Professional Documents
Culture Documents
ENGLISH
INSTRUCTIONS MANUAL
REFERENCES
FDA – 1987 Guideline on Sterile Drug Products produced by Aseptic Process
ACGIH – Guideline for the Assessment of Bioaerosol in the Indoor Environment
ASTM – Draft Protocol – Committee D22.05.06
USP 24-NF 19 par.1116– Microbiological Evaluation of Clean Rooms and other Controlled Environments
EU Guide for GMP – Manufacture of Sterile Medicinal Products Control of Medicines and Inspection
CEN/TC 243 Norms for Clean Room Technology
ISO/DIS 14698-1
ISO EN-17025 Good Laboratori Practice
Your local distributor:
International PBI S.p.A. Via Novara, 89 – 20153 Milano – Italy – Tel + 39 02 48779-1 – Fax + 39 02 40090010
E-mail: info@internationalpbi.it – www.internationalpbi.it
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 1
MANUALE ISTRUZIONI INSTRUCTION MANUAL
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It is intended to help you operate and maintain your new instrument properly. Keep it handy for answers to your
questions.
Use this appliance only for its intended purpose as described in this Use and Care book.
This instrument must be properly installed in accordance with the Installation Instructions before it is used.
Repair or replace immediately all electric service cords that have become frayed or otherwise damaged. Do not
use cord that shows cracks or abrasion damage along its length or at either the plug or connector end.
INFORMAZIONI DI SICUREZZA
Usare lo strumento solo per gli scopi indicati e come descritto nel Manuale.
Lo strumento deve essere correttamente installato secondo quanto indicato nel manuale,prima di procedere al
suo impiego.
Riparare o sostituire immediatamente il cavo elettrico di allacciamento nel caso sia danneggiato; non usare mai
un cavo che presenti incrinature,abrasioni sia nella sua lunghezza che in corrispondenza della spina o del
connettore terminale.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 2
SUMMARY
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TABLE OF CONTENTS
SECTION TWO
Operating Instructions 6
1. Principle 6
2. The basic idea 6
3. Installation 7
3.1 The Practical Use 7
3.2. List of MENU and SUB-MENU 8
3.3. Preliminary Inspection 9
3.4. 55 mm Contact Plate holder adjusting 10
3.5. 84 mm Maxi Contact Plate use (optional) 10
3.6. Petri: head adapter (optional) 10
3.7. 90 mm Petri Dishes filling 10
3.8. Tripod Installation (optional) 10
4. Software Function 11
4.1. Routine Sampling 11
4.2. Select Volume function 12
4.3. Utility Mode function 13
4.3.1. Set Time 13
4.3.2. Sampling Site 14
4.3.3. Operator Identification 15
4.3.4. Language 16
4.3.5. Display Record 16
4.3.6. Clear Record 17
4.3.7. Remote Control 17
4.3.8. Calibration 17
4.4. Program Volume function 18
4.5. Set Delay function 19
4.6. Multi Mode function 20
4.7. Configuration function 22
4.8. Power Off function 25
5. Operations 26
5.1. Contact Plate holder adjustment 26
5.2. Contact Plate handling 26
5.3. Sanitation of air sampler 27
5.4. Use in Clean Rooms 27
5.5. Contact Plate Preparation 28
5.6. Total Bacterial Count and/or Micro-organisms identification by dilution 28
5.7. Multi Point Sampling with several indipendent air samplers 28
5.8. Multi-Point Sampling with several connected air samplers 29
5.9. Final Operations 29
6. Result Calculation and Recording 29
6.1. CFU/1000 Litres 29
6.2. Data Recording 31
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 3
SECTION THREE
7. Specifications 32
7.1. Sampling Time Requested For Different Air Volumes 35
7.2. Battery Charger Operation 35
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7.3. Automatic Switch OFF 35
7.4. Sampling at High Altitude Over The Sea Level 36
7.5. Automatic Flux Control 36
7.6. Calibration Reminder 36
SECTION FOUR
8. Maintenance 37
8.1. Cleaning 37
8.2. Validation and Calibration 37
8.3. Performance Routine Monitoring 38
8.4. Trouble Shooting 38
8.5. Battery Replacement 38
8.6. Accessory and Spare Part List 38
SECTION FIVE
EN 17025 Documentation 39
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 4
SECTION ONE
BRIEF OPERATING INSTRUCTIONS FOR SAS SUPER ISO 100 AND 180
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The air flow is visualized on digital display at the fourth automatic succession presentation each time the
instrument is switched on.
Touch the screen for at least two seconds to switch on the instrument.
Press START to sample the same air volume as the last sampling cycle.
