THE WORLD LEADER IN CLEAN AIR SOLUTIONS

Pharmaceutical Clean Air Solutions

PARTICULATE AND GASEOUS FILTRATION

BETTER AIR IS OUR BUSINESS

Optimizing Process Performance for Protecting Human Health

Globalization, aging population, and economic shifts are transforming the
pharmaceutical landscape. New medical needs and therapeutic areas are
emerging that will put more pressure on innovation, productivity, and
time-to-market. At the same time, sustainability has entered the playing field
with a focus on energy efficiency, waste management, and emission reduction.
All these developments shed a new perspective on the role for air filtration.

The Importance of Clean Air

Clean air is something nearly impossible to identify by our human senses. Most
airborne particulates are so small that they cannot be perceived with the naked eye.
In most cases, we do not know when something is wrong with the air quality until it
is already too late and we see the damage that has occurred.
Within the pharmaceutical industry, strict requirements on air purity levels are
needed because of the direct effect airborne contamination has on the quality
of the pharmaceutical products. Human health and safety depend on it.

The Role for Air Filtration

No clean air is possible without a carefully selected and reliably functioning air
filtration system. The performance of installed air filters, whether terminal filters or
prefilters, directly determines how effectively harmful contaminants are prevented
from entering the airstream in process environments. As such, air filtration
represents a vital link in the overall pharmaceutical process chain.
This brochure provides insight into the most important aspects for realizing clean
air conditions in pharmaceutical applications. The indispensable role for air filtration
is explained through the lens of AAFs in-depth expertise, state-of-the-art air
filtration solutions, and value-added support concepts.

Proven Expertise of AAF

AAF offers the most comprehensive
air filtration portfolio in the industry,
covering particulate and gas-phase
filters, in offering a customized
clean air solution. Each product is
carefully designed, manufactured,
and tested in full compliance with
all applicable standards to meet the
most challenging demands at the
lowest energy consumption.
AAF manufacturing takes place
in ISO 9001 and ISO 14001
certified facilities. AAF HEPA (High
Efficiency Particulate Air) filters are
produced, tested, and packaged
in a state-of-the-art ISO 7 or
cleaner cleanroom environment for
optimized filter performance and
quality assurance.
Many pharmaceutical applications
today already benefit from AAFs
recognized expertise in air filtration.
The combination of an extensive
product portfolio with high level
technical support capabilities has
provided significantly improved
results for many satisfied customers.
AAF has an in-depth understanding
of the challenges and opportunities
for pharmaceutical and medical
device manufacturing processes.
This understanding and technical
ability makes AAF the preferred
partner in optimizing process
performance for protecting
human health.
Erik Geertsema
Test Engineer,
AAF International
We manufacture and
individually test all our
HEPA filters in a modern
cleanroom environment.
We believe that only then,
product performance is
assured through which
the most stringent
customer requirements
can be met.

Controlling Contaminants
The production of sterile products should be carried out under high levels of
air cleanliness. Contamination of raw materials, finished goods, or personnel
must be avoided at all times through the implementation of appropriate
technical and organizational measures. The significance of such contamination
risk may vary with the type of contaminant and the product that is being
contaminated, but reliable airborne contamination control remains critical in
all situations.

Quality of Medicinal Products

Everything that could come into direct contact with a pharmaceutical product is a
potential risk toward contamination. Limiting exposure to airborne contaminants is
critical, as they may result in health and safety issues. Preventive measures and quality
management procedures are described in several industry guidelines: CFR - Code of
Federal Regulations Title 21, Guidance for Industry - Sterile Drug Products Produced
by Aseptic Processing - Current Good Manufacturing Practice 2004, and European
Union (EU) Guidelines to Good Manufacturing Practice (GMP) Medicinal Products
for Human and Veterinary Use - Annex 1 - Manufacture of Sterile Medicinal Products,
2008. These guidelines are to ensure consistent production and control of
pharmaceutical products for human use.
Air filtration plays a critical role in making sure that these objectives are met and that
the risk of any adverse effects on product quality is reduced.

Typical Airborne Contaminants

Airborne contaminants differ in size and impact on a pharmaceutical manufacturing

process. Figure 1 shows a typical size range of airborne particles and microorganisms.
Each particle size range requires a specific air filtration technique to obtain the required
air quality levels.

Figure 1:

Particle size (m)

Typical Size Range of Airborne Contaminants

Filter Type

100

Coarse filters

Human sneeze

Medium/fine
filters

Spores

10

Hydrocarbon aerosol
Bacteria

0.1

Suspended inorganic dust

Viruses

HEPA/ULPA
filters
0.01

Classifying Air Filters

The type of activities within a particular pharmaceutical processing environment
will determine the level of cleanliness that is required. To ensure that stringent
air quality levels for safely manufacturing medicinal products are met, a
carefully designed air filtration system is vital. Based on their performance
efficiency, air filters are classified according to two widely accepted standards,
ASHRAE 52.2 and the Institute of Environmental Sciences and Technology
(IEST) Recommended Practice (RP) IEST-RP-CC001. Internationally EN1822 and
the ISO standard 29463 (High Efficiency Filters and Filter Media for Removing
Particles in Air) is the accepted classification method (table 1).

