Instrument offering

Health is a major concern the world over and that's why the production of pharmaceuticals is strictly regulated. The plant, production line and associated instrumentation must comply with increasingly demanding international standards, which are regulated by a number of associations including the FDA, cGMP, 3A and EHEDG.

Pharmaceutical equipment has to be validated in accordance with these regulations through the compilation of documentary evidence. The resulting Validation Plan is composed of four main areas: design, installation, operation and performance.

Endress+Hauser provides a range of instrumentation documentation, certification and monitoring instructions. Each aspect of conformity to the Validation Plan has to be documented e.g. Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). Endress+Hauser has the know-how to work with you to support your validation efforts, providing the full complement of certification.

Products and services to suit your requirements

Endress+Hauser offers a quality guarantee encompassing service, on-site calibration, technical training, commissioning, configuration and maintenance contracts. Furthermore, the services we provide can be easily integrated into your Validation Plan.

Industry-optimised products

Endress+Hauser instrumentation has industry-optimised hygienic options available for the pharmaceutical, cosmetic and biotech industries.

EHEDG certification demonstrates compliance to sterilisation cycles or clean-in-place systems, whilst 3A approval is the proof of a hygienic concept, avoiding any dead zone.

Nothing is left to chance with hygiene - the materials in contact with the process are listed by the FDA. AISI316L stainless steel is widely used, as well as ultra pure ceramic. Polymers are in accordance with the 21CFR177 FDA specification. Resistance to saturated vapour is guaranteed up to 150°C, so that compatibility to cleaning agents is assured.