persist

In addition to the successful operation of isolators and plants, SKAN also supports its customers with SKANalytix in the area of data analysis, data evaluation and documentation. To meet the different requirements SKAN offers the analytical service packages active, clean and persist.
The services include the analysis of the cleanability of isolators, the evaluation and development of individual cleaning processes, the determination of suitable packaging materials and the H₂O₂ influence on sterility tests.

It goes without saying that we follow the standards of “Good Manufacturing Practice” (GMP) as well as common standards and guidelines both in the execution and documentation of services.

With millions and billions of humans taking more medicines than at any time in history, an unanticipated drug safety problem can rapidly escalate to become a major public health threat.
Tackling this potential threat demands a multifaceted safety effort based on interdisciplinary scientific teamwork throughout the value chain.
SKAN accepts this responsibility and offers analytical services to jointly identify potential hazards and to protect customers’ products.

Clean addresses the question “How clean does the production line need to be to prevent any risks that could potentially arise from contamination?”.
“It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.”
and further on “The ability to detect the harm (detectability) also factors in the estimation of risk.”
SKAN offers the clean service portfolio to strongly support our customers in developing effective cleaning strategies and ultimately to prevent harm to the patient.