Reinraum
Key WordsSterile test environment | Aseptic isolator | Fast decontamination with H2O2 | Cleanroom class A (ISO 5) | Software according to GAMP | Test cost comparison
Abstract
Can a decontaminable isolator with cleanroom class A (ISO 5) in the work chamber, which is located in a class C (ISO 7) cleanroom, replace the sterile test in a manned cleanroom class A (ISO 5)? According to the available knowledge, this question can be answered with “yes” in full. The isolator offers a sterile test environment and largely prevents secondary contamination of the test items by the operator.
Containers with a content of up to 10 l can be tested with 1 or 2 batches. Containers with gas-permeable packaging can also be tested in the isolator, if decontamination with H2O2 is avoided and only the germ reduction procedures that are customary in a manned cleanroom are carried out. This means that the isolator can be used for almost all applications in sterile testing.
Correspondence:
Frank Lehmann, SKAN AG, Kreuzstrasse 5, 4123 Allschwil (Switzerland); e-mail: frank.lehmann@skan.ch
![]() | Frank Lehmann Frank Lehmann studied Process Engineering at the University of Applied Sciences in Esslingen, Germany. Now there are more than 20 years of experience in various positions in the cleanroom and pharma industry like product development engineer and project manager. He realized containment projects for different customers all over the world such as aseptic filling lines and toxic isolators. At SKAN AG, Switzerland he is now responsible for sales engineering and product |