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We are able to meet the stringent requirements of the world's most demanding regulatory bodies. Automation for the medical and pharmaceutical markets not only has to satisfy the efficiency, safety and product quality demands of clients, but also has to satisfy a variety of regulatory requirements as laid down by various trade associations and government bodies.

We understand the design constraints laid upon equipment which has to be in direct contact with active pharmacuetical ingredients (API's), or which has to operate in a clean room environment. To ensure that quality is built into every stage of the production process, our equipment is designed to the current Good Manufacturing Practices (cGMP's). Our control systems are designed to Good Automated Manufacturing Practice (GAMP).

We can offer a complete validation and qualification service for any of our equipment, including

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

We can also assist with the production risk assessments, FMEA's and validation master plans.

 
 

 

 

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