ENVIRONMENTAL MONITORING

Environmental monitoring of the manufacturing and testing facility is an important part of GMP compliance. The only way to confidently eliminate contamination in the finished product is to trace it back to the source and either remove the source or remove or limit the points of contact with the product to the source of contamination.

We offer hands on assistance with sampling your environment. Typical environmental sampling points include, but are not limited to:

• Water System Samples (in process loop as well as point of use)
• Processing Tanks
• Filling Lines (Hoppers, Conveyor Belts, Cappers, Nozzles, etc.)
• Holding Tanks and Storage Drums
• Pumps
• Hosing

Air Quality throughout the facility should be monitored, with the best applicable method. In non-sterile environments that have direct access to warehousing and dock areas, simple air settle plate monitoring will suffice. Typical mold and yeast counts will vary by season and position in the facility. In cleanroom environments, glove prints and contact plates as well as particle counting are utilized to assure that the room attains a certain class or standard per ISO, FED STD or EU GGMP.

An important aspect of environmental monitoring is a thorough system overview. Deibel Labs will visit your facility to walk through step by step each processing point to assess possible sources of contamination, or niches where bacterial contamination can hide.

Deibel Laboratories can assist your production and quality teams with developing environmental monitoring programs tailored to your facility and manufacturing process. See also our Risk Assessment and Gap Analysis pages.