Microbial Air Sampling

Viable monitoring data is critical for any pharmaceutical company. GMP monitoring programs are typically comprised of the following elements:
  • Environmental monitoring of non-viable particles
  • Environmental and personnel monitoring for viable particles
  • Aseptic process simulation often referred to as “MEDIA FILL”
Sampling Methods
Microbial Air Sampling of ambient air may be performed in a “passive” or “active” manner.  The use of settle plates is an example of passive air sampling and the use of a Microbial Air Sampler is an example of active Air Sampling. Both methods are described in the GMP Annex-1 in chapter 9 and both give useful information on the biocontamination levels in the controlled environment.
Depending on the method and the grade of the AREA according to the GMP standards the action limits are defined in GMP Annex-1 (chapter 9), the Annex-1 is currently under revision and action limits will most probably be changed to the levels shown below, source GMP annex-1 draft version 2021. ‘No growth’ is allowed for the Grade-A Area for any of the sampling methods in the new draft of Annex-1.
Viable Monitoring GMP Annex-1 (Draft 2021)
Maximum action Limits for viable particle contamination
Viable Sampling conform GMP Annex-1
International standards have been published for biocontamination control in cleanrooms and other controlled environments (ISO 14698-1/2). Microbial air sampling devices are widely used in industries like Healthcare, Pharmaceuticals, Medical devices as well as in the food and beverage markets. The applications range from aseptic viable process monitoring, remote isolator monitoring, compressed gas monitoring to routine clean room monitoring, and many others.
Our microbial air samplers from EMTEK and Pharmagraph meet and exceed user expectations for their accuracy, stability of measurement, ease of use, low cost of ownership, long lifespan and overall product quality. our samplers can be used as portable samplers and can also be easily integrated into any environmental monitoring system.
Execution and reporting
“Microbial Air Sampling is the process by which air from a controlled, or uncontrolled environment is evaluated for the load of bacterial and fungal micro-organisms it may contain.” The sample locations, frequency of monitoring, the monitoring method and incubation conditions must be defined in the monitoring program and must be based on a risk-assessment. The monitoring programme should be considered in the overall context of the trend analysis and the contamination control strategy (CCS) for the production site.
Viable monitoring must be carried out on Surfaces of equipment, walls, doors, on personnel and via active air sampling. When choosing an active air sampler one should consider the following prerequisites.
Monitoring
Prerequisites for Air Sampler Selection:
  • Physical- and biological efficiency validated?
  • Is remote monitoring possible?
  • What flowrate will best suite my sampling application?
  • Suited for compressed gas sampling?
  • Easily sanitized and disinfected?
  • Material enclosure of the airsampler?
  • Is the exhaust air filtered
  • Can the sampling head be sterilized in an autoclave
  • Sterilisable sampling head?
  • Expected negative effects on laminar flow?
  • Remote control and remote sampling?
  • Portable design or remote air sampler?
  • Is the sampler used for cross flow?
  • Connection to Environmental Monitoring System?

Our Microbial Air Samplers

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