ASHRAE 52.2

ASHRAE Standard 52.2 (Method of Testing General Ventilation Air-cleaning Devices

for Removal Efficiency by Particle Size) describes a method of laboratory testing to
measure the performance of air filters as a function of particle size. The method of
testing measures the performance of air filters in removing particles of specific
sizes as the filters become loaded by standard loading dust. The dust is fed at
intervals to simulate accumulation of particles during service life. The standard defines
procedures for generating the aerosols required for conducting the test. The standard
also provides a method for counting airborne particles of 0.3 micrometers to 10
micrometers upstream and downstream of the air filter in order to calculate removal
efficiency by particle size. The overall reporting value of the air filter is expressed as
Minimum Efficiency Reporting Value (MERV) (table 2).

Table 1: ISO 29463 Filter Classes

and Equivalents
ISO Filter
Class

Efficiency

IEST* EN 1822

ISO 15 E
>95%
-
H 11
ISO 20 E
>99%
-
ISO 25 E
>99.5%
-
H 12
ISO 30 E
>99.9%
-
ISO 35 H
>99.95%
-
H 13
-
>99.97% A,B,E,H,I ISO 40 H
>99.99%
C,J(K)
ISO 45 H
>99.995%
K
H 14
ISO 50 U
>99.999%
D
ISO 55 U >99.9995%
F
U 15
ISO 60 U >99.9999%
G
ISO 65 U >99.99995%
G
U 16
ISO 70 U >99.99999%
G
ISO 75 U >99.999995%
G
U 17
*IEST Type A, B, C, D, and E are classified per
test results using photometers (Mil Std 282).
Types F, G, H, I, J, and K are classified per test
results using particle counters.

AAF offers a broad range of ASHRAE 52.2 compliant and energy efficient air
filters as prefiltration to final HEPA filters. The choice of prefiltration will determine
the cleanliness of the air entering the final filter and therefore its lifetime.
Table 2: Air Filter Classification per ASHRAE 52.2.

Standard 52.2
Complete Average Particle Size Efficiency, %
Minimum
in Size Range, m
Efficiency
Reporting Value
Range 1
Range 2
Range 3
(MERV)
0.30 - 1.0
1.0 - 3.0
3.0 - 10.0

1
2
3
4

5

6

7

8
9

10

11

12
13

14

15

16

IEST-RP-CC001

n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
E1 < 75
75 E1 < 85
85 E1 < 95
95 E1

n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
E2 < 50
50 E2 < 65
65 E2 < 80
80 E2
90 E2
90 E2
90 E2
95 E2

Average
Arrestance, %,
Addendum B

E3 < 20
Aavg. < 65
E3 < 20
65 Aavg. < 70
E3 < 20
70 Aavg. < 75
E3 < 20
75 Aavg.
20 E3 < 35
n/a
35 E3 < 50
n/a
50 E3 < 70
n/a
70 E3 n/a
85 E3 n/a
85 E3 n/a
85 E3 n/a
90 E3 n/a
90 E3 n/a
90 E3 n/a
90 E3 n/a
95 E3 n/a

To ensure the highest levels of air purity, pharmaceutical processes need to rely on high efficiency particulate air filters as terminal
filters. These air filters are subject to classification according to IEST-RP-CC001 (HEPA and ULPA filters). This recommended practice
(RP) covers basic provisions for HEPA and ULPA filter units as a basis for agreement between customers and suppliers.

Air Filter Classification According to IEST-RP-CC001

Testing Capabilities of AAF

Table 3: Recommended Test and Minimum Rating for Filters Types A Through K.
Filter
Penetration Test
Last (Scan) Test 1
Minimum Designated

Type
Efficiency
Leak

Method
Aerosol
Method
Aerosol Comments Rating Penetration

HEPA

MIL-STD-282

Thermal DOP

99.97%

n/a

99.97%

n/a

HEPA
MIL-STD-282 Thermal DOP Photometer Polydisperse
(type C)1 DOP/PAO

99.99%

0.010%

HEPA
MIL-STD-282 Thermal DOP Photometer Polydisperse
(type D)1 DOP/PAO

99.999%

0.0050%

HEPA
(type E)1

99.97%

n/a

(type A)

None

None

HEPA
MIL-STD-282 Thermal DOP
None
None
(type B)

MIL-STD-282

Thermal DOP

None

None

Two-flow
leak test

Two-flow

HEPA
IEST-RP-CC007
Open
Particle
Open
99.9995% at 0.00250%
(type F)1 Counter 0.1-0.2 or

0.2-0.3 m
HEPA IEST-RP-CC0072
Open Particle Open 99.9999% at
0.0010%
(type G)1 Counter 0.1-0.2 or

0.2-0.3 m
HEPA
IEST-RP-CC007
Open
None
None
99.97% at
0.1-0.2 or
(type H)1

0.2-0.3 m

n/a

HEPA
IEST-RP-CC007
Open None Open
Two-flow
99.97% at
n/a
leak test
0.1-0.2 or
(type I)1

0.2-0.3 m
HEPA
IEST-RP-CC007
Open
Particle Polydisperse
99.99% at
Counter or
DOP/PAO
0.1-0.2 or
(type J)1
Photometer 0.2-0.3 m

0.010%

HEPA
IEST-RP-CC007
Open
Particle Polydisperse
99.995% at
Counter
DOP/PAO
0.1-0.2 or
(type K)1
Photometer 0.2-0.3 m

0.0080%

Either of the two scan test methods or an alternative method may be used for filter types C, D, F, and agreed. Designated leak details for these
filter types are given in IEST-RP-CC034.
Filter medium tested at most-penetrating particle size (MPPS) prior to filter assembly. All filters are leak-tested but in some instances may not
be tested for overall penetration. The MPPS for testing this filter type is determined from the media according to IEST-RP-CC021.

