Qualification Plan

Prepared for Thermo King, for validation of temperature–controlled equipment Multi-Temperatures units for truck:

T-1000R Spectrum, T-1200R Spectrum, UT-1200 Spectrum and UT-R Spectrum

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

Note To ensure total flexibility the validation is to be performed at all stated ranges from above.

Purpose

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.

User Requirements Specifications (URS)

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

Overall Qualification Results

Unit Specifications Box Specifications
Unit Model Refrigerant Doors Installation class
(ATP Mark) 		Internal
Front/Back/Side Minimal Maximal
T-1000R Spectrum 2 S3+S3 R-404A/
R-452A		 2 Back + 1 Side IR (FRC) 41 m3 56 m3
T-1200R Spectrum 2 S3+S3
UT-1200R Spectrum 2 S3+S3 IN (FNC) 48 m3 54 m3
UT-R Spectrum 2 S3+S3 2 Back IR (FRC) 38 m3 56 m3

Unit Specifications Pharmaceutical Temperature Ranges Test Ambient
Unit Model Refrigerant +15/+25 °C +2/+8 °C -20 °C <-20 °C Extreme Extreme
Ambient Chilled Frozen Deep Frozen HIGH LOW
T-1000R Spectrum 2 S3+S3 R-404A/
R-452A		 Qualified Qualified N.A N.A 40 °C –30 °C
T-1200R Spectrum 2 S3+S3 Qualified
UT-1200R Spectrum 2 S3+S3 N.A
UT-R Spectrum 2 S3+S3 Qualified Qualified above –27 °C

Design Qualification (DQ)

Those equipment-types:

  • A 2 zones IR 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 IR 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 IN 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..

Note Please refer to the document GDP-TK-DQ-SP-ST.

Installation Qualification (IQ)

The specific equipment has been installed successfully and was proved to comply with the design qualification and installation qualification of the sample-type equipment.

Note Please refer to the document GDP-TK-DQ-SP-MT.

Operational Qualification (OQ)

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.

Note Please refer to the document GDP-TK-IQ-SP-MT.

Performance Qualification (PQ)

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.

Note Please refer to the document GDP-TK-IQ-SP-MT.

Qualification with a Sample–Type Approach

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.

Responsibility

The qualification activities will be organized by the qualification team:

Organisation Activity
Thermo King Pharma Team

  • Define GDP Protocol for transport equipment.

  • Define GDP qualification per sample-type.

  • Create and update GDP qualification documentation.

  • Create GDP certificate for each new or existing equipment proven GDP qualified
Trane Technologies Engineering Center

  • Conduct thermal mapping tests of selected transport Equipment in line with GDP.

  • Provide results of thermal mapping tests performed.
External pharmaceutical consultant company

  • Provide the approval of the sample-type GDP qualification.

  • Sign GDP certificate for each new or existing equipment proven GDP qualified.
Thermo King authorized dealers

  • 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.