Wireless Sensors in a GMP Environment

Wireless Sensors in a GMP Environment

I am often asked about wireless sensors in a GMP environment and their application. They are a very attractive option for retrofitting an existing facility because they are easy to install, tailor to the requirements, affordable and don’t require expensive cabling or wall penetrations. The following details will help you determine your requirements in this emerging area.

What’s available?

There is a vast amount of data we collect from our facilities these days and an ever-increasing range of devices to collect and transmit this data. Retrofitting hard wired devices is expensive and disruptive, however many suppliers have instruments that can be interfaced into a wireless sensor network.

What to look for

There are a number of things to look for when investigating implementing a wireless sensor network within your GMP facility.

From a hardware perspective, you should consider the following:

Pros and cons of wireless sensors

From a software perspective, you should ensure the software supplied with the sensors is 21 CFR Part 11 and/or Annex 11 compliant. If it is not, some manufacturers offer gateways (e.g. MODBUS gateway) to make the data available to a compliant SCADA system.

The following pros and cons should be considered when selecting wireless sensors for your facility.

Risk Assessment

A detailed risk assessment should form part of any GMP system installation, however there are a few extra things to consider with a wireless system, such as:

  1. How secure is the system? Any data that travels via wireless has the ability to be intercepted. It could be worth consulting with the IT department because if wireless is already in use, they may have already performed a detailed risk assessment on the use of wireless within the facility. There may be many reasons why some companies or departments see wireless as too big of a risk.
  2. What will happen to the data if the signal drops out? Obviously the risk of data loss exists even with traditional wired sensors however the likelihood of this occurring with wireless could be higher. You will need to consider if the data affects product quality and how release will be effected if there is a data failure. Keep in mind that data corruption is highly unlikely, for example a 22.4°C signal will not become 32.4°C, rather you will just be left with a gap in your data. This is where on-board memory and self-healing of failed links could benefit.
  3. How will changes in the facility impact the wireless signals? When new equipment is added within your facility, you may need to revalidate the wireless signals in the area to confirm that the new equipment isn’t causing interference.

Validation considerations Making up your mind

Compared to traditional wired sensors, there are a number of extra validation considerations to address. Depending on the results of your risk analysis, these could include:

Making up your mind

Wireless is a great option for retrofitting existing and new facilities, however it also comes with greater levels of risk assessment, validation and scheduled maintenance.

As wireless sensor technology and features increase and prices continues to decrease, there will likely be expanding acceptance of wireless sensor in GMP facilities.

The FDA has developed a guidance document on Radio Frequency Wireless Technology in Medical Devices which, although related to Medical Devices, has some excellent general information on wireless systems and technology for all regulated environments.