Single-Use by Design
No residue from anyone else’s molecule — by design, not by cleaning.
02/
Conventional stainless-steel suites carry the residue of every product before yours, and rely on cleaning validation to prove it is gone. Our product-contact train is fully single-use, from the mixer system through to the filling line. Every campaign begins with new, sterile, product-dedicated components, so carry-over from another sponsor’s molecule is eliminated by design rather than argued away in a report.
100%
single-use train
Grade A
in Grade B
0.2 µm
with PUPSIT
RTU
vials & stoppers
Photos of GMP facility at OmniParticles
What we offer
1
Single-Use Mixer System and fully single-use product-contact train
Eliminate product-contact carry-over between campaigns — no shared product-contact surfaces between sponsors.
2
Closed single-use fluid path from compounding to the filling needle
Remove product-contact cleaning validation from the critical path, shortening setup and changeover timelines.
3
Grade A aseptic filling in oRABS, Grade B background
Fill under Grade A conditions in open RABS (oRABS) within a Grade B classified background, aligned with the current EU GMP Annex 1. Grade C compounding and preparation areas, Grade D support zones.
4
0.2 µm sterilizing filtration with PUPSIT
Sterilize the product stream by 0.2 µm filtration with pre-use post-sterilization integrity testing (PUPSIT).
5
RTU vials and stoppers (ISO 8362) · Continuous environmental monitoring
Minimize operator intervention using ready-to-use (RTU) vials and stoppers, removing on-site washing and depyrogenation. Monitor viable and non-viable particulates continuously, with real-time alarms, throughout filling operations.