Q1 Scientific is a pioneer in the Irish industry and is a world leader in the provision of stability storage for the Pharmaceutical, Medical Device and Life Science industries. As a trusted stability storage supplier, there are a number of safety factors which must be considered within each stability room. Chief among these is the consideration of the alarmed monitoring system that will be used within each room. This system is critical to ensure each room is maintaining the temperature and humidity conditions it is set to, as this system will alert personnel to any deviations from the room set point.
Due to the recent building of new stability rooms, Q1 Scientific recently introduced a new monitoring system, with the steps involved to do so outlined below.
When choosing which type of monitoring system to select, there are a number of factors to consider, as various monitoring systems can differ dramatically. Some important factors to consider are detailed below.
One of the first considerations should be regarding the monitoring device type, as this is the heart of the system. The device connects to the probe to measure and record temperature and humidity. The device may be a standalone monitoring device; a networked/LAN device, or a wireless device with a base station or gateway. All of these options may have local memory also, to store measured data. All three options are worthy of consideration, and are specific to the individuals requirements. Consideration should be given to the area the device will be monitoring data in, as this may affect signal strength for example with a wireless device, or may make it difficult to wire a device.
Thought should also be given to the type of data storage required. All monitoring devices will include immediate data reporting, however most also have the capacity to record data for historical purposes. The location and amount of memory determine how much historical data will be available. There are generally four types of memory storage:
- Internal memory
- Local base station or gateway
- Local PC
- Cloud-based service
The type chosen will depend on how readily available you require monitoring data. With an internal memory and a local PC system, data is only available once downloaded manually, while a cloud-based or local base station/gateway may be more readily available.
Software type should also be strongly assessed, as this will allow for retrieval of data, and will determine what you can do with data. Oftentimes the type of monitoring system you choose will determine the software type, as these are frequently interlinked. Many systems now offer web-based software, which require a standard browser to operate, removing the need to install software on PCs. The features available should be evaluated based on your company needs. Features such as alarm management, system configuration, data retrieval and data charting should all be considered.
In order to ensure immediate notification of temperature excursions, alarming is essential. Alarms may be local; requiring users to be in the vicinity of the alarm, or remote; allowing notification no matter where the user is. Alarms can be delivered in a number of methods, including audible room alarms, emails, SMS and phone calls. The type of alarm chosen will typically depend on how critical the product being monitored is. Audible/visible alarms may suffice if a user will always be in a position to be alerted to the alarm. Email and SMS alerts will not depend on this, but may be missed if the system does not require confirmation of alert. Phone calls may be most useful if monitoring is critical, as many systems will have a list of users which will be run through until a user answers and acknowledges the alarm, preventing it being missed.
Once the above have been taken into consideration, and the appropriate system chosen for your company’s needs, the system will need to be formally introduced. The first step will be to ensure the manufacturer is aware of your company’s system requirements, and can meet these requirements. A User Requirement Specification (URS) should be completed, taking into consideration the various needs of each company department, and signed by the manufacturer, prior to system purchase.
The compliance of the system should be assessed, as 21 CFR Part 11 compliance is essential in the pharmaceutical industry. The GAMP rating of the system will also need to be evaluated, as this will affect validation requirements.
Once this is complete, the system can be ordered and introduced through the quality system, to ensure no vital steps are missed. A risk assessment may also be completed at this point, addressing any potential issues which could occur with introduction.
There are many actions that should be considered with installation. These include ensuring documentation is supplied from the supplier on the use of the alarm system, ensuring calibration is complete on the individual loggers prior to use, and completion of an IQ/OQ on the system. Procedures should also be in place detailing the use of the system.
Once the system is implemented by an approved contractor, a regular schedule of maintenance should be completed on the system. This can include annual calibration, annual system validation such as a process verification of the system, and a schedule of data logger battery changes, if applicable. All systems should be continually assessed to ensure they are operating to the required industry standards.