BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 1

BEKO TECHNOLOGIES

Whitepaper Compressed Air

in the Pharmaceutical Industry

Better through Responsibility

BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 2

Content
3 Compressed air – an important component in many processes
4 Which compressed air quality is necessary for a safe production process?
6 Quality requirements depending on the application
8 DIN-ISO standard 8573-1
10 How does compressed air become contaminated?
12 Hazard analysis and risk assessment
13 Where compressed air treatment is essential – examples from the pharmaceutical industry
14 Intelligent compressed air treatment requires expertise
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 3

Compressed air –
an important component in many processes

T he production of medicinal products without constant

compressed air supply is barely conceivable. The
medium compressed air is used at many points in the
This whitepaper provides an insight into the topic of
compressed air in the pharmaceutical industry. It deals
with guidelines and laws, the quality of compressed air
production process, during tablet production, for example, as well as possible impurities and their sources. Practical
cleaning plants and containers, transporting components examples will also be used to demonstrate why systematic
or at packaging systems. For these reasons, production compressed air treatment and seamless monitoring
companies in the pharmaceutical industry should pay of compressed air are essential for process reliability in
special attention to the medium compressed air in their pharmaceutical manufacturing.
quality management.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 4

Which compressed air

quality is necessary for a safe production process?

T he greatest challenge to compressed air quality man-

agement is that there are no concrete legal regulations
for the quality of compressed air. Requirements concern-
and in anaesthetics. International laws and standards such
as the European Pharmacopeia and the United States
Pharmacopeia (USP) regulate this. Both of them define
ing perfect quality and harmlessness only exist for the the quality of the air and its regular monitoring.
medicinal product itself. For this reason, pharmaceutical
companies must define for themselves which compressed
air quality they require for their own process. It is the
responsibility of the manufacturer to guarantee the
quality of the final product.

An exception to this general rule is so-called aer

medicinalis – compressed air which is mainly used as a
medicinal production for ventilation and aerosol therapy
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 5

Good Manufacturing Practice (GMP)

G MAC
T o produce a safe medicinal product, the medium
compressed air and thus the entire compressed air
plant must be taken into consideration, since this
S S IN HI
CE NE represents a potential risk to the quality of the final
O RY
product. This is always obligatory for companies pro-
PR

» « ducing according to GMP rules (“Good Manufacturing

P r a tic e
Go

Practice”).
LOC ATION
SANITARY

Quality

GMP
od Ma

The reason is simple: the GMP are in place to ensure that

PRODUCT medicinal products are of a consistently high quality in
nu order to guarantee maximum consumer protection.
f a c tu rin
g

Concrete specifications are not made, rather instruments

M

IN are provided to foresee all possible situations. This

EL
A

TE
NA O NN includes preventative maintenance, for example. One of
NCE P ERS
the core elements of GMP is complete documentation,
which also applies for all compressed air-related issues.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 6

Quality requirements
depending on the application

F or the special case of clean rooms, the requirements

for compressed air quality are clearly defined.
Compressed air can occur in all cleanroom classes and,
A reference point for the selection of compressed air
quality to match the respective process is the following
categorisation of applications with their different
according to the FDA Guide for Industry, must at least cor- requirements on compressed air (see page 7).
respond to the quality of the ambient air into which it es- One decisive factor is whether the compressed air is in
capes. The requirements for cleanroom classes A, B, C and direct or indirect contact with the product.
D can be found in the GMP guideline Appendix 1 “Sterile
Manufacturing“.

For compressed air applications outside the clean room,

the quality requirements are less clearly defined.
 BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 7

COMPRESSED APPLICATION
DESCRIPTION
AIR TYPE EXAMPLES
High requirements

Compressed air used on patients with

Medicinal » Ventilation of patients a physiological and pharmacological
compressed air/ using compressed air effect. In this case, compressed air is
breathing air » Aerosol therapy a medicinal product and requires
authorisation.

