EM Sampling Automation solution for clean rooms

Today, the process of environmental monitoring (EM) in clean rooms is an arduous, time-consuming task performed manually by EM, QC or manufacturing staff. It requires extensive and constant training to perform this task, often in addition to other requirements.
 
Furthermore, human presence in clean rooms is the largest source of contamination in controlled environments and a constant risk to any sterile product manufactured there.

Operating these tasks manually and the associated data collection may also lead to a risk of traceability loss, between the sample and the sampling point, but also on the sample itself, when the identification is handwritten and information has to be manually entered into the EM or LIMS.

To date, there is no commercially available solution to automate these tasks.

An autonomous EM sampling system capable of performing environmental monitoring tasks in any clean room without requiring manual operation or assistance from operators present in the room.
This will reduce the need for human intervention in clean room environments and assist in maintaining data integrity and traceability.
 

• Version 1 (Figure 1): Mobile air sampling   
  • Fully autonomous active air sampling in clean rooms  
  • Connected to an EM software/LIMS for full data integrity  
  • Traceability covered by an integrated barcode reader 

• Version 2 (Figure 2): Fully integrated EM automation   
  • Version 1 + additional features  
  • Parallel sampling through placement of multiple mobile air samplers  
  • Surface sampling via contact plates and swabs