Sartorius MD8 16746-01--SHB User manual

1000029970
Installation Instructions | Installationsanleitung | Manuel d’installation |
Manuale di installazione | Instrucciones de instalación | Instruções de instalação
Translation of the Original Installation Instructions | Original-Installationsanleitung |
Traduction du manuel d’installation original | Traduzione del manuale originale |
Traducción de las instrucciones de instalación originales | Tradução das instruções de
funcionamento originais
MD8 Airscan Sampling Head | MD8 Airscan
Sammelkopf | Tête de prélèvement MD8 Airscan |
Gruppo aspirante MD8 Airscan | Unidad de
aspiración MD8 Airscan | Unidade de aspiração
MD8 Airscan
16746-01--SHB | 16746-01--SHT
Sampling Head for Airborne Microbe Collector | Sammelkopf für Luftkeimsammler |
Tête de prélèvement pour collecteur de germes | Gruppo aspirante per campionatori
d’aria | Unidad de aspiración para colector de gérmenes aéreos | Unidade de
aspiração para amostradores de ar

English – page 3
Deutsch – Seite 22
Français – page 41
Italiano – pagina 60
Español – página 79
Português – página 98

MD8 Airscan Sampling Head Installation Instructions 3
Contents
Contents
1 About these Instructions......... 4
1.1 Validity.....................4
1.2 Accompanying Documents ....4
1.3 Symbols Used ...............4
1.3.1 Warnings ............ 4
1.3.2 Other Symbols........ 4
2 Safety Instructions .............. 5
2.1 Intended Use ................5
2.2 Significance of These
Instructions .................6
2.3 Working on the Electrical
Equipment ..................6
2.4 Accessories, Consumables and
Spare Parts..................6
3 Device Description .............. 7
3.1 Device Overview .............7
3.2 Bayonet Connection..........8
3.3 Tri-Clamp Connector
(TC 50.5)....................8
3.4 Air Inlet ....................9
3.5 Air Outlet..................10
3.6 Adapter Bayonet on
Tri-Clamp TC 50.5 ...........10
3.7 Filter Adapter ..............11
3.8 Airborne Microbe Collection ..11
4 Installation.................... 12
4.1 Equipment Supplied .........12
4.2 Prerequisites for Installation ..12
4.3 Unpacking the Equipment ....13
4.4 Setting up the
Sampling Head .............13
4.5 Conducting Exhaust
Air Away ..................17
5 Technical Data................. 19
5.1 General Data ...............19
5.2 Ambient Conditions .........19
6 Accessories and Consumables ... 20
6.1 Accessories.................20
6.2 Consumables ...............21

4 MD8 Airscan Sampling Head Installation Instructions
About these Instructions
1 About these Instructions
1.1 Validity
These instructions apply to the device in the following versions:
Device Type
Sampling head with bayonet connection 16746-01--SHB
Sampling head with Tri-Clamp connection (TC 50,5) 16746-01--SHT
1.2 Accompanying Documents
t In addition to these instructions, observe the following documents:
− MD8 Airscan Command Unit Operating Instructions
− Documentation on the filter
− If the sampling head is installed in a system: Instructions for the system
1.3 Symbols Used
1.3.1 Warnings
NOTICE
Denotes a danger that can result in property damage if the risk is not avoided.
1.3.2 Other Symbols
tRequired action: Describes actions that must be performed.
yResult: Describes the result of the actions carried out.

MD8 Airscan Sampling Head Installation Instructions 5
Safety Instructions
2 Safety Instructions
2.1 Intended Use
The MD8 Airscan Sampling Head serves as a vacuum source to pump ambient air.
The sampling head is suitable for the following applications:
− Use in controlled areas such as clean rooms
− Use in systems, e.g. sterility isolators, filling systems, blow-fill-seal machines
− Use in non-controlled areas such as laboratories
The sampling head must be operated with the MD8 Airscan Command Unit and with
a filter. The sampling head cannot be operated without a command unit. The filter is
designed for single use and must be disposed of each time after operation.
Do not allow the sampling head to come into contact with liquids. Do not use the
sampling head in potentially explosive atmospheres. Only use the sampling head
indoors.
Only use the sampling head with the equipment and under the operating conditions
described in the Technical Data. Do not rebuild or technically alter the sampling head.
Any further use beyond this is considered improper and is prohibited. These
instructions are part of the product. The device is exclusively designed for use
according to these instructions.

