Overview Of Validated Procedures - Erbe 20196-115 Manual Del Usuario

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6.11 Overview of Validated Procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent neodisher
mediclean forte (Dr. Weigert GmbH & Co. KG, Hamburg/Ger-
many) and disinfectant Cidex OPA (Johnson & Johnson Med-
ical Limited, Gargrave, Skipton).
– neodisher mediclean forte: Dosage ½ oz/gallon of warm
tap water, 5 minutes exposure time at room tempera-
ture.
– Cidex OPA: Minimum effective concentration (MEC)
0,3%, 12 minutes exposure time at 61-68 °F (16-20 °C).
• Cleaning/disinfection by machine in a STERIS Reliance Gen-
fore washer/disinfector GEN FH07-1XX (STERIS Corporation,
Mentor OH, USA) using neodisher mediclean forte detergent
(Dr. Weigert GmbH & Co. KG, Hamburg/Germany).
– Prewash: 2 minutes under cold tap water.
– Main wash: 5 minutes at 140°F (60°C) with neodisher
MediClean forte, dosage ¼ oz/gallon.
– Final rinse: 1 minute under hot tap water.
– Product drying: 7 minutes at 194°F (90°C).
– Disinfection: 5 minutes at 194 °F (90 °C).
• Sterilization in an autoclave Systec V-150 (Systec GmbH,
Linden/Germany).
– Steam sterilization with saturated steam, fractionated
vacuum procedure, 3 minutes, 270 °F (132 °C), 44 psi
(3 bar).
Erbe recommends the processing procedures described in these
instructions for use. Equivalent different procedures are possible
if not explicitly excluded. It is incumbent on the user to ensure
the suitability of the actual procedures used by means of suit-
able measures (e.g. validation, routine monitoring, check of ma-
terial compatibility).
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