To change the volume of air, touch MENU, to reach “select volume”, touch ENTER and use arrows to choose the
desired new volume of air.
Refer to instruction manual to change settings.
Touch ENTER to confirm selection.
Touch MENU and arrows for menu selection to modify other pre-set parameters:
SELECT VOLUME
POWER OFF
UTILITY MODE
CONFIGURATION
MULTI MODE
SET DELAY
PROGRAM VOLUME
S/N 05-01-1013
08/31/06 11.31
SITE AAAAAAAA
500 Lt. DELAY 00 MIN
ID 12345678
START MENU
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 5
SECTION TWO
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OPERATING INSTRUCTIONS
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 6
SAS SUPER ISO 100 and SAS SUPER ISO 180:
Two instruments for two different applications.
The two air samplers have the same performances with the only difference being in the rate of air aspirated:
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SAS SUPER ISO 100 = 100 litres of air per minute
SAS SUPER ISO 180 = 180 litres of air per minute.
The SAS SUPER ISO 180 is appropriate in Clean Rooms and other applications demanding fast sampling times. In
Clean Rooms, for example, it is important to test larger volumes of air, because the microbial air contamination is very
low.
The SAS SUPER ISO 180 reduces the required time to obtain a sample with an important saving of time.
Both SAS SUPER ISO 100 and SAS SUPER ISO 180 are identified by the “SAS SUPER ISO” logo on the front part of
the instrument.
3. INSTALLATION
SAS SUPER ISO 100 & SAS SUPER ISO 180 FLOW SCHEME
1. Remove the aspirating head. 5. At the end of the cycle, remove the aspirating
2. Insert an identified, closed and prepared Contact head.
Plate and remove plate lid. 6. Close and remove the Contact Plate.
3. Replace the aspirating head. 7. Incubate.
4. Select required air flow and start the unit. The air 8. Count the colonies, record the results on the
flow is directed onto the agar surface of the microbiological air sampling report and interpret
Contact Plate. results.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 7
3.2. List of menus and utility sub-menus
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START This message indicates the air sampler is ready to repeat the same volume of
prior sampling
MENU This message indicates the air sampler is programmed to enter the following
Sub-Menus:
SELECT VOLUME With this function the volume of aspirated air can be modified according to 8
programmed values
PROGRAM VOLUME With this function the 8 programmed values can be modified
SET DELAY With this function the air sampler can be programmed to start sampling after a
programmable delay (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60 minutes)
MULTIMODE With this function the air sampler can be programmed to extend the total
sampling time using “sequential interval time” sampling by these Sub Menus:
INTERVAL TIME
It can be programmed from 1 to 59 minutes
NUMBERS OF RUNS
They can be programmed from 1 to 19 air aspirations
SINGLE RUN VOLUME
It can be programmed from 1 to 1999 litres
TOTAL RUNS
It shows the total volume of aspirated air
CONFIGURATION With this function you can use the sas with eight programmable configuration
UTILITY MODE With this function the air sampler is programmed to enter the following Sub-
Menu:
SET TIME
To program date and time
SITE
To identify the sampling point
IDENTIFY
To identify the operator’s name
LANGUAGE
To display text in different languages
DISPLAY RECORD
To show the recorded sampling data
CLEAR RECORD
To clear the recorded sampling data
REMOTE CONTROL
Not used
CALIBRATION
To calibrate the volume of aspirated air
POWER OFF With this function the air sampler can be switched off by touching the ENTER
button.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 8
3.3 Preliminary Inspection
The apparatus is subject to specific working tests before shipping and it is carefully packed to avoid possible damage
during transit. However, a visible check should be carried out as soon as possible to determine any transit damage. This
must be reported immediately. The following procedures should be followed to check that the unit is functioning
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correctly.
The battery pack of the instrument must be charged for at least 5 hours before the test
N:B: In the following displays, the entry of “XX” indicates numerical figures.
S/N XX-XX-XXXX
DATE TIME
SITE XXXXXXXX
Touch START on the screen to start air sampling with the last cycle. The motor will run until the figures in the brackets
reach the same figure as displayed to the right and then it will stop.
DATE TIME
START STOP
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 9
3.4 “55 mm Contact Plates” Holder Adjustment
The Contact Plate holders can be adjusted (using a screw driver) in case the available plates slightly different in
diameter from the standard 55 mm Contact Plate (see Figure 1 page 26).
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3.5 “84 mm Maxi-Contact Plates”
If high fungal contamination is expected in the sampled air, Maxi-Contact Plates are suggested. This is because moulds
tend to spread and consequently make counting difficult after incubation.