» Transport of medicinal products and

their components such as powders
Process air and » Compressed air for loosening up bulk goods The compressed air is either a
conveying » Compressed air at spray nozzles constituent part of the medicinal
air for the » Compressed air in CIP cleaning product (excipient) or in direct/
pharmaceutical
» Compressed air for packaging indirect contact with the product.
industry
» Compressed air in bio-technological processes
» Compressed air for analysis technology
Low requirements

» Compressed air for controlling and

Control air/ regulating production lines
» Compressed air for blowing particle Compressed air that does not come
general technical into contact with the final product
compressed air contamination off workpieces
» Compressed air for cleaning particle filters
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 8

DIN-ISO standard 8573-1

T he ISO 8573 series of standards deals with the subject

of compressed air quality in nine parts. Parts two
to nine cover test methods. Part 8573-1 classifies
Oil content
Specification of the residual amount of oil aerosols and
compressed air on the basis of the maximum permitted hydrocarbons that may be contained in the compressed air.
contamination content (particles, water and oil).
The table on page 9 shows the limit values of the individual
The standard DIN ISO 8573-1 defines the quality compressed air classes for the three categories as well as the
classes of the compressed air with regard to: products, that provide the right compressed air treatment.

> In order to establish more transparency and safety,

Particle size and density
the German Mechanical Engineering Industry
Specification of size and concentration of the solid parti- Association (VDMA) has drawn up the VDMA
cles that may still be contained in the compressed air. Standard Sheet 15390.
It describes in detail which typical quality classes are
recommended by VDMA for the different compressed
Pressure dew point/humidity content
air applications. The compressed air quality classes
Determination of the temperature at which water vapour in accordance with ISO 8573-1 are used. This standard
condenses to water at the current operating pressure. is intended to support users with definition of
their requirements and selection of the treatment
components.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 9

Oil content
Pressure
Solid particles, maximum number of particles per m³ (liquid, aerosol,
dew point
Class oil vapour) Which treatment technologies
0,1 μm < d ≤ 0,5 μm 0,5 μm < d ≤ 1,0 μm 1,0 μm < d ≤ 5,0 μm °C mg/m 3 can be used to ensure
the respective limit values
0 In accordance with the device operator‘s or supplier‘s specification, stricter requirements than class 1 are met?
1 ≤ 20.000 ≤ 400 ≤ 10 ≤ -70 ≤ 0,01

2 ≤ 400.000 ≤ 6.000 ≤ 100 ≤ -40 ≤ 0,1

3 – ≤ 90.000 ≤ 1.000 ≤ -20 ≤1 Compressed air filter

4 – – ≤ 10.000 ≤ +3 ≤5

5 – – ≤ 100.000 ≤ +7 >5 Compressed air dryer

6 – – – ≤ +10 –

Activated carbon filter/

adsorber and
Special case: germ-free/sterile catalysis technology
DIN ISO standard 8573-1 does not define any limit values for germs/micro-organisms.
However, absolutely germ-free compressed air is extremely important for manu-
facturing processes in the pharmaceutical industry, because germs and
micro-organisms on the medicinal product endanger the health of the consumer.
These can also be removed permanently from the compressed air using compressed
air treatment technology like sterile filters or catalysis technology.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 10

How does
compressed air become contaminated?

T here are many ways for contamination such as

particles, oils, germs and humidity to enter the
compressed air. They are often already present in the
The contamination presents risks: on the one hand, it
presents a real risk to the quality of the final product and
thus the consumer, on the other it can impair the function
ambient air and get into the compressed air system of the compressed air plant and lead to premature wear of
through the compressor intake air. The reason for the plant components.
contamination can be a major road or construction
site nearby, for example. The risk of humidity occurring
in the compressed gas system increases with air
humidity in the ambient air.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 11

VALVES AND PRELIMINARY

ENVIRONMENT COMPRESSOR PIPE SUPPLIER
FITTINGS

Additional hazards exist Oil-lubricated compressors Many components in the Once a pipe is contami- If the raw materials de-
depending on the direct can be a source of compressed air network nated, there is a constant livered for manufacturing
surroundings and individual residual oil vapours in the are lubricated with greases risk: over the years, deposits the product already contain
circumstances: in addition compressed air system. or silicones for better of grease or oil can form in contamination, this can be
to dust and humidity, oil and functioning. These existing pipe networks and transferred to the product
micro-organisms can also substances can easily get can influence the flowing as well.
get into the compressed gas into the compressed air. compressed air.
system via the ambient air.

Does an oil-free compressor offer air complete safety?

