Boston Scientific

HEAPY provided commissioning services for a gowning room addition to the existing clean room facility. The existing facility was U-shaped and had more than 20 gowning rooms that 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 clean room, resulting in 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 clean rooms.

The commissioning team verified the equipment was installed and operating properly to ensure the intended life cycle, reliability, and reduction in maintenance expense along with FDA compliance.  The results best exemplify the value that a comprehensive 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 its 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 (e.g., filter issues and obstruction, verification of proper installation).

This is a 24/7/365 facility, so annual testing occurs during the only 8-hour period the facility is shut down throughout the year. Boston Scientific relies on HEAPY to be effective and efficient to prevent lost productivity.