Operating Manual MELAdoc label printer
5
Documentation of the batch clearance
Batch clearance assesses and documents the success of the sterilization procedure.
Assessing the success of the process
The success of the sterilization procedure is assessed using the protocol print out, the
autoclave display or a software output.
A log print-out requires written evaluation. The print-out can be signed or a label can be
affixed to the rear side.
Controlling the batch indicators added
The use of an indicator system increases process reliability. The MELAcontrol
®
Helix
test body can be used as a batch indicator for class “B“ autoclaves or large steam
sterilizers.
Batch indicators
can increase reliability.
For further validation of the success of the
sterilization procedure we recommend adding batch indicators (e.g. MELAcontrol). The
impossibility of making a certain prediction of the likely appearance of a successfully
coloured indicator after five or more years (return discolouration), means that it is
necessary to make a written record of the successful colour change. It is not necessary to
store the indicators.
Documentation of the (daily) procedure clearance in the batch control sheet, consisting of
label, entry and signature.
Labelling and clearance of the sterilized equipment
Every sterilization package must be controlled and cleared after successful sterilization.
Visual control
The transparent sterilization packaging must be undamaged and dry. The container
must be closed securely or sealed with sterilization tape, so that any early opening
during the storage time can be recognized easily. Also check the labelling of the
container (information regarding the contents).
Controlling the treatment indicators
The treatment indicators on the transparent sterilization packaging or the sterilization-
tape used must have coloured successfully.
Labelling the sterile equipment
The sterile equipment is cleared by adding a label. It is possible that individual items
in a batch cannot be cleared e.g. due to damage to the individual transparent
sterilization packaging.