The “84 mm Maxi-Contact Plates” are inserted into the SAS SUPER ISO 100 or SAS SUPER ISO 180 using a special
adaptor (Cat.n. 19123). For more details see Application Note N. 89.
An adapter is available in aluminium or stainless steel which allows the use of standard 90 mm Petri Dishes with SAS.
We recommend to fill the standard 90 mm disposable Petri dish with no more than 18-20 ml of agar to avoid that
the medium can touch the inside surface of the aspirating head.
The SAS SUPER ISO 100 & SAS SUPER ISO 180 can be fixed to a table tripod or a floor tripod or a wall support. The
screw thread connection is located under the unit, between the two front feet. When not in use, the connection cavity is
protected by a metal screw insert.
head
55 mm Contact Plate
standard version
head
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 10
4. SOFTWARE FUNCTION
Touch the screen for at least two seconds to switch on the unit.
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The air sampler is provided with eight programmable air volumes (“Select volume”) stored in the memory and eight
sampler configuration (“Configuration”) selected by the operator.
The selection of the volume is made by pressing the “UP” or “DOWN” arrows when the program is in the
relevant sub-menu.
4.1. To start with the same air volume as the previous sample
Switch on the unit by touching the screen for at least two seconds. After the visual display presentation you will see the
following display with the last aspirated volume of air
Time
Date
08/31/06 11.31 Battery Status
Touch START on the screen to start air sampling with the last cycle. The motor will run until the figures in the brackets
reach the same figure as displayed to the right and then it will stop.
08/31/06 11.31
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 11
4.2 . SELECT VOLUME function (To start with one of the eight memorized volume)
Switch on the unit by touching the screen for at least two seconds. After the visual display presentation you will see the
following display with the last aspirated volume of air
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08/31/06 11.31
START MENU
Touch MENU and select SELECT VOLUME function by touching "UP" or "DOWN" arrows
MENU'
SELECT VOLUME
CLEAR ENTER
Touch ENTER and select a volume by touching "UP" or "DOWN" arrows (for example 1250 Litres)
SELECT VOLUME
[ 1250 ] Litres
CLEAR ENTER
Touch ENTER to select the volume, the display will show the selected volume
08/31/06 11.31
START MENU
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 12
4.3 UTILITY MODE function
In this program the following SUB-MENUS are listed: Set time, Site, Identify, Language, Display Record, Clear
Record, Remote Control, Calibration.
Always start from UTILITY MODE to reach one of these SUB-MENUS.
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Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select UTILITY MODE function by touching "UP" or "DOWN" arrows
MENU'
UTILITY MODE
CLEAR ENTER
UTILITY MODE
SET TIME
CLEAR ENTER
MM/DD/YY HH:mm
08/31/06 11:33
^^
CLEAR ENTER
Change the number indicated by "^^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next
number.
MM/DD/YY HH:mm
08/31/06 11:33
^^
CLEAR ENTER
repeat until you reach the last number and the confirm by touching ENTER.
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4.3.2. “SITE”
This option is used to memorize the name of the site in the file “DISPLAY RECORD” (see paragraph 4.3.5). The site
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identification should be changed for samples taken at different sites especially if the results are to be printed.
Select SITE function from UTILITY MODE Program.
UTILITY MODE
SITE
CLEAR ENTER
SITE
[ ABCDEFGH ]
^
CLEAR ENTER
Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.
SITE
[ SBCDEFGH ]
^
CLEAR ENTER
repeat until you reach the last figure and the confirm by touching ENTER.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 14
4.3.3. “IDENTIFY”
This option is used to identify the operator. This should be changed if different operators use the sampler and especially
if the date is to be printed. The data is recorded in the file “DISPLAY RECORD” (see paragraph 4.3.5).
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Select IDENTIFY function from UTILITY MODE Program.
UTILITY MODE
IDENTIFY
CLEAR ENTER
IDENTIFY
[ 12345678 ]
^
CLEAR ENTER
Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.
IDENTIFY
[ 3234578 ]
^
CLEAR ENTER
repeat until you reach the last figure and the confirm by touching ENTER.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 15
4.3.4. “LANGUAGE”
The text of the Menus may be selected choosing from different languages.
Select LANGUAGE function from UTILITY MODE Program.
ENGLISH
UTILITY MODE
LANGUAGE
CLEAR ENTER
LANGUAGE
ENGLISH
CLEAR ENTER
Change the language by touching "UP" or "DOWN" arrows and touch ENTER to select the desired language; the
display will be showed in the selected language.
Touch CLEAR to exit this function.
