The integration of RFID technology with a compliant database can, for example, simplify basic laboratory cGMP. In particular,
the use of RFID allows real-time environmental monitoring of laboratory temperature and humidity. As many laboratory air conditioning
systems are based on simple volume displacement calculations, variation in environmental conditions is inevitable; the use
of RFID technology allows the environmental conditions experienced by key laboratory assets to be tracked and extended to
critical temperature monitoring and alarm systems. FDA CFR Part 58, Subpart D stipulates the requirement for maintaining a
controlled environment for equipment operating in a GLP/GMP setting. Documenting that the environment is suitable for a particular
instrument should be included as part of the IQ and an RFID-based monitoring system provides an effective way to prove the
environmental conditions are suitable should they be challenged during an FDA inspection.
The authors say…
Small, low-cost RFID tags are attached to analytical laboratory instrumentation, including the different components of a single
instrument stack (e.g., HPLC system/LC/MS system). Rather than passive tags, active tags are used that send RF signals every
few seconds to a small receiver that collects information from multiple instruments. The receiver in turn communicates with
PCbased software through the laboratory's network infrastructure. Crucially, for GLP/GMP regulated laboratories, a real-time
RFID system can provide global or multi-location inventory tracking of all laboratory instrumentation. It is also capable
of tracking movement or removal of components that would void the system qualification. Without proper control and re-qualification
of a HPLC system, for example, an unwanted compliance risk is presented. Instrument qualification becomes void following a
breakdown, or replacement of component parts, such as exchanging a module (e.g., a detector or pump).
RFID systems ensure inventory lists are always accurate and uptodate. Asset attributes such as physical location, contractual
information, maintenance schedules and IQ/OQ/PQ compliance documents can be stored in a single database, enabling complete
asset lifecycle management. For certain laboratories, where crosscontamination presents an issue, there are strict requirements
for segregation of tools, instruments, clothing and equipment. RFID tagging can be used to automate and actively manage this
Further, the benefit of adopting an RFID-based asset management system to aid regulatory body inspections includes proactive
response to audits through accurate, on-demand inventory reports. It is also possible to automate regulatory compliance efforts
through the use of alerts for asset location changes. Preventative maintenance can be effectively carried out through rapid
location of assets requiring periodical servicing to ensure instruments are qualified at the correct time intervals.
The ongoing cost of maintaining an asset management and document tracking system, as well as the cost of periodic asset inventory
checking, should be taken into account when considering investment in an RFID asset management system. Barcode and ERP systems
do not allow realtime monitoring and require inventory recounts to ensure assets have not been moved or removed from a designated
area. This, however, is not required when integrating an RFID asset management system into an analytical testing laboratory,
thus saving time and cost. Further, the number of systems or components that are 'lost' within a facility is reduced and lease
penalties can be avoided via alerts that identify instruments approaching lease expiration.
RFID provides a tool for real-time, two-way data communication and can close information gaps in asset management for pharmaceutical
manufacturing supply chain, analytical testing laboratories and hospitals.4 The technology provides details of asset location and it can monitor critical information pertaining to each asset; as such,
RFID is fast becoming an integral part of everyday life. Its application within the pharmaceutical industry is becoming more
widespread for use in control of personnel access to research facilities, through to providing accurate monitoring of laboratory
instrumentation and ultimately to delivering genuine, safe therapeutic products to patients.
Ralph M. Dioguardi is Global Business Leader, OneSource Services (Laboratory Relocation, Qualification and RFID), PerkinElmer Inc.
Paul Smith is European Validation Program Manager, PerkinElmer Inc.
1. RFID Journal LIVE! 14–16 April 2010, Orlando, Florida, USA.
2. K. Finkenzeller, RFID – Handbook, Second Edition (Wiley & Sons, Ltd., USA, April 2003).
3. R.E. Spekman and P.J. Sweeney II, Int. J. Phys. Dist. Log. Man., 36(10), 736–754 (2006).
4. A. McDonough, Cath Lab Digest, 16, October 2008.