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User Guide
Trailer 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
March 2022
T T K K 6 6 1 1 2 2 9 9 7 7 – – 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 PharmaSolutions SLXe 400
Summary of Contents for Trane Technologies THERMO KING PharmaSolutions SLXe 400
- Page 1 User Guide Trailer 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 7 7 –...
- Page 2 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 ©2022 Trane Technologies TK 61297–8–MS-EN...
- Page 3 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 (03/22) New format General Information Units Covered: Single-temperature Trailer Units SLX 400, SLX 300 SLXe 400, SLXe 300 SLXi 400, SLXi 300 Kit Pharma Solutions Trailer ST...
- 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): •...
- 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 Blank Pages This manual may contain blank pages at the end of chapters. This is normal. There is no information missing from the manual.
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Page 6: Table Of Contents
Table of Contents 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 ................................8 8 Danger, Warning, Caution, and Notice . - 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 Optiset – Pharma Settings..............23 Refrigerated Unit Capacity .
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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 •...
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Page 15: Purpose
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 T T r r a a i i l l e e r r S S i i n n g g l l e e - - T T e e m m p p e e r r a a t t u u r r e e U U n n i i t t s s : : S S L L X X e e 4 4 0 0 0 0 , , S S L L X X e e - - 3 3 0 0 0 0 , , S S L L X X 4 4 0 0 0 0 , , S S L L X X - - 3 3 0 0 0 0 , , S S L L X X i i 4 4 0 0 0 0 a a n n d d S S L L X X i i 3 3 0 0 0 0 Thermo King designs and builds temperature controlled transport equipment. -
Page 16: 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 17: 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 18: 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 2. - Page 19 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.
- 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 4.
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Page 21: Scope
Design 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 S S i i n n g g l l e e - - t t e e m m p p e e r r a a t t u u r r e e T T r r a a i i l l e e r r s s : : S S L L X X i i 4 4 0 0 0 0 , , S S L L X X i i 3 3 0 0 0 0 , , S S L L X X e e 4 4 0 0 0 0 , , S S L L X X e e - - 3 3 0 0 0 0 , , S S L L X X 4 4 0 0 0 0 a a n n d d S S L L X X - - 3 3 0 0 0 0 Thermo King designs and builds temperature controlled transport equipment. -
Page 22: Acceptance Criteria
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 Acceptance Criteria Regarding the acceptance criteria considered in Thermo King Protocol, the air temperature should remain within the required temperature range. -
Page 23: Air Chute
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 2. Thermo King Recommended Return Air Bulkhead Specification 1099 mm 2205 mm BEG240... -
Page 24: Refrigerated Unit Capacity
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 To allow the SLXi 300, SLX 300, SLXe 300, SLXi 400, SLX 400 and SLXe 400 single temperature to be used in this demanding environment the unit will need to be configured and operated to a strict list of guidelines. - Page 25 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 S S i i n n g g l l e e - - t t e e m m p p e e r r a a t t u u r r e e T T r r a a i i l l e e r r s s : : S S L L X X i i 4 4 0 0 0 0 , , S S L L X X i i 3 3 0 0 0 0 , , S S L L X X e e 4 4 0 0 0 0 , , S S L L X X e e - - 3 3 0 0 0 0 , , S S L L X X 4 4 0 0 0 0 a a n n d d S S L L X X - - 3 3 0 0 0 0 The installation Qualification is completed and conforms to the requirements of the Design Qualification: G G D D P P - - T T K K - - D D Q Q _ _ T T R R - - S S T T .
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Page 26: 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 S S i i n n g g l l e e - - t t e e m m p p e e r r a a t t u u r r e e T T r r a a i i l l e e r r s s : : S S L L X X i i 4 4 0 0 0 0 , , S S L L X X i i 3 3 0 0 0 0 , , S S L L X X e e 4 4 0 0 0 0 , , S S L L X X e e - - 3 3 0 0 0 0 , , S S L L X X 4 4 0 0 0 0 a a n n d d S S L L X X - - 3 3 0 0 0 0 Description of the Qualified Operation T T h h e e t t r r a a i i l l e e r r s s h h a a l l l l b b e e u u s s e e d d : :... -
Page 27: 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 F F o o r r t t h h i i s s 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 t t h h r r e e e e i i s s s s u u e e s s a a r r e e i i m m p p o o r r t t a a n n t t : : •... - Page 28 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 29: 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 Thermocouple Locations 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. -
Page 30: 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 Operational Qualification Checklist 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. -
Page 31: 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 S S i i n n g g l l e e - - t t e e m m p p e e r r a a t t u u r r e e T T r r a a i i l l e e r r s s : : S S L L X X i i 4 4 0 0 0 0 , , S S L L X X i i 3 3 0 0 0 0 , , S S L L X X e e 4 4 0 0 0 0 , , S S L L X X e e - - 3 3 0 0 0 0 , , S S L L X X 4 4 0 0 0 0 a a n n d d S S L L X X - - 3 3 0 0 0 0 Introduction Thermo King designs and builds temperature controlled transport equipment. - Page 32 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 12.
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Page 33: 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 Recommendations •... - Page 34 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 61297–8–MS-EN...
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Page 35: 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 61297–8–MS-EN... - Page 36 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 37 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 38 N N o o t t e e s s TK 61297–8–MS-EN...
- Page 39 N N o o t t e e s s TK 61297–8–MS-EN...
- Page 40 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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