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Environmental Quality Corner with Ken Appel

FDA Compliance

Comparing Pharmaceutical Continuous Monitoring Systems: Part 1

Looking at compliance, risk, and cost for stand-alone, wired, and wireless systems

Published: Monday, November 15, 2010 - 06:00

Ken Appel is the manager of regulated industries for Veriteq.


he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help regulators be more efficient with their resources, but they also will require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on its quality systems. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Now is the time to revisit cost-vs.-benefit analyses for continuous monitoring systems (e.g., wired or wireless networks, and standalone monitoring instruments) that facilitate proof of regulatory compliance.

Moreover, the ever-increasing costs for active pharmaceutical ingredients (APIs) and the research and development efforts to create them mean that the economic effect of monitoring-system failure is greater than ever before. All monitoring methods, whether wired, wireless, or standalone, should be scrutinized for systemic weaknesses that allow human error to compromise product quality, system-failure probabilities, and overall costs of ownership.

Quality, facility, and information technology (IT) managers employ different methods for maintaining the quality of products and information. This two-part article evaluates six different temperature- and humidity-monitoring methods, and presents the risks and costs of ownership for each. Monitoring in pharmaceutical environments such as freezers, stability rooms, and warehouses can include:

1. Chart recorders
2. Non-networked or standalone data loggers
3. Wired systems with uninterruptible power supply (UPS) power backups
4. Wired systems with UPS power backups and power over Ethernet (POE) connections
5. Wireless WiFi
6. Wireless mesh


Paper-based chart recorders, powered either by AC power or batteries, are the oldest technology. Standalone non-networked data loggers also use either AC or batteries, and require manual downloading of data at regular intervals.

Wired networking technology has been around for decades. Although this technology continues to evolve and remains the mainstay of most pharmaceutical operations, wireless is fast becoming an interesting alternative.

Each method of communicating data has its advantages and disadvantages. When it comes to regulatory-compliant applications involving public health, however, the criteria for using one method over the other should be well understood. The following two charts provide an overview of risk factors and cost-of-ownership differences between the continuous monitoring systems.

Figure 1: General guidelines to risks associated with meeting GMP requirements


Figure 2: General guidelines for some of the more salient factors affecting costs of ownership related to the six monitoring options. Varying plant sizes and scale of operations affect the impacts of various cost factors.

Paper-based chart recorders

During the last decade, nearly every leading pharmaceutical company that had relied on paper-chart recorders either replaced them with a network-based system or is in the thinking stages of doing so. Chart recorders can still be found in the marketplace that cost as little as a few hundred dollars. Most pharmaceutical quality managers consider this technology to be obsolete due to the considerable costs of maintaining chart recorder-based monitoring systems and the obvious risks of handling paper-based records with limited or no alarm notification. Costly staff hours must be devoted to tracking which charts must be changed when, and which batteries need to be changed in what intervals. AC power-based chart recorders without batteries offer no ability for continuous data records in the event of power outages.

Auditors are aware that chart recorders rely on humans for daily or weekly checks to replace paper, check pens, and write deviation reports. The possibilities for human error are multifold. Although to date there have been no known instances of regulators rejecting chart recorder-based monitoring systems, these agencies do encourage moving away from manually-intensive processes toward more automation to tighten up quality systems and make better use of resources.

Data loggers

Unlike paper chart recorders, standalone data loggers are not as likely to break. They do, however, incur considerable labor costs for manually downloading data, especially in large plants where hundreds of data loggers are required to ensure environmental standards in both processing and storage areas. These costs are magnified in the current environment where inspection-readiness can be an issue—keep in mind the FDA's 15-day period for responding to observational deficiencies. Operational costs for complying with regulators' requests for information, and the interference with normal operations that audits can involve, can be considerable. As with chart recorders, the capability to access accurate and complete records throughout the record-retention period as required by FDA 21 CFR Part 11 and EU GMP Annex 11 may be compromised if it takes too long to the locate records or they are incomplete.

There are also multiple human-error sources with systems based on standalone data-loggers. First, staff may neglect to download data before the instrument's storage capacity is exceeded. Second, battery-powered standalone data logger systems also require ongoing monitoring of batteries, which creates an opening for lost data. Third, AC-powered data loggers without batteries may not provide gap-free records in the event of power outages.

If one considers technological investments as ways to automate routine tasks to eliminate the costs of labor and potential human error, then standalone data loggers do not generally pass muster. Relying on human labor to download data, investigate overlooked deviations, and maintain these files opens the door to regulatory objections and the staggering costs that ensue with production delays. With the exception of monitoring the contents of a few chambers, standalone recorders put undue risk on companies more than automated monitoring methods.

Wired networks with or without POE capabilities

The pharmaceutical industry, like many others, has long relied on a wired infrastructure using Ethernet standards for making the connection to transmit and receive data. A hard-wired network allows communications to proceed securely and continuously with few possibilities to intercept or interrupt the flow of data.

UPSs ensure that servers are always available for data exchange. However, a potential problem with data continuity could arise with a power outage to the facility. The UPS maintains server and perhaps portions of the network's uptime, but devices connected to the network may be without power, which could mean loss of critical data. Until recently, traditional wired networks lacked a cost-effective alternative to maintain data.

Power over Ethernet, originally implemented for voice over internet technology, allows electrical power and data to travel on the same Ethernet cable. Since 2003, companies have been integrating data and power standards on the manufacturing floor with POE-capable devices (IEEE 802.af). The advantages of deploying a POE network are many:

• It saves the cost of running additional AC power, which usually requires a licensed electrician, aided by the low cost of network switches with built-in POE power capability.
• It provides greater flexibility to locate devices around the plant because they can be installed wherever a LAN cable can be run.
• It increases data protection from power outages because the server's UPS provides backup to POE-connected devices.
• It uses less energy and can be managed from a central location.
• It protects critical data throughout an outage period. Security, maintenance, and access can all be managed within an existing IT framework because staff is trained on setting up and maintaining communications networks based on worldwide standards.


In part two of this series, we will examine wireless networks and how each continuous-monitoring system contributes to overall costs of ownership, risks of quality systems failure, and the ability to respond to audits by regulators.


About The Author

Environmental Quality Corner with Ken Appel’s picture

Environmental Quality Corner with Ken Appel

Ken Appel, author of Quality Digest’s Environmental Quality Corner, is manager regulated markets for Veriteq, a Vaisala company. Veriteq provides environmental monitoring of temperature, humidity and other critical variables in controlled environments for regulated industries and other critical storage applications where product loss or audit failures are unacceptable.