All HEPA and ULPA filters produced

by AAF are built in an ISO 7
cleanroom environment and tested
in an ISO 4 cleanroom with full
compliance to IEST standards. In
a modern test rig, each air filter is
individually tested by well-trained
AAF personnel before shipment to
the customer.
HEPA and ULPA filters are leak tested
using a challenge aerosol. The test
results are documented in a test
report for each individual HEPA or
ULPA filter. It gives full information
about the tested air filter, test
parameters (airflow, test method
and aerosol), and the test results
according to IEST-RP-CC001, and
are available for every filter when
requested. Air filter labels include the
identification of the air filter type, a
serial number for full traceability, the
test standard used, the filter class,
and the nominal airflow rate at which
the air filter has been classified.
Strict quality procedures ensure that
all HEPA and ULPA filters leaving the
AAF factory are leak-free, perform
according to applicable standards,
and are consistent with the individual
customer requirements.

Filters that meet the requirements of

IEST-RP-CC001 are suitable for use in clean
air devices and cleanrooms that fall within
the scope of ISO 14644 and for use in supply
air and contaminated exhaust systems that
require extremely high filter efficiency (99.97%
or higher) for submicrometer (m) particles.
IEST-RP-CC001 describes 11 levels of filter
performance and six grades of filter costruction. A customer should specify the level
of performance and grade of construction
required. A customer should also specify the
filter efficiency required if it is not covered by
the performance level specified in this RP
(table 3).

Classifying Cleanrooms

Classification Standards

Pharmaceutical cleanrooms and clean air devices are classified

according to ISO 14644-1. The level of airborne particulate
cleanliness, applicable to a clean area, is expressed as an ISO
class. The lower the classification number, the higher the level
of cleanliness. The ISO class represents maximum allowable
concentrations for considered particle sizes, ranging from 0.1 m
up to 5.0 m. Figure 2 shows a graphical illustration of the nine
ISO cleanroom classes with the concentration limits for the given
particle sizes. Different room classes are typically necessary for
the various pharmaceutical clean areas and production steps
taking place.
For the operational environmental monitoring of the production
of sterile preparations, EU GMP distinguishes four alpha grades.
Each grade is assigned maximum permitted airborne particle
concentrations for sizes 0.5 m and 5.0 m at-rest and
in operation state. Particles of 0.5 m and larger can be
considered as the most critical particle sizes that need to be
effectively filtered out by HEPA filtration for obtaining the required
aseptic process conditions. GMP grade A is the most stringent
classification and equals ISO 5 according to ISO 14644-1. This
type of area is expected to be almost completely free from
particle sizes 5.0 m, both at-rest and in operation condition.

Figure 2:
ISO 14644-1 Cleanroom Class Particulate
Concentration Limits

Airborne particle
concentration (particles/m3)

The production of sterile pharmaceuticals is subject to

special requirements in order to minimize risks of
particulate and microbial contamination. Manufacturing
is carried out in clean areas within which the concentration
of airborne particles needs to be controlled. The
classification and monitoring of such clean areas follow
the ISO 14644 standard and the EU GMP Directive
2003/94/EC.

109
108

ISO C

lass
9
ISO C
lass
8
ISO C
lass
7
ISO C
lass
6
ISO C
lass
5

107
106
105
104
103
102
101

ISO C

lass
4
ISO C
lass
3
ISO C
lass
2
ISO C
lass
1

100
0.1
0.2 0.3
Particle size (m)

0.5

1.0

5.0

The graph shows the minimum and maximum particle size limits acceptable
for each of the ISO classes shown. The classification lines do not represent
actual particle size distributions found in cleanrooms and clean zones.

Sterile Manufacturing Activities

The pharmaceutical industry is expected to take proactive

steps in ensuring that products are safe and effective. EU GMP
regulations require building a quality approach into the
manufacturing process, to minimize or eliminate risk of cross
contamination and errors (table 5).

Table 4: Cleanroom Classification According to EU GMP Annex 1

Maximum Permitted Number of Particles /m3 Equal to or
Greater than the Tabulated Size

At-rest
In Operation
International C
leanroom Standard

Comparison for At-rest
Grade

0.5 m

5.0 m

0.5 m

5.0 m

FED 209E

FED 209D

ISO 14644

3,520

20

3,520

20

M 3.5

Class 100

ISO 5

3,520

29

352,000

2,900

M 3.5

Class 100

ISO 5

352,000

2,900

3,520,000

29,000

M 5.5

Class 10,000

ISO 7

3,520,000

29,000

Not Defined

Not Defined

M 6.5

Class 100,000

ISO 8

Monitoring Microbial Contamination

EU GMP Annex 1

Clean areas for the production of sterile products are classified

according to the required characteristics of the environment.
Each manufacturing operation requires an appropriate
environmental cleanliness level for minimizing the risks of
particulate and microbial contamination of the concerning
starting material or product. EU GMP Annex 1 sets limits for
microbial contamination for each of the four identified
cleanroom grades (table 4).
The air in risk zone areas, particularly vulnerable to biocontamination, needs to be protected from viable particles, consisting
of one or more live organisms. Methods for evaluation and
control are provided by ISO 14698 (Biocontamination Control).

