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E n g i n ee r i n g f o r N o n - E n g i n ee r s

Monitoring by
Data Logging

Brandon J. Patterson, Sr. Process Engineer, Kymanox

Justin Pawlik and Brandon J. Patterson

32   Journal of GXP Compliance

“Engineering for Non-Engineers” discusses science and engineering principles
associated with equipment, utilities, facilities, and associated GMP systems useful to practitioners in compliance and validation. We intend this column to be a
useful resource for daily work applications.
Reader comments, questions, and suggestions are needed to help us fulfill our
objective for this column. Suggestions for future discussion topics or questions
to be addressed are requested. Case studies illustrating engineering principles
submitted by readers are also most welcome. Please send your comments and
suggestions to column coordinator Stephen Perry at stephen.perry@kymanox.com
or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS DISCUSSED
The following key points are discussed in this article:
• Data logging is the activity of collecting information from electronic
sensing instrumentation over specified time periods at predetermined
intervals
• Data collected may include temperature, relative humidity, chemical
concentrations (i.e., % CO2), pressure, particle counters, electrical current, and many other forms of data
• Applications include areas required to maintain a specific condition
such as warehouses, production rooms, refrigerators, freezers, and
sterilizers
• Data loggers may be stand-alone or integrated with tethered computers
• Temperature is typically recorded by thermocouples, thermistors, or
resistance temperature detectors (RTDs)
• Data loggers may be configured including wiring, multiple channels,
or by self-contained instruments
• Data loggers must be calibrated using an appropriate tolerance; the
calibration should be National Institute of Standards and Technology
(NIST) traceable and be documented in a manner consistent with good
documentation practices (GDPs)
• Data loggers are used in validation to qualify environmental chambers,
steam sterilizers, warehouses, and other controlled environments
• Probe placement is the most important aspect of data collection.

including stand-alone and computer-based instruments • Temperature elements used in data loggers.” The data are then analyzed to determine the worst-case locations within the area or system (i. Applications And Importance Of Data Logging Data logging is used in engineering and validation activities to gather sequential readings that can be analyzed to gain a greater understanding of a system. steam sterilizers. Many of the concepts discussed in this article can also be applied to other forms of data logging. This discussion of data loggers will address the following topics: • Types of data loggers. Pat terson Sampling interval and duration of sampling are other important aspects of the test protocol. Others.. these calculations make it possible to draw conclusions about the system from the data collected. Data loggers must comply with the critical aspects of 21 CFR Part 11 including security access and data integrity. multiple channels. including wiring. be the primary focus of this article. • Electronic data in data loggers is stored in secure files that may be downloaded for data treatment. Spring 2009 Volume 13 Number 2 33 . such as a refrigerator. Data logging also enables a significant number of measurements to be collected over short or long periods of time.Justin Pawlik and Brandon J. Data logging is critical to obtaining an accurate and detailed representation of how a system operates. This practice is common in the pharmaceutical. biotech. The large number of measurements can easily surpass the quantity of points required to be statistically significant. The data are then used to perform additional calculations including the following: • Minimums • Maximums • Averages • Standard deviations • Lethality of a sterilization cycle (F-sub-zero). probe placement. and data analysis and retrievability. with appropriate instruments. • Quality and compliance personnel should focus on critical performance aspects of data loggers including calibration. and medical device industries and will. change temperature very fast. the hottest or coldest locations). Examples include: • Relative humidity • Pressure • Electrical currents. However. such as a sterilizer.e. and self-contained instruments • Calibration of data loggers • Use of data loggers in validation (qualification). change temperature slowly. therefore. INTRODUCTION—WHAT IS DATA LOGGING? Data logging is the process of collecting information over a certain period of time at predetermined time intervals. Because a complete data-logging event contains hundreds to thousands of data points. Data are usually collected simultaneously at multiple locations within the area being tested. Locations are carefully chosen so that the entire area is “mapped. Systems that may utilize data logging can include any area that has a requirement to maintain a given temperature specification such as the following: • Warehouses • Production rooms • Refrigerators • Freezers • Sterilizers. and resistance temperature detectors (RTDs) • The configuration of data loggers. and production rooms •C  ollecting data. Data logging instruments allow highly accurate measurements to be obtained. thermistors. These systems may also have long cycle times that make it impractical for manual data recording. One of the most common types of data logging is temperature data recording. including environmental chambers. sampling interval and test duration. many other forms of data can be collected. including probe placement. The data is generally collected sequentially and at rates faster than what is possible by human observation. including thermocouples. warehouses. Some systems.

