Parker Hannifin Corporation

Filtration and Separation Division

242 Neck Road
Haverhill, MA 01835
phone: 800 343 4048 or 978 858 0505
fax: 978 556 7501

[Link]

Reducing Contamination Risks of

Compressed Air in Food Plants:

Benchmarking Good Manufacturing Practices

A GMP Template for Food Plants

using risk-based systems:
 HACCP Procedures
 GFSI - SQF Code

Lee Scott
LSCOTT@[Link]

May, 2013
Objective
The objective of this technical paper is to benchmark The Risk-Based HACCP Environment:
published Good Manufacturing Practices as they relate When conducting a Hazard Analysis Critical Control Point
to compressed air use in a food processing facility in (HACCP) analysis any point-of-use contact between the
both a HACCP and/or Global Food Safety Initiative compressed air and food should be considered a potential
(SQF or BRC) environment. risk point. Developing an effective HACCP Prerequisite
Program (PRP) for compressed air to support Critical
Control Points (CCP) is an effective way to mitigate those
Introduction risks. As PRPs are generally founded upon GMPs and
Any modern food manufacturing facility employs the use of
SSOPs this paper is intended to be an aid in deciphering best
compressed air extensively in the plant. As common as this
practices for compressed air.
is, the potential hazards associated with this powerful utility
are not obvious and apparent. Food hygiene legislation to
protect the consumer places the duty of care on the food
manufacturer. For this reason, many companies often devise
their own internal air quality standards based upon what they
think or have been told is ‘best practice’. This is no wonder,
as the published collections of Good Manufacturing
Practices (GMP) that relate to compressed air are nebulous
and difficult to wade through. Understandably this has led
to a significant difference in the quality of compressed air
used throughout the industry, with major differences even
existing in plants owned by the same company. The goal of
this paper is to help make sense of it all.

Focus on Preventative Food Safety:

The recent focus on preventative food safety has been
reinforced in the public sector in the US by the FDA’s Food
Safety Modernization Act (FSMA) as well as the private
sector’s Global Food Safety Initiative (GFSI). Both take
aim at improving the knowledge of risk factors and
preventative practices effectively raising the bar on food
safety. The combination of improvements in food science
and manufacturing processes provide the GFSI and FSMA a
springboard for improved food safety and awareness
regarding microbial contamination of food.

Whether it is one of the many voluntary schemes (GFSI) or

The GFSI/SQF Environment:
The number of Food manufacturing companies adopting
mandated (FSMA), there are elements to these codes that put
GFSI endorsed food quality schemes is steadily growing.
a heavy focus on risk-based (HACCP-like) food safety
One of the most popular schemes in the US is the SQF Code.
management programs. The USDA has mandated risk-
The 7th edition of the SQF code, released in July of 2012,
based programs since the late 1990’s. Risk-based food
now specifies in Modules 9, 10, 11, and 13 that:
safety programs are unique to each facility and food product
being manufactured and rely heavily upon the employment
 “compressed air used in the manufacturing process
of GMPs and Sanitation Standard Operating Procedures
(SSOPs). shall be clean and present no risk to food safety.”
 “compressed air used in the manufacturing process
The challenge with risk-based food safety systems is that shall be regularly monitored for purity.”
they are not prescriptive. This works to the benefit of food
manufacturers who are experts in their field of
manufacturing and processes; however, it presents
challenges with ancillary processes and procedures where
the guidelines and GMPs are vague and non-specific.
Knowing the Potential Risks Managing the Risks:
Air is not as clean as it appears to be. Untreated compressed Compressor room drying and filtration is good, but it’s not
air contains many potentially harmful or dangerous enough for a food processing plant. System filtration can do
contaminants which must be removed or reduced to a good job reducing the amount of contaminants that are
acceptable levels in order to protect the consumer and introduced into the downstream distribution system;
provide a safe and cost effective production facility. Along however, that alone does not meet the requirements of the
with moisture and particulate matter, inlet air to a published GMPs that address compressed air – nor is it fully
compressor generally carries 5 to 50 bacteria per ft³. A 75 effective. In this scenario the risk of food adulteration is still
hp compressor with a capacity of 300 SCFM therefore takes quite high. The warm, oxygen rich environment inside the
in 100,000 to 1 million bacteria each hour13. These bacteria downstream air reservoirs, piping, fittings, and controls are
get compressed along with the air and begin their journey ideal harborage sites for microbial biofilm growth –
through the compressed air system. Introducing this type of especially when fed with food grade compressor oils that
microbial contamination to food products is very risky and inevitably migrate downstream. For this reason a number of
would be considered a lack of control by the facility. the published GMPs call for point-of-use filtration that
Understanding how to operationalize the treatment of should be in place for all points where compressed air either
compressed air in a facility will help ward off that risk. directly or indirectly contacts food.

