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.