centre.

• EAIT_1 Return air sensor

• EAOT_1 Supply air sensor

Thermocouples Ti1_01, Ti1_06, Ti1_11, and Ti1_16 are located at Top right corner 150 mm away from any wall/door.

Thermocouples Ti1_02, Ti1_07, Ti1_12, and Ti1_17 are located at Right bottom corner 150 mm away from any wall/door.

Thermocouples Ti1_03, Ti1_08, Ti1_13 and Ti1_18 are located at Left bottom corner 150 mm away from any wall/door.

Thermocouples Ti1_04, Ti1_09, Ti1_14 and Ti1_19 are located at Top left corner 150 mm away from any wall/door.

Thermocouples Ti1_05, Ti1_10, Ti1_15 and Ti1_20 are located in the centre.

Ambient Sensors Te01 and Te09 are located at Top right corner 150 mm away from any wall/door.

Ambient Sensors Te02 and Te10 are located at Right bottom corner 150 mm away from any wall/door.

Ambient Sensors Te03 and Te11 are located at Left bottom corner 150 mm away from any wall/door.

Ambient Sensors Te04 and Te12 are located at Left bottom corner 150 mm away from any wall/door.

Ambient Sensors Te05 is located at Center of the left wall 150 mm away from any wall/door.

Ambient Sensors Te06 is located at Center of the floor 150 mm away from any wall/door.

Ambient Sensors Te07 is located at Center of the right wall 150 mm away from any wall/door.

Ambient Sensors Te08 is located at Center of the ceiling 150 mm away from any wall/door.

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-DQ-TR-MT_A.

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

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.

• The splitting of the zones for multi-temperature operation must be as stated in the qualification test: 2/3 and 1/3.

• For the configuration trailer with S3A, Zone 2 maximum split must be 1/3. If a larger Zone 2 compartment is required, please consult with your Thermo King Dealer.

When operating in multi-temperatures mode:

• For A-500 Spectrum with S3A remote evaporator software version must be equal to or higher than v.3.0.2.

• CONTROLLING SENSOR for both FRESH and FROZEN range is set RETURN AIR for Zone 1.

• Blower speed for DIESEL operation pull down and steady state is set HIGH.

• Blower speed for ELECTRIC operation pull down and steady state is MAXIMUM.

• Customers who will use the mentioned equipment as a single-temperature unit, the dividing door must be stowed in such a way that it does not interrupt the airflow from the main host unit evaporator and, Zone 2 must be switched off.