HEPA

MODULE

154

FILTERS
PROUDLY SPONSORED BY

Skills summary
■ What? For applications such as biological safety cabinets, hospital
A guide to HEPA filters and key operating suites, instrument cleanrooms and pharmaceutical
requirements for the pharmaceutical facilities that require the almost total removal of sub-micron
industry.
particles, it is necessary to use filters of very high efficiency.
■ Who? This Skills Workshop looks specifically at High Efficiency Particulate Air
This Skills Workshop will be of use to all
those engaged in the design, installation, or HEPA filters. It covers their classification and regulation, installation
commissioning and maintenance of and testing, fields of application, properties and maintenance.
filtration systems that use HEPA filters,
especially in pharmaceutical settings. This skills workshop was supplied by Camfil: www.camfil.com

What is HEPA? If you follow rigorously the EN1822 standard, the HEPA filter only includes
HEPA is the acronym for “high efficiency particulate air” or “high efficiency two classification grades: H13 99.95% MPPS and H14 99.995% MPPS.
particulate arrestance”. The HEPA filter is a type of mechanical filter. It works For these filter classifications, manufacturers are obliged to provide
by providing a barrier in the form of a very dense filter media which is made the customer with an individual efficiency and “Leak Test” certificates.
up of very fine fibres that trap practically all particles. HEPA filters are not a Minimum requirements for these test certs should include:
recent innovation, they were developed by the American federal government 1. Filter serial number
in the early 1950s. Their original purpose was to capture the contaminants 2. Initial pressure drop readings
associated with the manufacture of the atomic bomb in the Manhattan Project.
3. Production dates and times
Today, HEPA technology helps to protect advanced and sensitive manufacturing 4. Filter classification.
processes and protect people from microbiological contamination in
research laboratories. HEPA filters are also used to eliminate infectious
pollutants from the air in the health sector where the risk of infection
is high, such as operating theatres. They also protect the environment
by eliminating polluting particles from industrial extraction systems.

How HEPA filters are classified and regulated

In Europe, the EN1822 standard is used. This standard divides
the EPA, HEPA and ULPA high efficiency air filter tests into five
parts. High-efficiency air filters are classified based on the
MPPS (Most Penetrating Particle Size). Mandatory efficiency
tests (leak) are required for class H13 filters and higher.
In the past it was believed that the most difficult particle size to filter
was 0.3μm. The appearance of electronic microscopes and optical particle
counters determined that the MPPS was between 0.12 and 0.25μm.

HEPA filter scanning certificate

according to EN1822

“ISO29463 – High efficiency filters and filters to

remove particles in the air” – is an ISO standard
based on EN1822. It is divided into five parts which
are named in the same way as in EN1822,
although ISO29463 includes additional
Classification table according to EN1822 classifications, i.e. 99.90%, which is ISO30E.

October–November 2023 | www.airah.org.au/hvacrnews | HVAC&R News | 15

HVAC&R Skills Workshop

Oil Loading on HEPA/ULPA Media: Resistance

3.5

Resistance at 5.3 cm/s (Inches w.c.)

3 Glass

2.5 ePTFE

1.5

0.5

0
0 5 10 15 20 25 30
Oil Mass per Area (g/m2)

Oil Loading on HEPA/ULPA Media: Penetration

1.000
Classification table according to ISO29463

MPPS Penetration at 2.0 cm/s (% )

ePTFE
IEST, an international engineering society based in 0.100
H13

the United States, has established various test

methods. IEST-RP-CC001, 007, 021 and 034 refer to 0.010 H14

high efficiency air filters. This standard covers

Glass
different areas, such as filter media performance, classification, design 0.001

requirements, and filter media testing requirements.

0.000
0 5 10 15 20 25 30
Oil Mass per Area (g/m2)