UTILITY MODE
DISPLAY RECORD
CLEAR ENTER
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 16
Date
End sampling time
DISPLAY RECORD
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Record position
number 001 08/31/06 11.31
Multimode indicator
BBCD/3345 Lt. 1250 *
Site/Identity CLEAR
Aspirated Liters
You can view all the completed cycle by touching "UP" or "DOWN" arrows. The symbol "*" is displayed near the
volume aspirated if the volume was aspirated with the multimode function.
Touch CLEAR to exit this function.
UTILITY MODE
CLEAR RECORD
CLEAR ENTER
CLEAR RECORD
CONFIRM
CLEAR ENTER
Touch ENTER to confirm the deletion of data or touch CLEAR to exit the function
4.3.8. “CALIBRATION”
The “Calibration” function is a password-protected menu accessible only by an authorized technician.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 17
4.4. PROGRAM VOLUME function (modification of the value of a stored volume)
Using this procedure, it is possible to memorise up to eight different volumes (from 1 to 1999 litres of air).
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Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select PROGRAM VOLUME function by touching "UP" or "DOWN" arrows
MENU'
PROGRAM VOLUME
CLEAR ENTER
SELECT VOLUME
[ 1250 ] Litres
CLEAR ENTER
MODIFY RUN
[ 1250 ]
^
CLEAR ENTER
Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.
MODIFY RUN
[ 0250 ]
^
CLEAR ENTER
repeat until you reach the last figure and the confirm by touching ENTER.
Note: The maximum air volume is 1999 Liters
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 18
4.5. Using a “SET DELAY” program to delay instrument start
This function is used to set a delay time before the sampling cycle.
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Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select SET DELAY function by touching "UP" or "DOWN" arrows
MENU'
SET DELAY
CLEAR ENTER
SET DELAY
[ 00 ] Minutes
CLEAR ENTER
select the desired delay time by touching the "UP" or "DOWN" button. The available delay time are 0-1-2-3-4-5-6-7-8-
9-10-20-30-40-50-60 minutes.
When a delay is set (for example 5 minutes) , on the main display you will see the delay time
08/31/06 11.31
START MENU
The message “DELAY” will flash until the selected time is reached. The display flashes to confirm delayed start has
been selected.
08/31/06 11.31
**DELAY**
START MENU
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4.6. MULTI MODE function
This program is very useful for extending the time of sampling with the purpose of obtaining a more representative
environmental sample “in actual operating conditions”. The total air volume to be sampled is aspirated with two or
more sub-volume aspirations (E.g.:1000 litres in ten runs of 100 litres at five minute intervals).Before entering the
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MULTI MODE Program you should therefore decide (a) total volume of air to be sampled onto the Contact Plate; (b)
number of runs; (c) interval time. See Application Note N.95 for more details.
Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select MULTI MODE function by touching "UP" or "DOWN" arrows
MENU'
MULTI MODE
CLEAR ENTER
INTERVAL TIME
[ 00 ] Minutes
^
CLEAR ENTER
select the desired interval time between sampling by touching the "UP" or "DOWN" button. Touch the ENTER button
to go to the next digit.
The interval time can be set from 0 to 59 minutes.
NUMBERS OF RUNS
[ 01 ] RUN
^
CLEAR ENTER
select the desired numbers of sampling cycles by touching the "UP" or "DOWN" button. Touch the ENTER button to
go to the next digit.
The maximum nubers of cylce is 19.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 20
SINGLE RUN VOLUME
[ 0000 ] Litres
^
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CLEAR ENTER
select the desired volume of aspirated air for each sampling by touching the "UP" or "DOWN" button. Touch the
ENTER button to go to the next digit.
The maximum aspirated volume of cylce is 1999 Litres.
Touch ENTER to confirm
The display will show the TOTAL volume of air to be aspirated at the end of the cycles. Check if it is correct volume. If
not, touch the CLEAR button and start again. For example if you set 5 cycle of 200 liters each you will aspirate 1000
liters of air
TOTAL RUN
[ 1000 ] Litres
CLEAR ENTER
Touching ENTER to confirm it will set the SAS in the multi mode
08/31/06 11.31
START MENU
08/31/06 11.31
At the end of the run the SAS will display a flashing delay before the next cycle; and the number of completed cycles
and residual cycles (runs) are also displayed.
08/31/06 11.31
START STOP
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 21
4.7. CONFIGURATION function
4.7.1 To start with one of the eight operator programmable configuration memorised
If the operator requires to use a preset configuration (composed of site, identity, numbers of runs, numbers of cycle) up
to 8 additional configuration can be programmed into the unit.