Where the Air Contacts the Food: The first line of defense to ward off potential microbial
Sometimes it is not apparent where the compressed air is contamination of the food product from compressed air is to
contacting the food. Working surfaces like counters and use point-of-use sterile air filtration. With a properly
conveyors are obvious and manageable contact points. The designed compressed air system employing the
air is invisible. It leaves no visible trace where it contacts benchmarked GMPs (outlined later in this document) along
the food, other food contact surfaces, or the packaging. with well-designed SSOP (Sanitation Standard Operating
Without adequate hurdles and physical barriers in place the Procedure) maintenance and monitoring programs – the risk
microbial, particulate, and (in some cases) compressor oil associated with compressed air at points of contact can be
contamination is left behind after the air dissipates. mitigated significantly. A system design employing sterile
air filtration at point-of-use puts a physical barrier in the air
Some examples of direct and indirect contact points are: stream guarding against microbial contamination of the
food. Combining this system design with a HACCP
 Bagging
Prerequisite Program (PRP) formalizing these GMPs and
 Sparging/Mixing SSOPs makes a cost effective, efficient, and defensible risk
 Drying management plan.
 Air Knives
 Pneumatic Exhaust (i.e., cylinder exhaust)

Compressed Air System Sources of Contamination

 Below is a list of existing, published, and sanctioned Good
Manufacturing Practices when it comes to compressed air in
food manufacturing.
Ready-to-Eat Foods (RTE)
RTE foods are at high risk of contamination from  US Code of Federal Regulations:
sources such as compressed air. Any microbial
contamination introduced in the later stages of RTE o 21CFR, Chapter 1, Part 110, Section g
food processing can stay with the food all the way to the  FDA Guidance for Industry:
consumer, as few hurdles or barriers are generally in o Control of Listeria monocytogenes in Refrigerated or
place to eliminate the hazards. Frozen Ready-To-Eat (RTE) Foods
 3-A Standards
Point-of-use sterile air filtration is critical to ensuring
RTE food safety at any point where compressed air can o 604-05 Accepted Practices for Supplying Air Under
contact the food or food contact surfaces. Pressure in Contact With Milk, Milk Products and
Product Contact Surfaces
 British Compressed Air Society (BCAS)
Microbes: Arrested Development – o Food Grade Compressed Air: Code of Practice
Benefits of Dry Air:  British Retail Consortium (BRC): Issue 6
The warm, dark, moist environment inside a compressed air  SQF Code: 7th edition, July 2012
system is the perfect condition for microbes to flourish and
grow. Drying the air to a low dew point is an effective way  International Featured Standards (IFS)
to inhibit this microbial growth. Inhibit – not kill. Microbes o Version 6
need food, water, and the right temperature to grow. Take  Global Red Meat Standard (GRMS): 4th ed.
one or two of those nutrients away, and the growth stops -  ISO 22000:2005
temporarily. Some of the microbial pathogens that are
hazards to food safety form spores and/or protect themselves  British Standards Institute (BSI)
by moving into a dormant stage when nutrients in the o PAS 220:2008 Prerequisite Programs
surrounding environment are depleted. These dormant
spores resume propagation as soon as the missing nutrients
(moisture) become available again through contact with the Monitoring Compressed Air for Purity:
food. Whether it is specified or implied by the food safety scheme
being employed in a plant, regularly testing the purity of
“Bacterial spores survive very dry conditions without compressed air coming in contact with food is a best
any problem. Vegetative bacterial cells can survive practice. A single test at one point in time is not enough.
dried states for a period of time. In fact, lyophilization Compressed air systems are dynamic and the compressor
(freeze drying) is a common way to preserve bacteria. intake is subject to microbial, particulate, and moisture
Once conditions are favorable for growth (moisture, variations throughout the year as well as buildup of
nutrients etc. , the bacteria can grow again. The contamination in the system.
foodborne pathogen Salmonella is notorious for
surviving under water limited conditions.” 14 The table below outlines the compressed air testing
specification for each of the standards/codes listed above:
The best practice for food safety is to first dry the air and
more importantly use point-of-use filtration to capture the Code or Standard Verbiage relative to compressed air testing
microbes and spores so they never come in contact the food. Compressed air is identified specifically as a 
IFS, ISO, GRMS potential risk to be evaluated and monitored 
as necessary.
Good Manufacturing Practices – Compressed air monitoring is not specifically 
USDA & FDA (21CFR), 3‐A,
Industry Standards to Reference: mentioned ‐ it is implied by employing GMPs.
Identifying the risk and potential hazards with compressed Specific verbiage requiring test compressed air 
air in a food plant is the easy part. Determining Good BCAS, BRC, SQF
periodically.
Manufacturing Practices for cleaning up the air is not so
straightforward. The process and methods of compressed air testing for
microbiological contaminant content is outlined very well in
the ISO 8573-7:2003 document.
Benchmarking GMPs:
Employing the most critical elements from all of the published GMPs ensures that you have the bases covered for compressed air
quality at the point of contact. Using filtration that meets the most discriminating industry standards ensures compliance with ALL
of the published GMPs. An outline of published GMPs and standards is shown below:

Benchmarking of Compressed Air GMPs
Particulate 
Removal
(includes 
Good Manufacturing Practices ‐  microbiological  Location of 
Compressed Air in Food Plant Dew Point Oil Removal particles) Efficiency Filtration
Compressed air or other gases mechanically introduced into food or used to clean food‐
FDA Code of Federal Regulations
contact surfaces or equipment shall be treated in such a way that food is not contaminated 
Title 21CFR, Part 110.40 (g)¹
with unlawful indirect food additives.

FDA Guidance RTE foods² 0.3 Micron

12 The FSMA does not introduce any specific regulations related to compressed 
FDA and the FSMA
air.  It primarily requires companies under FDA jurisdiction to employ
(Food Safety Modernization Act)
a risk‐based (HACCP‐like) food safety management scheme. Point of use
10
3‐A Standard 604‐05‐3A³ Point of Use‐Contact (sterile air): 99.999%
10
Section: D6.6.1 All other: 99%
Britsh Compressed Air Society (BCAS)4
‐40° F/C < 0.01 mg/m³ 0.1 ‐ 0.5 Micron
Section 6
9
British Retail Consortium (BRC) Compressed air used directly in contact with the product shall be filtered.
Safe Quality Foods (SQF) 7.1  edition5 .   Compressed air used in the manufacturing process shall be clean and present no risk to food 
Section(s): 9.5.7; 10.5.7; 11.5.7; 13.5.4 safety.
SQF Guidance Document for 
0.01 Micron 99.999% Point of use
Module 11 May 2013
International Featured Standards (IFS) 
Compressed air shall not pose a risk of contamination.
version 6 6 .  Section [Link]
7 Hazards relevant to food safety shall be controlled in critical control points (CCP) and/or by 
Global Red Meat Standard (GRMS)
GMP measures.
8
ISO 22000:2005 ISO22000:2005 := Prerequisite Programs should be in place to address supplies of air (Section 7.2.3.C)
                    
+  BSI PAS 220:2008 Section 6.5 := (Summarized) Compressed air systems shall be constructed and maintained 
Prerequisite Program (PRP) so as to prevent contamination.  Requirments for filtration, microbilogy, and humidity (RH%) shall be 
(like BSI PAS 220:2008 )
11 specified.  Filtration of the air should be as close to the point of use as is practicable.

Most discriminating filtration standard: < 0.01 mg/m³ 0.01 Micron Point of Use‐Contact: 99.999% Point of use

 = Not Specified
 = Most critical standard
Let’s boil it all down:

The Best Manufacturing Practices for compressed air

in a food plant:
 Remove as much moisture as possible from the air before distributing it
throughout the plant. A dew point of -40 F/C is ideal.
 Use point-of-use sterile air filtration wherever compressed air comes in
contact directly or indirectly with food or food contact surfaces.
 Ensure the final stage of point-of-use filtration has a rating of 0.01 micron
with a DOP efficiency rating that is equal to or better than 99.999%10.

