TECHNICAL

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TEMPERATURE AND
HUMIDITY REQUIREMENTS
in Pharmaceutical Facilities
By Nicholas R. Haycocks, Norman A. Goldschmidt, and Ulla Thomsen

Defining room temperature and humidity limits is Table 1: EU regulations related to temperature and humidity
controls [1, 2].
a frequent topic of debate when designing and
Source Regulatory Guidance
operating pharmaceutical and biotechnology
EudraLex Volume 4, 3.3. Lighting, temperature, humidity and ventilation should be
facilities. What are appropriate alarm limits and Part 1, Chapter 3 appropriate and such that they do not adversely affect, directly or
acceptable durations for an alarm condition? indirectly, either the medicinal products during their manufacture
and storage, or the accurate functioning of equipment.
Understanding the source of temperature and 3.19. Storage areas should be designed or adapted to ensure good
humidity requirements, and strategies for setting storage conditions. In particular, they should be clean and dry and
maintained within acceptable temperature limits. Where special
limits, can ensure both compliance and optimum storage conditions are required (e.g. temperature, humidity) these
use of energy. This article provides guidance on should be provided, checked and monitored.
EudraLex Volume 4, 16. Other characteristics such as temperature and relative humidity
these topics, with supporting rationales.
Annex 1 depend on the product and nature of the operations carried out. These

A
parameters should not interfere with the defined cleanliness standard.
lthough temperature and humidity are both understood to 73. Activities in clean areas and especially when aseptic operations
are in progress should be kept to a minimum and movement of
be critical factors in the design and operation of compliant
personnel should be controlled and methodical, to avoid excessive
manufacturing facilities, regulations on these topics are shedding of particles and organisms due to over-vigorous
surprisingly vague. In general, regulations suggest that activity. The ambient temperature and humidity should not be
temperature and humidity should be appropriate within manu- uncomfortably high because of the nature of the garments worn.a
facturing areas, with attention given to long-term storage areas, a
Note that this guidance indicates that temperature may be governed by factors other than
although needs are understood to be largely product specific. product or process requirements, such as the level of gowning.
Tables 1 and 2 present key EU and US regulatory guidance from
EudraLex [1, 2] and the US Code of Federal Regulations (CFR) [3], Table 2: US regulations related to temperature and humidity
respectively. controls [3].
CFR Section Regulatory Guidance
CONSIDERATIONS WHEN SPECIFYING DESIGN RANGES 211.42.3.10 Operations shall be performed within specifically defined areas of
If there are no temperature or humidity limits for the product/ adequate size. There shall be separate or defined areas or such
process (which is often the case in closed processes with “internal” other control systems for the firm’s operations as are necessary
environmental controls), the temperature control of surrounding to prevent contamination or mix-ups during the course of the
spaces defaults to that which is required for human comfort and to following procedures…Aseptic processing, which includes as
appropriate…(ii) Temperature and humidity controls.
minimize shedding. An approach that ensures facility conditions
are appropriate for the product and process, as well as for the 211.46b Equipment for adequate control over air pressure, micro-
organisms, dust, humidity, and temperature shall be provided
gowning level of the workers, forms a reasonable basis for estab-
when appropriate for the manufacture, processing, packing, or
lishing the conditions for cGMP facilities. holding of a drug product.
211.142 Warehousing procedures. Written procedures describing the
Comfortable Conditions warehousing of drug products shall be established and followed.
Good engineering practice suggests specifying conditions that (b) Storage of drug products under appropriate conditions of
provide comfortable conditions for most workers. Factors to con- temperature, humidity, and light so that the identity, strength,
sider when defining comfortable conditions include: quality, and purity of the drug products are not affected.

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Figure 1: Seasonal comfort (temperature and RH). ©ASHRAE, Figure 2: Microbial growth rate as a function of temperature.
www.ashrae.org. Used with permission from 2017 ANSI/ASHRAE Notice that the curves are skewed toward the optimum
Standard 55 [4]. temperature. The skewing of the growth curve is thought to
reflect the rapid denaturation of proteins as the temperature rises
past the optimum for growth of the microorganism. (Courtesy of
OpenStax Microbiology.)

