Atmospheric contamination
entering the compressor
- Water Vapor
- Micro-organisms
- Atmospheric Dirt
- Oil Vapor
Contamination introduced
by the compressor
- Water Aerosols
- Condensed Liquid Water
- Liquid Oil
- Oil Aerosols
Contamination
Introduced by
the air receiver
and distrbution
piping
- Rust
- Pipe scale
Total contamination
entering the compressed
air distribution system
- Water Vapor
- Micro-organisms
- Atmospheric Dirt
- Oil Vapor
- Water Aerosols
- Condensed Liquid Water
- Liquid Oil
- Oil Aerosols
- Rust
- Pipe scale
Contaminant Source
No. 1
Ambient Air
Contaminant Source
No. 2
The Air Compressor
Contaminant Source
No. 3
The Air Receiver
Contaminant Source
No. 4
The Distribution Piping
Compressed Air System Sources of Contamination
o
o
o
o
o
o
Code or Standard Verbiage relative to compressed air testing
IFS, ISO, GRMS
Compressed air is identified specifically as a
potential risk to be evaluated and monitored
as necessary.
USDA & FDA (21CFR), 3-A,
Compressed air monitoring is not specifically
mentioned - it is implied by employing GMPs.
BCAS, BRC, SQF
Specific verbiage requiring test compressed air
periodically.
Good Manufacturing Practices -
Compressed Air in Food Plant Dew Point Oil Removal
Particulate
Removal
(includes
microbiological
particles) Efficiency
Location of
Filtration
FDA Code of Federal Regulations
Title 21CFR, Part 110.40 (g)¹
FDA Guidance RTE foods² 0.3 Micron
FDA and the FSMA12
(Food Safety Modernization Act)
3-A Standard 604-05-3A³
Section: D6.6.1
Britsh Compressed Air Society (BCAS)4
Section 6
-40° F/C < 0.01 mg/m³ 0.1 - 0.5 Micron
British Retail Consortium (BRC)9
Safe Quality Foods (SQF) 7.1 edition5.
Section(s): 9.5.7; 10.5.7; 11.5.7; 13.5.4
SQF Guidance Document for
Module 11 May 2013
0.01 Micron 99.999% Point of use
International Featured Standards (IFS)
version 6 6 . Section 4.9.10.2
Global Red Meat Standard (GRMS)7
ISO 22000:20058
+
Prerequisite Program (PRP)
(like BSI PAS 220:200811)
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
Compressed air used in the manufacturing process shall be clean and present no risk to food
safety.
Compressed air shall not pose a risk of contamination.
Hazards relevant to food safety shall be controlled in critical control points (CCP) and/or by
GMP measures.
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
so as to prevent contamination. Requirments for filtration, microbilogy, and humidity (RH%) shall be
specified. Filtration of the air should be as close to the point of use as is practicable.
Benchmarking of Compressed Air GMPs
Compressed air or other gases mechanically introduced into food or used to clean food-
contact surfaces or equipment shall be treated in such a way that food is not contaminated
with unlawful indirect food additives.
Point of use
The FSMA does not introduce any specific regulations related to compressed
air. It primarily requires companies under FDA jurisdiction to employ
a risk-based (HACCP-like) food safety management scheme.
Point of Use-Contact (sterile air): 99.999%10
All other: 99%10
Compressed air used directly in contact with the product shall be filtered.
Compressed air at 100
psig contains 8 times
the amount of bacteria
and contaminants as
atmospheric air
Mesophilic Aerobic
bacteria and fungi love the
warm dark environment
inside a compressed air
system.
The 7
th
edition, published July 2012, has
added the following verbiage to Module 11:
Good Manufacturing Practices for
Processing of Food Products:
11.5.7 Air Quality
11.5.7.1
Compressed air used in the
manufacturing process shall be clean
and present no risk to food safety.
11.5.7.2
Compressed air used in the
manufacturing process shall be regularly
monitored for purity.
Implementing the GMP’s and SSOP’s shown
to the left will fulfill the requirements of the
new 11.5.7.1.
A periodic test (based on empirically derived
test intervals) to confirm the absence of
contamination should be performed at all
points in the system where air could contact
the food. This will fulfill the requirements of
11.5.7.2.
SQF Certification Levels:
Level 1
The GMPs & SSOPs stated here will
prepare the system design for future
higher level certifications.
Level 2
The GMPs & SSOPs stated here are
very good foundations for a solid
Prerequisite Program to support a plant’s
HACCP plan.
Level 3
The Prerequisites from Level 2
combined with a formalized air quality
testing program will provide the highest
level of confidence in a safe compressed
air system.
Notes References
1
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110&showFR
=1&subpartNode=21:2.0.1.1.10.3
2
http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/food
processinghaccp/ucm073110.htm
3 3A Standard 604-05 may be purchased at: www.techstreet.com/3Agate.html
4 http://www.bcas.org.uk/compressed-air-codes-of-practice.php
5 http://www.sqfi.com/standards/
6
http://www.ifs-certification.com/index.php/en/ifs-certified-companies-en/ifs-standards/ifs-food
7 http://www.grms.org/GRMS_standard.aspx
8
http://www.iso.org/iso/home/search.htm?qt=22000&sort=rel&type=simple&published=on
9 http://www.brcglobalstandards.com/GlobalStandards/Standards/Food.aspx
10
as measured by the Dioctylphthalate Fog Method (DOP) test - MIL-STD-282; method 102.9.1
11 http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030181317
12 http://www.fda.gov/food/foodsafety/fsma/default.htm
13 Camfil-Farr Food Processing Industry application brochure www.camfilfarr.com
14
McLandsborough, Dr. Lynne A., PhD, Associate Professor and Director of
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: 978 478 2501
www.parker.com/balston
