Responsibility Of The Operator - Christ Beta 1-8 LSCbasic Operating Manual

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3.3

Responsibility of the operator

Version 03/2018, Rev. 1.5 of 09/03/2020 • sb-dc
Translation of the original operating manual
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).
Working area
The operator must
•
perform a risk assessment concerning potential accidents in connection
with the freeze-dryer and take design-related countermeasures, if
necessary.
•
perform 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.
•
have the system maintained at regular intervals (see chapter 8 -
"Maintenance and service").
Any parts or components that are not in perfect working order must be
replaced without delay.
Additional points concerning the freeze-drying of solvent-containing
products
With regards of corrosion resistance, the use of some organic solvents in
aqueous solutions with low concentrations is acceptable.
Under certain circumstances, the freeze-drying of products containing
solvents may lead to the formation of explosive mixtures. This is why the
operator must draw up special operating instructions/SOPs including
precise instructions
•
concerning the deactivation of specific components, such as PT100
(see chapter 1.2 - "Intended use", section "Freeze-drying of solvent-
containing products "),
Freeze-dryer Beta 1-8 LSCbasic
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