Provided by: OpenStax CNX. http://cnx.org/contents/e42bd376-624b-4c0f-972f-

[email protected] License: CC BY: Attribution. License terms: Download for free at
http://cnx.org/contents/[email protected]

u Metabolic rate (activity level) or 7, in operation), which may include plant uniforms, coveralls,
u Amount of clothing hoods, overboots, sleeves, and double gloves. In these situations, it
u Temperature is usual to set the lower end of temperature acceptance criteria
u Local airspeed quite low (e.g., 10°C). When designing internationally, it is impor-
u Humidity tant to also consider local customs and practices, as these may
u Skin state (wetness) impact workers’ comfort.
u Individual preferences
Microbial Growth
There are several methods for defi ning the conditions that most It is well known that temperature and humidity impact microbial
people will find comfortable. For example, in the US, ANSI/ growth and germination of spores (Figure 2) [6].
ASHRAE Standard 55 Thermal Environmental Conditions for Human Temperature is a consideration for microbial growth: An
Occupancy [4] establishes a range of indoor conditions (tempera- increase in room temperature from 20°C to 25°C can roughly dou-
ture and relative humidity [RH]) intended to provide acceptable ble the rate of bacterial multiplication. Mold propagation is more
thermal comfort for building occupants (Figure 1). This American likely at warmer temperatures (up to about 35°C–40°C). Humidity
Society of Heating, Refrigerating and Air-Conditioning Engineers also has an impact on the ability of the environment to support
(ASHRAE) standard was first published in 1996 and has been regu- growth of any viable contaminants.
larly updated since 2004, with the most recent version published
in 2017. The Chartered Institute of Building Services Engineers in Water Activity
the UK produces similar guidance [5]. The ISPE Good Practice Guide: Process Gases [7] discusses water
The comfort levels indicated in Figure 1 assume the building activity in relation to microbial and sporicidal growth. This guid-
occupant is wearing “street clothes” without overgarments. The ance is based on USP<1112>: Application of Water Activity
addition of gowning would drive acceptable temperature and Determination to Nonsterile Pharmaceutical Products [8], which
humidity levels down (in order to maintain a consistent RH). states:
Common industry practice is to provide lower environmental Water activity, aW, is the ratio of vapor pressure of H2O in prod-
temperatures as the level of gowning increases. We suggest that uct (P) to vapor pressure of pure H2O (Po) at the same tempera-
room temperatures for occupants wearing “street clothes” should ture. It is numerically equal to 1/100 of the relative humidity
have a setpoint around 22°C, whereas ISO 8 environments should (RH) generated by the product in a closed system. RH can be
have a setpoint around 20°C and ISO 7 environments a setpoint calculated from direct measurements of partial vapor pressure
closer to 17°C–18°C. or dew point or indirect measurement by sensors whose physical
These suggestions are based on the need for higher levels of or electric characteristics are altered by the RH to which they
gowning in more highly classified areas (Grade A or B [2], or ISO 5 are exposed.

62 P h a r m a ce u t ic a l E ngine e r ing
Figure 3: Water activity versus bacterial growth.

Lip
id
Ox
i da
tio
n

Figure 4: Environmental health and comfort. Reprinted from [9].

The relationship between aW and equilibrium relative when they fi nd a suitable growth environment. They can enter a
humidity (ERH) is represented by the following equations: facility on people or materials.
Bacterial spores are typically 1–2 μm in length and 0.5–1.0 μm
aW = P/Po and ERH (%) = aW × 100 in diameter. Mold spores are typically larger, between 4 and
20 microns [10]. Mycotoxins are toxins produced by some species
Microbial growth and germination of spores are very unlikely in of mold (secondary metabolites) and are as small as 0.1 μm.
areas with an RH below 60% (see Figure 3). Figure 4 shows the Aspergillus species and Penicillium species mold spores range from
relationship between environmental health and comfort [9]. 1 to 8 μm.
Vegetative cells would normally be carried on particles, such Keep in mind that although high-efficiency particulate air
as skin flakes, and are fragile. Mold spores and bacterial spores are (HEPA) and ultra-low particulate air (ULPA) filters are highly
much hardier; they can exist as individual spores and then grow effective against microbial contamination, they are not truly

