Stringent Paperless Process Documentation for Media Preparation Labs
1 Aug 2012INTEGRA has announced that its MEDIACLAVE 10/30 media preparation systems have been upgraded to provide all the necessary tools to support the most stringent process documentation and validation needs.
More and more laboratories rely on electronic process documentation to avoid costs associated with paper use and excessive storage space requirements. However, laboratories must also ensure that their electronic process documentation comply with regulatory requirements. According to FDA (21 CFR Part 11) and EU (GMP Annex 11) protocols, electronic process file must be verified with a digital signature.
New generation MEDIACLAVE 10/30 systems now provide the feature of digitally signed log files as a safeguard against tampering with downloaded files. The signed log files fully comply with FDA (21CFR Part 11) and EU (GMP Annex 11) directives requirements for electronic process documentation.
A newly integrated USB port on MEDIACLAVE 10/30 systems allows the automated transfer of all run data log files to a flash drive. Saving and managing process data has never been so easy. Furthermore, MEDIACLAVE 10/30 systems are equipped with Ethernet connection, allowing connection to a PC, LAN or easy integration with LIMS. As a consequence run log files can be easily and simply transferred and archived to a personal computer or data storage device of your choice.
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MEDIACLAVE 10 - Media sterilizer
INTEGRA BiosciencesMEDIACLAVE 10 – For fast, reliable and safe media preparation The MEDIACLAVE 10 allows the rapid and gentle sterilisation of 1-10 L culture medium. Precise control of process parameters during the sterilisation process guarantees media of constant high quality. The intuitive multilingual user interface and the simple programming make it very easy, even for untrained users, to operate the MEDIACLAVE 10. Media preparation by the MEDIACLAVE 10 is very easy. The culture medium can be dissolved directly within the instrument. Automatic self checks and several monitoring systems guarantee highest operational safety. The MEDIACLAVE 10 can be conveniently connected to the INTEGRA Biosciences MEDIAJET, allowing the automated dispensing of media into up to 540 Petri dishes at the touch of a button. Features and benefits: • Flow heater system for fast and gentle media preparation. • Powerful bidirectional stirrer to guarantee homogeneous media. • Controlled vessel deaeration for complete media sterilisation • Indication of service intervals to avoid unscheduled downtime. • TÜV certified for compliance to international safety standards. • Integrated web server for online documentation of the process. • Electronically signed log files according to FDA and EU guidelines.
