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.

DELIVERABLES

What's Included?

URS development and design review tailored to your need.

Full IQ, OQ, and PQ execution

VHP cycle development and optimisation

Fixed-load and bracketing sanitisation cycles

Dry-cycle and wet-cycle troubleshooting

Aseptic process simulation and validation within the isolator

Glove-integrity testing and environmental control checks

Airflow and air visualisation studies

Barrier integrity and contamination-control verification

Periodic failure investigation and corrective cycle refinement

DISCOVERY CALL

Were ready when you are

Book a free discovery call & lets see if were a good fit

DISCOVERY CALL

Were ready when you are

Book a free discovery call & lets see if were a good fit

DISCOVERY CALL

Were ready when you are

Book a free discovery call & lets see if were a good fit

VALIDATION

SOLUTIONS

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Book a free 15 minute consultation call & let’s get started

VALIDATION

SOLUTIONS

Book a free 15 minute consultation call & let’s get started

VALIDATION

SOLUTIONS

Book a free 15 minute consultation call & let’s get started