Validating of seal devices
Validating of seal machines the topic validating controls already for
a long time medical congresses and fairs. By right, because due to
clearly risen quality requirements must concern themselves in the
future also world-wide each manufacturer of medicine products, each
hospital as well as the medical industry comprehensively with this
aspect of the quality management. In order to become fair these
requirements also with the seal process, developed hawo a compact
testing set, which gives the possibility of a consistent professional
validating to the user in accordance with the requirements of the EN
868-5. But which that is called actually ' validating of seal machines
'? The term is defined as follows in the standard ISO 9000:2000 (ISO
8402 replaces): Confirmation by investigation and supply of an
objective proof that the special requirements for a special intended
application purpose are fulfilled.Installation Qualification - first the critical parameters, which are
decisive for the quality of the seal seam, must be identified. These
are defined as follows with a seal machine: Seal temperature, contact
pressure and seal time (or flow velocity). The attitude of these
parameters depends to a large extent on the material which can be
sealed. The careful analysis of the material specifications e.g.
condition, thickness, side fold or is not of largest importance for
the correct attitude of the seal parameters by the user. Thus they are
responsible for the guarantee of a perfect seal seam. Operation
Qualification - actual validating of the seal equipment demands then
the proof that the parameters of the correct attitude follow. That is,
that the produced seal seam corresponds to the defaults of the EN
868-5 after each seal procedure.In accordance with this standard the firmness of the heat-sealing seam
before and after the sterilization must be 1,5N for each 15mm strip
width foil at least. An independent monitor must prove that the
special requirements are reached to a seal seam. This happens with
seal machines with the test on a tensile strength test equipment
(Tensile Strength test) in accordance with EN 868-5. Process
Qualification - ht with the new hawo seal seam test equipment 150 SCD
can such measurements simply and at each place be accomplished - was
produced independently of the kind and the function of the equipment
with that the seal seam. A test with this equipment makes a clear
statement about the breaking stress for the seal seam possible and
excludes thereby a subjective interpretation. In accordance with the
guidelines the EN 868-5 is cut off a 15mm of broad teststreifen. The
free ends of the low-cut sample are clamped into a clamping device.The equipment pulls apart then the seal seam sample with a fixed
stopped speed of accurately 200 mm/min, whereby the necessary traction
power is measured. The value resulting from it permits the comparison
with the firmness of at least 1,5N, demanded after EN 868-5, to the
user. According to the ISO 9000:2000 the evaluated result of
measurement is the supply of an objective proof whether the seal
equipment planned for the special application purpose of a
heat-sealing seam fulfills the special requirements. With
Nichterreichen of the demanded seal seam firmness the seal equipment
must be examined immediately. Process control - the documentation of
the relevant results of measurement can take place comfortably by
means of external printer. When connecting the equipment to a PC the
measuring curve is provided during the measuring procedure. The
determined data can be stored and served continuous process control.The equipment makes thus regular validating of its seal machines for
each user possible. The determined measuring data can be imprinted
then together with the seal parameters and the unit number directly on
the packing produced for the examination. The seal sample thus clearly
the seal equipment assigned hawo places to the user with the new seal
seam testing set ht 150 SCD a system for validating from seal machines
to the order, which can be handled simply, because finally the user is
responsible for safe packing of the sterile property.