5 facility maintenance needs in the pharmaceutical industry

The pharmaceutical industry is governed by stringent regulations and
hundreds of best practices. This sector, which generates US$300 billion every
year according to the World Health Organisation (WHO), has critical climate
control concerns with companies needing to constantly monitor their
buildings’ climates to maintain product integrity.

Storage in the pharmaceutical industry, especially of biopharmaceuticals,
is an important aspect of the process, and isn’t as simple as stacking goods in
an unregulated basement.

According to McKinsey & Company, large-scale biotechnology
production facilities cost between US$200 million and $500 million to construct,
with ongoing requirement for expertise and maintenance adding to the overall
cost.

It is, therefore, important to ensure these expenditures don’t get out
of control. If a critical HVAC unit fails in a hospital or storage facility,
unregulated temperatures could spoil products and render them useless. HVAC technicians
and facility managers responsible for facility maintenance should be aware of five
key concerns: Temperature, Wireless Communications, Storage Design, Freezing,
and Temperature Logger Maintenance.

1. Temperature

WHO has developed a set of guidelines that require pharmaceutical
products to be held in structures in temperatures between 15°C and 25°C; certain
conditions may allow for 30°C. This is based on the assumption that particular
pharmaceuticals and medical supplies don’t require any specific storage conditions.

Web-accessible temperature loggers from testo can alert facility
managers to any fluctuations remotely, allowing them to notify workers
in the vicinity so that the issue can be resolved.

2. Wireless communications

WHO states wireless systems must continuously collect and buffer
information even during power or network outages. These temperature sensors
must be accurate enough to register temperature deviations of 0.5°C or
less.

WHO also advises facility managers to use platforms to manage and
monitor multiple devices for added convenience. The ability to remotely
calibrate sensors allows for a more fluid workflow and enables
professionals to exercise tighter communication protection settings, especially
in Internet of Things (IoT) applications.

3. Storage design

WHO requires all pharmaceutical products to be stored in weatherproof
arid buildings that are also designed to facilitate easy access. Simple
shelving is sufficient for conventional materials while more sensitive items
may require specialised rooms.

For instance, vaccines require refrigerated environments, and therefore
must be held in cold-chain rooms. The humidity of these rooms must be
stringently controlled by facility managers by monitoring regularly with
handheld devices.

4. Freezing

Some pharmaceutical products do need cold storage but should not be
stored in freezing conditions as it may result in irreparable damage. WHO notes
that injectable contraceptives, ergometrine, adrenaline, insulin and hepatitis
B vaccines will be rendered ineffective if left exposed to excessively
cold temperatures.

5. Temperature logger
maintenance

Pharmaceutical storage environments must be maintained correctly and in working
condition at all times. In the event of a malfunction, if on-site technicians
can’t resolve the problem, the device manufacturer should be contacted
immediately.

When buying HVAC devices for the storage facility, testo advises
companies to procure from manufacturers that provide on-site services. This
will result in quick mitigation in the event of a problem.

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