Eastlake Quality Consulting GMP Term of the Week
By: Greg Weilersbacher, President, Eastlake Quality Consulting | 3 min read
Environmental Monitoring (EM) is the evaluation of the viable (living, i.e., mold, skin cells, etc.) and non-viable (non-living, i.e., synthetic fibers, dust, etc.) air and surface particulates in a pharmaceutical production cleanroom.
Why it matters: Each cleanroom classification has specifications for acceptance of the results. This ensures that the cleanroom is operating within regulatory requirements and not contaminating your product.
- Case Study – A west-coast Contract Development and Manufacturing Organization (CDMO) manufacturing solid oral products performed environmental monitoring of production cleanrooms on a monthly basis. Several out of specification results were obtained for viable air (e.g., air particles consisting of live organisms) in one their most frequently used cleanrooms. The results were inconsistent with historical EM records. The room was re-cleaned and sampled for viable air a few weeks later. These samples also generated failing results for viable air. The site Quality Assurance director decided to investigate the problem himself by gowning-up and inspecting the problematic cleanroom. When no obvious problems were observed, he decided to look under the tacky mat that was placed in front of the cleanroom’s exit door. To his surprise he found that the underside of the tacky mat was covered in black mold spores.
Discover how Eastlake Quality Consulting can improve your environmental monitoring program
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Eastlake Quality Consulting (EQC) can provide support in the areas of quality assurance, quality control, and manufacturing operations. We also offer training on GMP requirements and can assist with the development of policies and procedures. EQC is your partner for compliance with good manufacturing practices.
