Advanced Solutions for the Pharmaceutical Industry: Serialization, Cartoners, Filling Systems and Visual Inspection

For only a few years, the so-called “anti-counterfeiting” Directive of the European Union and Regulation (EU) 2016/161 of 02.10.20215 have been in force., and the resulting obligation for serialisation, we have been able to prove that our serialisation approach brings tangible benefits to users and has a positive impact on quality and ease of production:

• uniformity of the solution (no additional components or separate solutions for other levels),
• ease of integration with third-party systems (MAH, CMO, EMVO, KOVAL),
• full control of users and templates by the supervisory system.

Depending on the volume of production, the amount of space available and investment opportunities, it may be advisable to use semi or fully automatic equipment. The main difference lies in the preparation and collection of the finished collection packs. With semi-automatic equipment, the operator places the carton unfolded and glued from underneath. Through a pneumatic system actuated by the operator, the handle rotates 90° and starts the process of automatically filling the carton with whole layers of wrappings. Once the filling operation is complete, a filling sensor initiates the return of the case pack to its original position and the transfer of the case pack to a roller conveyor, where again the operator picks up the carton, seals the top and transfers it manually to palletisation. In the case of automatic equipment, the process of unfolding, closing, gluing and labelling of the master cartons takes place automatically. In addition, in the palletising area, cartons can be automatically transferred to pallets using robotic systems.

Siempharma offers machines for the inspection of liquid, lyophilised or powdered products stored :

• in ampoules
• in vials
• in carpules
• in bottles
• in ampoules and syringes

The solutions can handle 100 to 300 pieces per minute..

A wide range of inspection technologies:

• foreign reflective and non-reflective particles,
• fibres,
• glass,
• correct filling level,
• checking tip/cap (shape, height, black spots, position of cap),
• colour control of the ring/cap,
• product colour,
• print control;
• defects in glass elements,
• piston check (for cartridges).

Machines and monoblocs for the filling of packaging with liquids and their subsequent closing/closing are the result of years of experience with the design of this type of equipment. They are prepared to meet the needs of a market requiring high productivity, ease of format change and compliance with GMP standards. The innovative design of the various workstations allows for the correct application of laminar flow in the work area and quick format changes that can be easily repeated. The filling system (using volumetric or peristaltic pumps) is highly accurate thanks to the high level of technology used. Easy cleaning and inspection is guaranteed thanks to the separation between the package transfer area and the machine base. Siempharma’s solutions are designed to meet the different filling and capping criteria required by the pharmaceutical, nutraceutical and cosmetic sectors. Placement of the closer/closer can be performed by means of a fixed forced movement, raising and lowering or robotic positioning. In the case of closers, initial tightening and final tightening is carried out using dedicated closing heads characterised by electronic torque control. The monoblocks can be installed with up to three different locking units, suitable for guaranteeing the use of all the different types of caps used in the industry (with child protection, with opening protection, etc.). The reduced dimensions of these machines, their flexibility and their innovative design mean that they can be easily integrated into complete as well as existing packaging lines.

Depending on the volume of production, the amount of space available and investment opportunities, it may be advisable to use semi or fully automatic equipment. The main difference lies in the way the product is placed in the unit packaging (carton). With semi-automatic devices, the operator places the product in the wrapper, while the leaflet is placed automatically. The printing on the carton (LOT, batch number, expiry date, etc.) can be carried out by means of a so-called coding unit, which embosses the relevant data on the carton using fonts, or by means of the wide range of available printers. In the case of automatic cartoners, the whole process is continuous and the role of the operator is limited to the supervision of the machine (loading of the wrappers and leaflets). In addition, the process of changing the format is fully automatic without the need for a assistant technician.

In order for measurements of environmental conditions to be realised under conditions of multiple GxP practices, several basic conditions must be met:

• high quality of sensors enabling accurate and reliable measurements,
• integrity and data security on multiple levels,
• full documentation validation, and security of data on multiple levels
• extensive notification of alarm events to users.

Errors can be prevented in advance or eliminated altogether. Electronic batch recording systems are designed not only to improve the quality of the production process but also to increase its efficiency in a real way and avoid unnecessary costs. In terms of process data, continuous access is possible and early action can be taken on any adverse events detected in the process. The user is provided with precise instructions for each workstation, predefined operations and safety guidelines. Reports, documentation and other development support tools, are created in real time, in parallel with production. This type of electronic recording reduces the time taken to collect data, and analyse it, by 70% compared to paper documentation.

Automatic vision inspection directly translates into increased quality of the final product. Vision devices make it possible to inspect the unit product before packaging (tablet, ampoule, vial), during packaging (completeness of blister and carton, accounting of quantity), or during labelling (correctness and completeness of imprints). From individual verification components (i.e. camera or video scanner) to complete devices performing additional functions, i.e. verification of leakage and labelling. Extensive self-learning capabilities and artificial intelligence systems enhance the ability to detect defects and abnormalities, which, combined with high performance, produces results that are difficult to achieve during inspection by the human eye.

Our range of industrial robots for the pharmaceutical industry combines high-end products together with the experience of our specialists in working in environments regulated by EU GMP. Whether the intended workplace is the packaging area or the sterile area in the manufacturing process, we will select the best solution using a wide range of cooperative equipment (cobots), SCARA robots, parallel kinematics (Delta) or 6-axis robots operating in a clean air zone. Our solutions ensure high precision and repeatability, have the ability to operate in hard environmental conditions, without the constraints of contact with toxic substances. These capabilities allow a wide range of applications for robotic devices, particularly where the work involves a high risk to worker health.