Microbial Environmental Monitoring
To achieve compliance to regulatory guidance, a microbial monitoring program includes the following components:
- Active air (room or enclosure environment)
- Passive air (settle plates)
- Surfaces (contact plates and swabs)
- Personnel (gloves and garments)
- Compressed gases
- Materials and equipment that could compromise product microbiological quality
- Cleaning and sanitization process understanding
EU GMP 2008 and FDA GMP 2004 describe microbial limits for cleanrooms and are a reference for determining process alert and action limits. Keep in mind no microbial sampling plan can prove the absence of contamination even when nothing viable is recovered. A large proportion of microorganisms are viable but unable to grow on the traditional agar media. Microbial monitoring programs do not guarantee sterility of a given batch by collecting counts under defined specifications. However, they do help demonstrate the manufacturing process is in a continuous state of control.
Devices that Monitor Microbes
For the following active air devices, air is drawn through slits in the sampling head using an internal/external vacuum pump. The microorganisms impact on the agar surface in the same pattern as the sampling head slits.
- Contact/Petri Dish Sieve Impactor: MiniCapt® Mobile Microbial Air Sampler and MiniCapt Remote Microbial Air Sampler. These products have compressed gas applications.
- Sterilizable Atrium Impactor: BioCapt® Stainless Steel Impactor
- Single-Use Sterile Atrium Impactor: BioCapt® Single-Use Impactor
The next device is a surface swabbing kit that includes a sterile swab and nutrient broth tube.
- Surface Monitoring Kit: SurCapt® Microbial Surface Detection Kit
These devices contribute to the overall analysis and control of process microbes.
Download the application note for an in-depth analysis of microbiological control in cleanrooms, including recommendations and discussions on current regulatory practice.