Whether you are looking for facility monitoring services during commissioning of new facilities, after facility remediation events, after a planned shutdown, or during routine ongoing manufacturing, we offer the expertise needed for compliance.
READY TO GET
We partner with you to understand and build environmental monitoring programs that meet your unique compliance requirements.
Our service starts with a client consultation to determine testing needs. We perform testing to determine the viable population on surfaces, as well as the total particulates and viable particulates in air and compressed gasses.
There are two sampling options to conduct sampling. First, we offer services from our qualified technicians, who are experienced in executing on-site sampling. We can also supply the necessary materials and instructions to perform your own sampling, then you send the samples to our lab for incubation and enumeration.
All work is performed in strict compliance to cGMP requirements following USP, EP, JP, ISO or client specific requirements. When our qualified technicians perform sampling, we create customized final reports including test results and a map of the testing locations. If you perform sampling internally, you receive detailed results of the tests performed.
YOUR COMPREHENSIVE SERVICE PROVIDER
Our highly trained technicians are equipped with specialized instruments to offer support at any point of the certification process.
Our experienced microbiologists offer testing performed in compliance with current USP/NF, and client-supplied methodology.
Our consulting team can support compliance strategy, master planning, validation and contract services to ensure your facility satisfies industry standards.
THE SCIENCE OF SERVICE
Leave it up to us! Qualified Pace® technicians come to your site to carefully collect and document, then one of our laboratory sites provides quality testing and timely reporting.
PACE® PROVIDED KITS
We send the kit; you collect the samples, and the Pace® laboratory team takes care of the rest.
Trust the Pace® team to provide quality testing and timely reporting for your samples.
INTEGRATED LABORATORY SERVICES
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
ISO 14644-1 Cleanroom Standard
EU Guidelines to Good Manufacturing Practice
A2LA, BSI, CETA, ISO9001, NEBB
To help ensure compliance with USP General Chapter <797> and USP General Chapter <800>, our CETA National Board of Testing certified staff provide all required pharmacy cleanroom testing and certification.