In his capacity as managing director of Global Cold Chain Solutions, Andrew Meyer is regularly asked to audit current practices and test existing packaging, to confirm the validity and integrity of a company’s cold chain.
“We do see a lot strategies being utilised that are out of date with current thinking,” he relates, “and often we find that as a result, organisations aren’t meeting cold chain requirements.
"Validation that’s being relied on may not representative of the distribution channel being used, or the distribution has changed and revalidation hasn’t occurred.”
“Often products have changed,” Meyer adds, “and the cold chain hasn’t been reassessed to meet the new criteria of the products; possibly the stability data has also changed.
Andrew Meyer points to the validation of packaging and components as one of the critical issues that currently require attention.
“The testing we’ve conducted in the last five years reveals a large percentage of negative results in terms of packaging requirements,” he says. “I’m not saying all packaging is bad or all packaging fails, but often what companies are using doesn’t suit the purpose.”
“The good news is that in the last few years particularly, some very good designs have come out so there is activity from the suppliers and the whole dynamics of that market is changing a lot.”
Meyer says the industry now requires packaging that can deal with a full range of geographic and climate conditions.
“For export, more clients are wanting to send a single pack out to suit multiple hemisphere shipments,” he explains, “so we look at conditions between both southern hemisphere winters and northern hemisphere summers.
"When you’re dealing with cold chain packaging, you need to cater for both.”
"There’s certainly a lot more focus on this area recently, which is encouraging, and we’re seeing as much activity not only in cold chain, but in what we refer to as ‘controlled ambient products’ where products are required to be transported in temperatures of less than 25 or 30 degrees Celsius.”
Meyer, who is the keynote speaker at Cold Chain Management 2009, a conference to be held in September, has qualifications in refrigeration, electrical and electronics and global distribution and many years of experience in the management and restructure of international companies.
He says companies lack lower level hands-on procedures and knowledge to help achieve cold chain validation.
“Many of the enquiries we get go along the lines of ‘we would like a quote on a validated shipper’,” Meyer says by way of example.
“Normally our return question is ‘validated to what specification and profile?’ And usually at that point there’s silence on the phone.
"So we are questioning where companies are at, but at least there is enquiry out there, which we see as a positive move forward.”
Andrew Meyer argues the lack of global guidelines for accurately measuring or validating cold chain systems is a key issue.
“Generally, it’s left up to each company to develop their own systems for cold chain validation to ensure products are maintained at the correct temperatures,” he says. “This is not just an Australian problem; it’s an international problem.
“I suppose 95 per cent of the companies we’ve worked with don’t have the documents or the processes in place required to validate their cold chain, so often we’ve had to develop these protocols and procedures at least to give them a starting point. If there was a common draft or a set of guidelines, it would certainly help most companies.”
As a supplier to the industry, Meyer maintains it would be beneficial for the industry multiple companies could follow suit once cold chain validation was achieved within one organisation as this would bring costs down overall.
“From the pharmaceutical companies’ point of view, for instance, this would allow the purchase or products from a variety of suppliers with a degree of comfort that cold chain validation has a high level of integrity.”
“Unfortunately there are still a lot of products which have questionable validations,” Meyer admits, “which makes it difficult for purchasing divisions to make decisions based on quality information. On that point, I suppose we always recommend our clients study suppliers’ validation very carefully to ensure it meets their criteria.”
According to Meyer, monitoring is an area that’s been neglected and it’s one he intends to focus on at his session about understanding the essentials of temperature monitoring techniques and technologies.
“People often believe if they’ve got a data log or a temperature monitor it’s giving them the information they need. That’s not always the case,” he warns.
“Often the monitoring equipment is actually not suitable for the purpose for which it’s being used and therefore the information can’t be relied on as accurate. We see this quite regularly when we do revalidations on current processes; we get completely different results to what the customers have been expecting.”
In terms of the integrity of temperature data, Meyer says the US Food and Drug Administration (FDA) has issued a standard known as the FDA CFR 21 Part 11.
“Certainly, we’ve worked with many companies to implement strategies to address this so that they can rely on their data,” Meyer says.
“However, the qualification and the validation of existing procedures remains an area of crisis. Validation procedures either don’t exist in many companies or the detail is very shallow, so this is an area that we’ve concentrated on in the last few years.”
“I suppose the most confronting issues arise when companies are relooking at their cold chain,” Meyer maintains.
“They’re endeavouring to implement a validated cold chain strategy, and doing this economically is probably their largest challenge. We often see that they go down a path only to find there is major cost attached.
"So cold chain validation requires a large amount of commitment and companies need to take a global perspective.”
Andrew Meyer will be speaking at Cold Chain Management 2009 21-22 September at the Bayview Boulevard Sydney.
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