Boston Scientific

Sterilization Facility Commissioning

We approach our work from a Whole Facility Design Perspective, resulting in elegant, efficient engineering solutions that are practical and reliable, maximizing your long term benefit from your facility.

Challenge

Boston Scientific is a global leader in the field of medical solutions. With over 48,000 employees world-wide and numerous manufacturing facilities, Boston Scientific has developed extensive standards for the design, construction and commissioning of their facilities.

Boston Scientific was adding equipment to an existing Sterilization facility in Coventry, RI and selected Hallam-ICS to serve as the commissioning agent for the project. Hallam-ICS brings significant experience in the design and commissioning of cGMP facilities and was able to leverage this expertise for Boston Scientific.

Solution

The new equipment was being added to improve the existing process and to increase production capacity. New equipment that needed to be commissioned and/or validated included Preconditioning and Aeration systems, Sterilization Chambers, a hazardous material storage room and a new Air Pollution Control System.

Hallam-ICS worked closely with the design team, the owner and the subcontractors throughout the project. The new equipment was successfully commissioned and the Boston Scientific staff received the proper training and turnover documentation to allow them to operate and maintain the new equipment.

Results

Our team accomplished the following:

  • Successfully commissioned new sterilization and air pollution systems.
  • Provided comprehensive training and documentation for Boston Scientific staff.
  • Enhanced production capacity with compliant and efficient systems.