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absolute fi lters. If the microbial load upstream of these fi lters is Table 3: Suggested temperature ranges for facility space design
high enough, some penetration is possible. conditions.a
Lower Operating Upper
Space
Storage Spaces Limit, °C Range, °C Limit, °C
According to USP<659>: Packaging and Storage Requirements [11], Plant utilities room 5 15–27 90
temperature and humidity conditions for the acceptable storage of Clean utilities (technical space) 5 20–25 65
materials are divided into freezer, refrigerator, cold, cool, con- Raw materials warehouse (ambient) 10 15–30 35
trolled room temperature (CRT), warm, and excessive heat. With
Raw materials warehouse 15 20–25 30
regard to temperature and storage, USP<659> further states:
Specific directions are stated in some monographs with respect to CNC 15 20–24 30
storage conditions (e.g., the temperature or humidity) at which an CNC+/Grade D 15 18–22 30
article must be stored and shipped. Such directions apply except ISO 8/Grade C 15 18–22 30
where the label on the article has different storage conditions that ISO 7/Grade B 14 17–20 30
are based on stability studies. Where no specific directions or
ISO 5/Grade A 14 17–20 30
limitations are provided in the article’s labelling, articles must be
protected from moisture, freezing, and excessive heat, and, where Finished goods (refrigerated) 2 3–7 8
necessary, from light during shipping and distribution. Drug Finished goods (CRT) 15 20–25 30
substances are exempt from this standard. a
Alert alarms should be set close to the operating limits to provide early notification of
a potential issue; the limits given are proposed for initial settings used while gathering
Based on this guidance, we understand that the “ambient storage” operational data.

conditions used for ambient storage warehouses should be aligned

with the USP CRT guidance, which states, “Storage spaces classi-
fied as ‘ambient’ are therefore expected to be not more than 25°C on
average with a 15–30°C acceptance range” [11]. individual degradations that would occur at various tempera-
USP<659> defines CRT as follows [11]: tures”) in its CRT guidance [11]. However, it is common practice to
The temperature maintained thermostatically that encom- set “engineering” (alert) alarms for CRT storage spaces at 20°C and
passes the usual and customary working environment of 20°– 25°C with “quality” (action) alarms for these spaces at 15°C and
25° (68°–77°F). The following conditions also apply. Mean 30°C. Keep in mind that the wider the used operational range is,
kinetic temperature not to exceed 25°. Excursions between 15° the lower the energy consumption for heating, cooling, humidifi-
and 30° (59° and 86°F) that are experienced in pharmacies, cation, and dehumidification will be.
hospitals, and warehouses, and during shipping are allowed.
Provided the mean kinetic temperature does not exceed 25°, Manufacturing Areas
transient spikes up to 40° are permitted as long as they do not Temperature is generally controlled in the range of 15°C–25°C for
exceed 24 h. Spikes above 40° may be permitted only if the manufacturing and storage facilities, except where a process or
manufacturer so instructs. product requires more stringent control. In the case of human
comfort, the acceptable range may be broad (e.g., 20°C ± 5°C).
Articles may be labeled for storage at “controlled room tempera- However, general practice is to maintain control within a narrower
ture” or at “20°–25°”, or other wording based on the same mean range, such as ±2°C–3°C, and, in some cases (for example, for older
kinetic temperature…. control systems that may not be as responsive for temperature
control), it is advisable to use a range that allows the temperature
An article for which storage at Controlled room temperature is to heat up to a maximum temperature and cool down to a minimum
directed may, alternatively, be stored and shipped in a cool place temperature. It is also a good practice in terms of minimizing energy
or refrigerated, unless otherwise specified in the individual consumption to shift the setpoint seasonally to accommodate how
monograph or on the label. workers’ perceptions of comfort shift with seasonal changes (see
Figure 1).
Storage spaces classified as “ambient” are therefore expected to be Where temperature limits are defi ned by process or product
not more than 25°C on average, with a 15°C–30°C acceptance range. requirements, industry best practice is to ensure that the alert
range accounts for instrument error. The National Environmental
TEMPERATURE RANGE RECOMMENDATIONS Balancing Board suggests that instrument error should be within
CRT Storage Spaces 1.0% of reading [12]. This should be considered when setting alarm
The US Pharmacopeia uses the mean kinetic temperature (MKT, set points.
”the single calculated temperature at which the total amount of Ideally, alarm levels are determined after observing the varia-
degradation over a particular period is equal to the sum of the bility of specific systems. Typically, a short alarm time delay is

