Medicines con­taining highly potent sub­stances must be safe, and not just for patients. Already during the pro­duc­tion of such med­i­cines, for example for use in cancer ther­a­pies, machine oper­a­tors must be pro­tected as best as pos­sible from any con­tact with the product. This aspect is of par­tic­ular impor­tance to the phar­ma­ceu­tical and chem­ical com­pany Merck.

Jef­frey Camp­bell, Director of Engi­neering MRL, Phar­ma­ceu­tical Sci­ences at Merck New Jersey reports about the begin­ning of the coop­er­a­tion with Harro Höfliger: “In our search for a cap­sule filling machine with the highest oper­ator pro­tec­tion, the Modu‑C Con­tain­ment caught our atten­tion.” It was specif­i­cally devel­oped for the testing of new active ingre­di­ents as well as the pro­duc­tion of small batches with toxic and highly potent substances.

”In our search for a cap­sule filling machine with the highest oper­ator pro­tec­tion, the Modu‑C Con­tain­ment caught our atten­tion.“Jef­frey Camp­bell, Director of Engi­neering MRL, Phar­ma­ceu­tical Sci­ences at Merck New Jersey

“Ini­tial dosing tests in Harro Höfliger’s clean­rooms showed that the machine is ide­ally suited for our product,” reports Jef­frey Camp­bell. “Imme­di­ately after­wards, we made a ref­er­ence visit to a Swiss com­pany who already works with a sim­ilar system from Harro Höfliger. We had the oppor­tu­nity to study han­dling, cleaning, and inter­faces in oper­a­tion directly on site and to talk to the oper­a­tors. After that, it was clear that this was the right con­cept for us too.”

One machine – two new developments

The basic machine design was now found – but Merck had two spe­cial require­ments: First, a guar­antee that no powder dust would remain on any cap­sule after leaving the machine. Second, Merck wanted to enable their machine oper­a­tors to clean the machine without the need for a reliance on per­sonnel pro­tec­tive equipment.

In order to remove powder dust from the cap­sule shell, many com­pa­nies rely on an external cap­sule deduster. “How­ever, the impor­tant thing for us was to save space in the clean­room. Harro Höfliger there­fore devel­oped a deduster that is directly inte­grated into the machine,” says Jef­frey Campbell.

In this deduster sta­tion, each filled cap­sule passes sev­eral ring brushes, which remove even the smallest amounts of powder mechan­i­cally. Philipp Hoff­mann, Mechan­ical Design Engi­neer at Harro Höfliger: “After devel­op­ment of the sta­tion was com­pleted, we first tested it with very sticky whole egg powder. This showed that our in-house devel­op­ment can keep up with external dedusters.” 

”After devel­op­ment of the sta­tion was com­pleted, we first tested it with whole egg powder. This showed that our in-house devel­op­ment can keep up with external dedusters.“Philipp Hoff­mann, Mechan­ical Design Engi­neer at Harro Höfliger

With the newly devel­oped fog­ging sta­tion, the experts ful­filled the request for cleaning without the need for a reliance on per­sonnel pro­tec­tive equip­ment. Philipp Hoff­mann explains what makes this sta­tion spe­cial: “With fog­ging, oper­a­tors do not ini­tially have to open the machine door. Instead, they wet the pro­duc­tion area via glove ports with puri­fied water, using a manual hand spray gun. Alter­na­tively, the spray mist can also be gen­er­ated auto­mat­i­cally by noz­zles inside the machine. Product dust is bound in the process. The con­tain­ment can then be opened for the actual cleaning, without blowing up dust.”

Fac­tory Accep­tance Test from a distance

When the machine, which was designed according to the UL safety stan­dards applic­able in the US, was ready for ship­ment, an accep­tance test of a spe­cial kind was sched­uled. Jef­frey Camp­bell: “Due to the COVID-19 travel restric­tions, there was no way we could be present at the Fac­tory Accep­tance Test. Harro Höfliger there­fore posi­tioned two cam­eras on site: One pro­vided the overall view of the machine, the other the view into the inte­rior. Via livestream, we were able to attend the test com­fort­ably from New Jersey – and con­vince our­selves across the Atlantic of the impec­cable oper­a­tion of our new system.”

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Photos: Helmar Lünig, Merck, Janine Kyofsky