Clean Room conditions are provided with Air-Lock door systems with disinfection stations in all entrance and exit areas.

Production is carried out in the Clean Room production areas , which are conditioned in accordance with Class 10.000 standarts where critical variables such as temperature, humidity, positive pressure and particles that may affect product quality are constantly monitored and recorded.

Production is carried out in clean areas validated in ISO Class 7 in accordance with GMP rules and EN ISO 14644-1 standarts. In addition, the produc>on processes and the products we produce have been secured with the relevant Medical Device Directives and quality management systems and are certified with CE, ISO 9001, ISO 13485 and ISO 13795 + A1.

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