Data can be retrieved from the data logger directly to PDF format. Storage capacity ranges from 1920 to 16. The chart turns at a precise speed according to the programmed time period. Figure 1: Kaye Validator 2000. and the duration of monitoring protocols • Electronic data. A chart recorder is a common instrument included in this category. The software is used to setup the data logger. Data can be grouped to aid in calculations and graphing of the data. data loggers as well as 8-bit and 12-bit models. All data loggers utilize ACR System’s TrendReader software to configure the data loggers.E n g i n ee r s sampling intervals. battery. printing directly from software.E n g i n ee r i n g f o r N o n . and user levels. such as 24 hours or one week. which allows for easy access to the data from any computer. tethered to a laptop computer). The Kaye Validator is 21CFR Part 11 compliant. Strip chart recorders are similar to circular chart recorders. and export the data in various formats (including . The 12-bit models have an optional larger storage capacity and faster sampling rates of up to 25 points per second. including electronic files. As a result. much longer time durations can be charted before changing the paper. with the exception that they print from a paper roll. It uses a circular piece of paper and different pens to plot measurements. and key aspects of 21 CFR Part 11 compliance. Typically there are maximum four pens available to plot the data. (Reprinted with permission from ACR Systems) Stand-Alone Data Loggers A stand-alone instrument does not require a computer to operate and gather data. (photograph by Justin Pawlik) Specific issues of data loggers especially relevant to quality and compliance are also discussed. audit trails. memory.000 data points at sampling rates of 10 seconds to 2 hours. See Figure 1 for a photo of a Kaye Validator 2000. The TempTale . Up to three sensor input modules (SIMs) can be utilized. There are single-channel and multi-channel 34   Journal of GXP Compliance Figure 2: ACR Systems SmartReader. Multiple units can also be linked together with an Ethernet cable. Chart and strip recorders are limited in the number or data points that can be recorded simultaneously. TYPES OF DATA LOGGING INSTRUMENTS The following sections describe the available types of data logging instruments.csv files for Excel). Optional equipment is required to achieve this sampling rate. and includes passwords. exporting to Microsoft Excel.e. each SIMs can be configured with up to 12 sensors. The data loggers are self contained with internal sensors. TempTale (3) data loggers are available in single-use and multi-use models. and an LCD display. SmartReaders (2) are ACR Systems data loggers (see Figure 2) that are available in many configurations.. Data can also be exported to Excel for further analysis. Computer-Based Data Loggers A Kaye Validator 2000 (1) is a data logging instrument that can be used as a stand-alone or computer controlled data logger (i. view and graph the data.

