update
SNBL adopts new temp and humidity control system
The firm – the US unit of Japanese contract research organisation (CRO) Shin Nippon Biomedical Laboratories (SNBL) – has installed Johnson Controls’ Metasys building management system at its lab in Everett, Washington replacing the previous system which required “many manual checks and equipment adjustments.”
The system – which consists of multiple field controllers that send data back to a central monitoring hub – controls environmental conditions in the animal habitat areas and the testing laboratories as well as in the office space also housed at the site.
SNBL said the change will “improve its overall business quality and output” adding that it needed a system that would “constantly and consistently monitor and control its equipment and enable it to report the exact conditions of monitored areas to the FDA at any time.”
The emphasis on the system's regulatory compliance benefits is timely. In May, SNBL USA announced it had resolved seven of nine deficiencies identified in a US Food ad Drug Administration (FDA) warning letter it received in 2010 and that it working to address the outstanding issues
Animal safety
Outsourcing-pharma.com asked SNBL USA if the new system has safeguards to ensure the safety of laboratory animals in the event of system failure, but the firm did not respond ahead of publication.
In a statement the firm said it conducted a four month validation process before removing the old building system adding that its “quality assurance team conducted extensive confidence testing to ensure the…[new[ system would operate as designed and meet the strict government requirements.”
Ron Wren, director of operations director, said: "SNBL USA was looking for a robust, efficient and reliable building management system that can dynamically synthesize information from a variety of sources over SNBL’s entire infrastructure to help ensure the proper facility and environment conditions and protect all of our client studies.”
He added that the Metasys system “preserves the flexibility to monitor and control our systems, including additional safeguards that alert the appropriate team when facility and environment conditions change outside the scope of expectation.”
In a statement subsequently emailed to Outsourcing-pharma.com, SNBL USA COO Thomas Beck asked us to clarify that temperature and humidity controls at the lab have always been automated. He explained that: "This new system has allowed us to now monitor refrigerators and freezers."
He also asked us to stress - regarding the resolution of the 2010 FDA warning letter - that: "The FDA has stated that the team that visited us feels that we have adequately addressed those issues and is waiting for the Management at the FDA to issue the official response."
