High Purity Tank Installation and GAMP Control System

Process Automation and Batch Solution Weighing
 

  • Detailed engineering design
  • Handover
  • Health and Safety Management
  • Preliminary design including ±10% cost estimate
  • Site supervision
  • Turnkey Installation
  • Validation


Ipsen initially retained Malone Group to produce designs and cost estimate to automate the transfer, mixing and weighing of aqueous solutions and acids from bulk storage to their production laboratories.

The purpose was to eliminate the manual handling, storage and transfer of bulk IBCs within the manufacturing plant and free up space for future laboratory expansion.

This required working closely with Ipsen production and quality control personnel to produce a solution which met all the design, automation, operator interface and safety criteria.

Malone Group subsequently carried out a turnkey installation of the approved project which included stainless steel batch mixing and weighing vessels, operator platforms, interconnecting high purity PVDF and polished 316 stainless steel pipe work with automated and manual zero dead leg valves.

The automation, vessel level and volumetric measurement control was integrated into the production SCADA control system with an InTouch graphical operator interface to accurately and safely transfer the correct solutions from bulk storage tanks to the production laboratories.

All mechanical and electrical equipment was ATEX compliant for installation in a hazardous area, the project was also fully documented and validated at all stages of design, installation and operation to IMB and FDA regulations. 

 

Pharmaceutical