Traceability of the sterilisation process
In order to officially clear instruments and devices for use in the medical field after sterilisation, complete documentation of the release information is required. Our documentation module uses an integrated batch printer and state-of-the-art software from SegoSoft. This module greatly simplifies manual batch documentation and guarantees the complete traceability of all sterilisation processes.
Our documentation modules can be connected to your VARIOKLAV autoclave via an RS 232 or USB interface. You can still adjust the pressure and temperature sensors of the batch printers individually even after they have been installed. Normal paper is used for the printouts and can be stored for at least ten years.
GLP batch printer for GLP-compliant data logging of digital processes
Good Laboratory Practice (GLP for short) is a formal framework for conducting safety tests on certain substances or preparations, which is anchored in the Chemicals Act in Germany. Based on this, legislators require complete documentation of all digital process data, such as batch number, date, process steps (such as chamber temperatures, chamber pressure, possible alarm messages, filter count, etc.). This makes our GLP batch printers ideal for properly carrying out all routine procedures in safety level 2 laboratories.
IMS GMP batch printer for GMP-compliant data recording by an independent measuring system
For routine tasks in the laboratory, a GLP-compliant batch printer may be sufficient, but the sterilisation of class 3 waste, pharmaceutical production or the manufacture of medical devices pose special requirements for the documentation modules used.
As with our GLP batch printer, the IMS GMP batch printer module seamlessly documents all relevant process data of sterilisations performed: batch number, date and process steps from the beginning of sterilisation to the end are precisely recorded. Temperature and pressure data from control-independent reference sensors that have been calibrated according to ISO 9000 are also recorded here and shown in the display. As a result, IMS GMP batch printers are also suitable for the most demanding laboratory work and professional autoclaving in protection class 3.