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1
ROTRONIC TECHNICAL NOTE
basis for their own regulations. Wouldn’t the FDA guide- required and therefore a continu-
The guideline is the: ously monitoring system may
lines be the best to use
be redundant. However, in some
since they should be the cases an additional monitoring
Technical supplement to WHO most stringent? system for equipment can enhance
Technical Report Series, No. 961, record keeping and add as a sec-
Not necessarily. The FDA guide-
2011 Annex 9: Model guidance for ondary verification of the equip-
lines tell very little about how to
the storage and transport of time ment sensors.
conduct a mapping study or how to
and temperature–sensitive phar- environmentally monitor an area.
maceutical products WHO.org
FDA regulations simply state that a With all of these guideline
Supplement 8: Temperature map-
mapping study is needed. there must be something
ping of storage areas
more specific on how to
Some of these guidelines prepare and conduct a
Why are there so many bring up continuous envi- humidity and temperature
different regulations? ronmental monitoring. mapping?
Will I be required to do that?
The regulations have grown organi- For storage areas the WHO guide-
cally over time and sometimes can In storage areas a continuous line listed above is an excellent
cause confusion. Growth of these monitoring system is always a resource.
seemingly competing regulations is good idea. Your mapping study will For environmental chambers
due to factors such as industry determine the hot and cold zones and other equipment, you may
needs, different application needs, for “worst case” sensor placement. want to explore the “ISPE Con-
and regional or professional These worst case locations should trolled Temperature Chamber Map-
requirements. In most cases, the be considered when installing a ping (2012)”. This does provide
guidelines include guidance for permanent monitoring system. The some very good concepts for map-
mapping in storage, production and number of sensors used for a per- ping (i.e. a minimum of 9 probes
cold chain applications. Global har- manent system will be greatly for chambers less than 2 meters
monization of some of these regula- reduced and may require only a cubed, and minimum 15 probes for
tions is an ongoing discussion and few sensors once the problem anything above 2 meters cubed to
will continue over many years. areas have been determined 20 meters cubed).
Since most of the guidelines simply through the mapping study. A con- All of these documents are
state the need for environmental tinuous monitoring system will there for guidance, but remember
mapping and monitoring they are bring peace of mind that your prod- that they are not intended to
near equal in their requirements. uct components, manufacturing replace any existing guidelines or
space, or storage space is kept to inhibit better practices. Guide-
within specified environmental
Is there one Regulation conditions.
lines are a great starting point and
provide direction, but solid science
that supersedes all others? For equipment chambers the with solid data and documentation
No single regulation or guidance mapping study is normally con- will help greatly to deliver a suc-
document supersedes all others. ducted to prove that the existing cessful mapping project.
The main considerations for your equipment’s control system is func-
mapping study will be determined tioning properly. The equipment
by your specific product, applica- may already have the necessary
tion and industry. sensors and documentation system