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Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select CONFIGURATION function by touching "UP" or "DOWN" arrows
MENU'
CONFIGURATION
CLEAR ENTER
CONFIGURATION
SELECT
CLEAR ENTER
select SELECT function by touching "UP" or "DOWN" arrows and touch ENTER
Record position
number
select the preset configuration desired (between 1 and 8) by touching "UP" or "DOWN" arrows and touch ENTER to
confirm
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4.7.2 Modify the of the eight operator programmable configuration memorised
If you want to modify the preset configuration (composed of site, identity, numbers of runs, numbers of cycle) you must
use the MODIFY function
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Switch on the unit by touching the screen for at least two seconds.
Touch MENU and select CONFIGURATION function by touching "UP" or "DOWN" arrows
MENU'
CONFIGURATION
CLEAR ENTER
CONFIGURATION
MODIFY
CLEAR ENTER
select the SET function by touching "UP" or "DOWN" arrows and touch ENTER
MODIFY
CONFIGURATION [1]
CLEAR ENTER
You must choose the configuration that you want to modify function by touching "UP" or "DOWN" arrows and touch
ENTER; now you can modify the site name
SITE
[ ABCDEFGH ]
^
CLEAR ENTER
Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 23
SITE
[ SBCDEFGH ]
ENGLISH
^
CLEAR ENTER
repeat until you reach the last figure and the confirm by touching ENTER; now you can modify the identity
IDENTIFY
[ 12345678 ]
^
CLEAR ENTER
Change the figure indicated by "^" by touching "UP" or "DOWN" arrows and touch ENTER to go to the next figure.
IDENTIFY
[ 3234578 ]
^
CLEAR ENTER
repeat until you reach the last figure and the confirm by touching ENTER; now you can choose to program the SAS in
single mode or multimode.
INTERVAL TIME
[ 00 ] Minutes
^
CLEAR ENTER
select the desired interval time between sampling by touching the "UP" or "DOWN" button. Touch the ENTER button
to go to the next digit.
The interval time can be set from 0 to 59 minutes.
Note: If you want to program a single cycle set INTERVAL TIME to 0 minutes
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 24
NUMBERS OF RUNS
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[ 01 ] RUN
^
CLEAR ENTER
select the desired numbers of sampling cycles by touching the "UP" or "DOWN" button. Touch the ENTER button to
go to the next digit.
The maximum nubers of cylce is 19.
Note: If you want to program a single cycle set NUMBERS OF RUN to 1
Touch ENTER to confirm.
select the desired volume of aspirated air for each sampling by touching the "UP" or "DOWN" button. Touch the
ENTER button to go to the next digit.
The maximum aspirated volume of cylce is 1999 Litres.
Touch ENTER to confirm
The display will show the TOTAL volume of air to be aspirated at the end of the cycles. Check if it is correct volume. If
not, touch the CLEAR button and start again. For example if you set 5 cycle of 200 liters each you will aspirate 1000
liters of air
TOTAL RUN
[ 1000 ] Litres
CLEAR ENTER
Touch ENTER to confirm and save the configuration. See paragraph 4.7.1 for the procedure to run a preset
configuration.
MENU'
POWER OFF
CLEAR ENTER
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Note: The instrument will automatically switches off after 5 minutes of idle mode
5. OPERATIONS
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The plate holders are adjustable to allow different brands of Contact Plates to be fitted.
FIG. 1
Adjustable plate holders in the sampler head allow the operator to use contact plates from many sources without
concern for slight differences in plate size.
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5.3. Sanitation of the air sampler
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head can be sanitised by treating the inside and outside surfaces with a disinfecting alcohol wipe or swab.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 27
5.5. “Contact Plates” preparation
It is important that the volume of media dispensed into a “Contact Plate” is constant for the type of plate used. An
excess volume can create a convex surface that is too high and which may touch the inside of the sampler head. An
insufficient volume will create a concave surface, unsuitable for representative colony growth using SAS System.
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The volume of agar in a “55 mm Contact Plate” should be 16-18 ml and in a ”84 mm Maxi-Contact Plate” 24-26 ml.
For more details see Application Note N.78.
AREA Position SAS s/n Single Air Total Air Sub Sample Sampling Start delay
Volume Volume number interval
A A1 1.210 - 1.000 - - 5
A2 1.211 200 1.000 5 30 -
A3 1.213 250 1.000 4 30 -
B B1 1.214 250 1.000 4 30 -
B2 1.215 200 1.000 5 30 -
C C1 1.216 - 1.000 - - 20
(a) Air sampler SAS SUPER ISO 100 Serial Number 1210 was positioned in AREA A on site A1 and programmed
for a total air volume of 1000 litres in one run, starting after 5 minutes from the switching on of the instrument.