64 P h a r m a ce u t ic a l E ngine e r ing
incorporated to avoid any nuisance alarms set off by short-term Table 4: Suggested RH ranges for facility space design
fluctuations that may be caused by an influx of air from an adjacent conditions.a
area that is operating at different conditions, or any signal noise. Space Lower Operating Upper
Limit, Range, Limit,
% RH % RH % RH
DESIGN CONDITIONS
It is common for design conditions to be largely based around Plant utilities room N/A ≤80 90
comfort factors (except where special conditions outside of these Clean utilities (technical space) N/A ≤60 65b
are needed for products or processes). Therefore, short-term Raw materials warehouse N/A 20–80 90
excursions are often not a quality concern. Table 3 summarizes (ambient)
suggested temperature ranges to use as design conditions for vari- Raw materials warehouse N/A 30–60 65b
ous spaces, including controlled not classified (CNC) spaces. CNC (controlled)
spaces are [13]: CNC 25 30–60 65b
Areas where HVAC systems are specifically designed to reduce
CNC+/Grade D 25 30-60 65b
airborne contaminants below the level of the ambient environ-
ISO 8/Grade C 25 30–60 65b
ment and both temperature and RH are controlled more tightly
than in the ambient environment. Claims for environmental ISO 7/Grade B 25 30–60 65b
control in these areas are related to the design of the system; ISO 5/Grade A 25 30–60 65b
installation qualification is common. No claim is made or quali- Finished goods (refrigerated) N/A 20–80 90
fied for the specific control of particulate. Typical systems will Finished goods (CRT) N/A 20–75 80
have heating, cooling, and filtration meeting minimum effi-
Dry storage (CRT) N/A 30–40 45
ciency reporting values of 13 (F7) or better. These areas are
sometimes referred to as “pharmaceutical” or “clean” areas a
Broader operating ranges with higher upper limits have been successfully used with
appropriate qualification and monitoring of data regarding the impact of RH on local
within pharmaceutical facilities.
microbial growth. Alert alarms should be set close to the operating limits to provide early
notification of a potential issue; the limits given in the table are proposed for initial settings
used while gathering operational data. N/A = not applicable.
The temperature values presented are lower than suggested in b
Upper limits may be raised with proper qualification and data.
the ISPE Baseline Guide, Volume 6: Biopharmaceutical Manufacturing
Facilities, second edition [14], based on our experience of operator
comfort in the gowning associated with each classification of
space. Storage Spaces
According to the US Pharmacopeia, humidity conditions for the
HUMIDITY RANGE RECOMMENDATIONS acceptable storage of materials are divided into “dry” and unspec-
Design and Operating Ranges ified conditions. The USP<659> [11] definition of a “dry” place is as
As with temperature, regulatory guidance suggests that humidity follows:
levels should be appropriate for the product and process as well as A place that does not exceed 40% average relative humidity at
for operator comfort and to limit shedding and sweating. 20° (68°F) or the equivalent water vapor pressure at other tem-
Therefore, if humidity does not affect product and process, RH is peratures. The determination may be made by direct measure-
commonly maintained within a band, at levels less than 60% (see ment at the place. Determination is based on NLT [not less than]
Figure 4), with the lower RH limit defined by local custom and 12 equally spaced measurements that encompass either a sea-
practice. Controlling the lower range of humidity is not generally son, a year, or, where recorded data demonstrate, the storage
important to address microorganism-related concerns, but it may period of the article. There may be values of up to 45% relative
be important to manage static electricity, human comfort, and humidity provided that the average value does not exceed 40%
shedding. relative humidity. Storage in a Container validated to protect
The acceptance range can be broad: It is not uncommon to see the article from moisture vapor, including storage in bulk, is
humidity acceptance ranges between 30% and 60% RH, as sug- considered a Dry place.
gested by ASHRAE [4] (see Figure 4) and the ISPE Baseline Guide
[14]. Some companies successfully extend the acceptance range Humidity Alarm Set Points and Delay Times
from 20% to 70% RH, based on the location (with consideration of It should be noted that, at a constant absolute humidity, RH
local flora and fauna, cleaning methods, etc.). increases as temperature decreases, making low-temperature
To achieve the acceptance range, general practice is to main- environments more susceptible to exceeding RH limits. If mois-
tain setpoints near 25%–55% RH and allow the system to respond ture is a product or process requirement, it may be more efficient to
if RH levels exceed those limits. These limits may be adjusted sea- control moisture to an absolute level (grams of water per kilogram
sonally to accommodate how workers’ perceptions of comfort of air) to remove the effect of temperature; often the humidity
shift with seasonal changes (see Figure 1). issue is due to the partial vapor pressure.

