Calibration PROTEC heat sealers
With reference to ISO 11607-2 an Installation Qualification (IQ) needs to be performed. In this phase prove needs to be obtained and documented that the sealer has been properly installed and that the users have been trained how to use the heat sealing machine.
The sealing process is being defined on the following critical parameters: the temperature, speed and force. These factors each play an important part in ensuring a correct seal. These critical parameters need to be calibrated which is being done before each PROTEC sealer leaves our premises after manufacturing and a calibration report can be provided.
|Temperature||Calibration at two different temperatures.
Calibration range of 1% of the set temperature
|Speed||Calibration range set speed ± 5%|
|Pressure||Calibration range set pressure ± 5 Newton|
According ISO 11607-2 the critical parameters need to be routinely controlled and monitored. Alarms, warning systems and machine stops shall be challenged in the event that critical process parameters exceed predetermined limits.
The PROTEC models F108TX-P/USB, F110DEP-P/USB, F110DBC-P/USB, F220DEP-P/USB and F220DBC-P/USB are equipped with parameter control. This is the constant monitoring of the temperature, speed and pressure. These parameters are being checked with every single seal and in case one of these parameters is incorrect, the machine will give the operator a warning and it will stop sealing. This makes the sealer models with parameter control ISO 11607-2 compliant.
If the calibrated components are correct it can be concluded that the reprocessability of the seal is correct. It has to be pointed out that calibration does not say anything about the quality of the sealing seam. For this purpose a seal strength test needs to be carried out.
More information on this can be found under Service / Validation Seal Process.