Menu
Compliance
It’s all about Quality
It’s no surprise that the Quality department is the biggest team at Aseptic Technologies.
Quality is deeply embedded in all aspects of our operations as we manufacture and supply essential machinery and components for the pharmaceutical industry, particularly for its highly regulated injectable drugs.
From design through manufacturing and QC release, every detail of Aseptic Technologies’ products adheres to the highest standards of performance and quality.
To accomplish this, we integrated the following standards and principles into our Quality Management System:
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.
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.
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.
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.
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.
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.
