Clean Utilities

Actemium has 25 years of experience in design, installation, commissioning and validation of clean utilities for the pharmaceutical processes:

CU (Engineering, Construction, Automation, Validation)

  • PW, WFI Storage and distribution loop
  • Process compressed air, instrument compressed air distribution line
  • Clean steam distribution line
  • Processing Equipment clean utility hook up

Modular skid for clean utility

  • PW distribution skid (O3 sterilization skid, 85 degree water sterilization skid)
  • WFI distribution skid(85 and 121 degree water sterilization skid)
  • WFI user point cooling skid
  • Clean steam and processing air header
  • Clean steam sampling cooling skid

Design

Starting from the user requirement specifications and the usage matrix from the user’s point of view, we can:

  • prepare the complete PID’s for the clean utilities.
  • value the generation systems, the storage tanks, the distribution pumps, the distribution loops and the valves at the user points.
  • design the most optimal system to distribute the water throughout the plant, in line with ASME BPE-, USP-, EP- and ChP regulations.

Based on a detailed pressure drop calculation, we can determine the most economic head of the distribution pumps. We have designed various configurations for the loops:

  • One loop systems
  • Subloop systems
  • Subloops with pumps
  • Subloops with heat exchangers

Technical data sheets are prepared for all valves, instruments and equipment, and presented for approval prior to purchase.

During the design phase, our process engineers will prepare the specifications for software and hardware design for all the different systems.

 

Installation

The Actemium installation teams follow the highest standards on welding quality. Beofre we start welding on site, we will make sure that the applied welding parameters guarantee the best quality for the welds, in terms of discolourization and smoothness of the welds. No welds are executed when the oxygen level inside the spool pieces are above limit. We dispose of our own endoscopes to verify and register the quality of the executed welds, in accordance with the customer requirements.

Meanwhile, our software engineers are preparing the software, based on the technical design specifications.

 

Commissioning

The project team prepares detailed commissioning procedures and protocols to demonstrate that the installation is built and operating according to the technical specifications.

  • Mechanical completion documents
    • Material receiving inspections
    • PID check
    • Slope, dead-end, diaphragm valve installation check
    • …
  • FAT documents
    • Storage tanks
    • Electrical cabinet
    • Software
  • SAT documents
    • Normal start and stop procedure
    • Sanitization procedure
    • Normal operation
    • Pump performances
    • Heat exchanger performances
    • …

By the end of the commissioning, we have proven that the installation can run independently in accordance with the specifications. The installation can then be handed over to the customer for qualification, or we can execute this qualification ourselves.

Qualification

In this final phase we prepare detailed qualification procedures and protocols, in line with the general validation plan of the customer, in order to prove that the installation complies with the quality requirements defined in the user requirement specifications.

  • Design Qualification Is the installation designed in accordance with the quality requirements?
  • Installation Qualification Is the installation built in accordance with the quality requirements?
  • Operational Qualification Does the installation operate in accordance with the quality requirements?