Pat terson TYPES OF TEMPERATURE ELEMENTS The following sections describe the types of temperature elements involved in data logging. Thermocouple types include K. One junction (the hot junction) is typically encased in a sensor probe at the point of measurement. S. Type T is a widely used thermocouple type constructed of copper and constantan and has a temperature range of approximately -185°C to 300°C. They also offer mechanical. Thermocouples are grouped by types according to the materials of construction and sensitivity. stainless probe. so does resistance.Justin Pawlik and Brandon J. As temperature changes. The other junction (the cold junction) is connected to the measuring instrument. Veriteq Data Loggers (4) (see Figure 4) are self contained with internal sensors. save. T. Thermocouple temperature measurement is based on reading the voltage signal and the cold junction temperature. according to type. Figure 3: (Reprinted with permission from Sensitech) TempTale data logger. The information is then used to compute the temperature with mathematical equations that are applicable to the type of thermocouple used (5). and export the data. which in turn causes a large voltage drop. Storage capacity is 35. Thermistors A thermistor is a resistive device comprised of metal oxides that are formed into a bead and encapsulated in epoxy or glass. (Reprinted with permission from Veriteq) Manager Desktop software is also available and allows the user to view. memory. N. thermal. Thermocouples Thermocouples measure temperature by generating a small voltage signal that is proportional to the temperature difference between the junctions of two dissimilar metals. compare. The software is also used to perform calculations and to view. Thermistors are thermally-sensitive resistors and have. B. or wire coating (6). They have an operating range of -200°C to 1000°C. Configuration of the data logger is performed using the vLog software. Resistance Temperature Detectors Resistance temperature detectors (RTDs) are sensors used to measure temperature by correlating the resistance of the RTD element with temperature. or export the data (see Figure 3). The vLog software also provides audit trails and encrypted files that meet all the requirements of 21CFR Part 11 compliance. graph. Figure 4: Veriteq data logger. The Spring 2009 Volume 13 Number 2 35 . and electrical stability with a high degree of sensitivity (7). R. and E. save. print. Sensors are quite small and normally encased in a protective shell. print. or positive (PTC) resistance/temperature coefficient. J.100 samples and sampling rates range from 10 seconds to once a day with the VL 2000 series. NTC thermistors are temperature dependent semiconductor resistors. and battery. Most RTD elements consist of a length of finely coiled wire wrapped around a ceramic or glass core. graph. a negative (NTC).

They must also be post-calibrated following the collection of all data to ensure the instrument is still operating within its original specifications. which can be expensive. Tolerance The instruments must be calibrated to a more rigid tolerance than is required by the acceptance criteria of the quality document. This approach has some disadvantages. and analyzed separately.E n g i n ee r s element is usually quite fragile. Self-Contained Instruments Some models of the TempTale data loggers explained in the “Types Of Instruments” section of this article are examples of self-contained instruments. validation. are capable of recording multiple data points simultaneously. are being monitored. There is no defined limit for wire length. A conservative rule-ofthumb used by many established pharmaceutical companies is to calibrate to an accuracy ratio of 4:1. If a 4:1 ratio cannot be achieved. When data are being collected for use in production. The user must calibrate the sensors with the entire length of wire to determine if the sensors function acceptably with the chosen wire length. This also limits the possibility of poor signal transmission.0. such as warehouses. it is still a requirement to have the same number of thermocouples and data points. Wiring is available in various qualities from standard to ultra-premium. This type of RTD is often referred to as a Pt100 RTD for its material and resistance of 100 Ohms at 0°C. For example. The collection of the data onto a computer is also more time consuming because each data logger has to be connected. so it is often placed inside a sheathed probe for protection.25°C. INSTRUMENT CONFIGURATION The following sections describe the requirements involved in instrument configuration.E n g i n ee r i n g f o r N o n . The most common material used for RTDs is platinum. The RTD element is made from a pure material whose resistance at various temperatures has been documented. a risk .1°C. or quality records. The quality of the wire is more important for highly accurate instruments and calibrations or for long lengths of wire. Multiple Channels Some data logging instruments. The “Collecting Data” section of this article contains further discussion of this topic. In addition to the external channels for the thermocouples. more wire is almost always needed than originally anticipated. The material has a predictable change in resistance as the temperature changes. then a justification is usually required. This is a key point to remember because it may not be possible or practical to utilize the data logger itself as one of the recorded data points. such as the SmartReader Plus 8. In the end. There needs to be one instrument for every data point. if the quality document specifies that temperature meet the criteria of +/. Data logging is no exception. so a general guideline is to take your initial estimate and double it. Wiring Wiring is integral to the configuration of instruments that utilize external temperature elements. However. CALIBRATION Calibration is a common topic in any pharmaceutical activity that involves instruments. However. “Self contained” simply means that there are no wires or thermocouples attached to the instruments. It is this predictable change that is used to determine temperature (8). These instruments can simplify placement of the data loggers when large areas. then the instrument should be calibrated to +/. data loggers often contain an internal temperature element that is included in the total 36   Journal of GXP Compliance number of available channels. which is a 4:1 ratio. The instrument contains all of the sensing elements inside its case. This feature helps reduce the total number of instruments required for a project. Wire should be kept to a reasonable length in order to avoid difficulty in handling. downloaded. the instruments must be calibrated to the tolerance and range of the measurements taken. instruments such as the Kaye Validator can use wires up to 500 feet in length. If absolutely necessary.

