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Assuring Data Integrity in an Environmental Monitoring System

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FacilityPro® Processors

FacilityPro® Processors are the central hub for an environmental monitoring system. The Processors control sensors and other I/O, buffers data, and checks tolerances. FacilityPro Processors are available in three versions to support a range of applications. They provide the central hub for an environmental monitoring system. The Processors communicate with cleanroom sensors, including particle and microbial monitors, while buffering data and checking tolerances for alarm activation. As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software. FacilityPro Processors are available in three versions, with varying features to support a range of system designs and applications: FacilityPro 5000, FacilityPro 3000, and FacilityPro 1000. All three FacilityPro Processors are compatible with either the FacilityPro SCADA server software or the FacilityPro SMART server module. The FacilityPro 1000 Processor is also suitable for OEM applications, providing an integration path between Particle Measuring Systems sensors and third-party software platforms

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FacilityPro® Environmental Monitoring System

As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software.

Features

  • High reliability
  • Available in three versions: FacilityPro 5010, FacilityPro 3000 and FacilityPro 1000
  • Data integrity
  • Ultimate efficiency and error reduction
  • Simple implementation
  • Flexible integration

Benefits

  • Designed specifically for pharmaceutical environmental monitoring
  • Integration and control of viable and non-viable sampling
  • High data integrity
  • Ultimate efficiency and reduced error
  • Simple installation and validation
  • Flexible integration

Applications

Monitoring of critical environments, including:

  • Filling lines
  • Isolators and RABS
  • Blow-Fill-Seal
  • Lyophilizer processes and transfer carts
  • Biosafety cabinets and flow hoods
  • General cleanroom and facility monitoring

Supporting Materials

Application Notes & Brochures

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FAQs

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The trend is towards assuring the data security. Improved control over the Facility Monitoring System via a network in addition to strengthened data interpretation is becoming a central design focus. System architecture must evolve to protect against external tampering, a possibility even with the use of intranet. For example, one trend is the implementation of user-level login permissions that control the acquisition of data. Particle Measuring Systems products, especially those used in the Pharmaceutical market, are continuously evolving to meet these trends.Particle Measuring Systems has increased the risk mitigation of data acquisition and integrity, such as with the use of time stamps generated in the source sensors, and buffers at sensor and processor levels. To implement this approach while offering a reasonable price versus cost benefit to customers, Particle Measuring Systems developed its own processor in addition to storage and data management techniques. Mixing this approach with other commercial options would be expensive and impact reliability.The trend is a move towards a virtual world (including virtual machines) to have the advantage of faster installation and ease of support in combination with a well known technology with common standards for all computer systems in a cleanroom.There are two types of analog output typically used in a particle counter: current or voltage. Current is the most commonly used, because it can run a longer distance than voltage.There are two parameters to manage: Current Range:The industrial standard requires a current range from 4 mA to 20 mA so there is a range of 16 mA for signal transmission (i.e., 4 mA = 0 particles; 12 mA = 50 particles; 20 mA = 100 particles). Accuracy: This the minimum signal current the system is able to supply. It is linked to: Number of bits the analog/digital converter is capable of Distribution of the signal from the sensor to the acquisition board The combination of these two parameters needs to be set up in both the particle counter and in the system to satisfy regulations. Setup is difficult in, for example, a Class B with a 3,500 particle limit in setting the range with only 16 mA. This translates to 0.00457 mA per particle. To achieve such a specific value for each particle is difficult. Not being able to provide such resolution will result in significant errors in the readings.Due to the likelihood of error, Particle Measuring Systems suggests the avoidance of particle counters with analog output, and favors particle counters that transfer data via Ethenet or another method that provides proper resolution to the controlling software.Particle Measuring Systems designed its own Programmable Logic Controller (PLC) with three FacilityPro processor models: 5010, 3000 and 1000. Please refer to the specification sheet for comparison between models.Using the industrial automation architecture, even if using the PLC approach, increases the reliability of the system. Particle Measuring Systems technology in combination with the industrial automation design of Supervisory Control And Data Acquisition (SCADA) results in an increased mitigation of risk.The two worlds of PLC and DCS are converging due to the increasing power of industrial PCs. Typically, PLCs are used when a quick reply (in milliseconds) is required. DCS is best when the time to receive and manage data is not as critical, but where sophisticated management of large data quantities is required. The Particle Measuring Systems FacilityPro processor is closer in description to a DCS than a PLC. An environmental monitoring system should be an automated system. The instruments should be connected to an automated system that runs the same sampling procedures every time and gathers the results from those instruments. The data gathered needs to meet 21 CFR Part 11, in that it tracks any changes to the system as well as any operator interactions. If you use a non-automated system, such as recording the values manually, there is the possibility of changes to data or sampling routines that might go untracked. Data integrity is not maintained in this circumstance.FacilityPro can communicate with third party systems such as Siemens or Allen Bradley PLCs. For example, they can be used to control the filling lines or Building Management Systems.Within the Particle Measuring Systems SCADA system there are specific tools to extract data from the database to create the reports. The reports can be set up based on the customer’s required parameters. For example, a parameter could be specifying a time frame related to the data extraction for particle counts in a cleanroom.The buffer capacity for the FacilityPro processor is 8 hours for 32 sensors (particle and microbiological) and 96 analog sensors.The sensor sample rate is 10 seconds.At the instrument level (i.e., particle counters), and a sampling every 10 seconds, there is a 4 hour buffer of the data. At the processor level, there is an 8 hour buffer for the data in the event of communication loss with the SCADA software.It depends on the customer’s SOP. The production time and the audit trail review time frame should be the same time frame. All samples and actions should be monitored for compliance.Authorities do not indicate which architecture is preferred when applied to a monitoring system, but they do ask for users to be compliant with 21 CFR Part 11, to have disaster recovery procedure, to manage the data in the safest possible way, and to acquire the data in a secure fashion. All these goals are best achieved using industrial automation and Particle Measuring Systems technology.No, regulatory standards do not give this specific detail. However, it is good practice to mitigate the risk. If the system is able to work with some failures while assuring data integrity, the customer could recover the problem without stopping production, saving money.No, but it is used as risk mitigation. Auditors know the design’s advantage: a higher security level for data acquisition and storage of the industrial automation architecture.As with any system, the greater the quantity of samples the better the confidence in the results. A continuous Environmental Monitoring System (EMS) will allow for greater confidence in comparison to only using portable systems taking periodic samples. To increase the confidence that the area being monitored is under control, a continuous monitoring system is recommended. This question is related to performing a periodical check of the cleanroom, not to the continuous monitoring process of production. More information about cleanroom monitoring requirements can be found here.

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