The Role for Air Filtration

Especially for aseptically prepared parenteral medicine (such

as injectables and infusions) no contamination can be
accepted, otherwise severe harm or life-threatening health
risks to the patient can result. It is exactly in this area where
air filtration comes in as the critical link in the overall chain.
Air in critical areas should always be supplied at the terminal
stage by HEPA filtered unidirectional airflow, preceded by
sequential prefiltration steps. A leak-free and high filtration
efficiency performance of the HEPA filter is vital for ensuring
that air purity is optimized, the pressure differentials between
rooms are met, and healthy working conditions are achieved.

Table 5: Typical Cleanroom Activities for Terminal Sterilization and Aseptic Preparation
GMP Grade

Examples of Typical Activities

Terminal Sterilization

Aseptic Preparation

A
Filling of products for sterilization (unusual risk profile)
Handling of sterile starting materials and components
Preparation of materials and products (non-sterile filtering)

Handling and filling of aseptically prepared products
B

Filling of products for sterilization (usual risk profile)

Preparation of materials and products (sterile filtering)

Preparation of components (usual risk profile)

Background area for grade A zones

Preparation of components (unusual risk profile)
Handling of components after washing

Qualifying HEPA Filters

Pharmaceutical cleanrooms require an extensive validation
procedure before initiating pharmaceutical production.
The process then has to be revalidated in predefined
intervals. Validation and revalidation both serve to
determine if the process is capable of reproducible
commercial manufacturing. For HEPA terminal filtration
this implies initial qualification and periodic requalification
of its performance characteristics.

Qualification Procedure

FDA cGMP Guidelines: Sections IV-Buildings and Facilities;

Section IX-Validation of Aseptic Processes; and Section
X-Laboratory Controls describe the principles of validation
and qualification that are applicable to the production of
medicinal products. The procedure typically follows a V-shaped
model, consisting of three sequential steps (figure 3). Each of
these steps would pose its own stringent demands on HVAC
installations in general and HEPA filtration in specific. Selecting
high quality manufactured HEPA filters will enhance the
probability of success and will limit the risk of failure.
Installation Qualification (IQ): does the HEPA filter
specification match what I had ordered and expected?
Examples of HEPA filter requirements:
Individual test report according to IEST-RP-CC001
Complete and accurate labeling including serial
number for traceability
Correct packaging and testing information
Operational Qualification (OQ): does the HEPA filter
perform according to functional specifications during
at-rest operation?
Examples of HEPA filter requirements:
Absence of any visual damage to filter media,
gasket, and frame
Successful in-situ test result with confirmed filter integrity
Actual initial resistance performance consistent with
specification
Performance Qualification (PQ): does the HEPA filter
demonstrate reliable performance during full-scale
operation?
Examples of HEPA filter requirements:
Absence of leakage (e.g., media) and bypass
(e.g., gasket seal) according to IEST-RP-CC034
Consistent particulate collection efficiency over time
Absence of fiber shedding that could cause contamination

Figure 3:
Cleanroom Validation Procedure, Derived
from ISO 14644-4

User requirements
specifications

Verification
In operation

Functional
specifications

Verification

Design
specifications

Verification

At-rest

As-built

Cleanroom
construction

Performance
Qualification (PQ)

Operational
Qualification (OQ)

Installation
Qualification (IQ)

Installed HEPA Filter Integrity Testing

The purpose of installed HEPA filter integrity testing, also called in-situ testing,
is to confirm a flawless performance during normal operation. Filter integrity
measurements encompass tests for installed filter leakage, such as in the media
or sealant to frame, and bypass, such as in the frame, gasket, or grid system. As
such, it differs from factory leak testing that focuses on measuring filter integrity
under laboratory conditions.
Both filter leakage and bypass can result in a penetration of contaminants that
exceeds the expected value of downstream concentration. As these situations
may seriously harm the sterility of critical parameters, and therefore the quality
of medicinal products, periodic requalification of terminal HEPA filters is required.
Subject to risk assessment of the cleanroom activity, this interval is typically set
at six months for GMP grade A aseptic processes.
The most commonly used methods for testing the integrity of installed HEPA
filters are described in the ISO 14644-3 standard: Aerosol Photometer (AP) and
Discrete Particle Counter (DPC). The AP method typically uses a high concentration 10-40 ug/liter of oil-based aerosol, for scanning air filters for leakage.
A low concentration aerosol challenge exposure is always recommended as it
gives a less contaminated filtration system and therefore an optimized energy
efficiency and improved HEPA filter lifetime expectancy.

