Thermo King Pharma Solutions T-800R User Manual
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Thermo King Pharma Solutions T-800R User Manual

Thermo King Pharma Solutions T-800R User Manual

Sp truck single-temperature gdp compliant
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User Guide
SP Truck Single-Temperature
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
April 2022
T T K K 6 6 1 1 2 2 9 9 5 5 – – 1 1 – – M M S S - - E E N N
Revision A

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Summary of Contents for Thermo King Pharma Solutions T-800R

  • Page 1 User Guide SP Truck Single-Temperature 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 Revision A T T K K 6 6 1 1 2 2 9 9 5 5 –...
  • Page 2 This manual is published for informational purposes only. Thermo King® makes no representations warranties express or implied, with respect to the information recommendations and descriptions contained herein. Information provided should not be regarded as all-inclusive or covering all contingencies. If further information is required, Thermo King Service Department should be consulted.
  • Page 3 Regulations must be observed when working on refrigeration systems. 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.
  • Page 4 Certification Certificate of Approval of Trane Technologies Quality Management system. Contacting Thermo King Service 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) •...
  • Page 5 I I n n t t r r o o d d u u c c t t i i o o n n Roadside/Curbside Terminology Roadside/Curbside terminology: These terms can be confusing because of differences between North America and Europe.

  • Page 6: Table Of Contents

    45 feet Container with Thermo King T-1200R Intermodal ....... . .
  • Page 7 T T a a b b l l e e o o f f C C o o n n t t e e n n t t s s Acceptance Criteria............... . . 23 Temperature Range Table .

  • Page 8: Danger, Warning, Caution, And Notice

    Safety Precautions Danger, Warning, Caution, and Notice Thermo King® recommends that all service be performed by a Thermo King dealer and to be aware of several general safety practices. Safety advisories appear throughout this manual as required. Your personal safety and the proper operation of this unit depend upon the strict observance of these precautions.

  • Page 9: Tk Lithium Ion Battery Safety

    S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s W W a a r r n n i i n n g g P P e e r r s s o o n n a a l l P P r r o o t t e e c c t t i i v v e e E E q q u u i i p p m m e e n n t t ( ( P P P P E E ) ) R R e e q q u u i i r r e e d d ! ! A A b b a a t t t t e e r r y y c c a a n n b b e e d d a a n n g g e e r r o o u u s s .

  • Page 10: Refrigerant Hazards

    S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s Refrigerant Hazards D D a a n n g g e e r r H H a a z z a a r r d d o o u u s s P P r r e e s s s s u u r r e e s s ! ! A A l l w w a a y y s s s s t t o o r r e e r r e e f f r r i i g g e e r r a a n n t t i i n n p p r r o o p p e e r r c c o o n n t t a a i i n n e e r r s s , , o o u u t t o o f f d d i i r r e e c c t t s s u u n n l l i i g g h h t t a a n n d d a a w w a a y y f f r r o o m m i i n n t t e e n n s s e e h h e e a a t t .

  • Page 11: Electrical Hazards

    S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s N N o o t t i i c c e e E E q q u u i i p p m m e e n n t t D D a a m m a a g g e e ! ! D D o o n n o o t t m m i i x x r r e e f f r r i i g g e e r r a a n n t t o o i i l l s s .

  • Page 12: Low Voltage

    S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s W W a a r r n n i i n n g g H H a a z z a a r r d d o o u u s s V V o o l l t t a a g g e e ! ! N N e e v v e e r r w w o o r r k k a a l l o o n n e e o o n n h h i i g g h h v v o o l l t t a a g g e e c c i i r r c c u u i i t t s s i i n n t t h h e e r r e e f f r r i i g g e e r r a a t t i i o o n n u u n n i i t t .

  • Page 13: Welding Precautions

    S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s • Disconnect power to the unit. •...
  • Page 14 S S a a f f e e t t y y P P r r e e c c a a u u t t i i o o n n s s B B A A T T T T E E R R Y Y A A C C I I D D •...

  • Page 15: T-800R, T-1000R, T-1200R, Ut-1200 And T-1200R Intermodal

    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.

  • Page 16: Design Qualification (Dq)

    • 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.

  • Page 17: Qualification Facility

    Q Q u u a a l l i i f f i i c c a a t t i i o o n n P P l l a a n n Organisation Activity Thermo King Pharma Team • Define GDP Protocol for transport equipment.

  • Page 18: Risk Reporting Matrix

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

  • Page 19: Identified Risks And Preventative Actions

    Incorrect settings of To maintain the best temperature management within the load- set points for the space in winter and summer time, Thermo King recommends operation with the following set point temperatures: temperature range to Settings of the be maintained (Moder- •...
  • Page 20 Minimum sensor requirements and location should be in accordance with equipment manufacturer's recommendations. The calibration process should be in line with the EN13486. No regular A maintenance contract with Thermo King or authorized Thermo maintenance of the King dealer should be in place. transport equipment...
  • Page 21 Pharmaceutical products should not be transported in a mixed load with food products. Transport equipment Thermo King provides an Operational manual to use efficiently not used the transport equipment. Incorrect appropriately Lack of...

  • Page 22: Scope

    S S e e l l f f - - P P o o w w e e r r e e d d t t r r u u c c k k : : T T - - 8 8 0 0 0 0 R R , , T T - - 1 1 0 0 0 0 0 0 R R , , T T - - 1 1 2 2 0 0 0 0 R R a a n n d d U U T T - - 1 1 2 2 0 0 0 0 a a n n d d I I n n t t e e r r m m o o d d a a l l c c o o n n t t a a i i n n e e r r : : T T - - 1 1 2 2 0 0 0 0 R R I I n n t t e e r r m m o o d d a a l l Thermo King designs and builds temperature controlled transport equipment.

