Washing & Sterilization
Washing and sterilization systems, qualified to pass inspection.
Autoclaves, washer-disinfectors, de-pyrogenation tunnels, and freeze dryers, with cycle design, validation, and qualification by senior specialists, and the routine-monitoring know-how handed to your team. EU GMP and SFDA-aligned.
Design
Cycles designed to qualify the first time.
Washing and sterilization equipment lives or dies on the cycle. Load configuration, drainability, heat penetration, air removal, and lethality all carry regulatory weight. A cycle that looks fine on the HMI can fail PQ when the cold spot does not reach lethality. That is engineering judgment, not a vendor default.
We design and develop cycles for autoclaves, washer-disinfectors, de-pyrogenation tunnels, and freeze dryers. Load patterns, F0 and lethality targets, depyrogenation challenge, and drainability reviewed by a senior specialist who has qualified the same equipment type before.
Cycle development for autoclaves, washers, DHTs, and freeze dryers
Load configuration, drainability, and air removal designed for qualification
F0, lethality, and depyrogenation targets set against EU GMP and SFDA
Validation
FAT to PQ, without losing the validated state.
New installations, upgrades, or relocations. We see washing and sterilization equipment through FAT, SAT, IQ, OQ, and PQ. Heat distribution and penetration mapping, biological indicator challenges, and the requalification work that keeps a relocated autoclave or washer in its validated state.
Each phase is a fixed-fee milestone with defined acceptance criteria. You know what each gate costs, what it delivers, and what signs off before work begins. No hourly exposure during qualification. No scope creep when the contractor hits an issue.
Heat distribution and penetration mapping with biological indicator challenges
Relocation and requalification that restores the validated state
Fixed-fee IQ, OQ, and PQ milestones with signed acceptance
Ongoing Compliance
Routine monitoring your team can run.
Validation does not end at PQ. Sterilizer and washer performance drifts, biological indicator sourcing changes, and re-qualification cycles come due. We build the documentation that keeps you audit-ready and transfer the operational knowledge so your team maintains the validated state without us.
Routine cycle monitoring, requalification triggers, change-control logic, and out-of-spec response playbooks. Your operations and QA teams inherit a working system, not a consultant dependency. The next audit reads continuity. The next hire learns from documentation written to be learned from.
Routine cycle monitoring and trending transferred to your team
Requalification triggers and change-control logic documented
Out-of-spec and failed-cycle response playbook your QA can defend
Qualifying an autoclave, washer, or sterilizer?
Whether you are validating a new sterilizer or requalifying after a move, send us your brief and we come back within one business day with a named senior specialist and a scoped approach.