%PDF-1.4
%
1 0 obj
<<
/Type /Page
/Parent 47 0 R
/Resources 2 0 R
/Contents 3 0 R
/MediaBox [ 0 0 612 792 ]
/CropBox [ 0 0 612 792 ]
/Rotate 0
/QITE_pageid << /I 45 0 R /F 59 0 R /D (D:20041201122853)/P 1 >>
>>
endobj
2 0 obj
<<
/ProcSet [ /PDF /Text ]
/Font << /F2 24 0 R >>
/ExtGState << /GS1 56 0 R /GS2 55 0 R >>
/ColorSpace << /Cs5 53 0 R >>
>>
endobj
3 0 obj
<< /Length 6811 >>
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
36 0 0 36 253 597.0006 Tm
/Cs5 cs 0.161 0.145 0.149 sc
0 Tc
0 Tw
(T)Tj
0.396 0 TD
-0.0301 Tc
(emperature Mapping)Tj
-0.396 -1.1944 TD
(and Monitoring:)Tj
T*
[(Quality-Control T)73.8(ools )]TJ
0 -1.1667 TD
(for Pharmaceutical )Tj
T*
(and Medical Device)Tj
T*
0 Tc
(W)Tj
0.7849 0 TD
-0.0301 Tc
(arehousing)Tj
14 0 0 14 253 305.0006 Tm
-0.0001 Tc
[(By Gregor)-17.9(y Brian W)17.7(eddle)]TJ
0 -1.3571 TD
(Global Manager Critical Environments)Tj
0 -1.9286 TD
(Raymond L. Benton)Tj
0 -1.3571 TD
(Critical Environments Solutions Consultant)Tj
ET
/Cs5 CS 0.161 0.145 0.149 SC
0 J 0 j 1 w 10 M []0 d
253 231.1 m
534 231.1 l
253 323.5 m
534 323.5 l
S
Q
q
1 i
268.18 108 222.82 -48 re
488.962 240.001 m
W* n
-1 793 614 -794 re
9 783 m
W n
0 792.06 612 -792 re
W n
0 g
/GS2 gs
339.299 73.434 m
339.299 68.971 335.68 65.352 331.217 65.352 c
326.753 65.352 323.135 68.971 323.135 73.434 c
323.135 77.897 326.753 81.516 331.217 81.516 c
335.68 81.516 339.299 77.897 339.299 73.434 c
h
331.217 82.918 m
325.979 82.918 321.733 78.672 321.733 73.434 c
321.733 68.196 325.979 63.95 331.217 63.95 c
336.454 63.95 340.701 68.196 340.701 73.434 c
340.701 78.672 336.454 82.918 331.217 82.918 c
f
322.78 79.976 m
321.053 81.789 318.615 82.918 315.914 82.918 c
310.676 82.918 306.43 78.672 306.43 73.434 c
306.43 68.196 310.676 63.95 315.914 63.95 c
318.619 63.95 321.06 65.083 322.787 66.9 c
321.766 67.86 l
320.294 66.315 318.216 65.352 315.914 65.352 c
311.45 65.352 307.832 68.971 307.832 73.434 c
307.832 77.897 311.45 81.516 315.914 81.516 c
318.22 81.516 320.301 80.55 321.774 79 c
322.78 79.976 l
f
357.508 82.26 m
357.508 80.845 l
362.779 80.845 l
362.779 64.909 l
364.406 64.909 l
364.406 80.845 l
369.617 80.845 l
369.617 82.26 l
357.508 82.26 l
f
342.142 82.26 m
343.877 82.26 l
355.263 67.198 l
355.263 82.26 l
356.694 82.26 l
356.694 64.909 l
355.248 64.909 l
343.56 80.393 l
343.56 64.909 l
342.142 64.909 l
342.142 82.26 l
343.877 82.26 l
f
370.491 82.26 m
370.491 64.909 l
372.057 64.909 l
372.057 80.845 l
376.425 80.845 378.414 80.845 v
380.402 80.845 381.667 78.947 381.667 77.501 c
381.667 75.091 380.221 73.886 377.058 73.886 c
373.895 73.886 372.268 73.886 y
382.932 64.909 l
385.252 64.909 l
375.702 72.711 l
376.546 72.711 377.359 72.711 377.781 72.711 c
380.974 72.711 383.158 74.564 383.158 77.501 c
383.158 80.122 381.095 82.26 377.721 82.26 c
370.491 82.26 l