Aerosol loading on HEPA filter media

As well as being tested on installation, your HEPA filter is periodically
tested to ensure that it is still performing at its required efficiency.
To do this oil based aerosols are used to help validate processes.
But how can this regular testing affect the performance of a HEPA?
HEPA filters can be affected differently depending on the type of media
used in the filter (Glass Fibre, membrane) and the concentration levels of
Classification table according to IEST-RPCC001 the aerosols used in the validation process. Higher concentrations can
a Mass median diameter particles (or with a count median diameter increase pressure drop or there may be a fire risk and lifetime is shortened.
typically smaller than 0.2 μm as noted above).
b Use the particle size range that yields the lowest efficiency.
Example: A HEPA H14/-610x610, with 13m², nominal airflow of
603m³/h could be loaded with 6,500mg during one test.
Where does a HEPA filter get installed? This would occur with a load with 25μg/l concentration during
26min or with 10μg/l during little more than one hour.
This should be acceptable but it depends on how many
terminals are connected and challenged at the same time.
Care needs to be taken to work out the potential amount of
aerosol per filter to ensure medias are not overloaded.
Another important point to be aware of is the area where the filter will be
installed. This equipment must also be designed and manufactured to an Fields of application
appropriate leak-free criteria. The following details should be observed: The housings
• A smooth and levelled mounting face where the filter gasket can sit properly where HEPA
• A fixing system that ensures a homogeneous tightening torque around the filters are
entire filter gasket to avoid leaks between the gasket and the mounting face installed and
many other
• Leak-free equipment where the filter is installed
equipment,
in order to avoid a by-pass of unfiltered air
such as
• Materials resistant to cleaning and decontamination
biosafety
in order to prevent product degradation over time.
cabinets,
What on-site tests must be performed isolators,
on a HEPA filter after installation? sterilisation
tunnels, aseptic
In order to ensure that the filter is intact and that it has not been damaged
fillers, etc.,
during transport or installation, it is recommended to perform a leak test on the Example of HEPA filters being used
have many in a pharmaceutical lab facility
filter at the place of use. This test is also called an “integrity”, “smoke” or “DOP”
professional
test. The test consists of generating an aerosol (see table above) and passing
fields of application, for example, pharmaceutical laboratories.
it through the filter. One of the most commonly used aerosols is PAO (hot).
Other areas of application are hospitals, nuclear power plants, the food
Different regulations set different concentration ranges for this aerosol:
industry, veterinary laboratories, the cosmetics industry, biosafety centres,
IEST-RP-CC034: 10-20mg/m³ etc. Lately, HEPA filters have become more popular due to their use
in household vacuum cleaners, car cabin filters and air purifiers.
ISO-14644-3: 1-100mg/m³
After the aerosol is generated at the filter inlet port, the absence Properties of a HEPA filter
of leaks is verified by a photometer or a particle counter (DPC). Other questions and queries often arise when it comes to
To certify that the filter is “Leak Free”, the penetration percentage HEPA filters and their safe operation. When should I change my
must be below 0.01%. The aerosol concentration taken immediately HEPA filter, what is the expected lifetime, and how important is
upstream of the filters should not vary more than ±15% in time the handling of a HEPA filter are key concerns. Here follows a quick
averaged measured value and the mix must be homogenous. summary and recommendation in regards to these concerns.

16 | HVAC&R News | www.airah.org.au/hvacrnews | October–November 2023

 HVAC&R Skills Workshop

Application Key Requirements

Air handling units are used to supply air to all our buildings in many fields. These units typically have a range of prefilters installed
HVAC system/air to maintain good indoor air quality. The filters used in these comfort applications are now tested and rated according to ISO16890
handling units globally with respect to filtration efficiencies and Eurovent standards on energy consumption. In AHUs it is possible to install
HEPA filtration and there are HEPA filters that can retrofit into existing framework with header frames included in the design.
Cleanroom HEPA filters deployed in cleanroom ceilings are the usual way to create cleanrooms or controlled environments. The HEPA filters
supply air/ can be deployed as a hood type filter and housing combination. The widely used method to create cleanrooms or controlled
terminal environments is to install them in a separate terminal housing. Here the filter is installed from below in a housing and testing,
housings revalidation and maintenance can be carried out without interfering with the housing or cleanroom ceiling barrier.
For general cleanroom exhaust the HEPA is primarily used to protect the return air from room generated contaminants re-entering
the system. On exhaust applications HEPAs are also used to protect from industrial emissions so housings being considered are
Cleanroom similar to supply housings but with reverse airflow. However, on cleanroom exhaust applications the above points should be
exhaust air considered along with the possibility of the HEPA filter and housing coming into contact or filter contaminants from the room.
applications The possibility of pharmaceutical ingredients or excipients being present in the airstream and therefore in the filter is a concern
so appropriate PPE should be worn during filter maintenance. In these applications the possible use of safe change or Bag In
Bag Out (BIBO) housings should be considered. Here the housing chosen should be a containment housing, outlined next.
Downflow booths and LAF benches are used to protect operators from exposure to hazardous materials and
LAF benches/
compounds. Using HEPA filters in both the supply air and exhaust air, a downflow booth is designed to push air away
downflow
from the faces of the operators and to extract the potentially hazardous compounds at low levels. Laminar flow HEPA
booths
filters are important to ensure adequate control of the airflow direction for best protection of the operators.
In the life science industry, hot air up to 350°C is utilised in static ovens and depyrogenation tunnels to sterilise glass vials,
ampoules, and cartridges before they are aseptically filled. The hot air for this process is typically filtered through special
high‑temperature HEPA filters (HT filters) before it is distributed in a unidirectional airflow through the tunnel. To avoid product
contamination, cleanroom quality air is needed throughout the tunnel. These air filters are therefore of the highest particle
Depyrogentation collecting efficiency and HT filters of H13 grade are typically used today to filter the air for the hot zone (ISO 5 in the working
tunnels area acc. to ISO 14644). The choice of the right HT filters is critical to ensure consistent and optimum product safety, as well
as maximum production quality and uptime. In the depyrogenation tunnels used in pharmaceutical aseptic filling, these
high temperature filters are installed directly over the conveyor belt where vials, ampoules or cartridges are transported.
The HT filters are specially made to protect these ultraclean processes and have to meet the most stringent requirements
and standards. They are designed to maintain integrity and rated performance values at extremely high temperatures.
There are dedicated isolator filters that are H14 classified according to EN 1822. So they stop viruses, bacteria and other aerosol matter.
Isolators, enclosures, glove boxes, mini-environments, cells for remote handling, whatever the name given to it, this equipment
Glove boxes/ is subject to a special ventilation design to guarantee personnel and environmental safety. These filters can also be used for the
isolators ventilation of incubators, the protection of manometers, and the safety of valve exhausts. All these are solutions which we can
find in research, life science and healthcare industrial sectors. Basically, the point with these filters is to create a containment
barrier. Each filter must again have an individual test according to EN 1822 at MPPS plus a leak test of the filter element.
For handling airstreams with potent compounds (e.g., hazardous or sensitizing API ingredients) or biological contaminants in
biosafety laboratories, the containment or BIBO housing should be chosen. These housings use a system of safe change bags and
Containment procedures to keep the filter and personnel apart during change. This protects people, facilities and products from exposure or
applications cross contamination. Considerations should include the weight of the filter to ensure safe manual handling and the construction
to ensure that they are compatible to safe change bags. The housings and products used for these applications can also be
assessed according to the ISPE guideline documents in the SMEPAC committee’s guideline on performance assessment.