6 MD8 Airscan Sampling Head Installation Instructions
Safety Instructions
2.2 Significance of These Instructions
Failure to follow the instructions in this manual can have serious consequences,
e.g. exposure of individuals to electrical, mechanical or chemical hazards.
t Before working with the device: Read the instructions carefully and completely.
t If the instructions are lost: Request a replacement or download the latest version
from the Sartorius website (www.sartorius.com).
t The information contained in these instructions must be made available to all
individuals working with the device.
2.3 Working on the Electrical Equipment
Any work on or modifications to the electrical equipment of the device may only be
carried out by Sartorius Service personnel. The device may only be opened by Sartorius
Service personnel.
2.4 Accessories, Consumables and Spare Parts
The use of unsuitable accessories, consumables and spare parts can affect the
functionality and safety of the device and have the following consequences:
− Risk of injury to persons
− Damage to the device
− Malfunctions of the device
− Device failure
t Only use accessories, consumables and spare parts from Sartorius (for accessories,
see the MD8 Airscan Command Unit Operating Instructions). Information on
operational quality is available upon request from Sartorius.
t Only use accessories, consumables and spare parts that are in technically perfect
condition.

MD8 Airscan Sampling Head Installation Instructions 7
Device Description
3 Device Description
3.1 Device Overview
1
3
4
2
7
5
6
Fig.1: Sampling head with bayonet connection (example)
No. Designation Description
1 Filter holder Is designed as a bayonet connection or as a Tri-Clamp
connection (TC 50.5).
2 Air outlet Is designed as a Tri-Clamp connector (TC 50.5).
3 Connection for
command unit
Accommodates the command unit connection cable.
4 Device base
(ring-shaped)
Protects the sampling head against slipping.
Not depicted.
5 Manufacturer’s ID label Is affixed to the base plate. Not depicted.
6 Sampling head Includes the device motor, fan and control-relevant
components.
7 Air Inlet

8 MD8 Airscan Sampling Head Installation Instructions
Device Description
3.2 Bayonet Connection
The bayonet connector accommodates the filter adapter. Sampling heads with a
bayonet connection are particularly suitable for applications where the sampling head
is not installed in a system.
2
1
Fig.2: Bayonet Connection
No. Designation Description
1 Mounting Accommodates the filter adapter.
2 Groove Accommodates the seal. Inserted at factory.
3.3 Tri-Clamp Connector (TC 50.5)
Sampling heads with a Tri-Clamp connection (TC 50.5) are particularly suitable for
installation in systems, e.g. isolators, filling systems and blow-fill-seal machines.
2
1
Fig.3: Tri-Clamp connector (TC 50.5)
No. Designation Description
1 Mounting Allows installation in pipelines using a Tri-Clamp
connection.
2 Groove Accommodates the seal for the Tri-Clamp connection.

MD8 Airscan Sampling Head Installation Instructions 9
Device Description
3.4 Air Inlet
The air to be filtered is drawn in at the air inlet.
1
Fig.4: Air inlet at the sampling head with bayonet connection (example)
No. Designation Description
1 Stainless steel strainer Prevents larger objects from entering the sampling
head. Is installed inside the sampling head.
2 Sensor Detects the amount and speed of air drawn in.
Is installed inside the sampling head. Not depicted.
3 Gasket Is installed inside the sampling head. Not depicted.

10 MD8 Airscan Sampling Head Installation Instructions
Device Description
3.5 Air Outlet
At the air outlet, the air from the sampling head is directed into the ambient air or
into pipes. The air outlet is designed as a connector piece. The connector piece can
accommodate pipes and adapters.
2
1
Fig.5: Air outlet (example)
No. Designation Description
1 Connector piece Allows installation in pipelines using a Tri-Clamp
connection. Is designed as a Tri-Clamp 50.5.
2 Groove Accommodates the seal for the Tri-Clamp connection.
3 Gasket Is installed inside the connector piece. Not depicted.
3.6 Adapter Bayonet on Tri-Clamp TC 50.5
Sampling heads with a bayonet connection are particularly suitable for applications
where the sampling head is not meant to be installed in a system. This allows for
flexible operating conditions.
Sampling heads with a Tri-Clamp connection (TC 50.5) are particularly suitable for
installation in systems, e.g. isolators, filling systems and blow-fill-seal machines.
The Tri-Clamp connection (TC 50.5) allows the sampling heads to be connected to
the pipes of the existing systems.
The adapter from Bayonet to Tri-Clamp TC 50.5 converts the bayonet connection into
a Tri-Clamp connection. As a result, sampling heads with a bayonet connection can
also be connected to the pipelines of systems.

