Single-use systems (SUS) come with
increasingly complex challenges that
are often misconceived since industry is
still in the early stages of adopting this
technology. One of the more complicated
SUS aspects is sterilization validation.
A successful validation requires strong
collaboration early in the manufacturing
process design phase among all parties
The pharma firm, the SUS manufacturer,
the contract sterilization vendor and the
contract microbiology laboratory each
play a part within the validation process.
This partnership ensures shared understanding
between all four players on the
inherent complexity, uncertainty and
resource demand in SUS design, validation
and commercial manufacturing.
Additionally, common misconceptions,
false assumptions and veiled communication
between the pharma firm and the
SUS manufacturer must be highlighted,
brought into the open and addressed.
Such open collaboration cultivates invaluable
knowledge transfer, greatly minimizing
risk of SUS failures later on.