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User Guide
VP Truck Multi–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
July 2021
T T K K 6 6 1 1 4 4 3 3 3 3 - - 1 1 8 8 - - M M S S - - E E N N
Revision A
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Table of Contents
Related Manuals for Trane Technologies Thermo King E-200 MAX Spectrum 30/50
Summary of Contents for Trane Technologies Thermo King E-200 MAX Spectrum 30/50
- Page 1 User Guide VP Truck Multi–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 4 4 3 3 3 3 - - 1 1 8 8 - - M M S S - - E E N N July 2021...
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Page 2: Emergency Assistance
No payment at point of repair for customers with a ThermoKare service contract or with a guaranty of payment from their Thermo King home-dealer ©2021 Trane Technologies TK 61433-18-MS-EN... -
Page 3: Revision History
I I n n t t r r o o d d u u c c t t i i o o n n Revision History Revision A (07/21) New format General Information The maintenance information in this manual covers unit models: E-200 MAX Spectrum 30/50 V-500 MAX Spectrum 30/50 V-300 MAX Spectrum 30/50... -
Page 4: About This Manual
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): •... -
Page 5: Customer Satisfaction Survey
I I n n t t r r o o d d u u c c t t i i o o n n Blank Pages This manual may contain blank pages at the end of chapters. This is normal. There is no information missing from the manual. -
Page 6: Table Of Contents
Equipment Specifications ..............23 Truck/Van body with Thermo King E-200 MAX Spectrum 30/50 ES100N+ES100N ....23 IR body with Thermo King V-300 MAX Spectrum 30/50 . - 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 IN body with Thermo King V-300 MAX Spectrum 30/50 ........24 IN body with Thermo King V-800 MAX Spectrum 30/50 .
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Page 8: Safety Precautions
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 W W a a r r n n i i n n g g R R i i s s k k o o f f I I n n j j u u r r y y ! ! C C o o n n t t a a c c t t w w i i t t h h t t h h e e c c o o n n t t e e n n t t s s o o f f a a c c o o m m p p r r o o m m i i s s e e d d c c e e l l l l / / b b a a t t t t e e r r y y c c a a n n c c a a u u s s e e s s e e v v e e r r e e i i r r r r i i t t a a t t i i o o n n o o r r b b u u r r n n s s t t o o t t h h e e s s k k i i n n . -
Page 11: Refrigerant Oil 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 Oil Hazards 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 ! ! P P r r o o t t e e c c t t y y o o u u r r e e y y e e s s f f r r o o m m c c o o n n t t a a c c t t w w i i t t h h 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 . - Page 12 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 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 V V o o l l t t a a g g e e ! ! D D a a n n g g e e r r o o u u s s t t h h r r e e e e p p h h a a s s e e A A C C e e l l e e c c t t r r i i c c p p o o w w e e r r i i s s p p r r e e s s e e n n t t w w h h e e n n e e v v e e r r t t h h e e u u n n i i t t i i s s o o p p e e r r a a t t i i n n g g i i n n e e i i t t h h e e r r D D i i e e s s e e l l M M o o d d e e , , E E l l e e c c t t r r i i c c M M o o d d e e o o r r H H o o l l d d o o v v e e r r M M o o d d e e a a n n d d w w h h e e n n e e v v e e r r t t h h e e u u n n i i t t i i s s c c o o n n n n e e c c t t e e d d t t o o a a s s o o u u r r c c e e o o f f e e x x t t e e r r n n a a l l s s t t a a n n d d b b y y p p o o w w e e r r .
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Page 13: 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 Low Voltage W W a a r r n n i i n n g g L L i i v v e e E E l l e e c c t t r r i i c c a a l l C C o o m m p p o o n n e e n n t t s s ! ! C C o o n n t t r r o o l l c c i i r r c c u u i i t t s s u u s s e e d d i i n n 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 s s a a r r e e l l o o w w v v o o l l t t a a g g e e ( ( 1 1 2 2 t t o o 4 4 8 8 V V d d c c ) ) . - 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 • E E y y e e s s : : For contact with liquid, immediately flush eyes with large amounts of water and get prompt medical attention.
