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Good manufacturing practice autoclaves

Good Manufacturing Practice (GMP) Autoclaves

Astell Scientific is a recognised market leader in the manufacture of autoclaves. A focus on quality and repeatability is central to our autoclave production processes.

Good Manufacturing Practices (GMP) refers to a system of manufacturing that guarantees the repeatability of product quality to pre-set specifications. cGMP is simply Current Good Manufacturing Practices and refers to compliance with current regulations.

Demonstrating good manufacturing practices is often necessary to conform to the guidelines recommended by bodies that regulate the manufacture and sale of goods in industries such as food & drink, medical devices and pharmaceuticals.

These guidelines set out requirements that a manufacturer should meet to assure that their products are consistently manufactured to the highest quality standards. Each industry may differ significantly in their interpretation of Good Manufacturing Practices; however, the main purpose of GMP is to manufacture products under controlled conditions to an exceptionally high standard. 

cGMP steam autoclave sterilization

Astell Scientific manufactures it products taking into account the requirements and guidelines of GMP and cGMP, along with compliance to standards and directives such as ISO EN 9001:2015, and PED 2014/68/EU validated processes and procedures. Furthermore all autoclaves are designed and manufactured to the safety requirements of: Application of Risk Management to Medical devices ISO 14971:2012 and The Application of Usability Engineering BS EN 62366:2015.

Copies of Astell’s accreditation certificates are available to view in the Resources section of our website, along with any corresponding documentation. Questions relating to our Quality Management System (QMS), including GMP, should be directed through the Service & Technical Support team.

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