SP Truck Multi-Temperature

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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• The term “unit” is referring to temperature controlled units listed above.

• The term “body” refers to an “insulated equipment” as defined in ATP Annex 1

• The term “IN” refers to a “Normally insulated equipment” as defined in ATP Annex 1

• The term “IR” refers to a “Heavily insulated equipment” as defined in ATP Annex 1

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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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.

• Temperature below -20°C

• Temperature between +2°C and +8°C

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

This qualification plan describes the procedure for qualifying:

• a refrigeration truck type ATP-FRC certified consisting of an IR body (0.4 W/m².K or better insulation) and a refrigerated unit type Thermo King multi-temperatures T-1000R Spectrum or T-1200R Spectrum and UT-R Spectrum.

• a refrigeration truck type ATP-FNA certified consisting of an IN body (0.7 W/m².K or better insulation) and a refrigerated unit type Thermo King multi-temperatures UT-1200 Spectrum.

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 -30°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 2 zones I_R body of 9.12m x 2.47m x 2.54m (L x W x H) internal dimensions equipped of a Thermo King refrigerated unit T-1000R Spectrum S3+S3 or T-1200R Spectrum S3+S3.

• A 2 zones I_R body of 7.36m x 2.46m x 2.59m (L x W x H) internal dimensions equipped of a Thermo King refrigerated unit UT-R Spectrum S3+S3.

• A 2 zones I_N body of 8.93m x 2.47m x 2.44m (L x W x H) internal dimensions equipped of a Thermo King refrigerated unit UT-1200 Spectrum S3+S3.

The above 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 have 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 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 must 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.

Truck body with Thermo King T-1000R Spectrum or T-1200R Spectrum unit

• A 2 zones multi-temperatures truck body ATP IR standards with internal dimensions (L x W x H) of 9.12m x 2.47m x 2.54m resulting with an internal surface of 103.73 m². Owing to the many configurations the bodies' sizes are to be calculated in cubic metres therefore it results with a body with maximum total internal volume of 57 m³ . An internal volume that is smaller is permissible as long as the internal surface is not smaller by more than 20%.

• A K factor of 0.40 W/m².K. A better K factor is also permissible.

• Body white in colour. A maximum 20% of the external surface decal coverage is recommended.

• Body with double rear doors with door switches. A door arrangement that is better than this is also permissible. Unit is to be configured to force ZONE NULL when opening the doors. Thermal curtains are recommended.

• A transversal movable dividing wall with a K factor as required and laid out in ATP (see table 1 in section “Detail specifications”). A K factor that is better than those from table 1 is also permissible.

• Thermo King S3 remote evaporators installed in each of the 2 zones. Evaporator fans are to be configured to run in NULL mode. ZONE PRIORITY function must be DISABLED.

• A specific configuration file for pharmaceutical applications used for tighter temperature management.

• A temperature datalogger which complies with EN12830 standard with at least one sensor in each zone. Thermo King DAS or TouchPrint Datalogger are recommended.

Addition of truck body ATP IR standards with UT-1200 Spectrum S3+S3

2 zones multi-temperatures truck body ATP IR standard with a 0.40 W/m² K insulation or better with UT-1200 Spectrum S3+S3 is approved in parallel because it offers better insulation and ensure equivalent temperature management.

Addition of Whisper Option for T-1000R Spectrum and T-1200R Spectrum

T-1000R Spectrum S3+S3 Whisper and T-1200R Spectrum S3+S3 Whisper are approved in parallel.

Addition of rear rolling doors in lieu et place of double rear doors

If K factor co-efficient remains below 0.40 W/m² K and therefore the vehicle is FRC declared, body equipped with rear rolling doors instead of double rear doors are approved in parallel.

Variations on body sizes

Smaller body sizes appropriate to the unit design are also included because the performance will be improved as body size reduces:

• T-1000R Spectrum S3+S3 and T-1200R Spectrum S3+S3 should not be used on a body volume that is less than 45m³ and not more than 57m³; this would require a different specification unit.

• UT-1200 Spectrum S3+S3 should not be used on a body volume that is less than 43m³ and not more than 54m³; this would require a different specification unit.

The truck shall be used:

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

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

• In multi-temperature operation (< -20°C, +2°C to +8 °C or +15°C to +25°C) in two compartments.

• At ambient temperature between -30°C and +40°C.

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

• According to the drivers instructions supplied by Thermo King on use of Thermo King equipment.

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-SP-MT.

• 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 always 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 unit+body is qualified in multi-temperatures and single-temperature modes based on the details below:

  • In multi-temperature mode:

    In case of multi-temperatures operation, the dividing wall must be locked in vertical position and setpoint must be set according to the requested range in each zone. ZONE PRIORITY function must be DISABLED.

• For T-1200R Spectrum S3+S3:

  • Ranges < -20°C, +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones.

• For T-1000R Spectrum S3+S3 and UT-1200 S3+S3:

  • Ranges +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones.

