The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) and the Food and Drug Administration (FDA) of the United States of America (USA) are the regulatory authorities with responsibility in their respective countries. They work closely with each other to maintain compliance of Biotec & Pharma (B&P) organisations.
B&P’s must guarantee that their products have been maintained in strictly controlled environments. This often requires a significant expense in the implementation and overhead for advanced environmental monitoring systems. VIGIL+ is designed to provide affordable wireless environmental monitoring but with industry leading technology.
VIGIL+ provides secure realtime dashboards for users to check their medicines are kept within the compliance regulated levels. If the environment nears the danger level alerts are sent in real-time to key staff 24/7. VIGIL+ dashboards lets users see, at a glance, all their sensor readings and manage any changes via the intuitive dashboard on any internet enabled device.
Biotechnology and pharmaceutical companies both produce medicines, but the medicines made by biotechnology companies are derived from living organisms while those made by pharmaceutical companies generally have a chemical basis. Both share the requirement to store drugs in secure refrigerators for regulatory compliance.
Because VIGIL+ sensor readings are held in perpetuity means users can prove, via audit trail, that they have complied in accordance with the MHRA and FDA regulations. VIGIL+ autogenerates weekly and monthly reports and sends these to end users via email for handy review. Anything more longer term, for example; quarterly, annual, multi-annual or seasonal can be created via VIGIL+’s intuitive search engine within the ‘On Demand Report’ function.
In short VIGIL+ makes interpreting data meaningful, intuitive and incredibly easy to access.
B&P’s have many reasons to monitor the environment. VIGIL+ has a wide variety of sensors available. However there are some common areas they share.
Temperature is the most obvious condition to monitor, if the temperature rises without warning there is a problem and steps need to be taken to remedy the situation. Temperature creep is also important to know. As time goes by fridges and freezers can become less efficient, by spotting the inefficiency before it becomes a problem means preventative maintenance programs can be easily implemented.
Many medicines need to be refrigerated and loss of power can be catastrophic. Causes of loss of power are typically ripped circuit breakers, blown fuses, wiring issues, or faulty storage room control boards. A/C (Alternating Current) meters measure power consumption and this is a clear indicator to ensure everything is working fine. If the motor of the refrigeration unit is constantly running, this could indicate a refrigerant leak or another leak elsewhere that is allowing cold air to escape.
Leaking water or ice buildup indicates an underlying problem with the coolant inlet which will require professional maintenance to fix. Medicines should be destroyed if water contamination occurs.
Activity detection sensors are ideal to detect movement. Once an established a pattern of behaviour is identified, it is easy to be alerted if unexpected movement is detected. By monitoring when areas are entered and doors opened all helps prove that compliance is met.
Perimeter beams and door/window open/closed sensors are ideal for making sure no unauthorised access is made within an area.
Spook has designed a service called TRIG to monitor items in transit or at temporary static locations such as pop-up healthcare clinics.
Please contact us if you wish for further information on how Spook can help with your environmental and power monitoring needs.Contact us