How long will a HEPA filter last? What is the recommended final pressure
Filter life depends upon the operating conditions. A general recommendation drop for a HEPA filter?
is that, at minimum, the filter be replaced when the pressure drop reaches The rule of thumb in our industry has been double the initial assuming
two times the initial pressure drop (assuming “normal” design airflows). normal design airflows. For example, a high performing HEPA panel
filter applied in a terminal filter housing or plenum will have a clean
HEPA filters that are not subject to high contaminant concentrations may have
pressure drop of approximately 100Pa or 0.4"w.g. at 0.45M/s or 90fpm.
an indefinite life, depending on the operating conditions. Generally speaking,
Doubling the pressure drop as a change target to 200Pa or 0.8"w.g. is
10 years is the recommended life. Our experience with HEPA filters that
reasonable and prudent for filter performance and energy use considerations.
have been in operation in excess of 15-plus years without problems.
For an AHU mounted, exhaust, or Bag-in/Bag-out (BIBO) HEPA filter
In bio-pharma applications, especially in “critical” zones (Grade A space, the clean pressure drop is normally targeted at around 250Pa or 1"w.g.
for example), we have seen certain major pharma companies establishing a using double the clean pressure drop at 2.5M/s or 500fpm then the
time period and not pressure drop as the guideline for change. One guideline change out point would be 500Pa or 2"w.g. respectively. Filter pack depth,
suggests five years for the Grade A space and seven years for less critical spaces. filter efficiency and velocity can vary depending upon filter design, so be
sure to consult with your chosen filter supplier for technical assistance.
Factors that may influence filter service live include: volume of
outdoor air filtered, volume of re-circulated air filtered, aerosol What issues arise when installing and how
challenge exposure frequency and duration, the total amount of can handling damage be eliminated?
challenge aerosol impingement on the filter, the method of aerosol Handling during transport and installation is a possible cause of damage
introduction to the system and the filter efficiency of pre‑filtration. to HEPA filters. Care must be taken when handling filters. Costs associated
The use of coarse fiber (i.e., charged synthetic media filters) as prefilters due to filter damage are site or application specific but can be high and
may shorten HEPA filter life due to prefilter drop in efficiency over time will be higher in operational systems as the shutdown and restart costs can
due to inherent charge dissipation of the media. Wet filters should be be high due to production outages, revalidation and installation costs.
replaced as soon as possible and the conditions that caused the filter to What is MPPS?
become wet should be corrected. Filters that are allowed to remain wet for
MPPS is most penetrating particle size. MPPS is typically between 0.1 and
48 hours or more could be subject to mould growth within the media.
0.2µm. It will vary with velocity but at normal design for a terminal
The construction components of the filter are inert to contaminant filter this range is accurate 80 per cent of the time with a H14 filter at
amplification. Filters that are allowed to dry after being wet may have a higher 90fpm/0.45m/s it is 0.17/0.18µm. The MPPS should always be identified
pressure drop when compared to their pressure drop before they were wet. in factory scan tests and noted on the HEPA filter label. ■

October–November 2023 | www.airah.org.au/hvacrnews | HVAC&R News | 17