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Pharmaceutical Industry review/Фармацевтична галузь, 2023, #3 (96) June

Expanding quality control capabilities for the pharmaceutical industry

Universal Pack places great emphasis on quality control to ensure that its packaging machinery for single-dose products meets the highest standards in the pharmaceutical industry. The company has implemented rigorous quality control processes throughout its manufacturing and testing procedures.

Early stages: quality control in manufacturing process

Starting from the sourcing of components and materials, Universal Pack maintains strict supplier evaluation and selection criteria. It collaborates with trusted suppliers who adhere to stringent quality standards and industry regulations. The company manufactures more than 80% of high-quality components internally, to be tested in its metrological room.

During the manufacturing process, Universal Pack follows meticulous quality control protocols. Skilled technicians and engineers closely monitor each stage of production to guarantee that the machinery is built to precision. We conduct thorough inspections, perform functional tests, and verify the adherence to design specifications and safety standards.

Inspection, serialization and efficiency

The experience acquired in our long-lasting partnerships with major pharmaceutical corporations helped us develop the most suitable systems in terms of production management, products traceability and compliance with the latest regulations. This process of constant growth and innovation reflects on our prime-quality integrated automatic packaging lines.

Furthermore, Universal Pack incorporates advanced quality control technologies and instruments to validate the performance of its packaging machinery, to be installed either inline or at the end of the line. Relevant applications include dynamic and static check weighers for bags and cartons, pharma code readers on the reel, leaflet and carton bar code readers, cameras for OCV/OCR, tamper evident stamp application and check, coding and coding control on boxes, flap closure check.

Finally, in order to track any good produced by our packaging line, serialization and aggregation processes take place to ensure product traceability by assigning unique identification codes to individual pharmaceutical units, to enable effective tracking and authentication of products throughout the supply chain and to facilitate swift and targeted actions in case of recalls or quality issues, enhancing patient safety and minimizing supply chain disruptions.

Validation, certificates and traceability

We uniquely code every single component, keep full track of it and provide documentation certifying its compliance with Pharmaceutical industry regulations. An essential list includes for instance: certificates of all materials and parts in contact with the product, welding certificates, calibration certificates and parts full traceability. The provision goes beyond the latter certificates for proving the components quality and compliance, as it stretches to further documents concerning the line construction and effectiveness. The list goes on with IQ (Installation qualification), OQ (Operational qualification), PQ (Performance qualification), FDS (Functional design specifics), HDS (Hardware design specifics) and Risk analysis, FAT and SAT ad hoc protocols.

As fundamental parts of the safety measures in the pharmaceutical industry, security systems to govern access and recorded data on the production line can also be provided. Customers can manage different levels of access, making the machinery compliant with CFR 21 part 11 regulation.

Customer-driven innovation as a means of quality enhancing

Universal Pack also focuses on continuous improvement and customer satisfaction. It actively seeks feedback from clients and conduct after-sales evaluations to identify areas of enhancement. This feedback-driven approach allows the company to refine its processes, address any issues promptly, and consistently deliver high-quality packaging machinery.

Additionally, Universal Pack complies with international quality management standards such as UNI EN ISO 9001, which demonstrates its commitment to quality control and customer satisfaction. These standards serve as a framework for its quality management system, guiding its practices and ensuring consistent adherence to quality processes.

The company

Universal Pack is an international reference in the field of packaging. The company has over 50 years of experience in designing and building vertical machines and complete automatic lines for packaging single dose products for the food, pharma, chemical and cosmetic industries. It is present in over 150 countries and has installed more than 8000 systems. It offers cutting-edge solutions for any type of package: stick-packs, sachets sealed on all four sides, shaped pack and cartons.

In summary, Universal Pack prioritizes quality control throughout its manufacturing and testing processes. By implementing stringent quality control protocols, using advanced technologies, and adhering to international standards, the company ensures that its packaging machinery meets the highest quality standards in the pharmaceutical industry. This commitment to quality enables Universal Pack to deliver reliable, efficient, and safe packaging solutions to its valued customers.

https://butlerpartner.com/

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