Environmental Chambers Environmental chambers include any equipment that is designed to maintain certain environmental conditions. Failure at any of the data points in the sterilizer could indicate a mechanical problem with the sterilizer. Steam sterilizers operate at temperatures of at least 121. The calibration must be performed over the intended measuring range. Range Instruments cannot be assumed to provide accurate readings over their full operating range. Equipment in this category includes. the instrument should be “precalibrated” with a full calibration. Calibration Checks Prior to starting a data logging study. or CO2 level. This helps reduce the cost of calibration activities. which is the worst-case location. If the measurements are expected to be in the range of 20-40°C. such as temperature. or middle point. Thermocouples are inserted into the items in the sterilizer at the worst-case locations. of the system’s operating range. this assessment should be documented and include the downstream impact of an OOT or inaccurate measurement. QUALIFICATIONS USING DATA LOGGERS The following are several basic concepts common to all qualifications that utilize data loggers: • Generating a “temperature map” of the equipment or room during production • Creating a temperature map by placing probes at various locations throughout the space to identify the hottest and coldest locations within the space •V  erifying that the temperature cycles of the equipment or room remain within the required temperature ranges by analyzing the continuous data measurements. This specific instrument should not be used for taking measurements in a freezer that has an operating range of -40°C to -20°C. then the calibration at a minimum should include this range. Pat terson assessment should be performed to determine the required calibration tolerance and accuracy. This allows for temperature excursion that may not be anticipated. The qualification is written to ensure that the entire volume of the chamber is maintained within a specified operating temperature range for a given duration. Operational and/or performance qualification of these chambers involves temperature mapping the chamber in reasonable worst-case conditions. but is not limited to the following: • Refrigerators • Freezers • Ultra-freezers • Cryogenic tanks • Incubators. This test is an operational qualification of the sterilizer and is performed with an empty chamber.1°C. the instrument should be “post calibrated” with either a full calibration or a calibration check. A calibration check is a single-point calibration that is usually performed at the setpoint. or insufficient steam supply. Spring 2009 Volume 13 Number 2 37 . humidity. Following completion of the study.Justin Pawlik and Brandon J. Data logging is crucial to identifying whether or not all locations in the chamber reach and maintain 121. inadequate insulation. Performance qualification of the sterilizer is executed with a worst-case load using actual items that will be processed. The calibration must also be performed against a National Institute of Standards and Technology (NIST) traceable standard that has a tolerance less than or equal to the accuracy needed for the instrument. A full calibration includes multiple data points that bracket the range of measurements that will be collected.1°C for the duration of the sterilization cycle. This risk assessment can refer to any critical process parameter (CPP) justifications because similar information and logic is required. A wider range could also be used. Steam Sterilizers Steam sterilizers are used to keep items free of living microorganisms and bacterial endospheres prior to transfer into a sterile production room or for products prior to shipment. Because the sterilizer monitors temperate at the drain. a thermocouple should also be placed at this location. such as 10-50°C. There may be a leak in the door seal.

