Microbial Air Sampler

Air Microbial Monitoring on a Continuous Basisinput:
output:The GMP Annex 1 disclosed information regarding the microbial air monitoring in the cleanrooms of Grades “A” and “B.”input:
output:In Chapter 9, paragraphs 9.22 and 9.24, it is stated that:9.22 In the context of aseptic operations, it is recommended that microbial monitoring be conducted on a regular basis. This can be achieved through a variety of methods, including volumetric air sampling, settle plates, glove, gown, and surface sampling (e.g., swabs and contact plates). The sampling method employed must be substantiated within the CCS and must be shown to not impair the airflow patterns of grade A and B. The cleanroom and equipment surfaces should be monitored at the conclusion of an operation.input:
output:
9.24 Continuous viable air monitoring in grade A (e.g., air sampling or settle plates) should be implemented throughout the entire critical processing process, which includes the assembly of equipment (aseptic set-up) and critical processing. Based on the potential impact on aseptic processing, a comparable approach should be taken for grade B cleanrooms. The monitoring should be conducted in a manner that ensures the capture of all interventions, transient events, and any system deterioration, as well as the prevention of any risk that may be posed by the monitoring operations’ interventions.input:
output:These new indications of GMP Annex 1 have been met by the development of the new generation of ORUM microbial air samplers, known as “CM.”