A compressor compressing oil-free does not allow any additional oil to enter the compressed air system. But oil
aerosols are already contained in the intake air or can enter the compressed gas system through other components,
the compressed air still has to be treated.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 12

Hazard analysis and risk assessment

As described above, all users can specify the exact quality Monitor compressed air quality – but how?
classes in accordance with the DIN ISO Norm 8573-1 Manufacturers and users of compressed air in the
standard and consider their individual needs. pharmaceutical industry must check which dangers
caused by compressed air occur for the medicinal product.
However, manufacturers are obliged to document their Finally, measures must be defined to confine the risk.
decision with respect to safety measures within the Monitoring and documentation of compressed air quality
context of a hazard analysis and risk assessment and to at the critical points is vital in order to prove the quality
make this transparent. Self-monitoring instruments such of the compressed air and meet the obligation of proof
as QRM (Quality Risk Management), the HACCP (Hazard required for audits and inspections. Alongside quality-
Analysis and Critical Control Points) concept and FMEA related audits for the compressed air itself, the
(Failure Mode and Effects Analysis) provide help with this. compressed air system is looked at closely during audits
concerning energy, the environment and health & safety.
Safe compressed air of a consistent quality can only
be achieved by compressed air treatment including
comprehensive 24/7 monitoring.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 13

Where compressed air treatment is essential

Examples from the pharmaceutical industry

PFIZER MANUFACTURING DEUTSCHLAND GMBH materials, for ventilating steriliser chambers and for
To improve process reliability in production, the pharma- product superposition in manufacturing. In order to meet
ceutical company Pfizer permanently checks the quality of the high quality requirements resulting from direct
the compressed air by monitoring the residual oil content product contact, the company uses both activated carbon
using measuring technology and a built-in alarm system. filters and an innovative catalysis method which produces
This allows Pfizer to initiate counter-measures before limit compressed air which even exceeds the strict requirements
values are exceeded. Since the compressed air comes into of ISO 8573-1 Class 1.
direct contact with the medicinal product both during coat-
ing and blow-off processes at production machinery, the KLOSTERFRAU BERLIN GMBH
company treats its compressed air in accordance with GMP. The pharmaceutical company Klosterfrau Berlin GmbH
has to rely on stable, dry and oil-free compressed air in
TAKEDA (FORMERLY NYCOMED GROUP) its processes. Compressed air is used in the autoclaves in
The pharmaceutical manufacturer Takeda (formerly syringe production as well as for syringe filling, and thus
Nycomed) uses comprehensive system solutions to treat has to meet especially high requirements. Alongside com-
its process air reliably so that it is oil-free. Compressed pressed air filters, the company uses a heat regenerating
air is used in numerous processes here: as control air and adsorption dryer as well as intelligent measuring tech-
as an energy carrier for operating pneumatic devices, as nology for permanent compressed air monitoring and data
an adsorbent following the cleaning of primary packaging logging/documentation.
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 14

Intelligent
compressed air treatment requires expertise

M anufacturing companies in the pharmaceutical

industry that keep to guidelines such as GMP for
their compressed air applications and carry out a hazard
required for the specification of the necessary compressed
air quality class and the suitable – i.e. safe and energy-
efficient – design of the compressed air treatment.
analysis and risk assessment have created important
pre-requisites for safe compressed air application. Those
who monitor their compressed air quality 24/7 are one
step further.

In practice, the subject of compressed air is often a critical

point for product managers and quality managers. The
problem is that the requirements are often not worded
clearly in the guidelines, or the effects on the entire plant
are not mapped sufficiently. Detailed knowledge is
 BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 15

This is what we can do for you:

Reliable processing, treatment and complete monitoring for flawless results

BEKO TECHNOLOGIES takes the individual requirements BEKO TECHNOLOGIES is a manufacturer of system
of each application into account when designing the com- solutions for compressed air treatment and management.
pressed air treatment system, thus providing compressed We offer safe solutions for stable production processes.
air of the desired quality. So that you can always be sure Thanks to years of manufacturer expertise and our
that the compressed air complies with your requirements specialist branch-specific sales, we know the requirements
and all standards, we make quality measurable and and challenges for your branch very well.
controllable for you.
Service

Measurement

Filtration

Oilfree

Condensate technology

Drying
BEKO TECHNOLOGIES | Whitepaper Compressed Air in the Pharmaceutical Industry | 16

Do you have any further questions

about the best way of treating your compressed air?

W e have the answers – and suitable solutions for the entire treatment chain. We would be happy to tell you more
and present, our condensate processing, filtration, drying, measuring and process technology as well as our com-
prehensive services.

BEKO TECHNOLOGIES GMBH

Im Taubental 7 | D-41468 Neuss

Tel. +49 21 31 988 10 00

[email protected]
www.beko-technologies.com

80-00012
Better through Responsibility