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Freeze-dryer Alpha 3-4 LSCbasic
3 Safety
Version 11/2018, Rev. 1.9 of 01/12/2021
• sb
27 / 117
Translation of the original operating manuel
• 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
the material (stainless steel 1.4404 and 1.4435, borosilicate glass,
EPDM, PVDF, ceramic AI2O3 and PTFE) or decrease the mechanical
strength is prohibited.
• The system must be maintained at regular intervals (see chapter 8 -
• Any parts or components that are not in perfect working order must be
replaced without delay.
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