Express Pharma

When seal quality matters – I2VS

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When you open a bottle of pills you bought at the pharmacy, you assume that the manufacturer has sophisticated processes in place to assure the medicine or vitamins will do the job they’re supposed to. The integrity of the seal and how it could affect the contents of the bottle is something that most users never think of.

Surprisingly, after the bottles get sealed there wasn’t any way to test the quality of the seal aside from random sampling — until the Israeli company DIR Technologies (http://www.dir-technologies.com/) invented a system that checks every sealed package via thermal imaging. Operators can find and fix the factor causing the faulty seals whenever they occur, without destroying a sample or holding up the production line.

20171215ep66DIR’s Induction Integrity Verification System (I2VS) was launched in 2013 and was quickly adopted by some of the largest pharmaceutical and nutraceutical manufacturers worldwide, like Pfizer, Merck, Abbvie, Hetero Pharma and many more.

The importance and relevance of  product was recognised by the international community when in 2015 won the Innovation Award at the ACHEMA World Forum, (http://www.achema.de/en/home.html) an international event for chemical engineering and the process industry.

“The packaging of medicine is considered part of the medicine, because it directly affects the medicine’s quality,” says Fabian Schapiro, Marketing VP, DIR. “There is some type of technology to test every part of the packaging process except after the package is sealed. Every so often in a batch, someone takes a package off the line and checks it manually. But you don’t really know the quality of the rest, and if you find one with a problem, you don’t know how many are affected, leading to a significant waste of time and effort. It’s not a proper engineering process.”

DIR is an Israeli company with a strong background in thermal imaging. DIR’s founders and key managers came from the advanced Israeli defence industry, where they were scientists and developers.

“Thermal imaging reads the inherent heat signature from the sealing process that heats through the cap of the bottle and glues the lining to the bottle,” says Schapiro. “Until now, there was no way to know if that was done properly since the bottle is closed, but our imaging can see through the cap and if there is a problem with a seal you can discover that single one and get rid of it. The system can be adapted to any existing line, and can work at production speeds above 400 bottles per minute.”

He explains that sealing problems are bound to occur every now and then. “And some cases are difficult to discover, like if the company has received damaged raw material and the seal doesn’t sit right, or the liners are defective. It is a big leap from sampling to true process control where you check every single bottle and find out not only if something is good or bad, but also get an indication why it went wrong.”

For example, trends might reveal that more seals are found to be defective on a specific work shift, and the management can take steps to correct the situation.

Not only for pharma

To provide a suitable response to non-pharma users, DIR came with I²VS Lite, a simplified version intended for packagers of food, cosmetics, cleaning supplies, automotive and other non-pharma applications.

Anything with a heat-applied seal under its lid, from coffee to make-up, “is where we could fit in,” says Schapiro. The Lite version uses the same core technology but it’s more modular and less costly because it doesn’t have to comply with the pharma industry’s heavy set of regulations. “We’re pleased to now be able to offer the same leap from sampling to 100 per cent to packagers in additional industries.”

We are not alone

“One of the best indicators of the market need for the real time inspection of seals, is the number of competitors that started to copy the I2VS” says Schapiro. “In a very short period of time, we started to see similar systems being launched in India and the US. The main difference between the original I2VS and the copies, is the know-how behind it. The I2VS was developed by scientists that truly understand thermal imaging and have been working in this discipline for year. Anyone can buy a thermal camera and put some image processing algorithms in place, but there’s something else needed to achieve a robust and consistent system, and that’s understanding correctly what the camera is detecting and processing the data accordingly. That’s why the I2VS remains the leader of this market. It’s the only system done by the experts.”

ACE technologies is an official representative of DIR technologies in India.

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