  • Page 23: Truck Body With Thermo King Ut-1200

    A refrigerated unit Thermo King T-1200R Intermodal for temperature management. • Air chute conforming to Thermo King recommended standards in the ceiling of the container and to provide the same or better air distribution as the Thermo King Air Chute.

  • Page 24: Additional Validations And Variations

    D D e e s s i i g g n n Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 6. Test Results - Truck body of 48m with T-1000R Extreme Ambient...

  • Page 25: Detailed Specifications

    Air chute system is required only for the T-1200R Intermodal on a 45 feet container. It should conform to Thermo King recommended minimum standards in the ceiling of the trailer and to provide the same or better air distribution as the Thermo King Air Chute.
  • Page 26 D D e e s s i i g g n n Q Q u u a a l l i i f f i i c c a a t t i i o o n n Figure 3. Dimensions of UT-1200 refrigerated unit with 2 S3-evaporators (in mm) BED269 Figure 4.

  • Page 27: Intermodal Container Single-Temperatures And Qualified Configuration

    D D e e s s i i g g n n Q Q u u a a l l i i f f i i c c a a t t i i o o n n Intermodal Container Single-temperatures and Qualified Configuration Figure 6.
  • Page 28 For each individual equipment (truck + body + refrigerated unit) a specific T T K K P P h h a a r r m m a a S S o o l l u u t t i i o o n n s s - - I I Q Q O O Q Q C C h h e e c c k k - - M M U U L L document has to be completed by the Thermo King official dealer to confirm that Installation Qualification conforms to the requirements of the Design Qualification: G G D D P P - - T T K K - - D D Q Q - - S S P P - - S S T T .

  • Page 29: Description Of The Qualified Operation

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

  • Page 30: Load Space Considerations

    A A i i r r c c h h u u t t e e s s y y s s t t e e m m to conform to Thermo King recommended minimum standards in the ceiling of...

  • Page 31: Acceptance Criteria

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

  • Page 32: Thermocouple Locations

    O O p p e e r r a a t t i i o o n n a a l l Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 12.

  • Page 33: Operational Qualification On The Field

    For each individual equipment (vehicle + refrigerated unit) a specific T T K K P P h h a a r r m m a a S S o o l l u u t t i i o o n n s s - - I I Q Q O O Q Q C C h h e e c c k k - - M M U U L L 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.

  • Page 34: Introduction

    S S e e l l f f - - P P o o w w e e r r e e d d t t r r u u c c k k : : T T - - 8 8 0 0 0 0 R R , , T T - - 1 1 0 0 0 0 0 0 R R , , T T - - 1 1 2 2 0 0 0 0 R R a a n n d d U U T T - - 1 1 2 2 0 0 0 0 a a n n d d I I n n t t e e r r m m o o d d a a l l c c o o n n t t a a i i n n e e r r : : T T - - 1 1 2 2 0 0 0 0 R R I I n n t t e e r r m m o o d d a a l l Introduction 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.

  • Page 35: Purpose

    N N o o t t e e : : To ensure total flexibility the qualification is to be performed at all stated ranges from above. Purpose 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.

  • Page 36: Test Results - Door Openings

    P P e e r r f f o o r r m m a a n n c c e e Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 20.

  • Page 37: Test Results - Failure Tests

    P P e e r r f f o o r r m m a a n n c c e e Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 23.

  • Page 38: Hotspot / Coldspot Identification

    P P e e r r f f o o r r m m a a n n c c e e Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 26.

  • Page 39: Recommendations

    P P e e r r f f o o r r m m a a n n c c e e Q Q u u a a l l i i f f i i c c a a t t i i o o n n Table 31.
  • Page 40 Appendix C C e e r r t t i i f f i i c c a a t t e e o o f f P P r r a a g g u u e e A A c c c c r r e e d d i i t t a a t t i i o o n n - - I I S S O O 1 1 7 7 0 0 2 2 5 5 C C e e r r t t i i f f i i c c a a t t e e o o f f P P r r a a g g u u e e A A c c c c r r e e d d i i t t a a t t i i o o n n - - I I A A T T F F 1 1 6 6 9 9 4 4 9 9 TK 61295–1–MS-EN...

  • Page 41: A A P P P P E E N N D D I I X

    A A p p p p e e n n d d i i x x TK 61295–1–MS-EN...
  • Page 42 IATF Certificate number: 0456850 Certificate of Approval This is to certify that the Management System of: Thermo King Manufacturing s.r.o. No. 292 Kolín District, 280 02 Ovčáry, Czech Republic has been approved by LRQA to the following standards: IATF 16949:2016 Approval number(s): IATF 16949 –...
  • Page 43 A A p p p p e e n n d d i i x x Approval number(s): 00021327-001 Certificate number: 10465770 IATF Certificate number: 0456850 Certificate Schedule Location Activities Trane Technologies s.r.o., ETC Prague IATF 16949:2016 Testing, Laboratory, R&D. Florianova 2460, 253 01 Hostivice, Czech Republic Trane Technologies International Limited IATF 16949:2016...
  • Page 44 1938. For more information, visit www.thermoking.com or www.tranetechnologies.com. Thermo King has a policy of continuous product and product data improvements and reserves the right to change design and specifications without notice. We are committed to using environmentally conscious print practices.

This manual is also suitable for:

Pharma solutions t-1000rPharma solutions t-1200rPharma solutions t-1200r intermodalPharma solutions ut-1200

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