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Such a strategy has four essential parts:)Tj 1.4653 -2 TD 0 Tc ()Tj /F6 1 Tf 0.8473 0 TD -0.0001 Tc (Analyze:)Tj /F2 1 Tf 3.6943 0 TD (Determine the space conditions that must be)Tj -3.6943 -1.4 TD (maintained.)Tj -0.8473 -2 TD 0 Tc ()Tj /F6 1 Tf 0.8473 0 TD -0.0002 Tc (Act:)Tj /F2 1 Tf 1.8054 0 TD -0.0001 Tc (Put equipment, operating practices and data)Tj -1.8054 -1.4 TD (reporting in place to enable those conditions to be)Tj T* -0.0002 Tc (met.)Tj -0.8473 -2 TD 0 Tc ()Tj /F6 1 Tf 0.8473 0 TD -0.0001 Tc (Audit:)Tj /F2 1 Tf 2.6394 0 TD (Track space temperatures continuously and)Tj -2.6394 -1.4 TD (evaluate conditions as needed.)Tj -0.8473 -2 TD 0 Tc ()Tj /F6 1 Tf 0.8473 0 TD -0.0001 Tc (Adapt:)Tj /F2 1 Tf 2.8616 0 TD (Change the environmental control system as)Tj -2.8616 -1.4 TD (necessary; commit to continuous improvement.)Tj /F6 1 Tf 12 0 0 12 54 508.5002 Tm (Conclusion)Tj /F2 1 Tf 10 0 0 10 66 488.5002 Tm (Temperature mapping and monitoring, when conducted)Tj -1.2 -1.4 TD (by a qualified provider, are high-value quality-assurance)Tj T* (tools with the potential to aid in regulatory compliance.)Tj T* (Companies in need of mapping and monitoring services)Tj T* (should consult a provider not only with experience in facility)Tj T* (environmental control but well versed in the pharmaceutical)Tj T* (and biomedical industries and with a comprehensive knowl-)Tj T* (edge of FDA validation requirements.)Tj /F5 1 Tf 12 0 0 12 318 711.0002 Tm (About the Authors)Tj /F7 1 Tf 10 0 0 10 330 692.0002 Tm (Mr. Weddle is the Global Manager of Critical)Tj -1.2 -1.4 TD (Environments for Johnson Controls, Inc. He is responsible)Tj T* (for the direction and leadership of the Global Validation)Tj T* (Services Business Unit. Mr. Weddle provides validation pro-)Tj T* (gram development, solutions development, direct business)Tj T* (unit sales and area technical support. In his 19 years with)Tj T* (Johnson Controls, Mr. Weddle has held numerous positions)Tj T* (in application engineering, project management, and quality)Tj T* (assurance. He has also been Bio-Pharm team leader and)Tj T* (instructor. He holds a Bachelor of Science degree in)Tj T* (Mechanical Engineering from Purdue University and is a)Tj T* (licensed HPAC contractor.)Tj 1.2 -3.4 TD (Mr. Benton is currently a Critical Environments Solutions)Tj -1.2 -1.4 TD (Consultant in the Johnson Controls Validation Support)Tj T* (Services group. He holds a Bachelor of Science degree in)Tj T* (Mechanical Engineering from Purdue University. During his)Tj T* (ten years with Johnson Controls, Mr. Benton has been con-)Tj T* (tinuously involved with all aspects of delivering solutions to)Tj T* (the Life Sciences Market. In 1998, Mr. Benton accepted a)Tj T* (position with the Validation Support Services group. That)Tj T* (group developed and maintains a set of validation standards)Tj T* (that are deployed throughout the corporation and provides)Tj T* (consulting services to both internal and external customers.)Tj T* (Recently, Mr. Benton has focused on delivering solutions to)Tj T* (the Life Sciences Marketplace that address the FDAs 21 CFR)Tj T* (Part 11 regulations concerning Electronic Records and)Tj T* (Electronic Signatures.)Tj ET /Cs5 CS 0.161 0.145 0.149 SC 0 J 0 j 1 w 10 M []0 d 54 54 m 558 54 l S BT /F4 1 Tf 12 0 0 12 54 40.4336 Tm 0 Tc (4)Tj ET Q endstream endobj 13 0 obj << /Type /Page /QITE_pageid << /I 45 0 R /F 59 0 R /D (D:20041201122853)/P 5 >> /Resources 14 0 R /Contents 15 0 R /MediaBox [ 0 0 612 792 ] /CropBox [ 0 0 612 792 ] /Rotate 0 /Parent 47 0 R >> endobj 14 0 obj << /ProcSet [ /PDF /Text ] /Font << /F2 24 0 R /F4 25 0 R /F6 27 0 R >> /ExtGState << /GS1 56 0 R >> /ColorSpace << /Cs5 53 0 R >> >> endobj 15 0 obj << /Length 5826 >> stream 1 g /GS1 gs 9 783 m 9 783 l f q 1 i -1 793 614 -794 re 9 783 m W n 0 792.06 612 -792 re W n BT /F2 1 Tf 47.3 0 0 47.3 50.357 684.5008 Tm /Cs5 cs 0.161 0.145 0.149 sc 0 Tc 0 Tw (I)Tj 10 0 0 10 62.25 712.5008 Tm -0.0001 Tc (t is said that if you stand with one foot in scalding water)Tj 0 -1.4 TD (and the other in a block of ice, on average you are )Tj T* (comfortable. )Tj 0.375 -2 TD (That adage applies to large warehousing spaces regulated)Tj -1.2 -1.4 TD (solely by thermostats. A space measuring tens or hundreds)Tj T* (of thousands of square feet, reaching 40 to 80 feet high,)Tj T* (divided by floor-to-ceiling racks, and without a sophisticated)Tj T* (climate-control system, is likely to exhibit zones of different)Tj T* (temperatures, even when wall thermostats say conditions)Tj T* (are in the desired range.)Tj 1.2 -2 TD (While that may be of little consequence for storage of)Tj -1.2 -1.4 TD (office supplies, canned goods, hardware, toys, books and)Tj T* (other non-perishables, it raises concerns in the storage of)Tj T* (temperature- and humidity-sensitive product.)Tj 1.2 -2 TD (Makers of pharmaceuticals and medical devices, deeply)Tj -1.2 -1.4 TD (concerned about consumer safety, product quality, and FDA)Tj T* (compliance, are starting to take notice. Today, simple tech-)Tj T* (nology enables such companies to monitor conditions in)Tj T* (three dimensions within raw-material or finished product)Tj T* (storage areas.)Tj 1.2 -2 TD (This technology, using digital sensors from which tem-)Tj -1.2 -1.4 TD (perature and humidity data can be downloaded to a comput-)Tj T* (er and analyzed by simple software, can cost-effectively)Tj T* (provide a complete profile of storage-space conditions,)Tj T* (either as a snapshot in time \(temperature mapping\) or)Tj T* (continuously \(temperature monitoring\).)Tj 1.2 -2 TD (In either case, the warehouse owner or operator receives)Tj -1.2 -1.4 TD (hard data documenting that product is being stored at its)Tj T* (specified conditions, or pointing out potential problem areas)Tj T* (that should be addressed. Mapping and monitoring can be)Tj T* (valuable quality assurance tools for spaces that store bulk)Tj T* (and final pharmaceutical, biomedical products, ingredients,)Tj T* (medical devices, and other sensitive materials.)Tj /F6 1 Tf 12 0 0 12 54 200.5008 Tm (The state of storage)Tj /F2 1 Tf 10 0 0 10 66 180.5008 Tm (Pharmaceutical and biomedical companies face exacting)Tj -1.2 -1.4 TD (FDA standards affecting production. Space temperature and)Tj T* (humidity, air quality, equipment sanitation, and many other)Tj T* (conditions must be strictly controlled and validated. Those)Tj T* (stringent requirements thus far do not extend to warehous-)Tj T* (ing. Manufacturers are simply required to store perishable)Tj T* (product in the temperature, humidity and light conditions)Tj 26.4 61.5999 TD (they have found necessary to sustain product safety and )Tj 0 -1.4 TD (efficacy, based on stability testing. )Tj 1.2 -2 TD (Most product warehouses have limited environmental)Tj -1.2 -1.4 TD (control. Packaging obviously protects products against con-)Tj T* (tamination and degradation from light, but the contents)Tj T* (remain vulnerable to temperature and, in some