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The Use of Air Samplers for the Microbiological Assessment of Critical Zones During Manufacturing Processes.

Air Sampling & ISO 14698
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- What is air sampling?
- How does it work?
- Why is it necessary?
- What are the benefits?
- Where do I get more information?
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What is air sampling?
Supplier reference for these items:
settle plates
centrifugal samplers
filtration samplers
sieve air samplers
rapid results
slit to agar samplers
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Air sampling in the context of microbiological assessment is the
collection of air-borne microbial contaminants that may impact on product
spoilage, product safety and human health.
Collection of vegetative cells and spores may be achieved by passive or active
methods. Passive methods usually involve settle plates whereas active
methods include impaction and impingement devices.
The type of environment to be sampled varies from primary food production to
processed food factories, operating theatres, pharmaceutical clean rooms and
compressed gases.
The relatively low concentration of microorganisms in air means that collecting
them from this environment requires the sampling of large volumes of air. There
are a number of techniques that allow the quantitative determination of
microbial contamination or bioaerosols.
The collection methods available include: sedimentation (settle plates);
impaction on solid or semi-solid surfaces using variously:slit-to-agar;
sieve sampling; centrifugation; filtration; liquid
impingement. The volume of air for sample collection depends on the device
being used and on the anticipated concentration of the bioaerosol.
Where low concentrations of microbial contaminants are expected, e.g. clean
rooms, food production and operating theatres, impaction methods are generally
chosen. In highly contaminated environments then impaction techniques may
'oversample' even over short timescales and impingement or filter samples are
more appropriate. With strict adherence to manufacturer's flow rates, sampling
periods, culture media used, and device placement then most techniques should
yield comparable results which are normally expressed cfu/m³
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How does it work?
Microporous membrane filters, e.g. cellulose ester, polycarbonate, and
gelatin, may be used to collect a sample from a forced volume of air. The
resulting filter is placed on or in growth medium and incubated. Applied
stresses as a result of desiccation may affect the result.
Glass impingers collect a sample in a liquid reducing stress to the cells and
from which further techniques may be applied, e.g. filtration for subsequent
cell labeling and laser scanning, PCR.
Impaction methods involve the direction of an air jet onto a solid surface
usually a Petri dish containing a growth medium. The air sample is aspirated
through a slit or sieve arrangement that in turn affects the velocity of the
particles. The carrier air is then deflected away and in some cases measured by
anemometers that control the flow rates input by the user. The Petri dish is
then incubated and a cfu obtained, for a faster result collection can be onto a
water soluble gel or other collection liquid, which can be used in more rapid
analytical techniques such as fluoresent labelled cytometry, PCR or
immunoassay.
Air samplers have two main components. The sampling head and the control
unit/pump assembly. In portable devices such as the AES Sampl'air, EMD MAS 100,
BioTrace AirTrace/Spin Air, Millipore M air T, Oxoid M.A.Q.S., and the SAS
range from pbi, both these components are integrated. This facilitates the
movement of the device from location to location.
For more sensitive, controlled areas the sampling heads can be located remote
from the control unit, e.g. the AES Sampl'air MK2, EMD MAS ISO, Millipore M air
T for isolators. This allows the sampling head to be subject to the same
cleaning and disinfection protocols as the area being sampled. Units offering
specific functionality are also available, e.g. compressed gases can be sampled
using the EMD MAS CG and BioTrace AirTrace and in explosion risk areas the EMD
MAS 100 Ex.
Why is it necessary?
Monitoring of airborne contamination in pharmaceutical production
processes is a requirement of many regulatory authorities throughout the world,
e.g. FDA, MCA.
It is also adopted voluntarily in many food production environments as a
quantitative method for assessment of air as a 'hidden ingredient'.
Successful HACCP regimes will include the diligent monitoring of environmental
contaminants. There are also international standards relating to the air
monitoring in different environments, e.g. ISO 14698 and ISO 14644. Such
standards are beginning to supersede national guidelines in some countries.
What are the benefits?
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- Controlling airborne contamination is equally as important as
surface hygiene in both the prevention of product spoilage and product safety
assurance.
- The methods described here allow for the accurate and quantifiable
measurement of microbial risk factors. This satisfies cGMP requirements
and facilitates implementation of HACCP regimes.
- Compared to traditional approaches sample collection is more accurate
and takes less time.
- The techniques are applicable to environments not possible by
traditional approaches, e.g. compressed gases.
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Where do I get more information?
Suppliers by Sector:
News items:
Search rapidmicrobiology.com News Items:
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Accreditation
Air Samplers
Antibiotic sensitivity
Atmosphere Systems
Autoclaves/Sterilizers
Auto media prep
Biodefense
Blood culture
Clean Rooms
Counting [TVC]
Endotoxin
Env.mon surfaces
Identification
Lab. automation
Lab. disposables
LIMS
Media Fills
Media [chromogenic]
Media (dehydrated)
Media [prepared]
Pharma harmonization
Point of Care
QC Organisms
Rapid test (automated)
Rapid test (manual)
Sample Collection
Stains and Markers
Sterility testing
Swabs
Toxin tests
Urinary pathogens
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