Commissioning, Qualification, Operations & Retirement

The GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. Egemin Automation offers services for commissioning, qualification, operations and retirement for regulated industries in the pharmaceutical sector, biotechnology, medical devices, laboratories, etc.

Commissioning processes

We offer services for several commissioning processes following Good Engineering Practices:

• commissioning plan
• design reports
• checklist for inspections beforehand
• functional performance tests
• short-term diagnostic monitoring
• report on deviations in the processes
• training for operation and maintenance of the systems
• guarantee period/ seasonal tests

Our documents comply with the good documentation practices making it possible to use them for qualification purposes.

Qualification of installations and instruments

Our validation engineers are subject matter experts in qualification and verification of the following installations and instruments:

• filling lines
• depyrogenation tunnels
• packing machines
• autoclaves
• washing machines
• manufacturing and holding tanks
• CIP/SIP systems
• granulation and mixing equipment
• tableting and capsuling machines
• packing lines
• lab equipment
• cleanrooms and HVAC
• production systems such as (bio)reactors, dryers, filters, ...
• process control systems (PLC, PCS, ..)
• MES

In compliance with GAMP and/or ASTM E2500.

Operations

During operation of the installation the various processes, installations and equipment are subject to all kinds of modifications. Egemin Automation owns the know-how required for the related quality systems and processes such as:

• Change Control
• CAPA
• Deviation management

Retirement

Upon retirement of a GxP installation you must take special care of the decommissioning, data migration, etc. Egemin Automation can provide the necessary support in these domains as well.