If there are not enough probes to create a backup by doubling up data collection at any of the locations. repeatable operation of the room’s heating. Warehouses Warehouses are qualified based on the United States Pharmacopeia (USP) <1079> definition of controlled room temperature of 20-25°C (68-77°F). The following are additional room conditions specified in USP <1079>: • Cold storage of 2-8°C (35-46°F) • Cool 8-15°C (46-59°F) MKT • Controlled room temperature 20-25°C (68-77°F) MKT. Qualification also requires the mean kinetic temperature (MKT) to be calculated (9). then the applicable humidity range must also be qualified. The primary acceptance criterion is accumulated lethality (F0). There are usually a limited number of probes available for a study. However. the worst-case locations must be identified prior to starting the qualification.E n g i n ee r i n g f o r N o n . However. Data point locations may only include three to six points across the working height of the process. Accumulated lethality uses temperature. The accumulated lethality can be performed automatically by a Kaye Validator. or near air vents. Justification must be provided for each location. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation” (10). areas around doors. COLLECTING DATA Steps required in the collection of data are described in the following sections. if locations are carefully chosen to represent the entire useful area of the equipment. Although the room conditions do not directly impact product quality.E n g i n ee r s This ensures that all surfaces. and crevices of the items are properly sterilized. time. According to the International Conference on Harmonization (ICH) stability testing guideline. ventilation. As a result. next to steam lines. MKT is defined as “A single derived temperature that. Probe Placement Placement of the probes is an important step in the design of a successful data logging activity. this USP chapter is specific to storage and shipping practices (5). then the data collected will not be robust enough to defend using locations other than the points studied. then the qualification document . If the location of the probes is not justified and representative of the entire equipment or area. Production Rooms Qualification of production rooms is also dependent on the requirements of the products that are processed. and air conditioning (HVAC) system. then the qualification of the room could utilize the USP <1079> definition of controlled room temperature of 20-25°C (68-77°F). Like any other temperature mapping. then it is easy to justify utilization of locations that were not specifically tested. affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. there may not be a requirement to perform a complete temperature mapping of the room. if maintained over a defined period of time. Evenly spaced locations around the room are sufficient to capture the temperature variations caused by air ducts and equipment configuration. there must be a balance between these groups. If there are no product specifications for temperature or humidity. the qualification ensures operator comfort and reliable. In addition to temperature. if any of the products or materials stored in the warehouse require a specific humidity. and data from biological indicators to calculate a theoretical microbial reduction. Locations can be divided into the following groups: • Worst-case • Representative • Backups. which greatly simplifies the task of analyzing the data. then the room must be qualified to include those operating ranges. Locations could include the highest product storage levels. pockets. It is not likely that product will be stored 38   Journal of GXP Compliance at a level near the ceiling or very close to the floor. However. If the products must be maintained at a specific temperature or humidity. unlike warehouses or environmental chambers.

