Overview Of Validated Procedures; Disposal - Erbe 20132-106 Manual Del Usuario

OBJ_DOKU-189911-006.fm Seite 50 Donnerstag, 17. Juni 2021 9:31 09

7.11 Overview of validated procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent Cidezyme
and disinfectant Cidex OPA (Johnson & Johnson Medical
Limited, Gargrave, Skipton).
– Cidezyme: Dosage 1.6%, 5 minutes exposure time at
room temperature.
– Cidex OPA: Dosage 0.3%, 12 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.
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).
8

Disposal

Dispose of the product, packaging material and accessories (if
available) in accordance with the national guidelines and legis-
lation applicable in each case.
50