Tanis Technical Inc. recently completed the Validation of Yamanouchi Pharma Technologies’ new flagship Pilot Plant and R&D facility in Norman, Oklahoma (read YPT’s press release).

The 61,000 square foot facility required validation of all utilities, process equipment, lab equipment and the facility itself. The project required a turnkey validation effort on Tanis Technical’s part, including design review; education of building sub-contractors on the cGMP’s; IQ, OQ, CSV protocol generation and execution; complete SOP generation; and project management.

Equipment and Systems validated included:

· Fluid Bed Dryers
· Spray Dryers
· Tablet Presses
· Various Mills, Mixers and Blenders
· Tablet Treatment Systems
· Side-vented Tablet Coater

· Building Automation System
· Clean Dry Compressed Air
· USP Water
· HVAC
· Waste Water Treatment
· Dust Collection
· Nitrogen Gas
· Cold Storage System

· Dissolution System
· Volume Delivery System
· Environmental Chambers
· Glass Washer
· Light Chamber
· Titrators
· TOC Analyzer

Tanis Technical supplied as many as 15 Validation Engineers and support staff during peak times of the project. Ken Woychesko, Tanis Technical Inc. President, reflected on the project, “I’m proud of the job that Tanis Technical’s staff and contract Validation Engineers and support staff did on this project. The construction timeline changed dramatically throughout the project as they always do due to forces beyond anybody’s control, requiring the need for Tanis Technical’s team of project managers and engineers to be flexible, and to scale up or down as the project warranted, to ensure that validation of the facility was not delayed.”

Tanis Technical Inc. is experienced in both large and small validation projects. Click for more information on our Services or the Markets we serve.