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Page 15: Spectrum 30/50
Qualification Plan P P r r e e p p a a r r e e d d f f o o r r T T h h e e r r m m o o K K i i n n g g , , f f o o r r v v a a l l i i d d a a t t i i o o n n o o f f t t e e m m p p e e r r a a t t u u r r e e c c o o n n t t r r o o l l l l e e d d e e q q u u i i p p m m e e n n t t w w i i t t h h M M u u l l t t i i - - T T e e m m p p e e r r a a t t u u r r e e s s v v e e h h i i c c l l e e p p o o w w e e r r e e d d u u n n i i t t s s f f o o r r v v a a n n s s a a n n d d t t r r u u c c k k s s : : E-200 MAX Spectrum, V-300 MAX Spectrum 30/50, V-500 MAX Spectrum 30/50 and V-800 MAX Spectrum 30/50... -
Page 16: Overall Qualification Results
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 Overall qualification results Multi Temperatures Vehicle Powered units TL + +15/+25°C +2/+8°C <... -
Page 17: Performance Qualification (Pq)
For each new or existing equipment, perform IQ and OQ check. Qualification Facility 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. -
Page 18: Risk Reporting Matrix
Risk Analysis Thermo King The transport process is defined as a closed temperature controlled storage box in transit. This box can be used in a single temperature mode and set at four different temperature ranges (Deep Frozen, Frozen, Chilled and Ambient). The risk analysis based on the Failure Mode and Effects Analysis (FMEA) methodology has been conducted in order to ensure that potential problems during the process of distributing pharmaceutical products have been considered and addressed before the first use of the transport temperature controlled equipment. -
Page 19: Identified Risks And Preventative Actions
R R i i s s k k A A n n a a l l y y s s i i s s T T h h e e r r m m o o K K i i n n g g Identified Risks and Preventative Actions Table 1. - Page 20 R R i i s s k k A A n n a a l l y y s s i i s s T T h h e e r r m m o o K K i i n n g g Table 1.
- Page 21 R R i i s s k k A A n n a a l l y y s s i i s s T T h h e e r r m m o o K K i i n n g g Table 2.
- Page 22 R R i i s s k k A A n n a a l l y y s s i i s s T T h h e e r r m m o o K K i i n n g g Table 3.
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Page 23: Spectrum 30/50
A standard configuration is defined for each group. Equipment Specifications Truck/Van body with Thermo King E-200 MAX Spectrum 30/50 ES100N+ES100N • A multi-temperatures truck/van body ATP IR standards with internal dimensions (L x W x H) of 3.68m x 1.91m x 1.95m resulting with an internal surface of 35.86 m... -
Page 24: Ir Body With Thermo King V-500 Max Spectrum 30/50
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 • A longitudinal dividing wall with a K factor as required and laid out in ATP. Authorized compartment split: See Figure and Table in (“Qualified Configurations,”... -
Page 25: Qualified Configurations
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 • Insulated body with K factor of 0.70 W/m .K. -
Page 26: Longitudinal Layout
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 Longitudinal Layout Figure 3. -
Page 27: Addition Body 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 5. IR body with V-300 MAX Spectrum 30/50 ES150+ES150: Temperature Range Extreme Ambient Recommended Setpoint... -
Page 28: Detailed Specifications
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 4. E-200 Minimal Distances TouchLog Detailed Specifications Dividing wall ATP Specifications... - Page 29 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 10. Unit Model: V-300 MAX Spectrum 30/50 ES150+ES150 Total Nominal ES150 0°C...
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Page 30: Refrigerated Unit Dimensions
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 Refrigerated Unit Dimensions Figure 5. - Page 31 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 7. V-500 MAX Spectrum 30/50 BEE595 Figure 8.
- Page 32 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 BEE597 TK 61433-18-MS-EN...
