EM Sample Collection and Analysis

Once a cleanroom is qualified and certified, a routine environmental monitoring program must be established. This program details the sampling type, frequency, and trending requirements to ensure that a cleanroom can be maintained in a state of control. An environmental monitoring program’s success can be determined by its ability to provide meaningful data that can be utilized to:

  • Mitigate Risk

  • Proactively Identify Trends

  • Evaluate the Effectiveness of Cleaning and Personnel Practices

EM Sample Collection and Analysis
 
Not only is Alcami able to provide on-site sample collection; we are also able to incubate and analyze environmental monitoring samples collected by your team.
 

We have equipped our laboratories with advanced technology that adheres to the most strict regulatory requirements and is compliant with 21 CFR part 11. For total particle count testing, our team utilizes the Met-One 3400 series units. For viable active air testing, our team employs the MAS-100 units which can sample with either a settle or contact plate depending on client needs. The respective compressed gas units including Pinocchio viable air sampler are also available for use by the team for viable and total particle count analysis. Drager Aerotest units are offered for hydrocarbon and moisture content analysis of compressed gas systems.

In addition to routine environment and utilities monitoring, our team is able to support personnel plating and sampling performed during manufacturing activities and offers support in your remediation efforts in case of unfortunate events such as failure to HVAC systems, power outage, breach of cleanroom integrity, or spill.

 

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