Temperature Mapping and Monitoring: Quality-Control Tools for Pharmaceutical and Medical Device Warehousing
By Gregory Brian Weddle Global Manager Critical Environments Raymond L. Benton Critical Environments Solutions Consultant
and many other conditions must be strictly controlled and validated.and humidity-sensitive product. either as a snapshot in time (temperature mapping) or continuously (temperature monitoring). it raises concerns in the storage of temperature. but the contents remain vulnerable to temperature and. or pointing out potential problem areas that should be addressed. instead leasing the space from development companies. Makers of pharmaceuticals and medical devices. product quality. the warehouse owner or operator receives hard data documenting that product is being stored at its specified conditions. as FDA scrutiny grows stricter.
That adage applies to large warehousing spaces regulated solely by thermostats. and as consumers and the healthcare industry raise their expectations for product effectiveness and safety. air quality. medical devices.
In recent years. Facility personnel may crudely regulate temperature by keeping loading dock doors open or closed during extremely hot or cold days. For example. in-process materials. based on stability testing. The warehouse environment is typically regulated by simple line-voltage thermostats that activate heaters or ventilators when temperatures rise above a setpoint.
The state of storage
Pharmaceutical and biomedical companies face exacting FDA standards affecting production. pharmaceutical and medical device producers have not owned the warehouses. are starting to take notice. In either case. While that may be of little consequence for storage of office supplies. reaching 40 to 80 feet high. in some cases. biomedical products. The warehousing section will cover topics including incoming materials. Most product warehouses have limited environmental control. Manufacturers are simply required to store perishable product in the temperature. so variation in environmental conditions during that time will not degrade the product significantly. A space measuring tens or hundreds of thousands of square feet. can cost-effectively provide a complete profile of storage-space conditions. simple technology enables such companies to monitor conditions in three dimensions within raw-material or finished product storage areas. deeply concerned about consumer safety. environment. ingredients. ventilation and heating. humidity. divided by floor-to-ceiling racks. which may also manage and operate the buildings. manufacturers are focusing more attention on product storage. and other sensitive materials. and equipment operations. Those stringent requirements thus far do not extend to warehousing. flow of materials. and without a sophisticated climate-control system. using digital sensors from which temperature and humidity data can be downloaded to a computer and analyzed by simple software. equipment sanitation. or 2) building conditions veer out of control only in extremely hot or extremely cold weather. The building may have ceiling fans to circulate the air. with little likelihood of product degradation during those days.
they have found necessary to sustain product safety and efficacy. is likely to exhibit zones of different temperatures. Warehouses typically do not have air conditioning– the majority rely on ventilation alone or. which occurs on just a few days out of the year. Packaging obviously protects products against contamination and degradation from light. even when wall thermostats say conditions are in the desired range. on average you are comfortable. humidity and light conditions
. shipment of goods. toys. and FDA compliance. the Society for Life Sciences Professionals (ISPE) is developing a new volume in its series of Baseline® Pharmaceutical Engineering Guides devoted specifically to packaging. in colder climates. Warehouses in these sectors tend to experience high throughput. Historically. books and other non-perishables. canned goods. Underlying assumptions seem to be that 1) the product stays in the warehouse for only a week or a few days. Space temperature and humidity. This technology.I
t is said that if you stand with one foot in scalding water and the other in a block of ice. Mapping and monitoring can be valuable quality assurance tools for spaces that store bulk and final pharmaceutical. Today. hardware. spaces are reconfigured often as new products come in and as demand patterns change. utilities. labeling and warehousing operations (planned for release in mid-2004). facility planning.
In cases where significant temperature anomalies are documented. temperature mapping is a simple procedure. telecommunication companies and online merchants have proven highly vulnerable to temperature and humidity outside equipment makers’ specifications. In such facilities. automatically at prescribed intervals. control specialists visit the facility to look for the probable causes. Sensors are placed in a grid pattern at regular intervals around the warehouse. Still. making measurement and monitoring easier. especially if they have only rudimentary heating. sensor data is downloaded to a computer and analyzed. Software generates multiple twodimensional and three-dimensional color-coded charts and graphs that visually show temperature profiles and make it easy to identify specific problem areas (see accompanying examples). When the measurements are complete. For example: • Areas near the ceiling or exterior walls may stay warmer or cooler in response to temperatures outside. These and other factors may create substantial temperature differences from floor to ceiling and within building zones. This enables the building owner to track accurately how conditions change during a typical working day. data is downloaded. In addition. computers and servers operated by Internet service providers. experiences in other industries provide lessons on the importance of environmental control. Against such events. The sensors attach to the racks by way of simple plastic tie wraps.
Taking the temperature
Large. and through weekends. Companies that inadequately control their computer room environments have faced premature equipment failure and the threat of critical network outages potentially affecting millions of customers – not just when overall room temperature and humidity slip out of prescribed ranges but when “hot spots” and “cold spots” exist within rooms.Meanwhile. The basic measurement tools are small. • Doors left open to regulate overall temperature will affect conditions around nearby racks.
. Detailed temperature mapping and monitoring have helped many of these companies to identify environmental problems and take measures to bring their computer rooms back into control. batteryoperated sensors that measure temperature. overnight. At the end of the measurement period. more accurate and less costly. Each sensor bears a serial number that is matched with its coordinates. Certainly. no pharmaceutical or medical device manufacturer wants to face the prospect of a consumer safety concern involving its product that could be traced back to questionable or poorly documented storage practices. temperature mapping and monitoring can provide cost-effective insurance. In fact. out-of-spec conditions in a drug warehouse will not cause anything as sudden or dramatic as the failure of a cellular telephone network or the crash of a popular e-commerce web site. ventilating and air conditioning (HVAC) systems. especially if fans are undersized or improperly placed and so incapable of mixing the heated air effectively. • Temperatures may stratify simply because warmer air rises. near the ceiling. mapping studies should be performed twice – during midsummer and mid-winter – to account for seasonal effects. financial service firms.
