Freeze-dryer Epsilon 1-4 LSCplus
Freeze-dryer Epsilon 2-4 LSCplus
3 Safety
Version 07/2022, Rev. 3.0 of 20/07/2022
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Translation of the original operating manual
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3.3
Responsibility of the operator
The operator is the person who uses the freeze-dryer for commercial or
economic purposes or lets a third party use it and who bears the legal
product responsibility for the protection of the users, personnel or third
parties during operation.
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 operate the system by the
operator,
– have been trained in terms of the operation of this system,
– 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 read and understood this operating manual (in particular the
safety sections and warning notes) as well as any additional
applicable documents (see chapter 1.2 - "Further applicable
documents")and confirmed this with their signature.
• the areas of responsibility of the personnel concerning the operation,
maintenance and care of the unit are clearly defined.
• standard operating procedures (SOPs) concerning the various products
that are freeze-dried in the freeze-dryer are provided (see the section
below "Work area").
• 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 are checked at regular intervals (e.g. every month).
Work area
The operator must
• perform a risk assessment concerning potential accidents in connection
with the freeze-dryer and take design-related countermeasures, if
necessary.
• check the sound pressure level at the workplace of the operating
personnel after the setup of the freeze-dryer. The sound pressure level
depends on the local conditions (e.g. sound reflected from the ceiling
and surrounding walls, external sources of noise). If necessary, the
operating personnel must wear suitable personal protective equipment
or other suitable protective measures must be taken in line with the
applicable legal provisions in order to avoid noise-induced hearing loss.
• perform a risk assessment in view of the specific hazards associated
with specific products that are freeze-dried in the freeze-dryer (e.g.
ignition/explosion hazard, discharge of harmful product residues at the
outlets of the chamber) and take the corresponding measures, if
necessary.