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High RH levels can initiate a biological process. Because the Mold problems may be identified by higher particle counts,
biological processes of mold spore germination or bacterial repro- followed by visible signs of contamination, or through environ-
duction have time constants of their own, it is normal to accept a mental monitoring. According to an industry specialist in restora-
delay in the initiation of RH alarms that is shorter than the time tion, “under ideal conditions (optimal temperature and level of
required for the biological process to move to completion, and humidity), it takes 24 to 48 hours for mold to germinate and grow.
longer than the time required for typical wet tasks, like cleaning. Typically, the spores begin to colonize in 3 to 12 days and become
In the case of common mold types on building materials, the ger- visible in about 18–21 days” [16].
mination period often exceeds 24 hours. For this reason, although For mold spores to germinate and proliferate, conditions must
the speed of germination will likely increase with increases in RH, be conducive to growth. For example, a pipe leak could allow water
there is a period during which any RH level, even close to 100%, to enter drywall (gypsum board) or cleanroom panels, or water
may be tolerated for short times. Common wet cleaning processes used during cleaning could penetrate a joint to sit on timber. In a
rely on this principle, as the water that is applied to a surface dur- cold room or freezer, mold may grow when high humidity is caused
ing cleaning will not promote mold propagation so long as it evap- by an internal air leak around a utility penetration, leading to
orates within a reasonable period. However, if an area is allowed to internal condensation.
stay at a high humidity level for an extended period (e.g., in a If mold is suspected or confirmed, the following points may be
shower), microorganisms can propagate. worthy of investigation:
Alarm set points should consider instrument error. The u Residual moisture in ductwork: Common sources of moisture
National Environmental Balancing Board suggests that verifica- include damaged vapor barriers on ductwork insultation or
tion instrument error should be within 2% of the reading range the humidification system not draining fully.
[12]. Coupled with the measurement instrument error, this sug- u Residual moisture in and around air-handling units (AHUs):
gests that alert ranges should not normally be less than ±5%. poorly draining condensate pans under cooling coils, poor
For these reasons, it is suggested that alarms for RH incorporate sealing of insulated AHU panels, and air leakage from the neg-
delays as needed to accommodate excursions caused by normal ative pressure section can allow moisture and condensation.
operation (doors opening, cleaning, etc.). A period of 1–4 hours is u High room-humidity levels: Consider reducing the RH level to
common for an alarm delay, given that this period is usually approximately 55%.
enough to complete cleaning but does not provide time for u Leakage of contaminated air: Determine whether airf low
significant expansion of microbial colonies or germination of direction changed, even for a short time period. This issue can
mold spores. Delays of up to 24 hours may be justified based on the be caused by poor sealing between cleanroom panels. In one
time required for microbial contaminants to propagate in a region. case, the process area HVAC was turned off to ensure there
For existing facilities that are not designed to control RH to less was adequate contact time for the sanitizing material, and
than 65%, an alarm delay of 12 hours could be used for RH above this allowed contaminated air to leak in due to “loose” mastic
70%, prior to cessation of operations. Low-level alarm set points seals between panes; the adjacent service area was at a slightly
would be based on local practices. higher pressure, and there was a drain by the poor joint in the
Note that in all cases, vented steam or hot water vapor from service area.
component washing and equipment cleaning/sanitization should u Sanitization and cleaning practices: Are all cleaning materi-
have a local exhaust. als, including mops, sanitized? Are the cleaning or sanitizing
materials a potential source of contamination?
Design Conditions u Spore transfer from another area: For example, contamina-
It is common for design conditions to be based around a combina- tion could be due to an instrument tech wheeling a cart from
tion of comfort factors and upper limits to inhibit microbial growth one building to another, with inadequate wheel cleaning
(except in situations where special conditions are needed for prod- (dedicated carts are preferable). A worker’s shoes or clothing
ucts or processes, such as effervescent tablet manufacturing). could also carry contaminants from one region to another.
Again, short-term excursions are often not a quality concern. u The adequacy of sealed cleanroom fi nishes: In one instance,
Table 4 summarizes suggested RH ranges to use as design condi- mold was found on plywood blocking behind the wall fi nish,
tions for various spaces. where the seal was inadequate. In another case, mold was
found in a hole in the top of a door, which turned out to be
PRACTICAL ADVICE FOR CONTROLLING MOLD stainless cladding over wood.
Fungal spores are always present. If the prevailing conditions do u Sources of condensation between walls due to temperature
not encourage growth, there are no problems; however, many gradients in adjacent rooms: For example, if a wall in a cold
facilities experience mold issues. According to the Centers for room wall sweats, investigate whether the damp-proof
Disease Control and Prevention, when buildings are wet for more membrane is in the right location.
than 48 hours (e.g., following a flood or hurricane), “visible and u Equipment operating below the dewpoint of the conditioned
extensive mold growth” is likely [15]. space: This can result in the formation of condensation.

