ABB RVG200 Operating Manual

Data recording in pharmaceutical processes

Improve your process monitoring effectiveness using ABB’s RVG200 data recorder

A complete view of your pharmaceutical process data at your fingertips

Introduction

ABB’s RVG200 next generation paperless data recorder offers a host of additional features and functions, making it ideal for data recording in pharmaceutical manufacturing applications.

How can the RVG200 help?

Touchscreen technology for easy operation

Featuring touchscreen technology, the RVG200 makes it easier than ever to find the data you need. Intuitive icon-based menus and a ‘swipeable’ interface enable data to be quickly located and viewed in a variety of formats, including individual or grouped data in chart, bar graph or digital indicator displays.

Extensive security for optimum data protection

The RVG200 features a comprehensive range of security measures which enable it to comply with the Food and Drug Administration’s (FDA) stringent 21 CFR Part 11 criteria for acceptance of electronic process records. These measures include encrypted data files, multi-user password protection and automatic audit trail generation.

With the RVG200, you also have the option of a specific validation template, which helps to simplify the process of satisfying the overall installation and operation requirements of 21 CFR Part 11.

Audit log for maximum traceability

The RVG200’s audit log gives you a complete history of your process. The log automatically stores details of all

process events together with details of time, date and, where applicable, the details of any configuration or calibration changes, together with details of who made them.

When viewed alongside process data, the audit log provides comprehensive evidence of the validity of the process data and the recorder on which is was created.

F0 calculation for enhanced sterilisation efficiency

When compared to a basic time based system, the cycle time of a sterilisation process can be substantially reduced by the use of F0 calculation. By accounting for the time a process spends below and above the specified sterilising temperature, F0 calculation can improve efficiency whilst guaranteeing sterilisation effectiveness. An increase in the sterilisation temperature of just one degree from 121ºC to 122ºC, for example, can reduce the time needed to kill bacteria by 26%.

The use of the RVG200’s F0 calculation during a sterilisation cycle will take into account the heating and cooling phases, benefitting almost all sterilisation processes.

Batch recording for fast and detailed batch data

The RVG200’s batch recording option provides a simple means of recording when a particular batch is started or finished.

This data can be reviewed using ABB’s DataManagerPro analysis software. Providing a quick and simple way of retrieving batch data, DataManagerPro lets you retrieve data by entering the batch number, searching by type or product or by specifying the time and date of processing.

Barcode scanner for fast and accurate batch information entry

With the RVG200, you now have the option of connecting a barcode scanner into the device’s front or rear USB, providing a fast and more accurate alternative to manually keying in batch information.

Batch information can be scanned directly from product paperwork, eliminating the scope for human error.

Find out more

For more information about the benefits of using the RVG200 in your heat treatment process, please contact your local ABB sales representative or visit www.abb.com/recorders.

ABB Limited

Howard Road

St. Neots

Cambridgeshire PE19 8EU

UK

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Pharmaceutical xxxx 2013