The facility owner had a government contract to produce a drug, and the production environment had to meet rigorous FDA approval standards, but was unable to meet those standards. The government subsequently called in a prominent pharmaceutical company that provides medicines for an array of health concerns in several therapeutic areas because of their proven track record to produce.
The pharmaceutical company quickly got the cleanroom environment, including 10 different spaces, up to cleanroom construction standards, and contracted with AMTS to perform cleanroom certification, performance testing and HEPA filter integrity testing.
“Our team already had familiarity with the facility. And we were also able to quickly mobilize a team and equipment to meet an aggressive timeline. We understood the importance of performing our work quickly and professionally so that the facility could obtain the NEBB Certification and move forward with production,” says Jim Hubbard, Director of Eastern US Operations for AMCBP.
“Because we have experience planning and performing cleanroom construction solutions, and because we have team members with the NEBB Certified Professional certification, leading facilities trust AMTS to deliver,” finishes Hubbard.
With over 30 years of experience, and the NEBB Certification, the AM Cleanroom Build and Performance Engineers and Technicians can identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. Our Engineers and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 9, and have helped develop the industry’s standard protocols and testing specifications, as well as some of the key instrumentation, testing media, and standard documentation in use today. For more information on our Cleanroom Performance and Cleanroom Construction Solutions, please Contact Us.