SERVICES
Isolator and RABS qualification
BRIEF
Overview
At Validation Solutions, we provide complete qualification of isolators and RABS in full alignment with EU Annex 1 and modern sterility-assurance expectations. Alongside URS development and full IQ, OQ, and PQ execution, we specialise in VHP cycle development — including fixed-load cycles, bracketing approaches, and full optimisation of existing programmes. Our engineers deeply understand the physics of VHP, managing dry and wet cycles, resolving seasonal or periodic failures, and achieving consistent 6-log or 4-log biological inactivation as required. Every qualification strategy is tailored to your equipment design and contamination-control needs, delivering efficient, robust, inspection-ready barrier performance.
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