The firm launched its new QC (quality control) inspection tech, KKX3900, this month at Achema, in Germany.
The equipment measures capsules in four different ways – foreign particle detection via high resolution X-ray images, the more traditional method of check weighting, length control to detect whether the capsule has been pieced together correctly, and then automatically flags up any non-uniform capsules for visual inspection.
Finally, the tech provides one common batch report with all diagrams and results.
Speaking to in-PharmaTechnologist.com, product manager Melanie Beck said the X-ray platform is not strong enough to damage the API – in fact damage inflicted is 5,500 times less than that permitted by the regulators – but has enough power to detect all kinds of particle, including small fragments of plastic.
“We did a test with some very sensitive APIs where we compared the influence of X-ray with UV. UV has more influence than X-ray,” she said.
She added that the tech is currently more accurate than check weighting alone on small batch sizes of up to 3,100 capsules per minute, but than on bigger production lines check weighting is still more efficient.
However with a growing industry need for better product understanding, Beck said Bosch is developing a bigger version.
“There is a bigger need in the industry at the moment to form a greater understanding of the manufacturing process, and how to control it because of new guidance such as the FDA’s (US Food and Drug Administration) Process Analytical Technology guidance (PAT). It’s all about minimising risks, and reducing product recalls,” she said.
“This new equipment provides information that we have never got out of the capsule filling process. Before you would fill a capsule and then never see what’s in it once it is sealed. Now you have a high resolution image.”
In a press statement, senior VP of the pharma business unit, Wolfgang Szczerba also hinted towards more expansions in the QC arena.
Speaking about the firm’s recent takeover of Eisai Machinery’s portfolio of manual, semiautomatic and fully automatic inspection machines, he said: “This growth in PAT enhances the existing Bosch portfolio and fits extremely well into our overall strategy. It’s no coincidence that Eisai Machinery and Bosch Packaging Technology have worked together on numerous projects – the systems complement each other perfectly.”
The big issue
Besides appeasing the regulators, Bosch says its new quality tech is important for keeping manufacturing costs low.
Beck added: “Good quality controls save money because there is no need for product recalls. You also get a speedy time to market, which means less storage, and there is less product waste and so higher efficiency.
“If you can react with the information immediately you don’t lose time and money.”
The renewed paradigm spreads into other manufacturing activities, such as its liquid filling lines which were recently boosted when the company partnered Sartorius Stedim over its single-use fill and finish technology.
“With our joint expertise, we intend to develop configurable and customized single-use filling solutions and to provide strong validation and technical support,” Joachim Brenner who is responsible worldwide for the Bosch Pharma Liquid portfolio said in a statement.