f
402.002 73.723 m
402.002 69.049 398.174 65.261 393.453 65.261 c
388.731 65.261 384.904 69.049 384.904 73.723 c
384.904 78.396 388.731 82.184 393.453 82.184 c
398.174 82.184 402.002 78.396 402.002 73.723 c
h
393.453 83.495 m
388 83.495 383.579 79.12 383.579 73.723 c
383.579 68.325 388 63.95 393.453 63.95 c
398.906 63.95 403.326 68.325 403.326 73.723 c
403.326 79.12 398.906 83.495 393.453 83.495 c
f
414.321 64.909 m
414.321 66.325 l
406.399 66.325 l
406.399 82.26 l
404.772 82.26 l
404.772 64.909 l
414.321 64.909 l
f
427.094 78.163 m
425.678 78.163 l
425.678 80.122 423.328 81.748 420.617 81.748 c
417.575 81.748 415.466 80.272 415.466 78.073 c
415.466 75.784 418.111 74.99 420.858 74.609 c
424.985 74.037 427.696 72.964 427.696 69.548 c
427.696 66.325 424.654 64.337 420.436 64.337 c
416.129 64.337 413.418 66.355 413.418 70.602 c
414.833 70.602 l
414.833 66.867 417.454 65.572 420.497 65.572 c
424.202 65.572 426.28 67.259 426.28 69.578 c
426.28 71.928 423.726 72.87 420.979 73.253 c
417.093 73.796 413.869 74.82 413.869 78.043 c
413.869 81.477 417.665 83.104 420.647 83.104 c
423.84 83.104 427.094 81.447 427.094 78.163 c
f
402.002 80.576 m
402.002 75.823 398.174 71.971 393.453 71.971 c
388.731 71.971 384.904 75.823 384.904 80.576 c
384.904 85.329 388.731 89.181 393.453 89.181 c
398.174 89.181 402.002 85.329 402.002 80.576 c
h
393.453 90.514 m
388 90.514 383.579 86.065 383.579 80.576 c
383.579 75.087 388 70.638 393.453 70.638 c
398.906 70.638 403.326 75.087 403.326 80.576 c
403.326 86.065 398.906 90.514 393.453 90.514 c
f
402.002 87.083 m
402.002 82.33 398.174 78.477 393.453 78.477 c
388.731 78.477 384.904 82.33 384.904 87.083 c
384.904 91.835 388.731 95.688 393.453 95.688 c
398.174 95.688 402.002 91.835 402.002 87.083 c
h
393.453 97.021 m
388 97.021 383.579 92.571 383.579 87.083 c
383.579 81.594 388 77.144 393.453 77.144 c
398.906 77.144 403.326 81.594 403.326 87.083 c
403.326 92.571 398.906 97.021 393.453 97.021 c
f
402.002 94.072 m
402.002 89.319 398.174 85.466 393.453 85.466 c
388.731 85.466 384.904 89.319 384.904 94.072 c
384.904 98.824 388.731 102.677 393.453 102.677 c
398.174 102.677 402.002 98.824 402.002 94.072 c
h
393.453 104.01 m
388 104.01 383.579 99.56 383.579 94.071 c
383.579 88.583 388 84.133 393.453 84.133 c
398.906 84.133 403.326 88.583 403.326 94.071 c
403.326 99.56 398.906 104.01 393.453 104.01 c
f
382.239 102.476 m
380.793 102.476 l
380.793 94.644 380.793 91.451 v
380.793 88.077 378.655 85.727 375.07 85.727 c
371.666 85.727 369.286 88.318 369.286 91.421 c
367.81 91.421 l
367.81 87.384 371.244 84.371 375.04 84.371 c
379.227 84.371 382.239 87.203 382.239 91.451 c
382.239 92.354 382.239 102.476 y
f
421.129 102.504 m
422.997 102.504 l
434.384 87.442 l
434.384 102.504 l
435.815 102.504 l
435.815 85.152 l
434.369 85.152 l
422.681 100.636 l
422.681 85.152 l
421.129 85.152 l
421.129 102.504 l
422.997 102.504 l
f
450.771 98.256 m
449.355 98.256 l
449.355 100.214 447.006 101.841 444.295 101.841 c
441.252 101.841 439.143 100.365 439.143 98.166 c
439.143 95.876 441.788 95.082 444.536 94.702 c
448.663 94.129 451.374 93.057 451.374 89.641 c
451.374 86.417 448.331 84.429 444.114 84.429 c
439.806 84.429 437.095 86.448 437.095 90.695 c
438.511 90.695 l
438.511 86.96 441.132 85.664 444.174 85.664 c
447.879 85.664 449.958 87.351 449.958 89.671 c
449.958 92.02 447.403 92.963 444.656 93.346 c
440.77 93.888 437.547 94.912 437.547 98.136 c
437.547 101.57 441.342 103.196 444.325 103.196 c
447.518 103.196 450.771 101.54 450.771 98.256 c
f
417.409 93.559 m
417.409 85.152 l
419.036 85.152 l
419.036 102.504 l
417.409 102.504 l
417.409 94.975 l
406.323 94.975 l
406.323 102.504 l
404.697 102.504 l
404.697 85.152 l
406.323 85.152 l
406.323 93.559 l
417.409 93.559 l
f
471.978 102.504 m
473.846 102.504 l
485.233 87.442 l
485.233 102.504 l
486.664 102.504 l
486.664 85.152 l
485.218 85.152 l
473.53 100.636 l
473.53 85.152 l
471.978 85.152 l
471.978 102.504 l
473.846 102.504 l
f
469.375 93.768 m
469.375 89.286 465.743 85.654 461.261 85.654 c
456.78 85.654 453.147 89.286 453.147 93.768 c
453.147 98.249 456.78 101.882 461.261 101.882 c
465.743 101.882 469.375 98.249 469.375 93.768 c
h
461.261 103.29 m
456.003 103.29 451.739 99.026 451.739 93.768 c
451.739 88.509 456.003 84.246 461.261 84.246 c
466.52 84.246 470.783 88.509 470.783 93.768 c
470.783 99.026 466.52 103.29 461.261 103.29 c
f
Q
endstream
endobj
7 1 obj
<< /Type /Metadata /Subtype /XML /Length 1385 >>
stream
2004-12-01T18:27:27Z
2004-12-01T12:29:59-06:00
Acrobat Distiller 5.0.5 for Macintosh
Patti Wack
QuarkXPress. 4.1: LaserWriter 8 8.7.1
White Paper 3806 Temp mapping
2004-12-01T18:27:27Z
2004-12-01T12:29:59-06:00
Patti Wack
2004-12-01T12:29:59-06:00
White Paper 3806 Temp mapping
Patti Wack
White Paper 3806 Temp mapping
endstream
endobj
10 0 obj
<<
/Type /Page
/Parent 47 0 R
/Resources 11 0 R
/Contents 12 0 R
/MediaBox [ 0 0 612 792 ]
/CropBox [ 0 0 612 792 ]
/Rotate 0
/QITE_pageid << /I 45 0 R /F 59 0 R /D (D:20041201122853)/P 4 >>
>>
endobj
11 0 obj
<<
/ProcSet [ /PDF /Text ]
/Font << /F2 24 0 R /F4 25 0 R /F5 26 0 R /F6 27 0 R /F7 28 0 R >>
/ExtGState << /GS1 56 0 R >>
/ColorSpace << /Cs5 53 0 R >>
>>
endobj
12 0 obj
<< /Length 3602 >>
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 54 712.5002 Tm
/Cs5 cs 0.161 0.145 0.149 sc
-0.0001 Tc
0 Tw
(storage facility environmental control strategy can be imple-)Tj
0 -1.4 TD
(mented. 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. For example:)Tj
1.4653 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Areas near the ceiling or exterior walls may stay)Tj
0 -1.4 TD
(warmer or cooler in response to temperatures outside.)Tj
-0.8473 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Temperatures may stratify simply because warmer air)Tj
0 -1.4 TD
(rises. )Tj
-0.8473 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Temperatures will be higher near heaters, especially if)Tj
0 -1.4 TD
(fans are undersized or improperly placed and so inca-)Tj
T*
(pable of mixing the heated air effectively. )Tj
25.5527 60.8 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Racking and shelving configurations may contribute to)Tj
0 -1.4 TD
(hot spots by obstructing air circulation. )Tj
-0.8473 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Doors left open to regulate overall temperature will)Tj
0 -1.4 TD
(affect conditions around nearby racks. )Tj
-1.1126 -2 TD
(These and other factors may create substantial tempera-)Tj
-1.2 -1.4 TD
(ture differences from floor to ceiling and within building)Tj
T*
(zones. In fact, variations of several degrees C are common in)Tj
T*
(large storage facilities.)Tj
1.8 -2 TD
(In such facilities, temperature mapping is a simple pro-)Tj
-1.8 -1.4 TD
(cedure. The basic measurement tools are small, battery-)Tj
T*
(operated sensors that measure temperature, or both)Tj
T*
(temperature and humidity, automatically at prescribed inter-)Tj
T*
(vals. At the end of the measurement period, sensor data is)Tj
T*
0.0001 Tw
(downloaded to a computer and analyzed. This technology)Tj
T*
0 Tw
(enables detailed mapping studies with the bare minimum of)Tj
T*
(labor and so at affordable cost.)Tj
1.8 -2 TD
(Sensors are placed in a grid pattern at regular intervals)Tj
-1.8 -1.4 TD
(around the warehouse, typically at three levels: near the)Tj
T*
(floor, near the ceiling, and at a midpoint. The sensors attach)Tj
T*
(to the racks by way of simple plastic tie wraps. A map of the)Tj
T*
(facility is created and the coordinates of all sensors record-)Tj
T*
(ed. 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. They)Tj
T*
(include:)Tj
1.4653 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Removing product from problem areas \(such as hot)Tj
0 -1.4 TD
(spots near ceilings\).)Tj
-0.8473 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Changing work practices \(such as keeping doors open)Tj
0 -1.4 TD
(or closed\).)Tj
-0.8473 -2 TD
0 Tc
()Tj
0.8473 0 TD
-0.0001 Tc
(Changing racking or shelving configurations.)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
(3)Tj
ET
Q
q
1 i
50.03 490.5 257.82 -138.31 re
558.002 40.434 m
W* n
-1 793 614 -794 re
9 783 m
W n
0 792.06 612 -792 re
W n
q
260.1112 0 0 139.6516 49.5 351.6684 cm
/Im1 Do
Q
Q
q
1 i
-1 793 614 -794 re
9 783 m
W n
0 792.06 612 -792 re
W n
/Cs5 cs 1 1 1 sc
50 727.25 241.28 -208.25 re
f
Q
q
1 i
50 727.25 241.28 -208.25 re
W* n
q
243.1886 0 0 209.5617 49.32 518.3682 cm
/Im2 Do
Q
Q
q
1 i