MD8 Airscan Sampling Head Installation Instructions 11
Device Description
3.7 Filter Adapter
The filter adapter accommodates the filter and, depending on the model, is suitable
for accommodating gelatine membrane filters or cellulose nitrate membrane filters.
2
1
Fig.6: Filter adapter for gelatine membrane filters
No. Designation Description
1 Filter mount Accommodates the gelatine membrane filter.
2 Attachment for bayonet Is placed on the bayonet connection.
The filter adapter must be placed on a bayonet connection. An adapter with bayonet
connection is additionally required for sampling heads with a Tri-Clamp connection
(TC 50.5).
3.8 Airborne Microbe Collection
Pumping of Air Sample Volume (Isokinetic Sampling)
The sampling head generates a vacuum and pumps a defined air sample volume from
the ambient air. The air flow can be adapted to the ambient speeds so that the flow
velocities in critical areas, e.g. in clean rooms, are not disturbed and turbulences are
avoided.
Retention of Biological Particles
Active airborne microbe collection takes place in the filter. The biological particles
from the air, e.g. viruses, bacteria, yeasts and fungi, are retained in the filter. This
retention is almost independent of the configured air flow.

12 MD8 Airscan Sampling Head Installation Instructions
Installation
Incubation of the Filter
Since the filter does not contain germ-growth-influencing substances, the filter
must be transferred to a suitable nutrient medium and incubated, e.g. to an agar
plate with Sabouraud, for the detection of fungi and TSA for total microbial count
determination.
4 Installation
4.1 Equipment Supplied
Product Quantity
Sampling head with bayonet connection or Tri-Clamp
connection (TC 50.5)
1
Calibration report 1
Installation Instructions 1
4.2 Prerequisites for Installation
Procedure
t Make sure that the following conditions are met at the place of installation:
Condition Features
Ambient conditions − Suitability tested (for ambient conditions, see
Chapter 5.2, page 19)
Setup surface − Stable and level surface
− Sufficient room for the sampling head
(for information on space requirements,
see Chapter “5.1 General Data,” page 19)
− Sufficient bearing capacity for the sampling head
(for weight, see Chapter “5.1 General Data,”
page 19).

MD8 Airscan Sampling Head Installation Instructions 13
Installation
4.3 Unpacking the Equipment
Procedure
t Unpack the device.
t If the device is stored temporarily: Observe the storage instructions (for storage
information, refer to the MD8 Airscan Command Unit Operating Instructions).
4.4 Setting up the Sampling Head
Installation in controlled and non-controlled areas
The sampling head can be set up in non-controlled and controlled areas
(controlled areas, see Chapter “5.2 Ambient Conditions,” page 19).
When the sampling head is set up in controlled areas: The flow speeds in the
controlled area can be affected by the operation of the sampling head and
turbulences can occur. The sampling head suction rate must be adjusted to the
flow conditions in the controlled area in order to allow for isokinetic sampling
(to adjust the air flow, see MD8 Airscan Command Unit Operating Instructions).
In filling systems, isolators and blow-fill-seal systems, it is recommended that the
sampling head be installed outside this critical area and that the filter be connected
to the sampling head air inlet by means of pipes or hoses.

14 MD8 Airscan Sampling Head Installation Instructions
Installation
Sampling Head in Non-controlled Areas
9
8
7
6
5 34
2
1
Fig.7: Sampling head set up in the non-controlled area, connected by a PVC hose (example)
No. Designation Description
1 Adapter or connector for
Tri-Clamp connection
Connects the Tri-Clamp connection of the
sampling head to silicone hose.
2 Hose PVC hose
3 Hose adapter PVC hose adapter
4 Sterile barrier For example: Wall of a sterile isolator
5 Sterile filters For example: Sartofluor®capsule on both sides
with TC 50.5
6 Angle connector Connects Tri-Clamp (TC 50.5) adapter to
bayonet and sterile filter.
7 Tri-Clamp (TC 50.5) adapter
on bayonet
Mount with bayonet connection
8 Filter adapter Type: Adapter for gelatine membrane filter
(GMF)
9 Filter Type: Gelatine membrane filter (GMF)

MD8 Airscan Sampling Head Installation Instructions 15
Installation
Sampling Head in Controlled Areas
12
11
10
9
8 6 5 4 2 137
Fig.8: Sampling head set up in a controlled area, connected by a PVC hose; exhaust channeled into
non-controlled area (example)
Pos. Designation Description
1 Exhaust line PVC or silicone hose
2 Adapter TC 50.5 adapter on hose nozzle
3 Sterile barrier For example: Wall of a sterile isolator
4 TC 50.5 adapter on single-level
hose nozzle DN 25 adapter
Is inserted in the air outlet.
5 Adapter or connector for
Tri-Clamp connection
Connects the Tri-Clamp connection of the
sampling head to silicone hose.
6 Hose PVC hose
7 Hose adapter PVC hose adapter
8 Sterile filters For example: Sartofluor®capsule on both
sides with TC 50.5
9 Angle connector Connects Tri-Clamp (TC 50.5) adapter to
bayonet and sterile filter.
10 Tri-Clamp (TC 50.5) adapter on
bayonet
Mount with bayonet connection
11 Filter adapter Type: Adapter for gelatine membrane
filters (GMF)
12 Filter Type: Gelatine membrane filter (GMF)

