6
Conditions of use
CELLROLL is a modular and expandable roller system for cell cul-
tivation and preparation of cell products in roller bottles. It is suit-
able for use with adherent cells and cell suspensions. The instru-
ment is not designed for any other applications and should there-
fore not be used for such.
CELLSP N is a spinning system comprising four stirring units for
the gentle cultivation of cells and the preparation of cell products in
spinning vessels. It is suitable for use with cell suspensions and immo-
bilised adherent cells (e.g. microcarriers/alginate inclusion). The instru-
ment is not designed for any other applications and should there-
fore not be used for such.
Dangers involved when safety precautions are not
observed
CELLROLL/CELLSPIN are state-of-the-art instruments with respect
to current technology and are safe to use. Some danger may exist
if the instruments are used by untrained personnel. Any person given
the task of operating CELLROLL/CELLSPIN must first read the oper-
ating and safety instructions and understand them fully or be thor-
oughly trained by a superior in the use of the instruments before
operating the instrument.
Safety at work
Independent of any safety precautions listed here, all other relevant
safety aspects - e.g. GLP, GMP, professional trade associations,
Department of Health, trade supervisory authorities - must be
observed.
Qualification of operating personnel
Normally, a technical qualification is required. Specialist knowledge
is required when using CELLROLL/CELLSPIN if all danger is to be
avoided.
Personnel without formal technical qualifications do not as a rule
possess such specialised information and should therefore only be
allowed to operate CELLROLL/CELLSPIN if properly trained and
under the supervision of suitably qualified personnel.
Safety aspects for the user company
The supervisors of operating personnel must have read and under-
stood all the safety precautions involved and must ensure that these
are adhered to. They must also ensure that operating personnel also
understand and observe all safety rules.
Prior to operating CELLROLL/CELLSPIN, the supervisor must ensure
that no other dangers exist, especially if other instruments and sys-
tems are also being used.
If necessary, additional safety instructions must be compiled by the
supervisor. The user company must, if necessary, in order to exclude
all possible danger, compile explicit safety instructions and have these
signed by the staff responsible. In addition, clear competences must
be established as to who is responsible for the operation of CELL-
ROLL/CELLSPIN so that these potential dangers can be reduced
to an absolute minimum.