66 P h a r m a ce u t ic a l E ngine e r ing
Prompt remediation is required when mold is discovered. For About the authors
porous materials, cleaning or sanitizing is difficult, and replacing Nicholas R. Haycocks is a chartered mechanical engineer working in the quality organization with
contaminated materials is advised. If drywall is contaminated, 18 years of experience in the pharmaceutical industry. Currently, he is working in International
the only solution is demolition and replacement. For nonporous Distribution Quality within Amgen. Other experience includes working with Glaxo, GSK, Schering
materials, cleaning and sanitizing can be effective once the source Plough, and Amgen in their technical organizations, as well as on site supporting projects in
various locations, including China and Singapore. Nicholas has contributed to a number of ISPE
of moisture is removed.
guides, including the commissioning and qualification guide and the CTC mapping and HVAC
good practice guides. Nicholas has been an ISPE member since 2002.

Norman A. Goldschmidt is the President of Genesis AEC, an A&E/EPCM firm specializing

References in innovative, efficient designs for life sciences clients. His industry experience spans the
many types of facilities and processes necessary to bring a therapy to patients—from R&D
1. European Commission. “Chapter 3: Premise and Equipment.” In EudraLex Vol. 4: EU Guidelines
for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1: through manufacturing. Norman has over 30 years of experience in conceiving, designing, and
Basic Requirements for Medicinal Products. 2015. https://ec.europa.eu/health/sites/health/ delivering processes and facilities. He worked 20 years with Bristol-Myers Squibb, culminating
files/files/eudralex/vol-4/chapter_3.pdf as Executive Director, Global Engineering for Strategy and Design. Norman holds four patents
for innovations in HVAC and pharmaceutical processing. He is also an internationally recognized
2. European Commission. “Annex 1: Manufacture of Sterile Medicine Products.” In EudraLex expert in environmental control, cleanroom design, isolation technology, and compliance. He
Vol. 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and
has authored the HVAC/environmental control sections of seven ISPE guides, is an ISO author/
Veterinary Use. Part 1: Basic Requirements for Medicinal Products. 2008. https://ec.europa.
convener, and teaches for ISPE, the Parenteral Drug Association, and regulatory agencies. He
eu/health/sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
studied mechanical engineering at the University of Buffalo and engineering management at the
3. US Food and Drug Administration. 21 CFR 211: Current Good Manufacturing Practice for State University of New York Empire State College. Norman has been ISPE member since 1996.
Finished Pharmaceuticals. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=211 Ulla Thomsen has an MSC in mechanical engineering and works as HVAC subject matter expert
4. American Society of Heating, Refrigerating and Air-Conditioning Engineers. ANSI/ASHRAE for Novo Nordisk; her areas of work include design and compliance of aseptic filling facilities
Standard 55: Thermal Environmental Conditions for Human Occupancy. Peachtree Corners, and HVAC for pharma in general. Ulla has been an ISPE member since 2007.
GA: American Society of Heating, Refrigerating and Air-Conditioning Engineers, 2017.
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Call for
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spores-what-to-look-for Pharmaceutical Engineering®
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In US Pharmacopeia. Rockville, MD: United States Pharmacopeial Convention. information on scientific and technical
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Sciences Facilities.” Pharmaceutical Engineering 37, no. 2 (2017): 38–42. https://ispe.org/
pharmaceutical-engineering/march-april-2017/understanding-cleanliness-classifications- We are always looking for quality
life-science
articles, and welcome new
14. International Society for Pharmaceutical Engineering. Baseline Guide Vol 6: Biopharmaceutical submissions. Our editorial team will
Manufacturing Facilities, 2nd ed. North Bethesda, MD: International Society for Pharmaceutical
Engineering, 2013. work with you to refine your draft.

15. Brandt, M., C. Brown, J. Burkhart, et al., for Centers for Disease Control and Prevention.
“Mold Prevention Strategies and Possible Health Effects in the Aftermath of Hurricanes and
Major Floods.” Morbidity and Mortality Weekly Report 55, no. RR08 (2008): 1–27. https:// For more information and instructions, please consult
www.cdc.gov/mmwr/preview/mmwrhtml/rr5508a1.htm https://ispe.org/pharmaceutical-engineering/about/submit-article.

16. Blue River Restoration Services. “How Long Does It Take Mold to Grow?” Accessed
14 October 2020. https://www.brrnational.com/post/how-long-does-it-take-for-mold-to-
grow#:~:text=Under%20ideal%20conditions%20(optimal%20temperature,in%20about%20
18%2D21%20days

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