Assuring the product or device you manufacture meets the quality standards you demand is reliant on maintaining a GMP compliant facility. A well designed and executed Environmental Monitoring (EM) program can detect changes in the state-of-control within the environment.
The frequency, sampling and testing requirements required will depend on the type of environment and the product being produced or the activity being carried out. Results of monitoring need to be reviewed, analysed and trended.
Helvic can help you achieve the most effective and efficient EM program for your facility. Working with a laboratory partner you trust will give you piece of mind and will allow you to focus your employee resource on their intended roles. Services include:
- Advice and assistance with all aspects of your EM program
- Supply of media
- Growth promotion testing of media
- Sampling of manufacturing & cleanroom facilities including, settle plates, contact plates, swabs, air sampling
- Growth promotion
- Total Aerobic Microbial Count (TAMC)
- Organism Identification
- Biologics & Biopharmaceuticals
- Beauty, wash & care