  • The range < -20°C cannot be operated.

  • In single-temperature mode:

    In case of single-temperature operation the unit must run in SINGLE ZONE CONTROL (SZC)mode and the dividing wall must be stowed in such a way that it does not interrupt the airflow from each remote evaporator. For ease of use, SZC mode should be added to the Main (driver) menu.

• For T-1200R Spectrum S3+S3:

  • Ranges < -20°C, +2°C to +8 °C or +15°C to +25°C can be operated.

• For T-1000R Spectrum S3+S3 and UT-1200 S3+S3:

  • Ranges +2°C to +8 °C or +15°C to +25°C can be operated.

  • The range < -20°C cannot be operated:

• For UT-R Spectrum S3+S3:

  • Ranges +2°C to +8 °C or +15°C to +25°C can be operated in any of the 2 zones at the same time.

  • Ranges +2°C to +8 °C or +15°C to +25°C cannot be used if one zone is set for frozen.

  • Ranges < -20°C can be operated only with single zone control.

  • In case of single zone use (one zone, both compartments) the unit must run in SINGLE ZONE CONTROL (SZC) mode and the dividing wall must be stowed in such a way that it does not interrupt the airflow from each remote evaporator. For ease of use, SZC mode should be added to the Main (driver) menu.

• When operating the equipment in multi-temperatures mode, the splitting of the compartment zones should be up to 1/2 of the total body length:

• At ambient temperature between -30°C and +40 °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 +40 °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 body, depending on the difference in ambient temperature and temperature inside the box. To minimise this effect, this is recommended to open doors of the truck only at loading and unloading at temperature-controlled warehouse. In these warehouses the product and the environment are 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 must be used according to the driver's instructions supplied by Thermo King on use of Thermo King Equipment. These driver instructions are to be found in the specific Operator Manual.

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

• The load space considerations indicated here after must also be considered.

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

• A compartment moveable dividing wall is used in multi-temperatures applications to separate the compartments to allow them to operate at different temperatures. This dividing wall must not be positioned any less than 1300mm from the air outlet of the remote zone evaporator.

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

• An air gap between the load and the walls should be always maintained :

  • 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 wall should be stowed in such a way that it does not interrupt the airflow from each remote 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-SP-MT.

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.

• The capacity of the unit that is used to manage the temperature within the load space must 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 truck.

• The temperature logging equipment used for the calibration process must 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 dataloggers and must be registered as such. This will be checked and confirmed during the OQ (Operational Qualification) 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. Therefore, the locations of the thermo couplings are referred to as in the ATP guideline. ATP is using standard NFX 15-140. This means 15 thermocouples per zone are utilised in the box during the multi-temperature’s qualification test and 25 thermocouples for the single temperature qualification test. These loggers are calibrated, and the calibration documents are available under request.

T-1200R S3+S3, T-1000R S3+S3, UT-1200 S3+S3 and UT-R Spectrum S3+S3 thermocouple locations multi-temperatures operation Z1 length = 1/2 / Z2 length = 1/2 of total length

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• 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.

T-1200R S3+S3, T-1000R S3+S3, UT-1200 S3+S3 and UT-R Spectrum S3+S3 thermocouple locations, single temperature operation

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• EAIT_1 Return air sensor

• EAOT_1 Supply air sensor

• EAIT_2 Return air sensor (SZC)

• EAOT_2 Supply air sensor (SZC)

• Thermocouples Ti1_01, Ti1_06, Ti1_11, Ti1_16 are located at Top right .

• Thermocouples Ti1_02, Ti1_07, Ti1_12, Ti1_17 are located at Right bottom corner 150 mm from any wall.

• Thermocouples Ti1_03, Ti1_08, Ti1_13, Ti1_18 are located at Left bottom corner between boxes and wall.

• Thermocouples Ti1_04, Ti1_09, Ti1_14, Ti1_19 are located at Top left corner between boxes and wall.

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

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

This document confirms that:

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

• 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.

• 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-SP-MT, GDP-TK-IQ-SP-MT and GDP-TK-OQ-SP-MT.

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 multi-temperatures truck the specifications are as per the Design Qualification GDP-TK-DQ-SP-MT.

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 figures 8 and 11 for thermocouples locations.

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:

For T-1200R Spectrum S3+S3

• +20 °C for temperature range +15 °C to +25 °C

• +6 °C  for temperature range +2 °C to +8 °C

• -25 °C for temperature below -20 °C

For T-1000R Spectrum S3+S3

• +20 °C for temperature range +15 °C to +25 °C

• +6 °C  for temperature range +2 °C to +8 °C

For UT-1200 Spectrum S3+S3

• +20 °C for temperature range +15 °C to +25 °C

• +5 °C  for temperature range +2 °C to +8 °C

For UT-R Spectrum S3+S3

• +20 °C for temperature range +15 °C to +25 °C

• +5 °C for temperature range +2 °C to +8 °C

• -24 °C for temperature below -20 °C

• -29 °C for temperature below -27 °C