Before we dig deeper into the fundamentals of Isolator technology it’s important to understanding the regulatory expectations in aseptic processing for sterile drug product.
Conventional Cleanrooms
Conventional cleanrooms with gowned operators in Grade A areas with simple machine guards as separation to critical process equipment is no longer considered best practice within the industry.
Environmental control technologies are now available and should be utilized wherever possible.
These include:
- Restricted Access Barrier Systems (RABS)
- Isolators
The use of so-called conventional cleanroom technology may be acceptable for the processing of terminally sterilized products, APIs and products where there are technical issues which prevent the use of barrier technology for aseptic processing.
Minimize Human Intervention
The utilization of Isolator technology to minimize human intervention in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment.