(EM) Maintaining aseptic conditions
What is Environmental Monitoring (EM) Testing?
Environmental Monitoring is a general term covering a broad range of monitoring activities associated with maintaining controlled conditions. With regards to Microbiological Environmental Monitoring, we are referring to the viable count in the area.
Why do we do it?
There is a regulatory requirement to demonstrate cleanroom performance. The microbiological quality of finished product is paramount in patient safety, as such various regulatory bodies define the microbiological parameters that cleanrooms and controlled areas must meet. These are defined in:
- ISO Standards – included in the FDA guidance
- Eudralex – EU GMP guidelines
A robust environmental monitoring program combined with validated processes and analytical testing data can give confidence in the microbiological quality of the product.
How can we help assure compliance?
The expertise at Honeyman allows us to provide a fully comprehensive environmental monitoring support programme from design right through to the analytical requirements.
Our laboratories can provide fully outsourced cGMP solution including:
- Sample receipt and processing
- Enumeration of exposed plates
- Interpretation of total viable count
- Result trending
- Full out of specification investigations including microbiological and mycological identification
Our industry experts are able to offer consultancy on the following:
- Design and implementation of Environmental Monitoring Programs
- Troubleshooting on Environmental Monitoring out of specifications
- Action and Alert limit implementation and justification