With a thorough understanding of temperature regulations and guidelines within the healthcare, clinical research, laboratory and pharmaceutical sectors, combined with an advanced range of premium temperature measurement products, HH Solutions can advise and help relevant organisations achieve compliance and safeguard reputations.
HH Solutions is the authorised distributor of Comark Precision Instruments; as leading manufacturer in the field.
Companies and organisations operating within these sectors habitually apply due diligence methods to aid traceability and maintain temperature/humidity records. As monitoring technology has become more sophisticated, regulators are requiring more comprehensive temperature monitoring and reporting methods.
The MHRA for example, requires continuous temperature monitoring right across the cold chain - from manufacture and storage right through to transportation. Applied effectively, this not only provides evidence that stringent safety and quality standards are being maintained, it also helps to ensure hard won reputations are protected.
Many organisations already specify Comark Instruments to ensure that all relevant standards continue to be met.
Laboratories common requirements are monitoring and maintaining accurate records of the operating temperatures of key equipment such as fridges, freezers, incubators and water baths, or monitoring the ambient temperature in sensitive work areas. With many healthcare and pharmaceutical companies becoming increasingly global organisations, it is more important than ever to have safeguards in place to protect temperature sensitive medicines. The industry is highly regulated and costly and sensitive products could be in danger if optimum storage temperature and humidity levels are not maintained - and there’s the added risk of product recalls and loss of reputation.
The RF500 System allows constant 24/7 wireless monitoring of a range of environments, including fridges/ freezers where highly sensitive products are stored, 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 of the 2 channels 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.