cases,)Tj T* -0.0051 Tc (humidity. Warehouses typically do not have air conditioning)Tj T* -0.0001 Tc (the majority rely on ventilation alone or, in colder climates,)Tj T* (ventilation and heating.)Tj 1.2 -2 TD (The warehouse environment is typically regulated by sim-)Tj -1.2 -1.4 TD (ple line-voltage thermostats that activate heaters or ventila-)Tj T* (tors when temperatures rise above a setpoint. The building)Tj T* (may have ceiling fans to circulate the air. Facility personnel)Tj T* (may crudely regulate temperature by keeping loading dock)Tj T* (doors open or closed during extremely hot or cold days.)Tj 1.2 -2 TD (Historically, pharmaceutical and medical device produc-)Tj -1.2 -1.4 TD (ers have not owned the warehouses, instead leasing the)Tj T* (space from development companies, which may also man-)Tj T* (age and operate the buildings. Warehouses in these sectors)Tj T* (tend to experience high throughput; spaces are reconfigured)Tj T* (often as new products come in and as demand patterns)Tj T* (change. Underlying assumptions seem to be that 1\) the)Tj T* (product stays in the warehouse for only a week or a few)Tj T* (days, so variation in environmental conditions during that)Tj T* (time will not degrade the product significantly, or 2\) building)Tj T* (conditions veer out of control only in extremely hot or)Tj T* (extremely cold weather, which occurs on just a few days out)Tj T* (of the year, with little likelihood of product degradation )Tj T* (during those days. )Tj /F6 1 Tf 12 0 0 12 318 268.5001 Tm (Emerging concerns)Tj /F2 1 Tf 10 0 0 10 330 248.5002 Tm (In recent years, as FDA scrutiny grows stricter, and as)Tj -1.2 -1.4 TD (consumers and the healthcare industry raise their expecta-)Tj T* (tions for product effectiveness and safety, manufacturers are)Tj T* (focusing more attention on product storage. )Tj 1.2 -2 TD (For example, the Society for Life Sciences Professionals)Tj -1.2 -1.4 TD (\(ISPE\) is developing a new volume in its series of Baseline)Tj 5 0 0 5 547.8706 176.2502 Tm 0 Tc ()Tj 10 0 0 10 318 158.5002 Tm -0.0001 Tc (Pharmaceutical Engineering Guides devoted specifically to)Tj T* (packaging, labeling and warehousing operations \(planned)Tj T* (for release in mid-2004\). The warehousing section will cover)Tj T* (topics including incoming materials, in-process materials,)Tj T* (shipment of goods, facility planning, flow of materials, )Tj T* (utilities, environment, and equipment operations.)Tj ET /Cs5 CS 0.161 0.145 0.149 SC 0 J 0 j 1 w 10 M []0 d 54 54 m 558 54 l S BT /F4 1 Tf 12 0 0 12 551.3291 40.4336 Tm 0 Tc (1)Tj ET Q endstream endobj 16 0 obj << /Type /Page /QITE_pageid << /I 45 0 R /F 59 0 R /D (D:20041201122853)/P 6 >> /Resources 17 0 R /Contents 18 0 R /MediaBox [ 0 0 612 792 ] /CropBox [ 0 0 612 792 ] /Rotate 0 /Parent 47 0 R >> endobj 17 0 obj << /ProcSet [ /PDF /Text ] /Font << /F2 24 0 R /F4 25 0 R /F6 27 0 R >> /ExtGState << /GS1 56 0 R >> /ColorSpace << /Cs5 53 0 R >> >> endobj 18 0 obj << /Length 5619 >> stream 1 g /GS1 gs 9 783 m 9 783 l f q 1 i -1 793 614 -794 re 9 783 m W n 0 792.06 612 -792 re W n BT /F2 1 Tf 10 0 0 10 66 712.5002 Tm /Cs5 cs 0.161 0.145 0.149 sc -0.0001 Tc 0 Tw (Meanwhile, temperature and humidity sensing technology)Tj -1.2 -1.4 TD (has advanced, making measurement and monitoring easier,)Tj T* (more accurate and less costly. In addition, experiences in)Tj T* (other industries provide lessons on the importance of envi-)Tj T* (ronmental control. For example, computers and servers)Tj T* (operated by