Dedicated Support from AAF

With AAFs new Nelior Filtration
Technology, filters can now be scan
tested with the industry standard
photometer at the standard aerosol
concentrations set forward, as well
as the low aerosol concentration
DPC method. AAF engineers work
with state-of-the-art test equipment
and can provide a project team or
supervisor on site for practical
assistance. As AAF firmly believes
that independency in testing is
critical, its core policy is to educate
staff and test agencies locally for
transferring knowledge and sharing
best practices.
Please contact your local AAF
affiliate office for more details on
the in-situ testing support that
AAF can provide to ensure that
terminal filter performance is
optimized for its purpose.

Pharmaceutical Process Application

Design Considerations and AAF Air Filtration Solutions

1
Preparation and Cleaning

Sterile Filling and Closing

Checking and Packaging

FDA GMP Classification:

Grade C (ISO 7)

GMP Classification:
Grade A (ISO 5)

GMP Classification:
Grade D (ISO 8)

Activities:

Activities:

Support area with medium risk

preparation activities such as
cleaning, for conveyance into a
dry heat sterilization tunnel, before
entering the aseptic filling and
closing area.
Cleanroom Parameters:

Activities:

Process core isolator environment

with high risk aseptic filling and
closing operations for parenteral
products such as prefilled syringes,
cartridges, and vials in a GMP grade
B controlled background area.
Cleanroom Parameters:

Support area with medium risk

activities such as visual checks of
the aseptically prepared products,
batch quality inspections, labeling,
and secondary packaging.

Cleanroom Parameters:

Room height (ft.)

Room height (ft.)

N/A

Room height (ft.)

Area per
occupant (sq. ft.)

100

Area per
occupant (sq. ft.)

300

Area per
50
occupant (sq. ft.)

7.5

Equipment in room 30% floor

Equipment in room minimum

Equipment in room 50% floor

Occupant activity

occasional
movement

Occupant activity

minimum

Occupant activity constant

activity

Traffic in/out
per hour

2-6

Traffic in/out
per hour

N/A

Traffic in/out
per hour

more than 6

Room over
pressure

0-0.06 in. w.g.

(0-15 Pa)

Room over
pressure

0.06 in. w.g.

(15 Pa)

Room over
pressure

0.02-0.04 in. w.g.

(5-15 Pa)

Air changes
per hour

20-40

Air changes
per hour

500

Air changes
per hour

10-20

Air lock

small

Air lock

yes

Air lock

no

Airflow pattern

unidirectional

Airflow pattern

Airflow pattern

non-unidirectional

non-unidirectional

Clean air inlets

10-20
as % of ceiling area

Clean air inlets as 90

% of ceiling area

Clean air inlets as 5-10

% of ceiling area

Clean air inlet

locations

ceiling

Clean air inlet

ceiling (wall)
locations

Clean air inlet

locations

Terminal velocity
at clean air inlet

30-90 FPM
(0.15-0.45 m/s)

Terminal velocity
at clean air inlet

Terminal velocity 30-90 FPM

at clean air inlet (0.15-0.45 m/s)

Return air location low sidewall

10

60-90 FPM
(0.30-0.45 m/s)

Return air location low sidewall

ceiling /
high sidewall

Return air location sidewall

AAF Air Filtration Solutions

2 VariCel VXL

MEGApleat M8

14 SAAF Cassette MD
6

AstroCel III

1 MEGApleat M8

8 PharmaGel Module
10 FM2-LE
4

AstroCel II

8 PharmGel

Module

9 TM Hood

AstroCel II

7 AstroCel I HCX
3 VariCel 2HC

15 Bag In/Bag Out Housing

VITCAcel

13 AstroCel I HT500
12 AstroCel I HTP
11 VariCel II HT

Grade C

Grade A

Grade D

The illustration represents a simplified aseptic manufacturing process with the aim of visualizing AAFs air filtration solutions. Its exact design and the
air filtration system installed, will always be application specific. Please contact your local AAF affiliate office for a custom-made solution.

11

AAF Air Filtration Solutions

1 MEGApleat M8

Strongest and longest-lasting MERV 8

pleated filter. Lower pressure drop and
higher DHC means reductions in energy
consumption and operating costs.
Recommended Application:
First stage prefiltration and post stage
filtration in central air handling unit.
Brochure AFP-1-200
Optional product option: PerfectPleat HC M8

2 VariCel VXL

Configuration and Performance:

MERV 8
Media: 100% synthetic fiber blend
Filter frame: High wet-strength
beverage board
Metal backing: Heavy-duty,
galvanized expanded metal
Available in 1", 2" and 4" models

Minipleat V-bank design with the lowest

average resistance and highest DHC
over the life of the filter.

Configuration and Performance:

Recommended Application:
Second stage of filtration in central air
handling unit.

Media: Moisture-resistant,
dual-density microglass

Brochure AFP-1-162

MERV 15, MERV 14, MERV 13,

and MERV 11

Filter frame: High impact

polystyrene plastic
Temperature limit: 176F / 80C

Optional product option: VariCel

3 VariCel 2HC

Extended surface mini-pleat filter

with low pressure drop and slim-line
design for low space access or
space saving issues.
Recommended Application:
First stage filtration in Bag In/Bag Out
housing.

4 AstroCel II

MERV 15, MERV 14, and MERV 11

Media: Embossed synthetic
Filter frame: High impact
polystyrene plastic
Temperature limit: 150F / 66C

High efficiency mini-pleat filter

individually factory tested for
guaranteed performance.