The coldest locations could be at the top instead of the bottom. Pat terson should include provisions that it is acceptable if one or two probes malfunction or do not pass post calibration. In situations that do not make it possible or practical to utilize the data logger itself as one of the interior chamber data points. A sterilization cycle that is 40 minutes in duration may have an initial heating time of only several minutes. A 10-second sample interval will result in 240 data points per thermocouple. In larger areas. such as a Rees Monitoring system or OSI-Pi. This includes air diffusers for an HVAC system. For example. However. A full cycle. A basic understanding of the system is required before choosing the sampling interval. Choosing the appropriate sampling rate is important to obtaining meaningful data. it must be left outside of the chamber. such as a freezer. the temperature is more dependent on the location of the cooling source. the ambient room temperature. Its temperature changes rapidly as the chamber is heated. inconsistent insulation. Data points must be recorded at a small enough interval to capture the changing conditions of the system. Typically probes can be placed on top. • Identify monitoring sensors. from coldest to warmest back to the coldest temperature. a sample rate of 2 minutes is not sufficient to capture the true temperature curve of the sterilizer. This is performed with the purpose of “filling in” the space and to correlate readings with other sensors. they can be placed to the left and right sides of the shelves. the thermocouples are fed through an access port to the interior of the chamber while the data logger is left outside the freezer. If additional probes are available. The following are some general guidelines for choosing worst-case locations: • Heat rises (most of the time). and bottom shelves. There is always a sensor used by the system to control temperature. This data may be useful in determining whether or not the temperature cycles of the freezer are impacted by the temperature cycles of the room. Sampling Interval The sampling interval is the frequency at which data is recorded. One probe is placed next to the equipment’s temperature element used to control the chamber temperature. A sufficient sampling interval is approximately five minutes. which may range from one second to five days. For example. Instruments generally allow the user to choose the sampling interval. Therefore. • Representative locations are chosen second. • Identify heating or cooling sources. cooling coils in freezers. Chart recorders are often used on environmental chambers as a redundant monitoring system. in small chambers such as a freezer. such as rooms and warehouses. This allows the data logger to be the ideal probe to collect the ambient air temperature. • Identify locations of heat transfer. Probes are placed at the four corners of the top and bottom shelves of the chamber to represent worstcase locations. These locations are where temperature extremes can be expected due to the differences in height and proximity to door seals. Spring 2009 Volume 13 Number 2 39 . middle. higher locations are more likely to be warmer than lower locations. In this situation. a sampling interval of 10-15 seconds is recommended. However. this satisfies another possible probe location. typically takes about one hour. Some facilities use data historians that continuously collect data from the equipment. seals. This can include doors. It would be impossible to identify the exact time at which the sterilizer reached the target operating temperature. the manufacturer of the data logger may not recommend placing the instrument directly into a freezer operating at -30°C.Justin Pawlik and Brandon J. or steam ports in a steam sterilizer. may use longer sampling intervals. • Identify product storage locations. Choosing worst-case locations should be done first and requires some basic knowledge about the operation of the system. Systems that have longer cycle times. or return air vents. Figure 5 represents an environmental chamber that contains four levels where product can be stored. • Identify controlling sensors. Therefore. a sterilizer has a relatively short cycle time.

A study of a small room or environmental chamber may justify that 24 hours is a sufficient amount of time to capture day and night operation of the building’s HVAC system. Duration Of Monitoring Studies The duration of the study is also an important factor in creating a meaningful set of data.E n g i n ee r s Figure 5: Environmental chamber with four storage levels. The total duration of the study must capture enough of the system’s operation to justify consistent and repeatable opera40   Journal of GXP Compliance tion. however. A shorter interval could provide more detail. The study must also attempt to capture events that could be considered “worst-case” conditions. Time duration of 24 hours is also sufficient to capture the numerous temperature cycles of the refrigerator. Increasing the sampling interval decreases the ability to capture sudden changes. A large room or warehouse. in temperature. A longer interval increases the possibility of missing data points at the extremes of the cycles.E n g i n ee r i n g f o r N o n . but this results in a very large number of samples. This is the only method to ensure that . is impacted by the outside weather conditions. A warehouse study should be conducted for several weeks or months during the summer and winter. or spikes.

