Boston Scientific

Project Overview

HEAPY provided Commissioning Services for a Gowning Room Addition to the existing Cleanroom Facility. The existing facility was shaped like a U and had more than 20 gowning rooms which were very small and scattered throughout. The goal of the project was to improve efficiencies with a new entrance for employees to enter.  The massive gowning room allows hundreds of employees to gown in or out of the cleanroom allowing for a faster shift change.  This facility is utilized 24/7/365 for medical device production, and includes ISO class 8 gowning rooms leading into ISO Class 7 and 8 cleanrooms.

The Commissioning Team verified the equipment was installed and operating properly to ensure intended life cycle, reliability, and reduction in maintenance expense along with FDA compliance.  The results best exemplify the value the Commissioning Process brings to a project of this complexity and size. Thorough commissioning of the new project prevented downtime from occurring once occupied, reducing risk and cost impact to the operations and production teams.

In addition, HEAPY provides Boston Scientific with their annual Clean Room Certification for FDA Compliance, which includes meeting clean room standards of temperature, particle counts, ventilation, pressure and humidity. As a part of this process, HEAPY takes necessary readings and makes adjustments to help the client meet ISO 14644 for FDA compliance reporting. HEAPY troubleshoots any existing problems they may be experiencing (ie. filter issues and obstruction, verification of proper installation, etc.). As this is a 24/7/365 facility, this annual testing happens once a year, the only 8-hours the facility is shutdown throughout the year. Boston Scientific relies on HEAPY to be effective and efficient to prevent lost productivity.