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667 DICH.CONF. 2018_07_13

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About us

Sterilization with ethylene oxide services

Sterox

STEROX is an advanced sterilization centre, based on modern quality standards with minimum environmental impact.
It was born with the objective of satisfying medical devices producers, especially in Central Italy.

STEROX has ISO 9001 and ISO 13485 certificates by IMQ group.

The plant consists in two autoclaves , which both measure 44 m3 and each one can get 16 palletts, at the maximum height of 2.300 mm.

The centre has a 120 m3 per day sterilization capacity.

Repository, preconditioning and degasification are dedicated a space for a total of 1000m3.

The whole production cycle (from approval to release of sterilized product) is handled by highly specialized Sws, allowing a complete repeatability of sterilization cycles, severely reducing chances of error by the operator.

Servces and products

STEROX implemented on its plant a tracking system that allows monitoring of the whole production cycle:
tracking label
– Approval
– Preconditioning
– Sterilization
– Degassing
– Shipping

Certifications

STEROX offre tutte le convalide (IQ, OQ, PQ) fisiche-microbiologiche e tutti i controlli legati al processo di sterilizzazione.

I lavori di convalida sono eseguiti in conformità alle Norme tecniche del settore: Accredito di Accredia (ex SINAL), UNI EN 1422, UNI EN ISO 11135-1, UNI EN ISO/TS 11135-2, UNI EN ISO 10993-7.

STEROX si avvale di laboratori chimico-microbiologici autorizzati dal Ministero della Salute e accreditati all’ente italiano Accredia per tutte le analisi correlate al ciclo di sterilizzazione:

– Bioburden
– Sterilità
– Ricerca di Pirogeni
– EtO (ossido di etilene) residuo
– Cloridrina Etilenica
– Glicole Etilenico

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