0 '2-06 '2-07 '2-08 '2-09 '2-10 -30. Exporting To Excel Data can also be exported to Excel for additional analysis. Freezer 24-hour Temperature Map -22.0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 :0 00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 :10 :00 :50 :40 :30 :20 : 7 7 8 9 10 11 12 12 13 14 15 16 17 17 18 19 20 21 22 22 23 0 1 2 3 3 4 5 6 Time Spring 2009 Volume 13 Number 2 41 .csv) file. Pat terson the HVAC systems are capable of maintaining the required temperature specifications during both hot and cold months.0 '2-01 -26. Electronic Files Each of the data loggers examined in this article protects the collected data by creating secure files that cannot be altered. These original files usually require the proprietary software to view the data.Justin Pawlik and Brandon J. Any number of activities can be performed in Excel to format.0 '2-11 '2-12 -32. See Figure 6 for a graph of a 24-hour temperature map of a freezer. perform calculations. ELECTRONIC DATA The following sections discuss the elements of collecting and storing electronic data. However. The data is exported from the data logger software as a comma separated values (. Figure 6: Freezer 24-hour temperature map. Direct Printing From Software Because the original files are not easily accessible. This provides easy access to the data as is required during audits.0 '2-02 '2-03 '2-04 '2-05 -28.0 -34. not all data loggers and software can be considered 21CFR Part 11 compliant. the data can usually be printed to Adobe PDF files for universal access and viewing. Note that although secure data files are created. it is generally required to print the files and attach the printout to the qualification document. and graph the data.0 Degrees celcius -24. The original files and any PDF files generated should be burned to a CD and attached to the qualification document for retention.

Part 11 compliance is a very broad topic and cannot be explained in sufficient detail in this article. The sampling interval should be relatively short for dynamic systems. Make note that not all commercially available data loggers are capable of being 21CFR Part 11 compliant. including equipment.e. The test duration should capture several heating or cooling cycles.. •P  roper handling of the original. such as creating a single user name and password for all users. To ensure that the data has not been altered. Part 11 requirements may be mitigated or eliminated by proper documentation within the qualification document. and . The calibrated tolerance of the data loggers is tighter than the specifications for the system being tested. In addition. 42   Journal of GXP Compliance QUALITY CONCERNS The wide use of data logging in the pharmaceutical industry makes it very likely that most people will encounter this activity in some way or another during their careers. and any transcriptions to Excel and subsequent calculations are verified by a second person. the qualification should allow for the exclusion of one or two data loggers in the event of a malfunction or calibration failure. improper administrative procedures. The author of the test plan should exhibit a general knowledge of the system through the justifications provided in the test plan. could result in poor data integrity and do not satisfy the requirements of Part 11. •S  ampling interval and test duration are appropriate. Quality organizations may be approached to review or approve these activities. For example. and should provide a basic understanding of what is involved and some of the important factors to consider. calibration. • Extra probes are available in case of a malfunction or calibration failure. Electronic files are saved to a CD. configuration.E n g i n ee r i n g f o r N o n . the original files must also be maintained. The printed copy now serves as the lasting record of the data. The intent of this article is to make the reader aware that Part 11 should be considered when using data loggers and electronic records for the purposes of meeting current good manufacturing practice (CGMP) guidelines. printing of the final secure data files eliminates the electronic storage of the data. which include the following: • Start and stop times • Probe locations • Corresponding probe IDs • Signatures and dates. This helps to ensure that the tests are pre-approved and executed in such a way that the data is valid and meets CGMP requirements. standard operating procedures) to ensure data integrity issues do not become a problem for the validation. any software deficiency related to Part 11 compliance should be mitigated with written procedures (i. If no additional probes are included. 21 CFR Part 11 Compliance Whether or not Part 11 requirements are applicable to the records created by the data loggers depends on the unique situation of the user and how the instruments and data are handled. When evaluating a test plan. and printed data. Also. CONCLUSIONS This discussion of data logging has addressed several general topics. • Probes are placed in worst-case locations with supporting justification. The need for electronic signatures is eliminated if the qualification document contains all critical events. exporting the data to Excel does not maintain the integrity of the data and is considered transcription. transcribed. data handling. the following items could impact quality if not executed properly: • Data loggers are calibrated before and after the qualifications. Calibrations bracket the expected operating range of the equipment or room. a second person must verify all data transcription and calculations performed in Excel. For this reason. This article is merely an introduction to the concepts of data logging. Lastly. data loggers and software that claim to be Part 11 compliant still need to be used correctly to maintain the principles of Part 11. original data is printed and verified. probe placement.E n g i n ee r s However.

