spacer
home > white papers > New Temperature Profiles from a Global Study - Laminar Medica
WHITE PAPERS
logo_Laminar_Meo.jpg

Laminar Medica

phone 44 (0)14 4282 8664
email enquiries@laminarmedica.co.uk
web http://www.laminarmedica.com
email Unit 4 Tring Industrial Estate, Icknield Way, Tring, Hertfordshire, HP23 4JX

New Temperature Profiles from a Global Study

Recently there has been an influx of temperature mapping studies to collect sufficient ambient data to develop temperature profiles.  Solid temperature profiles on specific shipping routes are required to ensure streamlined packaging and robust lane qualification.

The most reliable method to develop temperature profiles is to capture the actual reading from shipments, as well as using the historical and meteorological data to increase the confidence level.

The Benefits of Ambient Temperature Profiling 

A Temperature Mapping Study is a comprehensive, systematic approach to:

·        Monitoring the distribution environment

·        Formatting a study for environmental data collection

·        Converting the data into a representative distribution temperature profile for specific shipping lanes with multiple confidence intervals

A thorough Temperature Mapping Study allows you to manage risk by understanding the ambient temperature ranges your shipment will encounter during transit. It also allows you to reduce the number of packaging versions needed by using the same types on routes with similar ambient temperature ranges.

There is no hard and fast rule, or universal accepted guidance, on how to develop temperature test profiles as each method varies widely (take for example ISTA 5B, 7D and most recently 7E in association with Standard 20 procedure). For these reasons, ISTA strongly recommends ‘that the users determine the applicability of any temperature cycle or ramp prior to use’.

The Laminar and DHL Global Temperature Mapping Study

Laminar Medica carried out a Global Temperature Mapping Study in association with DHL Supply Chain over a 23 month period from September 2008 to July 2010.  The main goals of the study were to:

·        Measure ambient temperature profiles

·        Collect enough data for statistical significance over the seasons

·        Include single air and dual airfreight legs

·        Identify areas of extreme ambient temperatures

The ultimate aim of the study was to use the data to validate current packaging test profiles, develop new profiles and appropriate packaging. 

In Laminar Medica’s study, two types of shipper were used - the Chilltherm® 21 and the Chilltherm® 470 (pallet size) shipper.  Data collection was carried out by locating externally a Temptale® 4 (TT4) electronic data logging device midway at the top of the system, where there was no interference with recording of the ambient air temperature.



This will ensure that freight costs are minimised, internal dimensions and optimised and there is an efficient use of materials.  Systems need to be designed with the following considerations:
·
         Payload space
·
         Shipping durations
·         Ambient profile (collection of shipping lane data)
·
         Temperature criteria (allowable excursions/flexibility, stability data)
·
         Design constraints (dimensions, physical weight, number of components, conditioning and packing challenges, and efficiency goals)
·
         Disposable/reusable infrastructure
·
         Transportation mode

The data collected from Laminar Medica’s and DHL Global Temperature Mapping Study has proved extremely useful in the design of customer specific systems, and for extra qualification, for those customers that have no historical data for their shipping lane.
SummaryMonitoring the distribution chain for changes in temperature as a result of environmental change and handling practice is an on-going necessity in order to establish trends, capture emerging modes and set realistic limits.On-going monitoring programs also provide supporting documentation for continuous improvement for temperature sensitive drug distribution.Not all variations in the distribution process can be eliminated, however, the risk can be minimised by using the information gathered in these types of studies to factor these differences into the packaging design and the customers’ logistics planning.  SOP’s must also be in place to standardise the process in handling and assembly. This will significantly reduce human errors and optimise the shipper’s performance.

For further information please contact Andrew Green, Marketing Manager, Laminar Medica Limited, Unit 4 Tring Industrial Estate, Icknield Way, Tring, Herts, HP23 4JX, UK.
Tel: +44 (0) 1442 828664, Email: a.green@laminarmedica.co.uk, Web: www.laminarmedica.com   
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

CBIs Global Risk Based Monitoring Event

CBI’s Global Risk Based Monitoring Event is approaching, taking place in London on 13 – 14 September 2018, designed for benchmarking with international peers to gauge RBM performance, efficiencies, implementation and technologies.
More info >>


White Papers

Cartridge Based Drug Delivery System

Weibel CDS AG

Cartridge based drug delivery systems small and easy to use? This question is discussed in this article by Ludwig Weibel, CEO and Hans Peter Manser, Business Director of Weibel CDS AG. A novel and innovative approach is presented offering patients numerous advantages making their life easier, saving time and avoiding needle stick injuries. Safer, easier and faster drug delivery – Weibel CDS AG, Switzerland develops and produces innovative, user friendly, application oriented injection systems and devices.
More info >>


Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement