temp mapping white paper

7/27/2019 Temp Mapping White Paper

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Temperature Mappingand Monitoring:Quality-Control Tools

for Pharmaceuticaland Medical DeviceWarehousing

By Gregory Brian Weddle

Global Manager Critical Environments

Raymond L. Benton

Critical Environments Solutions Consultant



It is said that if you stand with one foot in scalding water

and the other in a block of ice, on average you are

comfortable.

That adage applies to large warehousing spaces regulated

solely by thermostats. A space measuring tens or hundreds

of thousands of square feet, reaching 40 to 80 feet high,divided by floor-to-ceiling racks, and without a sophisticated

climate-control system, is likely to exhibit zones of different

temperatures, even when wall thermostats say conditions

are in the desired range.

While that may be of little consequence for storage of

office supplies, canned goods, hardware, toys, books and

other non-perishables, it raises concerns in the storage of

temperature- and humidity-sensitive product.

Makers of pharmaceuticals and medical devices, deeply

concerned about consumer safety, product quality, and FDAcompliance, are starting to take notice. Today, simple tech-

nology enables such companies to monitor conditions in

three dimensions within raw-material or finished product

storage areas.

This technology, using digital sensors from which tem-

perature and humidity data can be downloaded to a comput-

er and analyzed by simple software, can cost-effectively

provide a complete profile of storage-space conditions,

either as a snapshot in time (temperature mapping) or

continuously (temperature monitoring).

In either case, the warehouse owner or operator receives

hard data documenting that product is being stored at its

specified conditions, or pointing out potential problem areas

that should be addressed. Mapping and monitoring can be

valuable quality assurance tools for spaces that store bulk

and final pharmaceutical, biomedical products, ingredients,

medical devices, and other sensitive materials.

The state of storage

Pharmaceutical and biomedical companies face exactingFDA standards affecting production. Space temperature and

humidity, air quality, equipment sanitation, and many other

conditions must be strictly controlled and validated. Those

stringent requirements thus far do not extend to warehous-

ing. Manufacturers are simply required to store perishable

product in the temperature, humidity and light conditions

they have found necessary to sustain product safety and

efficacy, based on stability testing.

Most product warehouses have limited environmental

control. Packaging obviously protects products against con-

tamination and degradation from light, but the contents

remain vulnerable to temperature and, in some cases,humidity. Warehouses typically do not have air conditioning–

the majority rely on ventilation alone or, in colder climates,

ventilation and heating.

The warehouse environment is typically regulated by sim-

ple line-voltage thermostats that activate heaters or ventila-

tors when temperatures rise above a setpoint. The building

may have ceiling fans to circulate the air. Facility personnel

may crudely regulate temperature by keeping loading dock

doors open or closed during extremely hot or cold days.

Historically, pharmaceutical and medical device produc-ers have not owned the warehouses, instead leasing the

space from development companies, which may also man-

age and operate the buildings. Warehouses in these sectors

tend to experience high throughput; spaces are reconfigured

often as new products come in and as demand patterns

change. Underlying assumptions seem to be that 1) the

product stays in the warehouse for only a week or a few

days, so variation in environmental conditions during that

time will not degrade the product significantly, or 2) building

conditions veer out of control only in extremely hot or

extremely cold weather, which occurs on just a few days outof the year, with little likelihood of product degradation

during those days.

Emerging concerns

In recent years, as FDA scrutiny grows stricter, and as

consumers and the healthcare industry raise their expecta-

tions for product effectiveness and safety, manufacturers are

focusing more attention on product storage.

For example, the Society for Life Sciences Professionals

(ISPE) is developing a new volume in its series of Baseline®

Pharmaceutical Engineering Guides devoted specifically to

packaging, labeling and warehousing operations (planned

for release in mid-2004). The warehousing section will cover

topics including incoming materials, in-process materials,

shipment of goods, facility planning, flow of materials,

utilities, environment, and equipment operations.

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Meanwhile, temperature and humidity sensing technology

has advanced, making measurement and monitoring easier,

more accurate and less costly. In addition, experiences in

other industries provide lessons on the importance of envi-

ronmental control. For example, computers and servers

operated by Internet service providers, financial service

firms, telecommunication companies and online merchants

have proven highly vulnerable to temperature and humidity

outside equipment makers’ specifications.

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 tempera-

ture and humidity slip out of prescribed ranges but when

“hot spots” and “cold spots” exist within rooms. Detailed

temperature mapping and monitoring have helped many of

these companies to identify environmental problems andtake measures to bring their computer rooms back into

control.

Certainly, 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-com-

merce web site. Still, 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 prac-

tices. Against such events, temperature mapping and moni-

toring can provide cost-effective insurance.

Taking the temperature

Large, open spaces with high ceilings are vulnerable to

temperature and humidity variation, especially if they have

only rudimentary heating, ventilating and air conditioning

(HVAC) systems. For example:

• Areas near the ceiling or exterior walls may stay

warmer or cooler in response to temperatures outside.

• Temperatures may stratify simply because warmer air

rises.

• Temperatures will be higher near heaters, especially if

fans are undersized or improperly placed and so inca-

pable of mixing the heated air effectively.

• Racking and shelving configurations may contribute to

“hot spots” by obstructing air circulation.

• Doors left open to regulate overall temperature will

affect conditions around nearby racks.

These and other factors may create substantial tempera-

ture differences from floor to ceiling and within building

zones. In fact, variations of several degrees C are common in

large storage facilities.

In such facilities, temperature mapping is a simple pro-

cedure. The basic measurement tools are small, battery-

operated sensors that measure temperature, or both

temperature and humidity, automatically at prescribed inter-

vals. At the end of the measurement period, sensor data is

downloaded to a computer and analyzed. This technology

enables detailed mapping studies with the bare minimum of

labor and so at affordable cost.

Sensors are placed in a grid pattern at regular intervals

around the warehouse, typically at three levels: near the

floor, near the ceiling, and at a midpoint. The sensors attach

to the racks by way of simple plastic tie wraps. A map of the

facility is created and the coordinates of all sensors record-

ed. Each sensor bears a serial number that is matched with

its coordinates.

Typically, sensors operate for one to or two weeks, taking

measurements every 10 minutes. This enables the building

owner to track accurately how conditions change during a typ-ical working day, overnight, and through weekends. Ideally,

mapping studies should be performed twice – during mid-

summer and mid-winter – to account for seasonal effects.

When the measurements are complete, data is down-

loaded, and the mean kinetic temperature (MKT) is calculat-

ed for all the data points to determine whether conditions are

within prescribed limits. Software generates multiple two-

dimensional 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).

In cases where significant temperature anomalies are

documented, control specialists visit the facility to look for

the probable causes.

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• Repositioning racks or shelving to improve air

circulation.

• Changing the location of heating devices.

• Adding air conditioning.

• Improving ventilation.

• Installing more or larger-capacity fans.

• Adding humidification or dehumidification.

• Installing an HVAC control system.

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, long-term temperature

and humidity monitoring can be advantageous.

A monitoring system uses a matrix of permanent sen-

sors that record the same basic data collected in mapping

studies. The sensors can be easily moved as the storage

scheme or product mix changes.

An attractive option is to install sensors that communi-

cate continuously with a Part 11 compliant building automa-

tion system (BAS). The BAS can be programmed with alarm

setpoints so that personnel on duty around the clock can

alert service technicians by e-mail, page or telephone to

adverse changes in space conditions.

Monitoring provides added assurance that space condi-

tions match product storage specifications. 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 biomed-

ical companies already keep. With both kinds of data in

hand, 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.

Toward strategic planning

Temperature mapping is a key first step to understanding

environmental conditions in critical storage facilities. When

combined with ongoing temperature monitoring, a long-term

Putting data to workThe graphs and charts and on-site observations become

part of a complete report that notes any undesirable temper-

ature or humidity patterns and recommends potential reme-

dies. The report contains copies of all sensor calibration

certificates, questionnaires, and other information used to

complete the study. If the mapping study indicates undesir-

able conditions, facility owners can take a wide range of

measures, depending on the problems’ severity. They

include:

• Removing product from problem areas (such as hotspots near ceilings).

• Changing work practices (such as keeping doors open

or closed).

• Changing racking or shelving configurations.

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Summary of Maximum Temperature Data Points CollectedSummer 2002

Row Number

Summary of Minimum Temperature Data Points CollectedSummer 2002

Row Number

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storage facility environmental control strategy can be imple-

mented. Such a strategy has four essential parts:

• Analyze: Determine the space conditions that must be

maintained.

• Act: Put equipment, operating practices and data

reporting in place to enable those conditions to be

met.

• Audit: Track space temperatures continuously and

evaluate conditions as needed.

• Adapt: Change the environmental control system as

necessary; commit to continuous improvement.

Conclusion

Temperature mapping and monitoring, when conductedby 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 knowl-

edge of FDA validation requirements.

About the Authors

Mr. Weddle is the Global Manager of Critical

Environments for Johnson Controls, Inc. He is responsible

for the direction and leadership of the Global Validation

Services Business Unit. Mr. Weddle provides validation pro-

gram development, solutions development, direct business unit sales and area technical support. In his 19 years with

Johnson Controls, Mr. Weddle has held numerous positions

in application engineering, project management, and quality

assurance. He has also been Bio-Pharm team leader and

instructor. He holds a Bachelor of Science degree in

Mechanical Engineering from Purdue University and is a

licensed HPAC contractor.

Mr. Benton is currently a Critical Environments Solutions

Consultant in the Johnson Controls Validation Support

Services group. He holds a Bachelor of Science degree in

Mechanical Engineering from Purdue University. During his

ten years with Johnson Controls, Mr. Benton has been con-

tinuously involved with all aspects of delivering solutions to

the Life Sciences Market. In 1998, Mr. Benton accepted a

position with the Validation Support Services group. 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.

Recently, Mr. 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.

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