• 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").
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3.4 Operating personnel
It must be ensured that persons operating the unit
• are 18 years old or older,
• have been specifically ordered to operate the unit and made aware of
dangers originating from the freeze-dryer, supply media, starting and
end products by the operator,
• be familiar with the fundamental regulations concerning workplace
safety and accident prevention
• have been trained in terms of the operation of this unit, and
• have read and understood this operating manual (and in particular the
safety sections and warning notes) and confirmed this with their
signature.
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3.5 Informal safety notes
This operating manual is part of the product.
• This operating manual must be kept at the location of use of the freeze-
dryer. Ensure that it is accessible at all times.
• The operating manual must be handed over to every subsequent owner
or user of the freeze-dryer.
• Any changes, additions or updates received must be added to the
operating manual.
• In addition to the operating manual, the general and operational rules
and regulations for the prevention of accidents and the protection of the
environment must be provided.
• All of the safety and hazards notes on the freeze-dryer must be kept
readable at all times. If necessary, they must be replaced.
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