Configuration and Performance:

Recommended Application:
Terminal filtration for PharmaGel
Hood in GMP grade C-D
cleanrooms.

Filter frame: Anodized aluminum

C channel

Brochure AFP-1-404

12

Configuration and Performance:

HEPA or ULPA efficiency

Media: Ultrafine microglass

Seal: Gel, neoprene gasket, or

knife edge

5 VITCAcel

Individually tested pharmaceutical

mini-pleat filter with an extremely low
resistance and superior mechanical
media strength.
Recommended Application:
Terminal filtration for TM Hood or
FM2-LE in GMP grade A-B cleanrooms.

6 AstroCel III

Configuration and Performance:

HEPA or ULPA Efficiency
Media: Nelior
Filter frame: Anodized aluminum
Seal: Gel, neoprene gasket, or
knife edge

High efficiency filter in a V-shaped

configuration with optimized fiberglass
media packs for handling high airflow
rates.

Configuration and Performance:

Recommended Application:
Final stage filtration in central air
handling unit.

Seal: Gasket or gel

HEPA Efficiency
Media: Ultrafine microglass
Filter frame: Extruded aluminum

Brochure AFP-1-405

7 AstroCel I HCX

High capacity filter in separator style

configuration for handling high airflow
rates at an extremely low resistance.

Configuration and Performance:

Recommended Application:
Final stage filtration in Bag In/Bag Out
housing.

Filter frame: Metal or wood

HEPA Efficiency
Media: Ultrafine microglass
Seal: Gasket or gel

Brochure AFP-1-110

8 PharmaGel Module

Rigid and leak free filter housing

available in multiple executions and
designed for easy filter installation and
exchange.

Configuration and Performance:

Recommended Application:
Terminal filtration module in GMP
grade C-D cleanrooms.

Filter type: AstroCel II or VITCAcel

Construction: Aluminum
Connection: Top inlet
Seal: Gel

Brochure AFP-1-408

13

AAF Air Filtration Solutions

9 TM Hood

Hermetically sealed and light weight

filter module individually factory
tested for guaranteed high filtration
performance.

Configuration and
Performance:

Recommended Application:
Terminal filtration module in GMP
grade B cleanrooms.

Seal: Gasket or gel

Brochure AFP-1-475

10 FM2-LE

Self-contained, energy efficient ceiling

filter unit available in multiple sizes with
a high performance and low sound level
fan motor system.
Recommended Application:
Terminal filtration module in GMP
grade A cleanrooms.
Brochure AFP-1-420

11 VariCel II HT

Construction: Anodized
aluminum
Filter type: AstroCel II
or VITCAcel

Configuration and Performance:

Construction: 16-gauge mill
finish aluminum
Fan motor: AC motorized
impeller
Speed controller: Variable
Filter type: AstroCel II
or VITCAcel

Extended surface mini-pleat filter

designed for high temperature
operation.

Configuration and Performance:

Recommended Application:
High temperature filtration for dry heat
sterilization and depyrogenation.

Filter frame: Aluminized steel

12 AstroCel I HTP

MERV 11, MERV 13, and MERV 14

Media: Dual-density Microglass
Temperature limit: 350F - 500F /
176C - 260C

Deep-pleat high temperature HEPA filter

in a robust construction for superior
durability and reliable operation.

Configuration and Performance:

Recommended Application:
High temperature filtration for dry heat
sterilization and depyrogenation.

Media: Ultrafine microglass

Brochure AFP-1-115

Seal: Fiberglass

99.97% minimum efficiency

on 0.3 micrometer particles
Filter frame: Stainless steel with
support bars
Temperature limit: 662F / 350C
(750F / 400C 1h peak)

14

13 AstroCel I HT500

High capacity filter in separator style

configuration designed for high
temperature applications.

Configuration and Performance:

Recommended Application:
High temperature filtration for dry heat
sterilization and depyrogenation.

Media: Ultrafine microglass

Brochure AFP-1-115

Seal: Gel

99.97% minimum efficiency on

0.3 micrometer particles
Filter frame: Stainless steel
or aluminum
Temperature limit: 500F / 260C

14 SAAF Cassette MD

Patented V-bank gas-filtration cassette

designed for optimal gas removal.
Recommended Application:
Gas-phase filtration in central air
handling unit.

Configuration and Performance:

Construction: 100% recyclable/
incinerable High Impact Polystyrene
(HIPS) plastic
Chemical media: SAAFBlend GP

Brochure GPF-1-108

15 Bag In/Bag Out Housing

Side loading filter system for removing

contaminated particulate filters and/or
gas absorbers.

Configuration and Performance:

Recommended Application:
Safe change of contaminated filters
by radioactive, pathogenic, or toxic
substances.

Modularity: Up to six filters wide

Casing: 14 gauge,
304 stainless steel
Temperature: 150F / 66C

Brochure APC-1-260

Cleanroom Components

For guaranteeing an efficient installation and effective operation of terminal air

filtration systems, AAF offers a broad range of matching cleanroom components.
These components vary from ceiling grids to light fixtures. Please contact your
local AAF affiliate office for tailored advice and a custom-made solution, designed
by AAF cleanroom specialists.

