Pharmaceutical

Stringent standards must be adhered to in the manufacture, storage and distribution of pharmaceutical products. Good Automated Manufacturing Practice (GAMP) guidelines set down the main requirements that need to be considered. The US has led the way in developing its own interpretation of these guidelines as the world’s largest market for pharmaceutical products. Satisfying the Food & Drug Administration’s  (FDA’s) requirements set out in 21 CFR Part 11 is essential for companies wishing to prove their products have been safely produced. HH Solutions offers the very latest and a comprehesnive range of products specifically designed to meet the needs of the pharmaceutical industry.

The conditions under which pharmaceutical products are manufactured and stored can have a major impact on their quality; temperature and humidity are perhaps the two most critical. Collecting these records electronically requires a focus on security, relating particularly to the prevention of data tampering. Monitoring Systems must provide the ability to identify specific individuals and events to meet the requirements of 21 CFR Part 11.

The RF500 Wireless Monitoring System meets these requirements with features including;

• Access restricted to authorised individuals using Password protection.
• Audit trail facility containing details of time and date for every record created.
• The highest standards of data integrity protecting against unwanted loss of recorded data.
• Digital signatures to show the dat has only been accessed by authorised persons.

PRODUCT HIGHLIGHT

RF500
The RF500 System Transmitters allow for constant 24/7 wireless monitoring of a range of environments, including fridges, freezers & incubators where highly sensitive products are stored & tested, with the data transmitted back to a central ‘Gateway’ unit. For those working in laboratories where highly valuable samples or irreplaceable trial materials are stored, traceability is assured and legislative requirements are met with a network of alarms set to detect for any ‘out-of-range’ incidents that could damage stock.

By incorporating an RF512 transmitter, it is possible to measure and monitor blood core temperatures using a special duplex probe inserted into a blood bag containing a glycerol solution, then positioning it amongst the stored blood. Because each channel of the
RF512 transmitter can be programmed with different alarm temperatures and different alarm delays, simultaneous monitoring of the air temperature of the fridge/freezer can also be achieved. It is possible to dictate a short time delay for the fridge temperature and
have a zero time delay for alarm notification from the blood core sensor, thereby aiding compliance with MHRA and CFR 21 Part II guidelines* This is not a system for critical care as a first line of alarms. *Please check recommendations for your particular application.

To arrange a site survey and discussion of how the RF500 Wireless Monitoring System can meet your needs, please call our office on +353 (0)61 603742 or email us.