Microprocessor-controlled rotary sealer for medical packaging
The sterilization of medical instruments begins with the packaging. That is to saythat the packaging, and therefore also the validation of the packaging process, is crucial for guaranteeing sterility up to the point of use and for meeting quality standards.
The ISO 11607 standard demands explicitly reproducible processes in order to achieve optimum and constant results at all times during Operation Qualification. The critical process parameters must be monitored continuously. If there is any deviation, the device must immediately switch itself off and indicate what the problem s. The sealing of a sterile package is only possible with a sealing device, which can be validated in accordance with ISO 11607.
The hm 850 DC is the ideal sealer for the packaging of sterile goods in clinics and laboratories, satisfying the highest quality and safety standards.
- Microprocessor-controlled printing unit
- Suitable for sterile packaging* in accordance with ISO 11607/EN 868 and Tyvek
Validatable process in accordance with ISO 11607
- Installation Qualification: Continuous monitoring of the temperature, contact pressure and dwell speed parameters defined during Installation Qualification.
- Operation Qualification: Automatic cut-out in event of deviation fromdefined parameter settings during Operation Qualification.
- Performance Qualification: Direct connection to the seal check device ht 150 SCD for Performance Qualification
- Process Documentation: Possibility of mobile monitoring of the sealing parameters through a pocket PC and the hawo software hs 160 PTGo
- Seal Check function: Print-out of the sealing parameters on the back of the packet
Microprocessor-controlled printing unit
- Automatically updated sterilization and use by date
- Batch number
- Personnel number
- Symbols as per EN 980
- CE mark with subsequent text
- Text memory
- Print start from edge adjustable in mm
- Print image can be rotated 180° (inverted)
- Variable font width and character spacing
- Ribbon replacement from the front
- Internal printer can be switched off
Functions
- Menu-based operation via digital LCD display
- Programmable in several languages: standard texts in German, English, French, Italian and Spanish
- Batch counter can be reset
- Elapsed hour meter
- Clock and calendar function
- Data storage and date updates even when device is switched off
- Stand-by function: the device goes into energy-saving stand-by mode after a predefined time (10 - 120 min)
