Heart Valve Manufacturer

The Client was experiencing continuous issues with their current cleaning company where expectations were often not met. Considering that the Client had hired one of the largest Cleaning Companies in the United States, the Client was disappointed with the level of service they were receiving. 

After discussions with the Client's Quality Manager, Valcon Engineering concluded that the Client desired the following: 

• Professional cleaning for their ISO 5, 6, 7, & 8 cleanrooms
• A cleaning company with transparent and frequent communication
• A cleaning company that understood what the Client was working on to avoid any confusion between cleanings

The situation that primarily caused the Client to find an alternative cleanroom cleaning partner was after finding large particles (i.e. strands of hair, etc.) in the Client ISO Class 5 Cleanroom after routine cleanings.

Valcon Engineering was familiar with the scenario that the Client was experiencing with alternative cleanroom cleaning partners. Past Clients find that there are a limited number of cleanroom cleaning partners which result in selecting one of the larger partners - not because of quality - but due to lack of selection. 

The Client selected Valcon Engineering to replace the prior cleanroom cleaning partner after reviewing the key differentiators of Valcon Engineering: 

• Valcon Engineering has an engineering-first approach to services since Valcon Engineering was founded by engineers
• Valcon Technicians are trained on client-specific equipment to prevent mishandling
• Valcon Technicians receive continued education on industry best practices and cleanroom preventive maintenance
• Valcon Technicians are competent to perform root cause investigations and document the proper reports on typical cleanroom scenarios

Valcon Engineering and the Client worked together to develop a streamlined documentation process that followed cGMP and ISO9001:2015 standards including, but not limited to: 

• A detailed checklist of completed tasks for daily, weekly, monthly, and quarterly cleanings
• Inspection criteria and procedures for transparent approvals
• Unified document repository and records process

The Valcon Engineering team has made it a priority to become the Client's partner with regards to cleanroom management and maintenance. 

The Client successfully passed a 6-month certification after making the switch to Valcon Engineering validating that all cleanrooms met ISO14644:2015 Standards.

Valcon Engineering and the Client have implemented a meeting monthly to review the status of each cleanroom and discuss any feedback. Any minor adjustments that Valcon Engineering can make to better service the Client, Valcon Engineering makes it a priority and ensures that there is a transparent line of communication between Valcon Engineering's Technicians and the Client Engagement Teams.