It’s all about Quality

It’s all about Quality

Unsurprisingly, the Quality department is the largest team within Aseptic Technologies.

Quality is enrooted in everything we do as the manufacturer and supplier of critical machinery and components for the pharmaceutical industry, including for its most regulated products, injectable drugs.

Every aspect of Aseptic Technologies’ products meet the highest performance and quality requirements, from their design to the manufacturing and QC release process.

To achieve this, the following standards and principles were incorporated in our Quality Management System:

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ISO 9001

2015 — Quality management systems

Aseptic Technologies has implemented full control of all business processes with the aim of maintaining and improving the satisfaction and expectations of its customers.

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ISO 15378

2017 — Primary packaging materials for medicinal products

In addition to ISO 9001, this standard specifies Good Manufacturing Practice (GMP) requirements. Aseptic Technologies provides primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.

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Good Automated Manufacturing Practice (GAMP)

At Aseptic Technologies, validation and qualification processes for the aseptic filling equipment, as well as the relevant documentation, are developed according to GMP guidelines.

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