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DuPont extends temperature span of ULD protective covers

DuPont extends temperature span of ULD protective covers

ULD cover manufacturer DuPont is launching a new product that will offer protection from a wider range of temperatures. DuPont said its Tyvek Xtreme W50 ULD cover retained the reflective and permeability characteristics of its existing products for pharmaceuticals while extending both the hot and cold temperature performance span. This means the cover can be used for products that require frost as well as heat protection, while also needing an effective component in packaging systems for 'cold' temperature products. DuPont European business development manager Yves Le Minor said: “The ...

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2016 LogiPharm Europe’s Biggest Supply Chain Event

2016 LogiPharm Europe’s Biggest Supply Chain Event

Some highlights form the LogiPharma symposium in Montreux from 19th to 21st April 2016 by Alan Kennedy 2016 LogiPharm pulls together at Europe's biggest supply chain event for the life sciences sector Nearly five hundred life-sciences professionals, supply chain executives and related logistics specialists descended on the Montreux Music & Convention Centre in Montreux, Switzerland for a jam-packed, luminary-studded, LogiPharma supply chain symposium on 19th - 21st April. With more than fifty speakers, a host of workshops and debates and a bustling exhibition arena, the ...

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Improving pharmaceutical logistics cool-chain – Part 5

Improving pharmaceutical logistics cool-chain – Part 5

A case for improving pharmaceutical logistics cool-chain

The pharmaceutical industry often talks about improving pharmaceutical logistics cool-chain performance and efficiency. You then hear the terms 'partnering', 'collaborative working' and 'integrated supply chain'. We want to share with you an informative Consultation Paper. Written by Alan Kennedy, it's called "Medicine or snake oil? – A case for reform of the pharmaceutical logistics cool-chain". It presents the case for genuine team-work in this segment of the industry. The discussion paper debates the...

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Improving pharmaceutical logistics cool-chain – Part 4

Improving pharmaceutical logistics cool-chain – Part 4

A case for improving pharmaceutical logistics cool-chain

The pharmaceutical industry often talks about improving the pharmaceutical logistics cool-chain performance and efficiency. You then hear the terms 'partnering', 'collaborative working' and 'integrated supply chain'. We want to share with you an informative Consultation Paper. Written by Alan Kennedy, it's called "Medicine or snake oil? – A case for reform of the pharmaceutical logistics cool-chain". It presents the case for genuine team-work in this segment of the industry. The discussion paper debates...

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Improving pharmaceutical logistics cool-chain – Part 3

Improving pharmaceutical logistics cool-chain – Part 3

A case for improving pharmaceutical logistics cool-chain

The pharmaceutical industry often talks about improving the pharmaceutical logistics cool-chain performance and efficiency. You then hear the terms 'partnering', 'collaborative working' and 'integrated supply chain'. We want to share with you an informative Consultation Paper. Written by Alan Kennedy, it's called "Medicine or snake oil? – A case for reform of the pharmaceutical logistics cool-chain". It presents the case for genuine team-work in this segment of the industry. The discussion paper debates...

Read more
Improving pharmaceutical logistics cool-chain – Part 2

Improving pharmaceutical logistics cool-chain – Part 2

A case for improving pharmaceutical logistics cool-chain

The pharmaceutical industry often talks about improving the pharmaceutical logistics cool-chain performance and efficiency. You then hear the terms 'partnering', 'collaborative working' and 'integrated supply chain'. We want to share with you an informative Consultation Paper. Written by Alan Kennedy, it's called "Medicine or snake oil? – A case for reform of the pharmaceutical logistics cool-chain". It presents the case for genuine team-work in this segment of the industry. The discussion paper debates...

Read more
Improving pharmaceutical logistics cool-chain – Part 1

Improving pharmaceutical logistics cool-chain – Part 1

A case for improving pharmaceutical logistics cool-chain

The pharmaceutical industry often talks about improving the pharmaceutical logistics cool-chain performance and efficiency. You then hear the terms 'partnering', 'collaborative working' and 'integrated supply chain'.

Over the next 5 weeks, we want to share with you an informative Consultation Paper. Written by Alan Kennedy, it's called "Medicine or snake oil? – A case for reform of the pharmaceutical logistics cool-chain". It presents the case for genuine team-work in this segment of ...

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Tyvek® Performance Qualification

Tyvek® Performance Qualification

Have you got it Covered, Week 8

The Performance Qualification part of the validation exercise involved a dynamic transport test measuring representative pallets of material during conveyance over a demanding return freight route involving a number of steps and a range of typical, but not extreme, environmental stresses.

Decisions that had to be made when selecting the route included the length and duration of the route together with the coolchain facilities, the number of transit steps, the logistics suppliers, the mode of flight, the sh...

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Greenhouse Effects

Greenhouse Effects

Have you got it Covered, Week 7 The static OQ trials compared the use of clear and black cargo coverings with Tyvek® to determine their relative behaviour under identical environmental stimuli. The results were striking. Transparent cover materials were found to exhibit an alarming degree of heat entrapment and magnification, the so-called ‘greenhouse effect’, as the sun’s rays were captured and trapped. Common packaging materials such as stretchwrap and bubblewrap did not provide any protection against solar radiation, but rather amplified its warming effects way beyond the su...

