Environmental Monitoring For Aseptic Filling Operations
AST’s aseptic processing solutions are outfitted with the latest in intuitive cGMP technology designed to optimize the fill-finish process for the highest standards of quality and regulatory compliance.
Environmental monitoring is a critical consideration when designing and implementing your aseptic operation. With the growing development of highly targeted liquid pharmaceuticals, there are increased expectations around quality as reflected in regulatory emphases like the revised Annex 1. AST provides expertise and guidance for the proper EM placement and strategy for your environmental monitoring program.
Total particulate, active viable, and passive viable environmental monitoring stations placed strategically throughout processing stations ensure ideal environmental conditions and provide a record of environmental data to your batch record system.
AutoEM – AST’s automatic plate changer for active and passive viable monitoring
Automatic environmental monitoring is available to automate and de-risk environmental monitoring process interventions. The EM plate-changing tool utilizes pre-sterilized settling plates that are aseptically introduced into the fill line and loaded into an inline cassette dispenser. Plate changes are automated through the HMI, saving process time on typically manual, ergonomically unfriendly gloved interventions.