On-Site Cliché Production and Process Optimisation

In the diploma thesis, he will present the flexographic printing method, which is used, among other things, for printing on lidding foils in the pharmaceutical industry, the implementation of a laser engraving machine in a GMP environment, and the optimisation of procurement, acceptance and acceptance control of clichés that this implementation brings. In the conclusion of the diploma thesis, he will assess the impact that the implementation of the machine represents for the environment in terms of greenhouse gas emissions as a consequence of cliché transport. The impact assessment will be based on the ** SIST EN 16258: 2013** standard.

Solution and Method

In the diploma thesis, he will present the flexographic printing method, which is used, among other things, for printing on lidding foils in the pharmaceutical industry, the implementation of a laser engraving machine in a GMP environment, and the optimisation of procurement, acceptance and acceptance control of clichés that this implementation brings. The flexographic printing method is a technological process of ** direct rotary printing**, where a photopolymer cliché is used for printing. The printing elements on the cliché are in the form of solid surfaces, lines and halftone dots.

Their function is to transfer printing ink to the printing material. The expressiveness of colour tones depends on the side angles of the halftone cones and on the printing pressure, which can influence the deformation of the halftone cone. How much ink will be transferred to the printing form depends on the anilox roller, which is one of the key components of the flexographic printing machine.

We know different methods of their production. In modern times, photopolymer plates are mostly used in flexographic printing for cliché production. We distinguish between analogue copying and digital copying for cliché production.

In flexographic printing, we distinguish three design concepts of printing machines, namely rotation with printing units in one tower, rotation with sequential printing units, and rotation with a central printing unit. In the continuation of the diploma thesis, the activities that need to be carried out before the commissioning process are described, such as the URS specification, which represents the basis of the system design, where user requirements that the system must have are given. These activities also include the system impact assessment, where the system's impact on final product quality, data integrity and patient safety is identified, and the supplier quality assessment, which is part of the process of selecting the most suitable supplier.

This is followed by commissioning process activities, such as FAT and ** SAT** testing, which ensure appropriate system composition and operation (non-critical requirements from the URS specification are tested), and system commissioning, which is the final phase of the commissioning process. This is followed by the preparation of the qualification plan and the system qualification process and ** DQ, IQ, OQ, PQ** testing, with which we ensure appropriate system design, its correct installation and operation throughout the entire work process. With them, we ensure an efficient and repeatable work process.

These activities also include risk assessment, critical point risk assessment, and the preparation of a traceability matrix.

Results

In the conclusion of the diploma thesis, he will assess the impact that the implementation of the machine represents for the environment in terms of greenhouse gas emissions as a consequence of cliché transport. The impact assessment will be based on the SIST EN 16258: 2013 standard.