Freeze-dryer Gamma 1-16 LSCplus
Freeze-dryer Gamma 2-16 LSCplus
3 Safety
Version 04/2013, Rev. 2.10 of 09/03/2020
• sb-dc
25 / 126
Translation of the original operating manual
→
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 opera-
ting manual and the relevant EC health and safety directives and the nati-
onal 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 -
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 sol-
vents may lead to the formation of explosive mixtures. This is why the ope-
rator 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 "),
• concerning the chamber pressure and shelf temperature for every
product that is to be processed in the freeze-dryer,
• concerning the inspection of the freeze-dryer in view of damage caused
by the solvent that is used (see chapter 1.2 - "Intended use", section
"Freeze-drying of solvent-containing products").
