Air Sampler MAS 100 System Page 1 sur 5

Air Sampler MAS 100 System

Cat. No. 1.09090.0001

(1 plastic case)

Intended use

ChemDAT Image / Picture

The MAS 100 is an impactor type of instrument based upon the principles described by
Andersen, which aspirates air through a perforated plate. The resulting air-stream, which
contains particles is directed onto the agar surface of a standard Petri dish (Ø 90 mm; for
glass Petri dishes a seperate adapter 1.09082.0001 should be used). After a collection cycle
the Petri dish is incubated and the colonies are counted and expressed as colony forming
units (cfu/m3), see also under section "results" below.

The MAS 100 operates with a high performance suction device with continuous monitoring of
the airflow. This system measures the incoming airflow and regulates the aspirated air to a
constant flow of 100 liter/min. The MAS 100 compensates for all factors which could
influence the air flow, like the volume of agar in the Petri dish or the variation in Petri
dish diameter. The time of sampling should not exceed 10 minutes, also the suction speed
should not be higher than 100 liters per minute (see International Standard ISO/CD 14698-1,
page 16 under B.3.3.2, 1996), because of the risk of dehydration of the agar surface.
Furthermore the impact speed has to be <20 m/sec (see International Standard ISO/CD
14698-1, page 16 under B.3.3.2, 1996). The MAS 100 has a constant airflow of 100 liters /
min with a horizontal air velocity of 0,45 m / sec (identical to impact air speed of ~19
m/s) and thus corresponding to the International Standard ISO/CD 14689-1 and the
GMP-regulations for sterile pharmaceuticals in the EU.

major advantages of the MAS 100 Air YOUR BENEFIT

Sampler

use of any commercially available standard available around the world:

90 mm Petri dishes:
- prefilled as ready-to-use-plate(s)
- self-prepared (filled) plates
integrated volume sensor
simple guidance software
preprogrammed collection volumes:
10, 20, 50, 100, 200, 250, 500, 750 and
1.000 liter + one volume "free of choice"
- you are flexible and independent
- saves costs per test; no need to buy
specific consumables
compensates for external variations -
you get correct and reproducible results
(real airflow measurement)
only "yes or no" button to run the MAS
100 - handy and easy to use
application oriented - convenient

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programmable delay function (1 to 60 no turbulences created by test-person

minutes) e.g. in sterile area - reproducible results
international approvals: CE, UL, CSL recognized by international bodies
government calibration certificate for MAS working safety: calibration check once a
100 year
multifunctional sampling head: allows working safety: multifunctional and
measurements from horizontal to vertical stable in any position
airflow
year 2.000 compliant working safety: no millenium bug
universal power supply 110 - 240 Volts: worldwide usage
battery operation capacity for up to 7 hours on-site testing anywhere you are
automatic shut-off saves battery

Technical specification

- nominal airflow rate: 100 liters / min ± 2.0 %

- hight: 26 cm
- diameter: 11 cm
- weight: 2.2 kg
- body: anodized aluminium
- tripod adapter screw in the bottom plate
- battery pack: 10V NiCd rechargeable accumulator (for 110-240V)
- battery charger: 110-240V, 50-60 Hz
- motor: 6V
- driving motor: PWM frequency driving motor
- display: alphanumeric LCD-display, 32 characters
- RTC battery: up to 7 years lifetime
- processor: type 80C552
- airflow regulation: hot wire anemometer, numerical control
CE-approval: EN 55022 class B: EN 61000-4-2; EN 61000-4-4; ENV 50140; ENV 50141;
-
ENV 50204
- UL approval: E 177434

Interpretation of results
The number of cfu that are counted on the Petri dish after appropriate incubation needs a
statistical correction, then related to the number of organisms per cubic meter of air sampled.
This kind of correction was first described by FELLER, a mathematician in 1950: the following
formula describes the presumption that as the number of viable particles being impinged on a
given plate increases, the probability of the next particle going into an empty hole decreases:
Pr = N [1/N + 1/N-1 + 1/N-2 ............. 1/N-r+1]
Pr = probable statistical total; N = total number of holes in the sampling head (=400)
The results of this calculation has been put together on the so called "positive hole conversion
table MAS 100" (sse overleaf) and comes in a sealed plastic foil with each MAS 100 upon
delivery.

How to calculate a result:

chosen sampling volume on MAS 100: 250 liters
number of colonies on the agar plate: 109 cfu
corrected number of colonies (out of the Feller-table): 127 cfu

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Example: number of cfu / m3 is 127 ⇒ 127 cfu x 1.000 liter / 250 liters = 508 cfu / m3

Ordering information

cat. No. description pack size

Air Sampler MAS 100 1 case (plastic)
1.09090.0001 System
contents:
1 Air Sampler MAS 100
with perforated lid, dust-
cover
and battery pack
1 mains charger (110-
240V)
1 Allen key
1 plastified Feller table
1 calibration certificate
1 EU conformity declaration
1 Operators Manual

1.09087.0001 extra battery pack 1 ea

1.09088.0001 extra perforated lid 1 ea

(autoclavable)

1.09084.0001 extra dust-cover for 1 ea

perforated lid

1.09085.0001 extra mains charger (110- 1 ea

240V) for MAS 100

1.09082.0001 adapter for glass Petri dish 1 x 3 clamps

1.09089.0001 calibration unit MAS 100C 1 ea

Standards and guidelines (pharmaceutical industry):

Cleanroom classification acc. to EU GMP-guidelines (for sterile products) valid from

January 1, 1997

cleanroom class max. number of particles/m3 max. number of particles/m3

= 0,5 µm = 5 µm
A 3.500 0

B 350.000 2.000

C 3.500.000 20.000

D - -

Cleanroom classification acc. to Federal Standard 209E (United States); USP

cleanroom class max. number of particles/m3 max. number of particles/m3

= 0,5 µm = 5 µm
100 3.530 -

10.000 353.000 2.470

100.000 3.530.000 24.700

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Microbial limits

acc. to EU GMP-guidelines (for sterile products) valid from January 1, 1997

class cfu / m3 air sedimentation

finger print; 5
plate Rodac plate
finger
(Ø 90 mm); cfu / 4 (Ø 55 mm); cfu
cfu
h
A <1 <1 <1 <1

B 10 5 5 5

C 100 50 25

D 200 100 50 -

acc. to draft-USP chapter <1116>

class cfu / m3 air personell; masks,

surface personell, gloves
cap, overall
cfu / 24 cm2 cfu / 24 cm2
cfu / 24 cm2
100 <3 3 <1 <1

10.000 <20 5 20 10
10 (floor)

100.000 <100 - - -

Test frequencies (air sampling) for environmental monitoring:

acc. to USP chapter <1116> 2nd. Draft (March/April 1995)

aseptic production (cleanroom area) evaluation frequency

class 100 every shift

calss 10.000 daily

class 100.000 2 times per week

class 100.000 1 time per week

(non-product / container contact)

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MAS 100
© 2000 Merck KGaA, Darmstadt, Germany

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