Freeze-dryer Epsilon 1-4 LSCplus
Freeze-dryer Epsilon 2-4 LSCplus
3 Safety
26 / 148
Version 04/2014, Rev. 2.13 of 01/12/2021
• sb
Translation of the original operating manual
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→
3.3
Responsibility of the operator
Operating personnel
The operator is obliged to ensure that the persons working on/with the
freeze-dryer
• are 18 years old or older,
• have been specifically ordered to do so by the operator/owner and that
they have been duly informed about the specific hazards associated
with the system, supply media and starting/final products as well as
about the correct conduct and necessary measures to take in the event
of accidents or malfunctions,
• are familiar with the fundamental health, safety and accident prevention
regulations,
• have been trained in terms of the operation of this system,
• have read and understood this operating manual (in particular the safety
sections and warning notes) and confirmed this with their signature.
The areas of responsibility of the personnel concerning the operation,
maintenance and care of the unit must be clearly defined.
The safety-conscious work of the personnel in compliance with the
operating manual and the relevant EC health and safety directives and the
national laws concerning health and safety and the prevention of accidents
must be checked at regular intervals (e.g. every month).
Special equipment
– H
2
O
2
decontamination system: additional points
concerning decontamination with hydrogen peroxide (H
2
O
2
)
The operator is committed to having the decontamination of the freeze-
dryer performed solely by personnel
• who have been specifically ordered to do so by the operator and who
have been duly informed about the specific hazards associated with
hydrogen peroxide and about its safe handling based on the special
operating instructions/SOPs,
• who have been instructed by specialised personnel concerning the
operation of the hydrogen peroxide steam generator and freeze-dryer
and, in particular, concerning the "H
2
O
2
decontamination" mode.
Working area
The operator is responsible for
• performing a risk assessment concerning potential accidents in
connection with the freeze-dryer and take design-related
countermeasures, if necessary.
• performing a risk assessment in terms of the specific hazards
associated with the processing of the particular product in the freeze-
dryer (e.g. ignition/ explosion hazard, escape of harmful product
residues at the outlets of the chamber) and, if necessary, for taking
appropriate measures.
• performing a compatibility test of all the substances that are used in the
freeze-dryer (products to be dried as well as cleaning agents, etc.) and
that come into contact with the chamber walls, shelves, pipes/hoses
and seals. Substances that damage the material or weaken the
mechanical strength must not be used.