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The Danger of Stretchwrap

The Danger of Stretchwrap

Have you got it Covered, Week 6 Initial trials on Tyvek® covers in India had shown temperature differences of as much as 25°C between standard stretch-wrapped pallets and identical pallets cloaked with Tyvek® covers when both were subjected to solar radiation over a 3-day period. Similar measurements were subsequently repeated in many other geographical zones in Europe, Asia and the Americas. In another Tyvek® qualification test, four pallets of pharma products, two using Tyvek® covers and the other two covered with standard plastic stretchwrap, were temperaturemonitored throughout a s...

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Tyvek® Operational Qualification

Tyvek® Operational Qualification

Have you got it Covered, Week 5 The first part of the temperature validation exercise involved conducting a series of static tests designed to measure the performance of the Tyvek® covers in both summer and winter conditions. The effects of prolonged exposure to the sun were also measured along with the ability of the covers to protect against cold. These static tests were a vital part of the qualification programme since they were designed to explore and document the technical characteristics of the Tyvek® product. In other words, they identified the range of operating parameters under ...

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Part of an Overall Transport Validation Plan

Part of an Overall Transport Validation Plan

Have you got it Covered, Week 4 The new generation, Tyvek® Air Cargo covers from DuPont are a typical low-bulk and lightweight passive protection component. Designed to provide cost-effective off-the-shelf CRT protection for pharmaceuticals, these cargo covers employ a unique triple-action approach to temperature control which renders them a very effective and cost efficient solution to CRT control. It is this three-stage protection which differentiates Tyvek® from other cargo covers on the market and DuPont has conducted a number of generic and lane-specific validation exercises...

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Validation and Qualification?

Validation and Qualification?

Have you got it Covered, Week 3  Much confusion surrounds the terms 'Qualification' and 'Validation' when it comes to good coolchain practice. The terms ‘validation’ and ‘qualification' are often used interchangeably and both relate, essentially, to the process of proving that a process or equipment is ‘fit for purpose’. Certainly the most important thing of all is to ensure that something is fit for purpose rather than get bogged down in semantics.

However, the International Conference on Harmonisation (ICH) provides the following definitions...

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Coolchain Product Qualification

Coolchain Product Qualification

Have you got it Covered, Week 2 

Product Qualification is achieved by subjecting the individual components used to manage temperature sensitive products in a cool chain to two different types of test.

1. Fully controlled static tests (Operational Qualification or ‘OQ’).

2. Dynamic ‘in-use’ tests (Performance Qualification or ‘PQ’).

OQ is conducted under both ‘normal’ and ‘worst-case’ environmental conditions to determine the operational parameters of the individual components and to eval...

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Understanding coolchain component qualification

Understanding coolchain component qualification

Have you got it covered? With the growing number of pharma transport events being affected by unwanted temperature excursions, there is an urgent need to improve temperature management during product distribution.

The following series of insightful articles takes its inspiration from the White Paper published by DuPont™ Tyvek®, titled 'Have you got it Covered?' We will examine the process of coolchain component qualification in the context of thermal protection and overall transport qualification.

Week 1 This week we endeav...

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Harmonising distribution practices in the pharma industry

Harmonising distribution practices in the pharma industry

IATA’s manager of cargo standards, Andrea Gruber, comments on its CEIV Pharma certification programme, an initiative aiming to harmonise GDP compliance and standardise audit formats by introducing a globally recognised pharma logistics and handling certification standard. The programme has now been successfully piloted, and is rapidly gaining acceptance as a universal, independent and comprehensive compliance and training scheme. “The global nature of the pharma industry and its markets means that there needs to be a harmonised approach to distribution practices if costs and timescales are to be kept to a ...

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Aircraft offer speed advantage for time-sensitive products

Aircraft offer speed advantage for time-sensitive products

Big changes are afoot in the Pharma freight sector as it adapts to Alan Kennedy reports on the problem of divergent GDP guidelines, and hears from IATA’s Andrea Gruber about the organisation’s programme, which attempts to bring order to the table. The Pharma freight sector is going through a lot of changes, as it adapts to market, regulatory and technological trends. It relies heavily on air freight to move its products around the world. Although GDP legislation applies equally across logistical modes, the structure complexity of flying presents particular challenges. Aircraft offer an obvious speed advant...

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The temperature of perishable products

The temperature of perishable products

Controlling the temperature of perishable products during transit, especially pharmaceuticals, is crucial. Two questions we pose to Dia Romanowicz, Commecrial Cargo Sales manager at AmSafe Bridport. Q1: What’s the problem? A1: Three words: Tarmac standing time. This is where shipments of temperature- sensitive goods are left standing in fluctuating ambient conditions on the airside apron during loading and unloading. Approx. 5% of all transport events involve a temperature deviation from plan. IATA say that 57% of temperature excursions occur during these ‘uncontroll...

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