RABS is a type of physical barrier system used for aseptic processing of pharmaceutical products, reducing or eliminating interventions into the critical zone.
This unit is designed with rigid wall construction to limit contamination of products by operators (the dirtiest item in the cleanroom) during filling operations to improve quality, and for applications that have higher flexibility requirements. The RABS level of contamination control lies somewhere on the spectrum between conventional cleanroom aseptic processing and an isolator.
This RABS is set up in an ergonomic way to allow access through doors until the unit is in production. From that point on, gloveports can be used for adjustments and fine tuning or an occasional malfunction requiring human intervention. Ceiling HEPA filters are required inside the RABS over the fill line, which can be pre-existing or supplied if needed.
Containment Tool Box The potency of APIs (Active Pharmaceutical Ingredients) in OSD (Oral Solids Dosage) formulations has been increasing for years and the number of...
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