-1 793 614 -794 re
9 783 m
W n
0 792.06 612 -792 re
W n
/Cs5 cs 1 1 1 sc
47.53 510.87 260.76 -23.69 re
f
BT
/F9 1 Tf
8.8 0 0 8.8 56.6655 504.4569 Tm
0.161 0.145 0.149 sc
-0.0001 Tc
0 Tw
(Summary of Maximum Temperature Data Points Collected)Tj
10.5266 -1.2 TD
(Summer 2002)Tj
ET
1 1 1 sc
149.79 403.68 66.98 -18.41 re
f
BT
8 0 0 8 158.6172 397.8453 Tm
0.161 0.145 0.149 sc
(Row Number)Tj
ET
1 1 1 sc
46.8 720 254.71 -22.5 re
f
BT
8.8 0 0 8.8 53.8932 713.5891 Tm
0.161 0.145 0.149 sc
(Summary of Minimum Temperature Data Points Collected)Tj
10.415 -1.2 TD
(Summer 2002)Tj
ET
1 1 1 sc
201.85 547.24 71.89 -18.67 re
f
BT
8 0 0 8 201.8523 541.4146 Tm
0.161 0.145 0.149 sc
(Row Number)Tj
ET
1 1 1 sc
104.92 388.36 52.31 -37.46 re
f
BT
/F8 1 Tf
6 0 0 6 104.9205 383.8583 Tm
0.894 0.42 0.145 sc
0 Tc
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(31.00-31.50)Tj
/F8 1 Tf
1 0.835 0.357 sc
-1.1389 -1.5 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(30.50-31.00)Tj
/F8 1 Tf
0.992 0.792 0.624 sc
-1.1389 -1.5 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(30.00-30.50)Tj
/F8 1 Tf
0 0.573 0.494 sc
7.3219 3 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(29.50-30.00)Tj
/F8 1 Tf
0.525 0.773 0.725 sc
-1.1389 -1.5 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(29.00-29.50)Tj
/F8 1 Tf
0.537 0.827 0.878 sc
6.7407 1.5 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(28.50-29.00)Tj
/F8 1 Tf
0.945 0.929 0.824 sc
-1.1389 -1.5 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(28.00-28.50)Tj
ET
1 1 1 sc
250.83 697.68 51.39 -135.25 re
f
BT
/F8 1 Tf
6 0 0 6 250.8255 693.1805 Tm
0.898 0.902 0.906 sc
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(25.00-25.50)Tj
/F8 1 Tf
0 0.675 0.553 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(24.50-25.00)Tj
/F8 1 Tf
0.859 0.796 0 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(24.00-24.50)Tj
/F8 1 Tf
0.824 0.89 0.882 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(23.50-24.00)Tj
/F8 1 Tf
0.49 0.812 0.878 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(23.00-23.50)Tj
/F8 1 Tf
0 0.329 0.624 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(22.50-23.00)Tj
/F8 1 Tf
0.329 0.525 0.737 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(22.00-22.50)Tj
/F8 1 Tf
0 0.278 0.553 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(21.50-22.00)Tj
/F8 1 Tf
0.839 0.835 0.8 sc
-1.1389 -2.2333 TD
()Tj
/F2 1 Tf
0.161 0.145 0.149 sc
1.1389 0 TD
(21.00-21.50)Tj
ET
Q
endstream
endobj
22 0 obj
<< /Type /XObject /Subtype /Image /Width 260 /Height 140 /BitsPerComponent 8
/ColorSpace 53 0 R /Length 18964 /Filter /DCTDecode >>
stream
Adobe d
s !1AQa"q2B#R3b$r%C4Scs5D'6Tdt&
EFVU(eufv7GWgw8HXhx)9IYiy*:JZjz m !1AQa"q2#BRbr3$4CS%cs5DT
&6E'dtU7()euFVfvGWgw8HXhx9IYiy*:JZjz ? 6/63GfE9&bH"@5f$)˚8e3Q8Ȁ9hyb :wA *iy=