20 questions put to the presenters during the live session, answered on air or in writing afterwards.
In continuous manufacturing, is the powder moved to the tablet press loose, or extruded as a slug?
As a slug. Everything is mixed on the screw, then tightly packed and transported directly to the tablet press, which avoids powder segregation on the way.
Where are the punches and dies made?
In Germany, at the company's headquarters, where all parts are manufactured.
We want to adopt continuous manufacturing. What are the first real challenges?
Powder flow, because every ingredient is fed individually. Most excipients are now designed with continuous manufacturing in mind, which leaves the API as the variable to solve. Once that is characterized, the process gives both higher productivity and tighter control than batch.
Can the machine be used for botanicals, or is it really for pharmaceutical products?
The platform is designed primarily for pharmaceutical applications, but suitability always comes down to the product. If the powder can be handled by the chosen dosing technology, botanical products can be evaluated too. The starting point is always characterization rather than machine selection: customers send placebo material, trials run in the clean rooms, and the discussion follows from the results.
A capsule body can come through without a cap. Is the reject container closed, and how is that contamination controlled?
The machine monitors capsule closing and checks that the cap is present. Defective capsules are rejected individually, under full containment.
Is the product drawn into the cavity by vacuum?
Yes. Vacuum inside the drum helps fill the cavities with powder.
Which print technologies can you integrate with?
Thermal transfer is the most common, and more pharmaceutical customers are moving to laser. HERMA works with the major manufacturers of both, including Videojet, Domino, Keyence, and Markem-Imaje. An existing site standard can be integrated.
What about inspection systems?
Cognex and Keyence for straightforward applications. For serialization, partners include Optel and SEA Vision.
What support can I expect across North America?
A dedicated phone line with direct access to a technician, escalating to a video call and then to an on-site visit if needed. Spare parts are stocked in New Jersey for fast delivery.
You showed standard equipment and also a custom three-isolator setup. How often is the work customized, and how quickly can you do it?
Most of it is configured rather than off the shelf, because customers want something that fits their specific line. The three-isolator chain is the far end of that range. Plenty of customers want a standard unit in a couple of weeks instead. Adjusting sizes and adding ports is routine.
Embossing or debossing: which is the right word?
Both, depending on which side you are on. The punch face carries a raised logo, so tooling designers say embossing. On the finished tablet the logo is recessed, so for a pharma company it is debossing.
What is a good ratio of logo size to tablet size?
Between one-third and one-half of the tablet's width or diameter. On a 10 mm round tablet the logo should be around 5 mm. Smaller tablets need a proportionally larger logo to stay legible. Bigger performs better for both legibility and defect prevention, up to the point where the depth starts causing picking problems.
What are the drawbacks of engraving a tablet?
Four, in practice. It complicates film coating, it reduces the punch tip's force rating, it introduces the risk of picking during manufacturing, and it makes tooling more sensitive to wear, which shortens effective tool life.
Can it print shapes other than round tablets?
Yes. It handles a range of shapes and is not limited to round tablets.
Can it be bought as just a printer or just an inspection system?
Yes. It can be purchased as a standalone UV laser printer or as a standalone inspection system, and upgraded to the combined machine later.
What is the throughput?
400,000 tablets per hour on a 7 mm tablet.
What service support comes with it?
Engineers are based in North America and provide service and support as needed.
Our digital transformation pilot went well and then stalled. How do we restart it?
Get out of your own way. The industry is risk-averse for good reasons, and the reflex that any change means full revalidation is what keeps projects stuck. That assumption no longer holds.
How does the two-part GxP validation approach help with that?
The platform is validated once, with the documentation supplied, and the FDA's current position lets a company accept that work rather than repeat it. Deploying an individual solution then becomes a confirmation that it is fit for purpose, handled through SOP approval, not a fresh validation effort.
We are still on paper batch records and logbooks. Where do we start?
Ask your operators what the most frustrating part of their day is. Logbooks are usually the right first target: the process is simple and repeatable, the QA review burden disappears immediately, and operators stop signing their name dozens of times a shift.