General Safety Notes
Organizational Issues
The enterprise (i.e. the responsible authorities) shall ensure that the required
(legal issues, staff & working place)
conditions appropriate for the process are provided:
1. The personnel shall be qualified for the process, for which the bioreactor is applied,
they shall know the hazards possible, and carefully familiarize themselves with the
handling of all equipment, which is associated with the bioreactor.
BIOHAZARD
2. The access to the work place must be restricted for persons not authorized to
work with the bioreactor. If the process can cause hazards, e.g. resulting from
the culture or media, the work place shall be marked by appropriate safety labels,
such as “BIOHAZARD”, and be isolated by appropriate barriers.
[refer e.g., to
“Legal regulations on
biological safety”]
3. The work place shall be suitable for the process, i.e. be resistant against acids,
alkaline solutions or the media. In the case of contamination, e.g. by the culture,
it shall easily be possible to decontaminate, disinfect and clean the work place.
4. The enterprise (i.e. the responsible authorities) must issue safety regulations about
hazards which can occur in the process at the work place for the staff and work
environment. Required safety facilities have to be provided.
5. In general, the staff shall wear suitable working clothes and personal protective
equipments (e.g. gloves, safety goggles as well as respiratory protection, if
required).
Installation at the working place
The working place and the utility supplies shall fullfill the requirements according
to the specifications of the bioreactor.
2. Provide that the laboratory mains and the supplies of gasses fulfil the specifica-
tions of the bioreactor.
3. Only use equipment and peripheral devices which Sartorius Stedim Systems
has released for the BIOSTAT
®
CultiBag RM 600.
4. Tighten all connections of the laboratory, of the CultiBag RM 600 and the
peripheral devices especially carefully. Test for leaks and unintentional release.
5. Ensure that all equipment and the peripheral devices of the bioreactor are in good
condition. This is especially true for the CultiBag RM 600. Do not use damaged
parts (even if damages are only suspected).
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General Safety Notes