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Packaging Seal the deal
Container Closure Integrity Testing (CCIT) is a necessary step in ensuring that the integrity of a container closure system will last until the end of a product’s shelf life. With the help of Christian Proff, senior verification engineer at Hoffmann-La Roche, Jim Banks examines the relative merits of commonly used physical CCIT methods, such as helium leak testing and CO2
headspace analysis, and how different techniques might evolve in the future.
s one of many crucial processes in the pharmaceutical and biotech industries, container closure integrity testing (CCIT) plays a pivotal role in confirming that container closure systems (CCS) will keep products viable for use. Not only is patient safety at stake, as contamination with air, moisture, and microorganisms could severely impair the efficiency of drug treatments, but pharma companies could lose valuable batches of medicines or vaccines. The scope of CCIT has greatly expanded over the years, and because defects in pharmaceutical packaging components are not always obvious to the naked eye, many different methods have evolved to find even microscopic cracks in glass vials or subtle defects in elastomer stoppers. “You are protecting the product from the environment, and the environment from the product,” says Christian Proff, senior verification engineer at Hoffmann-La Roche. “Some medicines are highly toxic, including cancer drugs, so you don’t want them to end up in a toddler’s hands.” “Mainly, the focus is on the safety of the drug substance, making sure it is not being diluted or
A
contaminated, particularly if the drug is injected, as it bypasses most of the body’s defence mechanisms,” he adds. “If something gets in that can survive or proliferate, then drugs could potentially become a deadly threat.” Companies have long relied on probabilistic methods like microbial challenge, bubble emission, tracer gas detection, and blue dye ingress. All have their merits, but they provide subjective outcomes. Now, more deterministic methods, such as vacuum decay, pressure decay, headspace gas analysis, and vacuum deflection by laser measurement are often preferred. They are non-destructive and provide more objective measurements of leakage.
“A series of statistical events has to take place to give a positive readout for ingress, so there is a chance you can test a bad sample and not see the defect, which means you must test a large number in order to properly assess the risk of failing integrity,” Proff explains. “Microbial ingress is a probabilistic method as per US Pharmacopeia (USP) chapter 1207, which gives you a yes or a no – a qualitative answer – while physical test methods are generally deemed as deterministic, and provide quantitative results.”
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World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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