15

High Temperature HEPA Solution

To prevent Endotoxin contamination in sterile conditions, containers and
closure surfaces need to be depyrogenated. Endotoxins are removed by
applying dry heat sterilization, for which the air is to be cleaned by a reliable
HEPA filtration system. The new AstroCel I HTP high temperature
HEPA filter is designed to provide excellent protection of this critical
depryogenation process.

Reliable High Temperature Operation

In continuous service, the AstroCel I HTP filter offers a maximum temperature

resistance of 662F / 350C, with a peak of 752F / 400C for one hour. Its robust
stainless steel structure prevents potential damage of components that could occur
from the heat stretching during temperature rising and falling. Thorough heat-cycle
tests have confirmed a damage-free construction and a consistent performance in
pressure drop and dust holding capacity at 662F / 350C.
Two strong vertical support bars, inside the media pack, make sure that the media
pack stays fully intact, preventing winding of the pleats at the bottom. The sloped
design of the stainless steel separators reduces media stretching, which causes
particle shedding. The AstroCel I HTP filter offers a unique combination of high
temperature operation and superior durability, optimizing process results and
limiting unscheduled downtimes.

High Air Quality Conditions

The high temperature HEPA filter provides a high air quality level with a particulate
collection efficiency of 99.97% for 0.3 m particles at a nominal airflow of 1236 CFM.
With the possibility of this high airflow rate, ventilation can be optimized for enabling a
speedy temperature control. The silicone free construction of the AstroCel I HTP filter
further enhances the air purity level during the various steps of the drying process,
without the risk of denaturation by siloxane contamination caused by the filter itself.
For critical pharmaceutical aseptic process applications, in which no concessions
can be accepted to sterility and product quality, the AstroCel I HTP filter provides the
right solution for ensuring that the strict air cleanliness conditions are met.

16

New AstroCel I HTP high

temperature HEPA filter.

Certified Cleanrooms
It is critical that any filter manufacturer produce high efficiency filters to the
same level of quality and under similarly controlled production, test, and
packaging area conditions. The risk of contamination and expense resulting
from failure is too great to ignore. Filters introduced into a pharmaceutical
cleanroom directly affect the performance and viability of performance of
that clean area.

AAF State-of-the-Art Cleanroom

An essential part of contamination prevention is adequate separation of operation

areas. To maintain air quality, it is important to achieve a proper airflow from area of
higher cleanliness to adjacent less clean areas (from the FDA cGMP Guidelines).
Contamination can be the difference between success or failure. Not only does the
particulate collection performance of the high efficiency filter need to comply with
industry specifications, but also contamination resulting from the filter itself must be
eliminated. This requires manufacturing, testing, and packaging of high efficiency filters
under clean conditions for meeting the most demanding customer expectations. AAF
has acknowledged this importance, and constructed several new cleanroom areas
within its Columbia, Missouri manufacturing facility.
The entire Columbia Cleanroom area covers 9,247 square feet and consists of four
core process steps: filter media pleating, assembly, testing, and packaging.
By controlling our processes and maintaining a regimented quality program, including
manufacturing, testing, and packaging in cleanroom environments, we provide our
customers a total package for their most stringent requirements.

17

Nelior Filtration Technology

AAF VITCAcel filters feature Nelior Filtration Technology; the latest

advancement in high-performance air filtration, exclusively developed and
marketed by AAF. HEPA filters with Nelior Filtration Technology provide
significant benefits for pharmaceutical applications that operate under
strictly controlled conditions.

nelior

Filtration Technology

About Nelior Filtration Technology

Nelior Filtration Technology is based on a patented membrane air filtration media.

It features a superior composition and mechanical strength that give unique
performance characteristics to HEPA filtration, unmatched by any other air filtration
media currently available on the market.
The media is composed of an evenly distributed layer of fibers with nanometer-scale
diameters. It provides up to 50% lower operating resistance than traditional HEPA
filters in combination with an excellent overall particulate collection efficiency. The
superior mechanical strength is demonstrated by a high tensile strength, burst
pressure, and abrasion resistance. Nelior membrane media retains its integrity with
high resistance to any potential damage from filter handling prior to, at installation,
or during operation. This means that filter media failure risk can be minimized from
elements within the airstream during operation and the contamination risk from
microglass media shedding fibers downstream can be eliminated.

Resilient Nelior media at fold tip

@ 10,000x magnification.

With AAF Nelior Filtration Technology pharmaceutical applications can rely on a

sustainable performance with reduced operational risk, less energy consumption, and
substantial cost savings. For full details, please contact your local AAF affiliate office.

High Value Areas:

Consistent Air Quality
Providing a reliably high air quality to optimize contamination control
and meet the stringent conditions in clean environments.

Environmental Savings
Reducing operating resistance and extending life expectancy to
minimize energy consumption, CO 2 equivalents, and waste.

Improved Process Performance

Limiting risk of failures to enhance product quality and prevent
negative effects from unnecessary process interruptions.

Beneficial Total Cost of Ownership

Improving process reliability and overall efficiency to save life cycle
costs and improve profitability performance.

18

Fractured microglass media fibers at fold tip

@ 10,000x magnification.

