Partner in Medical Labelling

Can we carry out some of the IQ/OQ/PQ validation tests before the machine is delivered?

Yes, and this is one of the key distinguishing features of our approach. We design the validation tests together with you right from the start of the project and incorporate them into the schedule. Some of the tests (OQ/PQ) can be carried out at our premises with our assistance before the machine is physically delivered to your site. This means the machine arrives on the production line after most of the tests have been completed, rather than before - which shortens the time to line-up by several months.

Does the machine comply with GMP and ISO 13485 requirements? How can this be documented?

We provide a complete set of documentation required for an audit: certificates for materials in contact with the product (swabs, inks, screens), declarations of conformity, and test process documentation. The machine is designed with GMP requirements in mind right from the design stage - not as a retrofit. Customers in the medical sector have successfully passed end-user audits using our equipment.

What happens if change control requires a change to consumables?

We have our own in-house production facilities: a swab workshop, an ink mixing plant, die production and a screen exposure unit. We are not dependent on external material suppliers who change their formulations without notice. If a change is required, we inform you in advance, carry out comparative tests and issue a technical report. This ensures that change control proceeds in a predictable manner, rather than as an unplanned crisis.

What does the project schedule look like, and when can I see the checkpoints?

We manage every project through a 17-stage process with clearly defined checkpoints: technical concept approval (before machine production begins), internal PreFAT, FAT at our premises with training, dispatch, and SAT at the customer’s site. We present the schedule, with assigned deadlines and responsibilities, at the first project meeting. On Keller’s side, a single Project Manager acts as your point of contact throughout the project and proactively keeps you informed of the status, including any schedule-related risks.

Who is my contact at Keller and how many people do I need to coordinate?

One Project Manager on our side coordinates the entire project internally - with design engineers, automation engineers, software developers and the service team. You will communicate exclusively with this PM. You do not need to worry about who to contact at any given stage. The Project Manager proactively sends regular status reports in the form of photos or videos from the production hall.

Do you only supply the printing machine, or is it possible to integrate the entire production line?

We design and build complete production lines centred around the marking process. Examples include a syringe leak-test line and a medical device marking line with integrated quality testing. One supplier, one point of responsibility for the whole project – rather than having to coordinate 3-5 companies with fragmented responsibility in the event of a fault.

What happens if the end customer changes the specifications during the project?

Changes to specifications during implementation do occur - particularly in the pharmaceutical/medical sector. In such cases, PM Keller assesses the impact of the change on the schedule and budget, and provides you with specific options within 48 hours. We do not hide problems until the last minute. If the change requires an amendment to the contract, we make this clear before the change is implemented.

What does the warranty cover, and what happens once it expires?

Standard warranty: 12 months. When purchasing consumables from Keller - 24 months. Once the warranty has expired, we service the machine under our standard service terms - with no interruption to support. Importantly: we service all Keller machines, even those from over a dozen years ago.

Do you have legal and service representation in Poland?

Yes, we are a Polish company based in Dąbrówka near Poznań, which has been operating for 17 years. We provide service to Polish customers in Polish, by telephone, remotely and on-site. There are no language barriers, time zone differences or need to involve a foreign branch. All legal and commercial matters fall under Polish jurisdiction.

How can you be sure that you’ll still be in business and servicing the machine in 10–15 years’ time?

We have been operating for 17 years as a Polish family-run business with Polish capital - without a foreign investor who might close the branch or withdraw from the market. We have implemented 623 projects for 115 clients across 10 countries and continue to service every single one to this day, regardless of the year of manufacture. 34 per cent of our clients make repeat purchases – on average every 1–2 years. One household appliance manufacturer has purchased 34 machines from us over the course of 7 years. This is the best proof that our customers have no reason to leave us.

Why choose a Polish manufacturer when we have access to companies from Germany and Italy?

Manufacturers from Germany and Italy themselves buy machines from us - 6 machines in Germany, 9 in Italy. This is independent proof that we meet the standards of markets that produce competing appliances. An additional argument: as a Polish company, we provide service in Polish, short response times, access to locally manufactured spare parts within 3-5 days, and direct contact with senior management - without being redirected via a European head office.

Will the machine fit in our workshop without any alterations?

We design every machine to fit the customer’s available space - dimensions, shape, layout, height and feed direction. We do not sell machines with fixed dimensions to which the customer has to adapt their workshop. Before the design phase, we analyse the available space and deliver a machine with full target specifications that fits into the existing space without any additional CAPEX for refurbishment.

Do we need to order consumables from separate suppliers?

No. We have our own in-house production facilities: a silicone pad workshop (standard lead time 5 days, customised 10–15 days), a paint mixing facility, pad printing die production and a screen exposure unit. We select and test a complete set of materials for your product prior to implementation and issue a technical report. Having a single supplier for both machinery and materials eliminates the risk of incompatibility and simplifies change control.

We have no experience with industrial printing - can you help us choose the right technology?

Yes, and this is a situation we are very familiar with. Many of our clients in the pharmaceutical/medical sector are product manufacturers, not printers. We begin by analysing your product: material, geometry, quality requirements and production conditions. On this basis, we recommend a technology (screen printing, pad printing, hot stamping), carry out tests on your actual parts and present a report with samples - before a decision is made to purchase a machine.

Marking partner
for the medical and pharmaceutical sectors

Stability and repeatability of marking
in your production thanks to a comprehensively designed and implemented marking process.

What does Keller’s support look like in practice?

“Consistent marking is not the result of a single decision, but of a well-designed process.”

Marking partner for the medical and pharmaceutical sectors

Stability and repeatability of marking in your production thanks to a comprehensively designed and implemented marking process.

What does Keller’s support look like in practice?

“Consistent marking is not the result of a single decision, but of a well-designed process.”

Marking partner
for the medical and pharmaceutical sectors

Stability and repeatability of marking
in your production thanks to a comprehensively designed and implemented marking process.