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Our certifications.

We are a company specializing in medical and pharmaceutical packaging, located in the prestigious biomedical district of Mirandola. Compliance with industry regulations and our quality management system are at the heart of our daily operations, ensuring that we deliver safe, reliable, and efficient products that meet the industry’s high standards. At Encaplast®, we continue to invest in cutting-edge technologies, lean production, and ongoing training for our team, with the goal of maintaining a high level of performance and consistently exceeding customer expectations.
These certifications recognize our quality management system and the attention we devote to every stage of the production process, from design to final packaging.

EN ISO 13485:2016.

Encaplast® S.p.A. has been certified to the ISO 13485 standard since 2012, a highly prestigious recognition in the medical and pharmaceutical packaging sector. The ISO 13485 standard, titled “Medical devices — Quality management systems — Requirements for regulatory purposes,” represents a specific standard for companies operating in the medical sector. This certification encompasses the fundamental aspects of the ISO 9001 standard and introduces specific requirements for the medical device sector.

Achieving ISO 13485 certification demonstrates Encaplast® S.p.A.’s commitment to quality and compliance with applicable regulations. Thanks to a well-defined management system, we are able to guarantee safe, reliable products that meet the highest industry standards. This certification is a tangible sign of our ongoing commitment to providing exceptional medical and pharmaceutical packaging solutions.

CERTIFICATE
Encaplast S.p.A.
Production Department | Encaplast
Production Department | Encaplast

UNI EN ISO 9001:2015.

Encaplast S.p.A.® is also certified under ISO 9001, one of the most important international quality management standards. ISO 9001 certification represents a systematic approach to ensuring the effectiveness and efficiency of internal processes and the organization of activities, as well as the achievement of corporate objectives.

Obtaining ISO 9001 certification requires the implementation of a quality and organizational system that strictly complies with the requirements established by that standard. These requirements apply to all business processes, including sales, procurement, production, and many others. To ensure compliance, all processes are properly documented through a series of documents, such as the quality manual, procedures, and instructions, with results recorded to monitor and evaluate performance.

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ISO 15378:2017

Encaplast® S.p.A. is certified to ISO 15378:2017, a standard that defines the specific requirements for primary packaging materials used in the pharmaceutical industry. This certification is an extension of the ISO 9001 standard and places particular emphasis on Good Manufacturing Practices (GMP) applicable to the primary packaging materials sector.

The ISO 15378:2017 standard ensures that our quality management system is capable of supplying primary packaging materials for medicinal products that meet customer requirements, including regulatory requirements and international standards.

ISO 15378:2017 certification reflects Encaplast® S.p.A.’s ongoing commitment to providing safe and efficient packaging solutions. We are proud to contribute to the safety and quality of medicinal products through our quality management system, which complies with GMP and recognized international standards.

CERTIFICATE

ISCC PLUS Certificate

Encaplast® S.p.A. has obtained ISCC PLUS (International Sustainability and Carbon Certification) certification, a voluntary standard that supports the transition to a circular economy and a bioeconomy by validating the sustainability characteristics of alternative raw materials throughout the entire supply chain.

ISCC PLUS certification, implemented according to the Chain of Custody Mass Balance model, enables the traceability of certified raw materials throughout the supply chain and supports the use of alternative raw materials in production processes through an attribution system verified in accordance with the requirements of the ISCC PLUS scheme.

For Encaplast® S.p.A., achieving ISCC PLUS certification represents a further step in strengthening its management and traceability systems, offering customers the opportunity to integrate, where applicable, ISCC PLUS-certified raw materials into their packaging projects for the medical and pharmaceutical sectors through the Mass Balance approach.

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