Basic HTML Version
DB Schenker Logistics, the
transportation and logistics division of
Deutsche Bahn and one of the world’s
largest transportation and logistics
services providers, has expanded its
refrigerated fleet in Tilburg, Netherlands
with new trailers featuring ‘Good
Distribution Practices’ (GDP) qualified
Thermo King ‘SLXe Spectrum’ units.
The GDP-compliant PharmaSolutions
units from Thermo King, a manufacturer of
transport temperature control solutions
for a variety of mobile applications and
a brand of Ingersoll Rand, enable the 12
new DB Schenker refrigerated trailers
to transport pharmaceutical products
and ensure the high level of product
quality and integrity determined by good
manufacturing practices according to EU
guidelines.
“The reliable delivery of healthcare
products can be lifesaving. We take this
responsibility seriously and ensure that
the sensitive freight of our healthcare
sector customers is delivered safely,
securely and according to the strict
European requirements,” said Hans
Cleijsen, head of System Freight Tilburg,
at DB Schenker Logistics Netherlands.
“With Thermo King PharmaSolutions we
have the support that helps us to meet
our commitments.”
“As most medical and biological
products require a temperature
controlled environment at all stages
of manufacturing and distribution, the
control of storage and transportation
temperatures is vital in maintaining the
quality and effectiveness of medicine,”
said Roland Duquesne, director strategic
accounts and vertical markets at
Thermo King. “Our PharmaSolutions
GDP qualification package provides a
comprehensive and dedicated expertise
platform that addresses the precise
needs of the pharmaceutical industry,
covering a broad spectrum of equipment
and services to ensure patient safety.”
Thermo King developed a GDP protocol
covering the four stages outlined in
the European GDP guidelines. As part
of it, Thermo King conducts extreme
conditions thermal mapping of the
refrigerated unit and the ATP certified
body to prove that the equipment is
able to maintain the temperature within
the allowed ranges. This procedure
additionally contributes to customers’
time and qualification costs savings.
Patient safety
Industry statistics indicate that 25% of
vaccines reach their destination in a
degraded state because of incorrect
shipping, and approximately 30% of
scrapped sales at pharmaceutical
companies can be attributed to logistics
issues. Thermo King has been working
to decrease these percentages to
ensure top quality medical products for
patients worldwide. PharmaSolutions, a
comprehensive and dedicated expertise
platform from TK, addresses the precise
needs of the pharmaceutical industry
by delivering applications, advice and a
broad spectrum of services.
This solutions package purposefully
covers the four stages outlined in
the European Commission’s Good
Distributions Practice Guidelines of
Medicinal Products for Human Use to
include:
■
Design Qualification (DQ)
■
Installation Qualification (IQ)
■
Operations Qualification (OQ)
■
Performance Qualification (PQ)
PharmaSolutions offers a range of
equipment for temperature-controlled
transportation, from trailer to pulley-
motor truck, as well as ColdCube™
TK containers. All equipment has
been tested to conform with GDP
guidelines. The validation protocol has
been supervised and validated by an
independent pharmaceutical company
specialised in regulatory affairs of the
healthcare industry, with qualified
responsible personnel and pharmacists
highly-experienced in the design and
implementation of pharmaceutical
related Quality Systems
(e.g. ISO13485, GDP and GMP).
To confirm that the refrigerated
equipment is performing to
specification, tests have been
conducted in a temperature-controlled
chamber of the industry-certified
Ingersoll Rand Engineering and
Technology Centre (IRETC) in Prague.
This R&D facility is certified ISO 9001:
2000; ISO 14001 and ISO 18000 and
authorized for ATP certification. To
help customers improve their quality
risk management, the PharmaSolutions
service range can be delivered as a
complete package, individually, or as a
selection of services combined into a
PharmaAssist service contract.
Fleet Refrigeration
26
Logistics Business Magazine | November 2015
REFRIGERATED TRANSPORT