Fortune 250 Global E-Commerce Technology Company

The Valcon Engineering team was brought in by the Client to assist with the new construction of a cleanroom to support their research and manufacturing sensitive materials such as, but not limited to, various sensors. 

The cleanroom will need to be designed to maintain effective quality control with high-traffic areas, particularly for materials and gowning.  The cleanroom and its components will need to be verified and tested to ensure they meet industry standards and any future audits. Documentation of all services needs to be provided to ensure the completion of work. 

Valcon Engineering advised the Client as the lead project manager, facilitating the successful completion of the project through the Design & Construction, Qualification, and Protocol Documentation phases. Valcon Engineering also drafted cleaning, maintenance, operating, and gowning procedures for the customer and provided a 2-day hands-on training for proper gowning, cleaning, and cleanroom operation. 

The project was completed ahead of the 7-week project timeline estimate. With Terra Universal leading the cleanroom construction, Technical Safety Services leading certification, and Valcon Engineering leading construction qualification (CQ), validation, reporting, and staff training - the project was completed in just over 5 weeks. 

Validated to ISO 14644:2015, the cleanroom utilizes HEPA filtration to meet air exchange, air pressure, and particle count requirements for the main production areas to meet Class 6 and Class 7 requirements. The transfer rooms for gowning and materials were also validated to meet Class 8 requirements. 

At the completion of the project, Valcon Engineering provided all documentation of the build and standard operating procedures tailored to the Client’s needs enabling the Client to optionally manage the cleanroom on their own. 

To mitigate the responsibility of managing the cleanroom’s maintenance and cleanliness, the Client had decided to retain on-going support from Valcon Engineering’s Cleanroom Cleaning, Inventory management, and Basic Maintenance services. 

After the cleanroom finished construction and passed all ISO 14644:2005 qualifications, the Client and Valcon Engineering worked together to move in and set up the necessary equipment. 

Valcon Engineering specifically introduced and trained staff on how to properly work inside of a cleanroom to reduce the particulates exposed to the cleanroom. 

The Cleanroom Cleaning and Basic Maintenance provided by Valcon Engineering enables the Client’s project team to have a readily available contact for any questions that may arise during cleanroom use. 

Since the construction of the cleanroom, Valcon Engineering has been able to keep an ongoing relationship with the Client weekly, as well as provide reports on any observations or status updates that the team needs to be aware of. 

During the period of service, there was an incident where water leaked into the cleanroom from processes outside of the cleanroom. This was caught by the Valcon team, and immediately, the Valcon engineering team alerted the teams, opened and drafted an incident report, and helped the customer correct the issues so it does not occur again. Valcon also mitigated, fixed the leak, and cleaned the cleanroom immediately to resume operations. 

Valcon Engineering was capable of resolving these types of issues because the Valcon team consists of professional engineers, with training specialized to resolve problems onsite that may arise.

In addition to providing weekly and monthly cleaning services, Valcon Engineering has also led the replacement of pre-filters and HEPA filters along with a 6-month certification of the cleanroom to validate that the cleanroom is operational to specifications.