Compressed air at 100

psig contains 8 times Mesophilic Aerobic
the amount of bacteria bacteria and fungi love the
and contaminants as warm dark environment
atmospheric air inside a compressed air
system.
GMPs for Point-of-Use Compressed Air SSOP: Monitor Purity of Compressed Air:
 As a baseline - test compressed air at each food
Filtration: contact point periodically in accordance with
Point-of-use filtration is the best line of defense against ISO 8573-7:2003 standards. Determine test
microbial contamination of food in a compressed air system. interval empirically based upon presence of
Even the best of compressor room system filtration does not microbial contamination.
eliminate harborage sites and biofilm buildup in the
downstream compressed air piping system.

Best Practices:
GMP: System Design
Point-of-Use Filtration: SQF Code:
Wherever the compressed air comes in contact with the
food – either directly or indirectly - the following 3- The 7th edition, published July 2012, has
stages of filtration will significantly reduce the risk of added the following verbiage to Module 11:
microbial contamination of the food. Good Manufacturing Practices for
Processing of Food Products:

11.5.7 Air Quality

 [Link] 
Compressed air used in the 
manufacturing process shall be clean 
and present no risk to food safety. 
 [Link] 
 Stage 1: Remove bulk liquid and particulate matter Compressed air used in the 
down to 0.01 micron at >= 93% DOP efficiency10.
manufacturing process shall be regularly 
Automatic drain in filter.
monitored for purity. 
 Stage 2: Remove oil and water aerosols and
smaller particulate matter down to 0.01 micron at Putting it into practice:
>= 99.99% DOP efficiency10. Automatic drain in
filter. Implementing the GMP’s and SSOP’s shown
to the left will fulfill the requirements of the
 Stage 3: Remove microbial contamination down to new [Link].
0.01 micron at >= 99.9999% DOP efficiency10 with A periodic test (based on empirically derived
a sterile air filter. test intervals) to confirm the absence of
SSOP: Maintenance of Filters: contamination should be performed at all
 Stage 1: Change filter element every 6-12 months. points in the system where air could contact
the food. This will fulfill the requirements of
[Link].
 Stage 2: Change filter element every 6-12 months.
 Stage 3: Change filter element every 3-6 months – SQF Certification Levels:
or sooner – as necessary based on point-of-use air  Level 1
quality test for microbial content. The GMPs & SSOPs stated here will
prepare the system design for future
Optional: Steam sterilize stage 3 (provided the higher level certifications.
filter is designed for CIP sterilization). Follow  Level 2
manufacturer’s instructions. The GMPs & SSOPs stated here are
very good foundations for a solid
 Note: Sterile air filters are designed to capture Prerequisite Program to support a plant’s
microbial matter larger than the nominal element HACCP plan.
rating. Microbial matter will not create a  Level 3
differential in pressure across the element. The Prerequisites from Level 2
Therefore, measuring differential pressure across combined with a formalized air quality
the element will not give an accurate reading of testing program will provide the highest
contamination. Air testing and/or regularly level of confidence in a safe compressed
scheduled element changes are the best practice. air system.
 Notes  References 
[Link]
1 
=1&subpartNode=21:[Link].10.3  

  
[Link]
2 
processinghaccp/[Link]  

  
3  3A Standard 604‐05 may be purchased at: [Link]/[Link]  

  
4  [Link]  

  
5  [Link]  

  

6 
[Link]  

  
7  [Link]  

  

8 
[Link]  

  
9  [Link]  

  

10 
as measured by the Dioctylphthalate Fog Method (DOP) test ‐ MIL‐STD‐282; method 102.9.1 
     
11  [Link]  

  
12  [Link]  

13  Camfil‐Farr Food Processing Industry application brochure  [Link] 
 
McLandsborough, Dr. Lynne A., PhD, Associate Professor and Director of
14  Undergraduate Food Science Program, Department of Food Science, University of
Massachusetts, Amherst

Parker Hannifin Corporation

Filtration and Separation Division
242 Neck Road
Haverhill, MA 01835
Phone: 800 343 4048 or 978 858 0505
Fax: 978 556 7501

[Link]