Endress+Hauser - Instrumentation, Services and Solutions for Pharmaceutical Applications

Endress+Hauser's greatest innovation for the pharmaceutical industry, biotechnology, laboratories and cosmetics is its ability to provide complete solutions and services in addition to the industry-optimised instrumentation. With a proven track record, Endress+Hauser has the skills and experience to provide reliable measurement solutions in line with stringent industry laws and regulations.

• Cost reductions for end-users and intermediate (compliancy)
• More competencies brought to all the partners
• The critical issues are debated
• Consistent quality
• Black points eliminated (GAMP and GxPs guidelines)
• Latest technologies implemented together
• Increased focus on validation

THE 'PHARMACEUTICAL QUALITY' OF THE INSTRUMENTATION

Our product range meets industry standards:

• FDA listed materials for the wetted parts (21 CFR part 177)
• 3A authorisation, demonstrating the appropriate concept
• EHEDG certificates (SIP cycles up to 150°C)
• Materials certificates according to EN-10204

Instrumentation design focuses around the requirements of the pharmaceutical industry. Endress+Hauser devices come with a full range of hygienic and aseptic process connections such as Triclamp and Varivent etc for flush mounting, avoiding bacteria zones that could affect the quality of the medium.

SUPPORTING THE VALIDATION MASTER PLAN (VMP) AND QUALIFICATION

Hygiene and safety are of paramount importance for the productions units. Validation and Qualification must be conducted in accordance with the regulations ('V' model) throughout the compilation of documented evidence. Endress+Hauser provides the complete range of documentation, certificates, instructions and procedures which are mandatory for the Qualification steps Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). We also provide also technical support for writing the Standard Operating Procedures (SOPs) and other procedures according to the GAMP4. Endress+Hauser is with you every step of the way through all lifecycle phases - project phase, pre-operational phase and operational phase.

COMPLIANT SERVICES

Endress+Hauser services comply to the guidelines described in the 'Calibration Management Good Practice Guide' from the ISPE (January 2002).

Our skilled service engineers have GxP training and are familiar with the current specific environmental regulations.

SOLUTIONS

Pre-engineered solutions and Calibration Management Software (CMS) are the two main areas where customer expectation is high. Endress+Hauser provide complete compliant solutions. The implementation of the 21 CFR part 11 for pharmaceuticals, biotechnology, cosmetics, food and beverages, and fine chemistry is paramount.

• Our data acquisition system and recorder Memo-Graph S is fully FDA compliant
• Compucal, a specific Calibration Management Software is fully compliant
• Process applications are developped with our Solutions Teams and engineered accordingly to the Good Practices and to part 11

COMMUNICATION - THE KEY TO SUCCESS

There is no better way for succeeding in such a highly regulated environment than good communication. This contributes to the best possible results and highlights our commitment to customer satisfaction.

Please see the contact details below for further information.