(b) Air sampler SAS SUPER ISO 100 Serial Number 1211 was positioned in AREA A on site A2 and programmed for
a total air volume of 1000 litres in five times (200 litres during each run) with interval times of 30 minutes.
(c) Air sampler SAS SUPER ISO 100 Serial Number 1213 was positioned in AREA A on site A3 and programmed
for a total air volume of 1000 litres in four times (250 litres during each run) with interval times of 30 minutes.
(d) Air sampler SAS SUPER ISO 100 Serial Number 1214 was positioned in AREA B on site B1 and programmed for
a total air volume of 1000 litres in four times (250 litres during each run) with interval times of 30 minutes.
(e) Air sampler SAS SUPER 100 ISO Serial Number 1215 was positioned in AREA B on site B2 and programmed
for a total air volume of 1000 litres in five times (200 litres during each run) with interval times of 30 minutes.
(f) Air sampler SAS SUPER 100 ISO Serial Number 1216 was positioned in AREA C on site C1 and programmed for
a total air volume of 1000 litres in one run, starting after 20 minutes from the switching on of the instrument.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 28
5.8 Multi Point Sampling with several connected air samplers
Several SAS Super ISO 100 air samplers can be connected and controlled by PC.
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Switch off the unit by touching the STOP message during the sampling cycle or touching first MENU and then the
arrow to reach Power Off message; press ENTER to confirm.
The unit will switch off automatically after 5 minutes.
6. CALCULATION OF RESULTS
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 29
CORRECTION TABLE TO ADJUST COLONY COUNTS FROM A 487-HOLE IMPACTOR
USING 84 mm MAXI-CONTACT PLATES
Colonies MPN Colonies MPN Colonies MPN Colonies MPN Colonies MPN Colonies MPN
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r Pr r Pr r Pr r Pr r Pr r Pr
Pr x 1000
X =----------------------
V
Where:
V = Volume of sampled air = 200 litres of air
r = Colony Forming Units counted on “ 55 mm Contact Plates” = 67
Pr = Probable count obtained by positive hole correction = 80
x = Colony Forming Units per 1000 litres (= 1 cubic metre) of air
80 x 1000
x = ------------------------- = 400 CFU per 1000 litres of air (1000 litres=1m3)
200
To express the final result in CFU/ft3 multiply the CFU/m3 value by 0,02832
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6.2. Data recording
All data related to instrument identification, operator’s name, sampling site, date and hour of sampling, type of media,
CFU may be reported on the specific software.
ENGLISH
CORRECTION TABLE TO ADJUST COLONY COUNTS FROM
A 401- HOLE IMPACTOR USING STANDARD 90mm PETRI PLATES
r Pr r Pr r Pr r Pr r Pr r Pr r Pr r Pr
45 48 90 102 135 164 180 239 225 330 269 445 313 606
1 1 46 49 91 103 136 166 181 240 226 332 270 448 314 611
2 2 47 50 92 104 137 167 182 242 227 334 271 451 315 616
3 3 48 51 93 106 138 169 183 244 228 336 272 454 316 620
4 4 49 52 94 107 139 170 184 246 229 339 273 457 317 625
5 5 50 53 95 108 140 172 185 248 230 341 274 460 318 630
6 6 51 54 96 110 141 173 186 250 231 343 275 463 319 635
7 7 52 56 97 111 142 175 187 251 232 346 276 466 320 639
8 8 53 57 98 112 143 177 188 253 233 348 277 470 321 644
9 9 54 58 99 114 144 178 189 255 234 351 278 473 322 649
10 10 55 59 100 115 145 180 190 257 235 353 279 476 323 654
11 11 56 60 101 116 146 181 191 259 236 355 280 479 324 660
12 12 57 61 102 118 147 183 192 261 237 358 281 483 325 665
13 13 58 63 103 119 148 184 193 263 238 360 282 486 326 670
14 14 59 64 104 120 149 186 194 265 239 363 283 489 327 675
15 15 60 65 105 122 150 188 195 267 240 365 284 493 328 681
16 16 61 66 106 123 151 189 196 269 241 368 285 496 329 686
17 17 62 67 107 124 152 191 197 271 242 370 286 500 330 692
18 18 63 68 108 126 153 192 198 272 243 373 287 503 331 698
19 19 64 70 109 127 154 194 199 274 244 375 288 507 332 703
20 20 65 71 110 128 155 196 200 276 245 378 289 510 333 709
21 22 66 72 111 130 156 197 201 278 246 380 290 514 334 715
