Freeze-dryer Alpha 3-4 LSCbasic
3 Safety
Version 11/2018, Rev. 1.2 of 05/03/2019
• sb-pe
23 / 97
Translation of the original operating manuel
3.3
Responsibility of the operator
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 operator must observe the system limits defined by the
manufacturer in which a risk assessment for explosive atmospheres has
been performed. The defined system limits include
– the drying chamber up to the aeration valve, drain valve and
pressure control valve,
– the glass cover with/without a manifold and
– the chamber made of real glass.
• The freeze-dryer must correspond to the solvent package for flask
drying (part number: 102394) or to the solvent package "universal
system" (part number: 102395).
• Freeze-drying products with a high solvent concentration may lead to
the formation of potentially explosive gas mixtures. This is why the
operator must provide standard operating procedures (SOPs) for the
freeze-drying of the various products, including specifications
concerning the chamber pressure. The solvents that are used must be
of the temperature classes T1 to T4 as per DIN EN-60079-0:2014-06.
• The operator must comply with the specifications of DIN EN 378-
1:2018-04 and DIN EN 378-2:2018-04 for refrigeration systems and
heat pumps.
• The operator must comply with the specifications of DIN EN 378-
3:2017-03 and DIN EN 378-4:2017-03 for refrigeration systems and
heat pumps.
• The safety-conscious work of the personnel in compliance with the
instructions for use/operating instructions, SOPs and with the relevant
EC directives and the national laws concerning health and safety and
the prevention of accidents must be checked at regular intervals (e.g.
every month).
• The areas of responsibility of the personnel concerning the operation,
maintenance and care of the unit must be clearly defined.
• The operator must perform a risk assessment concerning potential
accidents in connection with the freeze-dryer and take appropriate
countermeasures, if necessary, for example the use of a safety cabinet.
• The operator must 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. The use of substances that damage