2009. He can be reached at brandon.com/thermometricsproducts. The user must then configure the equipment properly based on the system being qualified. 9. biotechnology. and calculations. com. the software is used to download the data from the data loggers and create a presentable analysis of the data. He can be reached at justin. memory.” Veriteq. technical project manager. and Air Conditioning ICH International Conference on Harmonisation MKT Mean Kinetic Temperature NIST National Institute for Standards and Technology NTC Negative Resistance/Temperature Coefficient RTD Resistance Temperature Detector PTC Positive Resistance/Temperature Coefficient SIM Sensor Input Module USP United States Pharmacopeia REFERENCES 1. and test duration should also be taken into account. including tables. process engineer at Kymanox. IL. Revision 1.com. Veriteq. Spring 2009 Volume 13 Number 2 43 . and maintenance supervisor.com. and a facility qualification. Highland Park.” Veriteq. Highland Park. ARTICLE ACRONYM LISTING CFR Code of Federal Regulations CGMP Current Good Manufacturing Practices CPP Critical Process Parameter F0 Accumulated Lethality GDPs Good Documentation Practices HVAC Heating. The equipment should be capable of performing the required testing by utilizing appropriate sampling rates. Perry is coordinator of “Engineering for Non-Engineers” and is the founder and president of Kymanox. “Thermometrics Products. retrieved March 3. software analysis. 8. product launches. 2009. Thermistors.com/validation/ thermocouples-vs-thermistors. retrieved March 3. sampling rate. and operations manager. Information about ACR Systems SmartReaders can be obtained online at http://www. Coordinator: Stephen M. retrieved March 3.com. 4. International Conference on Harmonization (ICH). equipment/process engineer.acrsystem.com. This article discusses the basics of data logging at a high level and provides the reader with the fundamental knowledge that assists in the review and approval of qualification documents utilizing data loggers. August 2001.gesensing.gesensing.perry@kymanox. ABOUT THE AUTHORS Author: Justin Pawlik is vice-president of midwest operations at Kymanox.patterson@kymanox. USP<1079> for Good Storage and Shipping Practices. “Temperature Measurement: Thermocouples vs.com Research author: Brandon J.pawlik@kymanox. “Thermal Validation in the Pharmaceutical Industry: An argument against the use of thermocouples. and medical device industries.com. Pat terson data analysis. http://www.veriteq.htm.Justin Pawlik and Brandon J. graphs. 2. Information about the Kaye Validator 2000 can be obtained online at http://www. a company specializing in technical project management and related services for the pharmaceutical. Information about Veriteq’s data logger can be found online at http://www. IL.” Gesensing. Q1A Stability Testing of New Drug Substances and Products. Calibration.com http://www. Veriteq.com/thermistor/. 2009. Justin has over a decade of manufacturing and quality experience in the pharmaceutical industry as a quality manager. http://www. 5. USP.com. 10.com and http://www. “What is a Resistance Temperature Detector (RTD)?” Omega. Patterson is a sr. retrieved March 3.omega.com/rtd. http://www.kayeinc. This is the basis for generating a meaningful set of data during qualification. Proper handling of the data and second person verifications are required to maintain the integrity of the data and to meet CGMP requirements. This fundamental knowledge is not intended to answer all questions. 6. but to provide a starting point to determine where additional information is required and to initiate more detailed discussions with the technical experts conducting the qualifications.com. Omega. Brandon has over eight years of CGMP manufacturing experience as a validation engineer. Ventilation.sensitech. Information about TempTale data loggers is available online at http://www. Gesensing. Brandon has participated in major equipment installations.veriteq. and security.html. 2009. 7. 3. Following the collection of the data.com.veriteq. He can be reached at stephen. probe placement.