- Page 33 Installation Qualification P P r r e e p p a a r r e e d d f f o o r r T T h h e e r r m m o o K K i i n n g g , , f f o o r r v v a a l l i i d d a a t t i i o o n n o o f f t t e e m m p p e e r r a a t t u u r r e e c c o o n n t t r r o o l l l l e e d d e e q q u u i i p p m m e e n n t t w w i i t t h h M M u u l l t t i i - - T T e e m m p p e e r r a a t t u u r r e e s s v v e e h h i i c c l l e e p p o o w w e e r r e e d d u u n n i i t t s s f f o o r r v v a a n n s s a a n n d d t t r r u u c c k k s s : : E E - - 2 2 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 E E S S 1 1 0 0 0 0 N N + + E E S S 1 1 0 0 0 0 N N , , V V - - 3 3 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 , , V V - - 5 5 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 a a n n d d V V - - 8 8 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 .
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Page 34: Description Of The Qualified Operation
Operational Qualification P P r r e e p p a a r r e e d d f f o o r r T T h h e e r r m m o o K K i i n n g g , , f f o o r r v v a a l l i i d d a a t t i i o o n n o o f f t t e e m m p p e e r r a a t t u u r r e e c c o o n n t t r r o o l l l l e e d d e e q q u u i i p p m m e e n n t t w w i i t t h h M M u u l l t t i i - - T T e e m m p p e e r r a a t t u u r r e e s s v v e e h h i i c c l l e e p p o o w w e e r r e e d d u u n n i i t t s s f f o o r r v v a a n n s s a a n n d d t t r r u u c c k k s s : : E E - - 2 2 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m , , V V - - 3 3 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 , , V V - - 5 5 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 a a n n d d V V - - 8 8 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 Description of the Qualified Operation... -
Page 35: Load Space Considerations
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 •... -
Page 36: Technical And User Data
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 Technical and User Data Risk Management for Transport Equipment Assumptions that are made:... - Page 37 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 •...
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Page 38: 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 20. - Page 39 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 Figure 9.
- Page 40 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 Figure 10.
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Page 41: Operational Qualification Checklist
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 Figure 11. -
Page 42: Introduction
Performance Qualification P P r r e e p p a a r r e e d d f f o o r r T T h h e e r r m m o o K K i i n n g g , , f f o o r r v v a a l l i i d d a a t t i i o o n n o o f f t t e e m m p p e e r r a a t t u u r r e e c c o o n n t t r r o o l l l l e e d d e e q q u u i i p p m m e e n n t t w w i i t t h h M M u u l l t t i i - - T T e e m m p p e e r r a a t t u u r r e e s s v v e e h h i i c c l l e e p p o o w w e e r r e e d d u u n n i i t t s s f f o o r r v v a a n n s s a a n n d d t t r r u u c c k k s s : : E E - - 2 2 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m , , V V - - 3 3 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 , , V V - - 5 5 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 a a n n d d V V - - 8 8 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m 3 3 0 0 / / 5 5 0 0 Introduction... -
Page 43: Scope
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 Scope 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. - Page 44 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 25.
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Page 45: Door-Opening 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 28. - Page 46 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.
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Page 47: 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 34. - Page 48 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 38.
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Page 49: 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 F F a a i i l l u u r r e e t t e e s s t t V V - - 8 8 0 0 0 0 M M A A X X S S p p e e c c t t r r u u m m E E S S 4 4 0 0 0 0 + + E E S S 4 4 0 0 0 0 Table 39. -
Page 50: 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 Temperature mapping results of the qualification are presented in a separate PQ report and are available on request following the signing of a NDA (Non-Disclosure Agreement). - Page 51 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 61433-18-MS-EN...
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Page 52: 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 61433-18-MS-EN... - Page 53 A A p p p p e e n n d d i i x x Certification date: 30 August 2022 Expiry date: 29 August 2025 Certificate number: 10465770 IATF Certificate number: 0456850 Certificate of Approval This is to certify that the Management System of: Thermo King Manufacturing s.r.o.
- Page 54 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 No. 292 Kolín District, 280 02 Ovčáry, Czech Republic Product Design.
- Page 55 N N o o t t e e s s TK 61433-18-MS-EN...
- Page 56 Thermo King – by Trane Technologies (NYSE: TT), a global climate innovator – is a worldwide leader in sustainable transport temperature control solutions. Thermo King has been providing transport temperature control solutions for a variety of applications, including trailers, truck bodies, buses, air, shipboard containers and railway cars since 1938.
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