Figure 4:

Mechanical Strength Reduces

Contamination Risks

Tensile Strength
Flat

350.0

Folded

Flat

Folded

312.8

318.0

300.0

A critical leak is given when more than 0.01 percent

of the upstream aerosol challenge penetrates a
test spot. If a critical leak has been determined, it is
customary to evaluate a possible impact on sterile
processing. If a local defect is being detected, this
would require a filter repair or replacement, retesting,
and finally the evaluation of possible effects on the
production line in question.

Tensile Strength (N)

250.0
200.0
150.0

Flat: 8x Higher
Folded: 84x Higher

100.0
50.0

41.6
3.8

0.0

Micro-Fiberglass

Nelior Media

Results based on Test Standard DIN EN 29073-3.

Figure 5:
Burst Pressure - Flat
7.0

6.4

Burst Pressure (kg/cm2 )

6.0
5.0

Following the recognized US guidance for Sterile Drug

Products Processing, HEPA filters should be tested
twice a year for leaks, to demonstrate filter integrity.

Endlessly Higher

4.0

To avoid leaks, the extremely sensitive surface of

traditional HEPA filters used to be protected by a grid on
the filter surface. New HEPA filters with latest generation
of membrane media represent a better solution due
to considerably improved mechanical strength and
reduced pressure difference, thus increasing economy
and quality of sterile production units.
Higher costs of such new filters are justified, since
the risk of damages, which might be detected not
before the following semi-annual leak testing cycle will
be considerably reduced - a good example for Best
available technology not entailing excessive costs.

3.0
2.0
1.0
0.0

0.0
Micro-Fiberglass

Nelior Media

Results based on Test Standard DIN EN 13938-2.

Figure 6:
Abrasion Resistance - Flat
20,000

Abrasion Resistance (# rubbing cycles)

20,000

Dr. Lothar Gail

GMP and cleanroom consultant VDI.

16,000
1000x Higher
12,000
8,000
4,000
0

20
Micro-Fiberglass

Nelior Media

Results based on Test Standard DIN EN 12947-2.

19

Pharmaceutical Clean Air Solutions

Air Filtration Glossary
Air filter
Unit installed in an air handling system designed to remove
particulates from the air passing through it.
Airflow
Distribution of air passing through a filter element per unit of time.
Airflow rate is usually expressed in ft3/min or CFM (m3/h or m3/s).
Airborne particles
Liquid or solid matter that is suspended in the air. Sizes of airborne
particles vary and are expressed in micrometer (m).
Arrestance
Removal of standard test dust expressed as weight percentage.
Average value is used for classification of coarse filters.
Coarse filter
Air filter classified in one of the classes G1 to G4 according to
EN779:2012 based on removal of synthetic loading dust. See
ASHRAE 52.2.

HEPA filter
High Efficiency Particulate Air filter classified with a minimum
efficiency of 99.97% when challenged with particles sized at
0.3 micrometers.
HVAC
Heating, Ventilation and Air Conditioning. Regulating system
including air filtration to control indoor air quality and comfort.
Life Cycle Valuation
Comparative calculation of air filters demonstrating the provided
environmental and financial cost during the installation period.
Mechanical strength
Indication of the elastic or inelastic behavior of air filtration media
under pressure demonstrating resistance to damage.
Media
Fibrous material used to remove solid or gaseous particulates
from the air passing through a filter element.

Efficiency
Removal of the number of defined particles by the air filter in
relation to the upstream concentration expressed in a percentage.

MPPS
Most Penetrating Particle Size. Represents the particle size at
which penetration of particles through the filter media is highest.

Energy efficiency
Ability of the air filter to minimize electricity consumption as a
function of its operating resistance and operating conditions.

Nelior Filtration Technology

Patented air filtration media based on fine nanometer-scale
membrane fibers, exclusively developed and marketed by AAF.

Face velocity
Airflow rate divided by the effective media area of a filter element.
Face velocity is usually expressed in FPM (m/s).

Operating resistance
Difference in pressure between upstream and downstream airflow
through an air filter. Also referred to as pressure drop.

Filter class
Indication of the air filtration performance measured according to
test procedures compliant to ASHRAE 52.2 and IEST RP CC001.

Prefilter
Air filter installed for removal of larger particles from the passing
air to protect the higher efficiency air filters in the next stage.

Filter integrity
The degree to which the air filter demonstrates a consistent
performance according to specification without leakage.

Terminal filter
High efficiency air filter used as final filtration stage to critical
process areas that require strict contamination control.

Filter qualification
Action of proving that the HEPA filter functions in line with
expectations by using methods according to ISO 14644-3:2005.

Test aerosol
Suspension of liquid or solid particles used to challenge air filter
media for factory efficiency tests and in-situ integrity tests.

Fine filter
Air filter classified in one of the classes F7 to F9 according to
EN779:2012 based on minimum efficiency of 0.4 m particles.

ULPA filter
Ultra Low Penetration Air filter classified with a minimum
efficiency 99.999% when tested in accordance with the
methods of IEST-RP-CC007.

AAF has a policy of continuous product research and

improvement and reserves the right to change design
and specifications without notice.
ISO Certified Firm
AAF-1-206 05/14

9920 Corporate Campus Drive, Suite 2200, Louisville, KY 40223-5690

888.223.2003 Fax 888.223.6500 | www.aafintl.com

2014 AAF International