Internet service providers, financial service)Tj T* (firms, telecommunication companies and online merchants)Tj T* (have proven highly vulnerable to temperature and humidity)Tj T* (outside equipment makers specifications.)Tj 1.2 -2 TD (Companies that inadequately control their computer room)Tj -1.2 -1.4 TD (environments have faced premature equipment failure and)Tj T* (the threat of critical network outages potentially affecting)Tj T* (millions of customers not just when overall room tempera-)Tj T* (ture and humidity slip out of prescribed ranges but when)Tj T* (hot spots and cold spots exist within rooms. Detailed)Tj T* (temperature mapping and monitoring have helped many of)Tj T* (these companies to identify environmental problems and)Tj T* (take measures to bring their computer rooms back into )Tj T* (control. )Tj 1.2 -2 TD (Certainly, out-of-spec conditions in a drug warehouse will)Tj -1.2 -1.4 TD (not cause anything as sudden or dramatic as the failure of a)Tj T* (cellular telephone network or the crash of a popular e-com-)Tj T* (merce web site. Still, no pharmaceutical or medical device)Tj T* (manufacturer wants to face the prospect of a consumer)Tj T* (safety concern involving its product that could be traced)Tj T* (back to questionable or poorly documented storage prac-)Tj T* (tices. Against such events, temperature mapping and moni-)Tj T* (toring can provide cost-effective insurance.)Tj /F6 1 Tf 12 0 0 12 54 282.5002 Tm 0 Tc (T)Tj 0.426 0 TD -0.0001 Tc (aking the temperature)Tj /F2 1 Tf 10 0 0 10 72 262.5001 Tm (Large, open spaces with high ceilings are vulnerable to)Tj -1.8 -1.4 TD (temperature and humidity variation, especially if they have)Tj T* (only rudimentary heating, ventilating and air conditioning)Tj T* (\(HVAC\) systems. 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Each sensor bears a serial number that is matched with)Tj T* (its coordinates.)Tj 1.2 -2 TD -0.0101 Tc (Typically, sensors operate for one to or two weeks, taking)Tj -1.2 -1.4 TD (measurements every 10 minutes. This enables the building)Tj T* (owner to track accurately how conditions change during a typ-)Tj T* 0.0001 Tw (ical working day, overnight, and through weekends. Ideally,)Tj T* (mapping studies should be performed twice during mid-)Tj T* 0 Tw (summer and mid-winter to account for seasonal effects.)Tj 1.2 -2 TD -0.0001 Tc (When the measurements are complete, data is down-)Tj -1.2 -1.4 TD (loaded, and the mean kinetic temperature \(MKT\) is calculat-)Tj T* (ed for all the data points to determine whether conditions are)Tj T* (within prescribed limits. Software generates multiple two-)Tj T* (dimensional and three-dimensional color-coded charts and)Tj T* (graphs that visually show temperature profiles and make it)Tj T* (easy to identify specific problem areas \(see accompanying)Tj T* (examples\). )Tj 1.2 -2 TD (In cases where significant temperature anomalies are)Tj -1.2 -1.4 TD (documented, control specialists visit the facility to look for)Tj T* (the probable causes.)Tj ET /Cs5 CS 0.161 0.145 0.149 SC 0 J 0 j 1 w 10 M []0 d 54 54 m 558 54 l S BT /F4 1 Tf 12 0 0 12 54 40.4336 Tm 0 Tc (2)Tj ET Q endstream endobj 19 0 obj << /Type /Page /QITE_pageid << /I 45 0 R /F 59 0 R /D (D:20041201122853)/P 7 >> /Resources 20 0 R /Contents 21 0 R /MediaBox [ 0 0 612 792 ] /CropBox [ 0 0 612 792 ] /Rotate 0 /Parent 47 0 R >> endobj 20 0 obj << /ProcSet [ /PDF /Text /ImageC ] /Font << /F2 24 0 R /F4 25 0 R /F6 27 0 R /F8 29 0 R /F9 30 0 R >> /XObject << /Im1 22 0 R /Im2 23 0 R >> /ExtGState << /GS1 56 0 R >> /ColorSpace << /Cs5 53 0 R >> >> endobj 21 0 obj << /Length 6840 >> stream 1 g /GS1 gs 9 783 m 9 783 l f q 1 i -1 793 614 -794 re 9 783 m W n 0 792.06 612 -792 re W n BT /F2 1 Tf 10 0 0 10 332.653 712.5002 Tm /Cs5 cs 0.161 0.145 0.149 sc 0 Tc 0 Tw ()Tj 0.8473 0 TD -0.0001 Tc (Repositioning racks or shelving to improve air )Tj 0 -1.4 TD (circulation.)Tj -0.8473 -2 TD 0 Tc ()Tj 0.8473 0 TD -0.0001 Tc (Changing the location of heating devices.)Tj -0.8473 -2 TD 0 Tc ()Tj 0.8473 0 TD -0.0001 Tc 0.0001 Tw (Adding air conditioning.)Tj -0.8473 -2 TD 0 Tc 0 Tw ()Tj 0.8473 0 TD -0.0001 Tc (Improving ventilation.)Tj -0.8473 -2 TD 0 Tc ()Tj 0.8473 0 TD -0.0001 Tc (Installing more or larger-capacity fans.)Tj -0.8473 -2 TD 0 Tc ()Tj 0.8473 0 TD -0.0001 Tc (Adding humidification or dehumidification.)Tj -0.8473 -2 TD 0 Tc ()Tj 0.8473 0 TD -0.0001 Tc (Installing an HVAC control system.)Tj /F6 1 Tf 12 0 0 12 318 544.5002 Tm 0 Tc (T)Tj 0.426 0 TD -0.0001 Tc (aking the next step)Tj /F2 1 Tf 10 0 0 10 336 524.5002 Tm (A temperature mapping study provides a one-time view)Tj -1.8 -1.4 TD (of storage conditions. Because facility configurations and)Tj T* (product mixes can change frequently, long-term temperature)Tj T* (and humidity monitoring can be advantageous. )Tj 1.8 -2 TD (A monitoring system uses a matrix of permanent sen-)Tj -1.8 -1.4 TD (sors that record the same basic data collected in mapping)Tj T* (studies. The sensors can be easily moved as the storage)Tj T* (scheme or product mix changes.)Tj 1.8 -2 TD (An attractive option is to install sensors that communi-)Tj -1.8 -1.4 TD (cate continuously with a Part 11 compliant building automa-)Tj T* (tion system \(BAS\). The BAS can be programmed with alarm)Tj T* (setpoints so that personnel on duty around the clock can)Tj T* (alert service technicians by e-mail, page or telephone to)Tj T* (adverse changes in space conditions.)Tj 1.8 -2 TD (Monitoring provides added assurance that space condi-)Tj -1.8 -1.4 TD (tions match product storage specifications. A continuous)Tj T* (record also can be valuable in case of an FDA inquiry or)Tj T* (audit especially if the monitoring information is combined)Tj T* (with the detailed inventory data pharmaceutical and biomed-)Tj T* (ical companies already keep. With both kinds of data in)Tj T* 0.0001 Tw (hand, a company could document the location in which a)Tj T* 0 Tw (given container of medicine was stored and the temperature)Tj T* (and humidity conditions that existed while it was there. )Tj /F6 1 Tf 12 0 0 12 318 164.5002 Tm 0 Tc (T)Tj 0.426 0 TD -0.0001 Tc (oward strategic planning)Tj /F2 1 Tf 10 0 0 10 330 144.5002 Tm (Temperature mapping is a key first step to understanding)Tj -1.2 -1.4 TD (environmental conditions in critical storage facilities. When)Tj T* (combined with ongoing temperature monitoring, a long-term)Tj /F6 1 Tf 12 0 0 12 54 333 Tm (Putting data to work)Tj /F2 1 Tf 10 0 0 10 66 313 Tm (The graphs and charts and on-site observations become)Tj -1.2 -1.4 TD (part of a complete report that notes any undesirable temper-)Tj T* (ature or humidity patterns and recommends potential reme-)Tj T* (dies. The report contains copies of all sensor calibration)Tj T* (certificates, questionnaires, and other information used to)Tj T* (complete the study. If the mapping study indicates undesir-)Tj T* (able conditions, facility owners can take a wide range of)Tj T* (measures, depending on the problems severity. 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