• Racking and shelving configurations may contribute to “hot spots” by obstructing air circulation. For example. taking measurements every 10 minutes. • Temperatures will be higher near heaters. variations of several degrees C are common in large storage facilities. temperature and humidity sensing technology has advanced. This technology enables detailed mapping studies with the bare minimum of labor and so at affordable cost. Ideally. and the mean kinetic temperature (MKT) is calculated for all the data points to determine whether conditions are within prescribed limits. Typically. typically at three levels: near the floor. and at a midpoint. A map of the facility is created and the coordinates of all sensors recorded. open spaces with high ceilings are vulnerable to temperature and humidity variation. sensors operate for one to or two weeks. or both temperature and humidity.
50 Ⅵ 30. They include: • Removing product from problem areas (such as hot spots near ceilings).
Toward strategic planning
Temperature mapping is a key first step to understanding environmental conditions in critical storage facilities. • Improving ventilation.Summary of Minimum Temperature Data Points Collected Summer 2002
Ⅵ 25.00-24.50 Ⅵ 29. When combined with ongoing temperature monitoring. and other information used to complete the study. With both kinds of data in hand. depending on the problems’ severity.
Summary of Maximum Temperature Data Points Collected Summer 2002
Ⅵ 31. page or telephone to adverse changes in space conditions.00-31. • Changing racking or shelving configurations.50
• Repositioning racks or shelving to improve air circulation.00 Ⅵ 24.00-22.50-25. A continuous record also can be valuable in case of an FDA inquiry or audit – especially if the monitoring information is combined with the detailed inventory data pharmaceutical and biomedical companies already keep. The sensors can be easily moved as the storage scheme or product mix changes.00 Ⅵ 29. • Changing work practices (such as keeping doors open or closed).
An attractive option is to install sensors that communicate continuously with a Part 11 compliant building automation system (BAS).00-25.50-22.50 Ⅵ 28.00 Ⅵ 23. If the mapping study indicates undesirable conditions.00-29. • Adding air conditioning.
Taking the next step
A temperature mapping study provides a one-time view of storage conditions. Because facility configurations and product mixes can change frequently.00 Ⅵ 22.00-30. The report contains copies of all sensor calibration certificates. a long-term
.00 Ⅵ 21. • Installing an HVAC control system. • Adding humidification or dehumidification. • Installing more or larger-capacity fans. long-term temperature and humidity monitoring can be advantageous. The BAS can be programmed with alarm setpoints so that personnel on duty around the clock can alert service technicians by e-mail. a company could document the location in which a given container of medicine was stored and the temperature and humidity conditions that existed while it was there. Monitoring provides added assurance that space conditions match product storage specifications.50 Ⅵ 22.00-28.00-21.50-29.50 Ⅵ 21.50-31.00-23.50 Ⅵ 23. A monitoring system uses a matrix of permanent sensors that record the same basic data collected in mapping studies.50
Putting data to work
The graphs and charts and on-site observations become part of a complete report that notes any undesirable temperature or humidity patterns and recommends potential remedies.50-23.50 Ⅵ 24.50-24. questionnaires.50-30. • Changing the location of heating devices.00 Ⅵ 30. facility owners can take a wide range of measures.00 Ⅵ 28.
About the Authors
Mr. In 1998. He has also been Bio-Pharm team leader and instructor. In his 19 years with Johnson Controls. He is responsible for the direction and leadership of the Global Validation Services Business Unit.storage facility environmental control strategy can be implemented. and quality assurance. Weddle has held numerous positions in application engineering. solutions development.
. Weddle is the Global Manager of Critical Environments for Johnson Controls. He holds a Bachelor of Science degree in Mechanical Engineering from Purdue University and is a licensed HPAC contractor. Inc. Mr. commit to continuous improvement. Recently. • Adapt: Change the environmental control system as necessary. Mr.
Temperature mapping and monitoring. Mr. That group developed and maintains a set of validation standards that are deployed throughout the corporation and provides consulting services to both internal and external customers. Weddle provides validation program development. operating practices and data reporting in place to enable those conditions to be met. • Act: Put equipment. direct business unit sales and area technical support. Mr. Mr. He holds a Bachelor of Science degree in Mechanical Engineering from Purdue University. Such a strategy has four essential parts: • Analyze: Determine the space conditions that must be maintained. • Audit: Track space temperatures continuously and evaluate conditions as needed. when conducted by a qualified provider. are high-value quality-assurance tools with the potential to aid in regulatory compliance. Companies in need of mapping and monitoring services should consult a provider not only with experience in facility environmental control but well versed in the pharmaceutical and biomedical industries and with a comprehensive knowledge of FDA validation requirements. Benton has been continuously involved with all aspects of delivering solutions to the Life Sciences Market. project management. During his ten years with Johnson Controls. Benton has focused on delivering solutions to the Life Sciences Marketplace that address the FDA’s 21 CFR Part 11 regulations concerning Electronic Records and Electronic Signatures. Benton is currently a Critical Environments Solutions Consultant in the Johnson Controls Validation Support Services group. Mr. Benton accepted a position with the Validation Support Services group.
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