16 MD8 Airscan Sampling Head Installation Instructions
Installation
Setting up the Sampling Head in a Controlled or
Non-controlled Area
Procedure
t Set up the sampling head at the intended
installation location in the controlled or
non-controlled area.
t When using a sampling head with a TC 50.5
Tri-Clamp connection: Mount a Tri-Clamp
bayonet adapter on the sampling head (1)
(see Chapter “6.1 Accessories,” page 20).
t Place a filter adapter on the bayonet connector (1).
Installing Filter Adapter in Controlled Area
Requirements
− The sampling head is installed in a non-controlled
area.
− The filter adapter is not mounted.
Procedure
t Install the filter adapter (1) in the controlled area.
Use suitable accessories and consumables (2),
e.g. connectors and sterile filters (see Chapter “6
Accessories and Consumables,” page 20).
t Connect a hose or a pipe (2). Use suitable
accessories (1), e.g. connecting pieces (see
Chapter “6 Accessories and Consumables,”
page 20).
1
1
1
2
21

MD8 Airscan Sampling Head Installation Instructions 17
Installation
t If a sampling head with a bayonet connector is
used: Mount bayonet to Tri-Clamp (TC 50.5)
adapter on the bayonet connection.
t Insert a gasket for the Tri-Clamp connection in the
groove (1) of the connector piece.
t NOTICE Damage to the sensor when connecting
pipes or adapters! Insert the piping and adapters
only so far as to not allow the stainless steel
strainer and the sensor to be touched.
t Connect the hose or piping to the air inlet of the
sampling head. Use suitable accessories, e.g.
connectors, adapters or Tri-Clamps (see
Chapter “6.1 Accessories,” page 20).
t Secure the connection using a Tri-Clamp.
4.5 Conducting Exhaust Air Away
The exhaust air that flows out of the sampling head air
outlet can be left in the ambient air or conducted into
an exhaust air system.
If the sampling head is operated in controlled areas
of clean room class A-B: The exhaust air should be
removed.
When the sampling head is operated in controlled
areas of clean room class C-D: It is recommended
that the exhaust air be removed if the particle
concentration in the exhaust air exceeds the
permissible air purity limit. To this end, observe the
applicable regulations on air purity, e.g. the valid
United States Pharmacopeia (USP), Eu.Ph or ISO
guidelines.
1

18 MD8 Airscan Sampling Head Installation Instructions
Installation
Procedure
t When the exhaust air is left in the ambient air:
Check the required clearance for the air outlet (for
information on clearance, see Chapter “5 Technical
Data,” page 19).
t If required: Position the sampling head
differently.
y The exhaust air flows into the ambient air.
t If the exhaust air is to be conducted away:
t Insert a gasket for the Tri-Clamp connection in
the groove (1) of the connector piece.
t Connect a hose or a pipe to the connector piece
(2). Use suitable accessories, e.g. connectors,
adapters or Tri-Clamps (see Chapter “6.1
Accessories,” page 20).
t Secure the connection using a Tri-Clamp.
1
2

MD8 Airscan Sampling Head Installation Instructions 19
Technical Data
5 Technical Data
5.1 General Data
Unit Sampling head
with bayonet
connection
Sampling head
with Tri-Clamp
connection
(TC 50.5)
Dimensions (L x W x H) mm 128 x 112 x 137 128 x 112 x 154
Weight kg 2.6 2.6
Power supply
Only using MD8 Airscan
Command Unit
Material
Seals Silicone Silicone
Surfaces Stainless steel Stainless steel
5.2 Ambient Conditions
Unit Value
Installation location
Standard laboratory rooms and clean rooms
according to ISO 5 to ISO 9;
m above sea
level
< 3000
Use in controlled areas: Clean room class A-D
Air outlet required clearance mm > 100
Recommended distance between sampling head and
persons at the place of installation of the sampling head
mm > 1000

20 MD8 Airscan Sampling Head Installation Instructions
Accessories and Consumables
Unit Value
Ambient temperature
Operation °C 4 – 40
Transport and storage °C 4 – 45
Temperature of the motor in the sampling head, max. °C 65
Relative humidity, max.
Operation % 80
Transport and storage % 90
Electromagnetic compatibility according to
DIN EN 61326-1: Electrical equipment for measurement,
control and laboratory use – EMC requirements – Part 1
Defined immunity to interference: Suitable for use in
industrial areas
Interference emission: Class B
6 Accessories and Consumables
6.1 Accessories
This table contains an excerpt of the accessories that can be ordered. For information
on other products, contact Sartorius.
Product Quantity Order number
Filter adapter for gelatine membrane
filters
1 17801
Tri-Clamp (TC 50.5) to bayonet
adapter, stainless steel
1 17659---003