Overview Of Validated Procedures - Erbe BiClamp Manual Del Usuario

OBJ_DOKU-194618-004.fm Seite 36 Dienstag, 6. Juli 2021 10:25 10
Steam sterilization
• Fractionated vacuum method with adequate product drying
• Holding time 3 to 18 minutes at 132 to 138 °C
• Sterilizers in accordance with applicable national standards
and regulations (e.g. DIN EN 13060 or DIN EN 285)
• Sterilization process validated according to DIN EN
ISO 17665
Please follow the recommendations issued by the sterilizer man-
ufacturer concerning loading, handling, and drying times.

5.10 Overview of validated procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent Cidezyme
LF/Enzol and disinfectant Cidex OPA (Johnson & Johnson
Medical Limited, Gargrave, Skipton).
– Cidezyme LF/Enzol: Dosage 3%, 5 minutes exposure
time at 40 °C.
– Cidex OPA: Dosage 0.3%, 5 minutes exposure time at
20 °C.
• Machine cleaning and disinfection in a G 7836 CD disinfector
(Miele & Cie. KG, Gütersloh, Germany) with the cleaning
agent neodisher mediclean forte (Dr. Weigert GmbH & Co.
KG, Hamburg, Germany).
– neodisher mediclean forte: Dosage 0.5%, 5 minutes ex-
posure time at 55 °C
– Disinfection: 5 minutes at 90 °C.
• Sterilization in an autoclave Systec V-150 (Systec GmbH,
Linden/Germany).
– Steam sterilization with saturated steam, fractionated
vacuum procedure, 3 minutes, 132 °C, 3 bar.
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