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ENCAPLAST S.P.A.
PACKAGING
SOLUTIONS
Manufacturing Process
Medical and Pharmaceutical Packaging solutions
Encaplast studies the best solution for its partners’ needs with its R&D Department, together with the Technical Department, in strict compliance with norms and quality standards.
Material cutting, printing, coupling/laminating and welding are the main steps of the productive process through which the packaging solutions for your needs are made.
Slitting
The productive process starts by cutting the material. From Tyvek® jumbo rolls, papers, aluminums and films, the machines shape the material according to the customer's needs.
Printing
Once shaped, the material is ready to be printed (where necessary). Logos, certifications, texts, infographics, details: thanks to the technical office, the most appropriate solutions are adopted. Encaplast has flexographic printing systems up to 6 colors, even duplex.
Coupling / Laminating
If necessary, at this stage of the productive process, the layers (papers, aluminums and films) are joined to create the desired packaging. Once paired/laminated it is time to weld!
Welding
One of the most delicate phases is welding. It is important to meet high quality standards to ensure maximum sealability, repeatability and performance of the materials used, without forgetting the peelability of the envelopes for the medical and pharmaceutical sector.
THE ISO 8 CLEAN ROOM AND THE STAFF
Product quality in the medical and pharmaceutical sector especially means production in protected and extremely clean environments. In the last few years, our clean room has been completely modernized, enhancing quality control systems and educating the staff according to the highest standards of reliability and professionalism. The clean room at Encaplast is highly innovative, with particular attention to the flow of goods and constantly updating with state-of-the-art machinery and techniques. It is important to emphasize that Encaplast‘s production offers high quality standards also due to the accuracy with which the “skilled hands” of our qualified personnel control every single produced packaging.
R&D and Technical Department
The central part in the company organization is the technical department, strengthened and expanded more and more over the years.
Ability to customize the different packaging solutions and constant customer support are the strengths of the technical department at Encaplast.
Press, Cutting and Coupling Department
We have developed a production area of 750sqm in which the Printing, Cutting and Coupling processes are included.
At the heart of this department is a modern flexo printing machine, which allows you to get customized prints up to 8 colors.
We process the customer’s printing requests by providing assistance in designing the graphics to be printed.
Certifications
EN ISO 13485:2016
Since 2012 Encaplast S.p.A. is certified according to ISO 13485: The ISO 13485 standard “Medical devices — Quality management systems — Requirements for regulatory purposes” identifies a standard for the quality management system specific to medical companies, which includes aspects of the ISO 9001 standard and specific requirements for the medical devices sector.
UNI EN ISO 9001:2015
Encaplast S.p.A. is certified according to ISO 9001: Obtaining the ISO 9001 certification means creating a qualitative/organizational system within the company that complies with the requirements of the standard. The requirements of this standard apply to all business processes, from sales to purchases, production, etc. Appropriate documentation of the processes (quality manual, procedures, instructions) with recorded results must be supplied.
EN ISO 15378:2018
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which meet customer requirements, including regulatory requirements and International Standards.
About us
Encaplast S.p.A. is a company founded in the early 80s by the Neri family and handed down for generations the same values of the past: quality, reliability and innovation.