22 23 67 73 112 131 157 199 202 280 247 383 291 517 335 721
23 24 68 74 113 133 158 201 203 282 248 386 292 521 336 727
24 25 69 76 114 134 159 202 204 284 249 388 293 525 337 733
25 26 70 77 115 135 160 204 205 287 250 391 294 528 338 740
26 27 71 78 116 137 161 206 206 289 251 393 295 532 339 746
27 28 72 79 117 138 162 207 207 291 252 396 296 536 340 752
28 29 73 80 118 140 163 209 208 293 253 399 297 540 341 759
29 30 74 82 119 141 164 211 209 295 254 402 298 544 342 766
30 31 75 83 120 142 165 212 210 297 255 404 299 548 343 772
31 32 76 84 121 144 166 214 211 299 256 407 300 551 344 779
32 33 77 85 122 145 167 216 212 301 257 410 301 555 345 786
33 34 78 87 123 147 168 217 213 303 258 413 302 559 346 794
34 35 79 88 124 148 169 219 214 305 259 415 303 563 347 801
35 37 80 89 125 150 170 221 215 307 260 418 304 568 348 808
36 38 81 90 126 151 171 223 216 310 261 421 305 572 349 816
37 39 82 92 127 152 172 224 217 312 262 424 306 576 350 823
38 40 83 93 128 154 173 226 218 314 263 427 307 580
39 41 84 94 129 155 174 228 219 316 264 430 308 584 r= colony forming
units counted
40 42 85 95 130 157 175 230 220 318 265 433 309 589
41 43 86 97 131 158 176 231 221 321 266 436 310 593 Pr= probable count
42 44 87 98 132 160 177 233 222 323 267 439 311 597
43 45 88 99 133 161 178 235 223 325 268 442 312 602
44 47 89 100 134 163 179 237 224 327
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 31
SECTION THREE
ENGLISH
7. SPECIFICATIONS
Principle
Air-borne micro-organisms are collected on microbiological agar by impaction produced by aspiration.
Voltage
8,4 Volts – 2,7 amp/h
Battery Pack
Rechargeable Nickel Metal Hydride (without memory effect).
Battery Autonomy
Aspiration of approx. 70.000 litres of air
Motor
6 Volts, 2,8 Watts
Size
120x125x275 mm
Weight
1850 g
Construction
Aspirating Head: aluminium or stainless steel
Turbine: antistatic plastic resin
Housing: polyurethane resin
Acoustic signal
An acoustic signal alerts the operator each time the screen has been touched and command accepted and at the end of
each aspirating cycle.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 32
SAS Super ISO 100 / SAS Super ISO 180 Contact Plate Chamber
ENGLISH
2 Air turbine
3 Contact Plate fixing spring clip
FIG.2
2
SAS Super ISO 100 / SAS Super ISO 180 Rear Panel
FIG. 3
5
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 33
SAS Super ISO 100 / SAS Super ISO 180 Front Control Panel
ENGLISH
7 Infrared sensor for remote control
8 Touch screen display
8
FIG. 4
SAS Super ISO 100 / SAS Super ISO 180 Bottom Panel
10 FIG. 5
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 34
7.1. Sampling time required for different air volumes
ENGLISH
LITRES OF AIR TIME REQUIRED LITRES OF AIR TIME REQUIRED
50 30 seconds 90 30 seconds
100 1 minutes 180 1 minute
200 2 minutes 360 2 minutes
300 3 minutes 540 3 minutes
400 4 minutes 720 4 minutes
500 5 minutes 900 5 minutes
600 6 minutes 1000 5 minutes 30 seconds
700 7 minutes
800 8 minutes
900 9 minutes
1000 10 minutes
When the battery charge is not enough to start a cycle, the instrument will show the following flashing message:
08/31/06 11.31
LOW BATTERY !!
START MENU
NOTES
(a) The correct metal hydride battery charger must be used to charge the SAS SUPER ISO 100 or SAS SUPER ISO
180!
(b) If the air sampler has not been used for several weeks, check the battery status!
(c) The efficiency of the battery is reduced when operating at temperatures below 0 °C.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 35
7.4. Sampling at high altitude over the sea level
The aspirated volume of air at high altitude could be different from the the declared instrument figures due to the
different barometric pressure and temperature. It is therefore necessary to re-validate the instrument at this specific
altitude to know the true value of aspirated air.
ENGLISH
The re-validation is performed using the “Pyramid” Unit. (See chapter 8.2)
08/31/06 11.31
FLUX ERROR !
START MENU
Check for air path obstruction or presence of Contact Plate and repeat the cycle.
