The new guidance is for "non-classified" environments in regulated industries such as those producing pharma, biotech, medical devices and life science R&D
The Institute of Environmental Sciences and Technology (IEST) has published new guidance for monitoring controlled environments. It says IEST-RP-CC049: Controlled Environments for Regulated Industries is the first-ever industry guidance document to provide criteria to assist manufacturers in implementing production methods and process controls— including facility environmental controls — for non-classified environments in regulated industries.
Experts at IEST, the leading contamination control authority and Secretariat to ISO/TC 209, developed the new Recommended Practice (RP) to fill a knowledge gap in industries such as pharmaceuticals, biologics, medical devices, nutraceuticals, healthcare, research and development, laboratories, component manufacturing, and emerging industries.
“This is a must-have document as many companies that have cleanrooms are surrounding those areas with controlled environments,” observes Anne Marie Dixon, Chair of IEST Contamination Control Division Working Group WG-CC049 that developed the Recommended Practice.
Dixon also serves as US Technical Advisory Group (TAG) Chair to ISO/TC 209 and is longtime consultant to regulated industries. “The FDA [US Food and Drug Administration] has had little help in this area, so IEST is endeavouring to take the forefront.”
“Until now, regulated industries mentioned in the Recommended Practice have had little guidance in regards to monitoring controlled, non-classified environments for viable and non-viable particles,” confirms IEST WG-CC049 expert Gordon Ely, who is also an industry manager of regulatory affairs.
“There are a few guidance documents specific to environmental monitoring that can be applied, but there is no overarching document that will give people in these industries a starting point when it comes to controlling contamination. The majority of the documents available are written for classified environments within these industries.”
IEST-RP-CC049.1 is recommended for personnel in: Quality Assurance , Quality Control, Production Management , Validation , Design engineering, Facilities.
This RP is not associated with cleanroom requirements or related documentation and does not apply to unregulated industries, including but not limited to semiconductor, electronics, aerospace, automotive, and nanotechnologies.