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CONTROLLED ENVIRONMENTS, VALIDATION AND CONTROL OF RATINGS


Biochem offers services for the evaluation of the environment and of the controlled processes, in order to verify and monitor the adequacy of the environments, equipment and procedures, and the compliance with rules.
All of the validation activities are based on the risk analysis approach. Biochem performs the measurement of particulate contamination and counting of microorganisms in the air of all Controlled Environments, the White House, the extractor fans or areas that require specific controls air to assess the degree of cleanliness, in accordance with ISO 14644 and ISO 14698. Biochem also offers: operating procedures of the personnel and procedures for cleaning sanitization (rooms, equipment; evaluation of the treatment and conditioning systems efficacy, definition of environmental parameters reference, validation of the process of sanitizing, pasteurisation, sterilization, inactivation of viruses; particles and microbial controls; training courses for the staff).

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* Misura della contaminazione microbica e particellare dell’aria
* Misura delle portate e del numero di ricircoli
* Controllo microbiologico dell’aria compressa ISO 8573-7
* Misura della contaminazione microbica di superfici e/o strumenti di lavoro
* Recovery time
* Residui di chemioterapici
* Residui di gas anestetici
* Residui di sostanze contaminanti
* Convalida dei Processi di sterilizzazione e disinfezione
* Convalida dei processi di lavaggio e pulizia
* Ricerca delle cause di eventuali inquinamenti
* Controllo della taratura di apparecchiature (Pressione, Umidità Relativa, Temperatura, ecc.)

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