08/31/06 11.31
CALIBRATION EXPIRED
CLEAR
This message remind you that you should send the instrument to International PBI or authorized dealer for calibration;
however touching CLEAR will let you use the instrument.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 36
SECTION FOUR
8. MAINTENANCE
ENGLISH
8.1 Cleaning
The SAS SUPER ISO 100 and SAS SUPER ISO 180 do not require special care
and maintenance procedures. Clean the outside surface with a normal mild NON
CORROSIVE detergent.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 37
8.3 Performance routine monitoring
The SAS SUPER ISO 100, SAS SUPER ISO 180 may be checked monthly / bimonthly (depending how often they are
used) using the “Pitot Kit” or “PYramid” units to monitor that they are working correctly and their performances has
not been affected by bad handling or damage. (See chapter 8.2)
ENGLISH
8.4 Calibration frequency
Generally, if instruments are used daily, calibrations should be performed every 6 months. Monthly or interval weekly
usage require annual calibrations.
Accessories
Cat.n. 15931 55 mm aluminium certified drilled head
Cat.n. 15503 55 mm stainless steel certified drilled head
Cat.n. 19123 84 mm aluminium certified drilled head complete with adaptor for Maxi Contact Plate
Cat.n. 18148 84 mm stainless steel certified drilled head – complete with adapter for Maxi Contact Plate
Cat.n.19117 90 mm aluminium standard Petri dish head and adaptor
Cat.n.19119 90 mm stainless steel standard Petri dish head and adaptor
Cat.n.19115 Atrium chamber for Clean Room application
Cat.n. 6064 Autoclavable plastic cover for sampling head
Cat.n.19239 Compressed air head
Cat.n. 5214 Table tripod
Cat.n. 5215 Floor tripod
Cat.n.20153 Aluminium carrying case
Cat.n.18143 Soft carrying case
Cat.n.18950 Infrared remote control
Cat.n.19834 “ARM” System to fix SAS Super ISO 100 to wall
Cat.n.20093 Installation Qualification manual
Cat.n.20094 Operator Qualification manual
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 38
Consumables
“AGAR CONTACT” READY TO USE MEDIA FILLED STERILE CONTACT PLATES
ENGLISH
5210 PCA 60 With “Plate Count Agar” for total viable count 80
7426 PCA TW 60 With “Plate Count Agar” and neutralizing agent for total viable count 80
17354 TSA TW 60 With “Tryptone Soy Agar” and neutralizing agent for total viable count 80
17573 SDA TW 60 With “Sabouraud Dextrose Agar” for fungi (yeasts and moulds) count and 80
neutrilizing agent for total viable count
7427 Gram 60 With “Violet Red Bile Agar” for gram negative count 80
SECTION FIVE
According to the Document EN 17025, to apply the current Good Laboratory Practice, it is necessary to identify each
instrument with a specific sheet. An example is here reported.
Form n. XXXX
Date XXXX
Company / Institute XXXX
Laboratory XXXX
Name of Instrument Microbiological Air Sampler
Model SAS SUPER ISO 100
Serial Number XXXX
Name of Producer International pbi
Name of Distributor XXXX
Condition at the moment of arrival (X) new; (x) used; (x) reconditioned
Date of Arrival / /
Date of initial use / /
Usual collocation Room XXXX
Servicing details See servicing POS
Instrument to be calibrated (X) Yes; (X) No
Periodic Calibration (X) monthly; (X) quaterly; (X) Yearly
Instrument to be validated (X) Yes; (X) No
Periodic Validation (X) half year; (X) yearly
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 39
To the attention of: Technical department International pbi S.p.A.
Via Novara, 89 - 20153 - Milano - Tel + 39 02/48.779.1-Fax +39 02/400.900.10
AUTHORISATION RETURN NUMBER TO BE ASKED TO THE EXPORT DPT
ENGLISH
Company:
Address:
City: Zip Code State
Phone Fax Email
Name to contact:
Lab/Division:
return request of technical service
Equipment:
Model Serial Number:
for calibration repair other (specify)
NOTE OF MALFUNCTIONING
ELECTRICAL PART
ELECTRONICAL PART
MECHANICAL PART
HYDRAULICS PART
NOTES:
Mod. PQ09.9
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 40
ENGLISH
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 41
WARRANTY
WARRANTY CONDITIONS
ENGLISH
International pbi warrants this product to be free of defects in materials and functionality
The repairs will be effected by International pbi or by authorized dealers as follows:
ATTENTION
TO OUR NEW CUSTOMER
As a user of our equipment you are covered for a 12 months guarantee for all spare parts as a result of mechanical
failure of the machine during normal use. In order to provide you with first class service, it is essential for us to know
all your references and which equipment you have. We kindly ask you therefore to fill in the attached guarantee and
return the card to us by first class mail.
International pbi S.p.A. « Sas Super Iso 100/180 » March 2007 Rev. 3 42