Application testing as the key to success
How Hapa contributes to pharma product safety through harmonized ink and technology development
Absolute security and reliability are essential when printing mandatory data on primary pharmaceutical packaging. The principal goal of Hapa is therefore to provide validated print performance for inline printing, particularly for systems integrated into packaging lines in a GMP-compliant setting. “Simply put, we are seeking to print our customers’ artwork on our customers’ material using our inks with a print process that is managed by our technology,” explains a Hapa product manager. “In order to do that, application testing is a foundation of all of our projects.” A key role is played in this context by close collaboration and coordination between Hapa’s Print Tech and ink development departments.
The Print Tech department’s core role is to ensure that the substrate, ink and printing process are compatible and will ensure the expected print quality and operational performance demanded by the application. Samples produced during the rigorous print trials are then subjected to a wide range of tests including rub and scratch resistance, tape resistance, overprint capability, ink flow behavior, and chemical resistance. Special attention is paid to the actual behavior of a printed blister during rotary sealing on the blister line.
The individual tests are carefully documented and entered into a database. “As an ISO 9001-compliant company seeking to provide GMP-compliant print processes, we maintain an audit trail for the database. We keep the physical samples for many years, which enables us to go back and reference the basis for all our projects,” says the in-house expert. Upon conclusion of each test series, the customer receives a detailed report outlining the tests performed and the testing conditions, indicating whether the project can be “Released”.
Hapa is able to call upon its decades of experience to address any issues discovered in the feasibility testing phase. “We will typically recommend a range of solutions that may be considered by the customer and the project teams. This may include recommendations for alternative substrates, pretreatment processes, or specific limitations on the printing process.
Our test reports always give the customer several options for pathways to achieve satisfactory product quality. It is for the customer to decide which of the routes is best, assisted by our consultancy and wide experience we provide.”
In the event that most other options are exhausted, Hapa is able to use its ink development expertise to assist. Hapa develops and produces its own inks specifically for the markets that Hapa serves. “Ink development takes time, which is why it is usually the final option” explains the product manager. “But it is an option that we have, and that’s why we have invested in Hapa inks. They’re an important part of our strategic offering to the market.”
Ink development is focused upon ensuring that non soluble pigments are suspended in a liquid to enable them to be jetted to give a dependable result, reliably. This pigment/dispersion combination needs to be mixed with compounds that will form the ink layer carrying the color, reacting predictably with the trigger for polymerization.
The ink is then adjusted to obtain the desired physical properties such as ink flexibility, toughness and adhesion. Selection of components is critical. Among the big issues addressed by the ink chemists are those relating to optical density, ink flow, adhesion and migration.
The Hapa laboratory has a wide array of analytical and testing facilities at its disposal for formulating inks to a required specification. Migration is an important topic. Hapa works in close collaboration with independent certified laboratories and we are able to consult clients on the steps to validate the safety of the printing process.
Thanks to collaboration between Hapa’s Print Tech and ink development departments, elevated security is assured from application testing and validation onwards. During the actual production, Hapa’s customers can therefore be certain that their print processes will operate reliably from the outset.