Aseptic processing aims to preserve product sterility during assembly using sterile components. Its purpose is to prevent microbial contamination.
This article provides supporting data for the validation of a single-use microbial sampler impactor that includes a preloaded agar plate.
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Abstract
- Julius R. Petri invented the Petri plate over 120 years ago while working in Robert Koch's laboratory.
- The Petri plate remains a widely recognized and straightforward device commonly utilized in microbiology laboratories.
- As time passed, the early glass Petri plates were replaced by single-use, sterile polystyrene Petri plates.
- The Petri plate was recently hailed as one of the most enduring and influential designs in microbiological instrumentation, as discussed in a 2014 American Pharmaceutical Review article by C. Denoya.
- Petri plates find application in microbial air monitoring, where a specific volume of air is directed onto the agar surface (active air sampling). Microbial contaminants in the air affect the agar surface, and colonies can be counted after incubation. During this process, the lid of an agar plate is manually removed when loading it into a stainless steel sampling device, which poses a risk of operator-induced contamination, resulting in a "false positive."
- The work presented here summarizes the validation of an innovative, single-use, sterile, transparent plastic impactor housing an integrated agar culture media plate.
- This design can serve as an alternative to stainless steel impactors. The single-use device eliminates the need for traditional agar plates and reduces the need for operator involvement in plate substitution, exposure, and removal.
- Data on the performance validation and the advantages of implementing this single-use device in clean rooms for aseptic manufacturing are presented below.
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