PBI SAS SUPER IAQ Instruction Manual
ENGLISH
“SAS SUPER IAQ” - Code n. 90578
IINNSSTTRRUUCCTTIIOONNSS M
MAANNUUAALL
Carefully read this Manual before operating your instrument.
This document is the property of International PBI Spa Milan
It may not be duplicated or distributed without the owner’s authorisation
Patent Pending
Manufactured by International PBI Spa Milan, Italy
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 23-NF 18 8
th
Supplement 1116 (May 1998) – 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
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
ENGLISH
INSTRUCTIONS MANUAL
READ CAREFULLY THIS HANDBOOK
SAFETY INSTRUCTIONS
• Use the device just for the indicated purposes.
• The Device must be correctly used according to manual instructions, before starting
any operation.
• Replace immediately any electrical cable when damaged ; never use a damaged or
worn electrical cable.
• Always disconnect the charger before:
A. Repairing or maintenance; these operations must be carried out by qualified staff;
B. Keep the unit clean;
• Use original spare parts and accessories for any replacement;
• Do not use this device in the presence of explosive gas.
GENERAL CAUTION
CAUTION
Be aware that the voltage and frequence of the electrical
system are compatible with the electrical requirements of the
battery charger.
CAUTION
Never use a non-OEM charger to charge the air sampler.
Use of improper charger may damaged the unit
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SUMMARY
SECTION ONE PAGE
Brief Operating Instructions 1
Visual Display Presentation 1
SECTION TWO
Operating Instructions 2
1. Principle 2
2. The basic idea 2
3. Installation 3
3.1 The Practical Use 3
3.2. List of MENU and SUB-MENU 4
3.3. Preliminary Inspection 5
3.4. 55 mm Contact Plate holder adjusting 6
3.5. 84 mm Maxi Contact Plate use (optional) 6
3.6. Tripod Installation (optional) 7
4. Operations 7
4.1. Start with the previous volume 8
4.2. User Mode 8
4.3. Program mode 9
4.4. Utility Mode Program 15
4.4.1. Set Time 15
4.4.2. Sampling Site 15
4.4.3. Operator Identification 16
4.4.4. Language 17
4.4.5. Clear Record 17
4.4.6. Display Record 18
4.4.8. Autoswitch OFF 19
4.5. Delay Mode 22
4.6. Low Battery Message 25
4.7. Remote Switch Use 26
4.8. Contact Plate Holder Adjustment 27
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SECTION TWO (continued) PAGE
4.9. Sanitation of Air Sampler 17
4.10. Contact Plate 17
4.11. Contact Plate Preparation 18
4.12. Total Bacterial Count and/or Micro-organisms Identification by
Dilution
19
5. Final Operation 19
6. Result Calculation and Recording 19
6.1. CFU/1000 Litres 19
SECTION THREE
7. Specifications 23
7.1. Messages Shown On Display 25
7.2. Sampling Time Requested For Different Air Volumes 26
7.3. Battery Charger Operation 26
7.4. Automatic Switch OFF 27
SECTION FOUR
8. Maintenance 28
8.1. Cleaning 28
8.2. Validation and Calibration 28
8.3. Performance Routine Monitoring 28
8.4. Trouble Shooting 29
8.5. Battery Replacement 29
8.6. Accessory and Spare Part List 30
SECTION FIVE
9. Brief Instructions 31
SECTION SIX
10. EN 17025 Documentation 32
“SAS Super IAQ” Rev. 1 Pg. 1
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SECTION ONE
• BRIEF OPERATING INSTRUCTIONS FOR SAS SUPER IAQ
The air flow is displayed after the automatic presentation each time the ins trument is switched
on.
Press ON/OFF switch.
Press START button to sample the same air volume of the last sampling cycle.
To change the air volume, use the arrow buttons and select “User Mode” from menu.
Refer to instruction manual to change settings.
Press ENTER to confirm selection.
Press arrows for menu selection to modify other pre-set parameters:
USER MODE
PROGRAM MODE
DELAY MODE
UTILITY MODE
Press ENTER to reach the sub-menu of the chosen parameter.
Refer to instruction manual to change settings.
Press ON/OFF switch at the end of sampling operations.
Press “CLEAR” each time you need to end an action. Then the unit will come back to the initial
configuration.
• VISUAL DISPLAY PRESENTATION
(Press ON/OFF black button switch).
Each time the ON/OFF switch is pressed, a ten seconds visual display presentation will appear
displaying the following information:
(1) INTERNATIONAL
PBI
(2) S/N XXXX
Rev. XXX.XX (Firmware revision)
(3) PRESS ARROWS
FOR NEW MENU SELECTION
(4) SAS SUPER IAQ
(5) ID XXXX
SITE XXXX
(6) START FOR XX
MM/DD/YY - HH/MM
This information are displayed automatically. Avoid pushing any button before the end of the
few seconds presentation; during this presentation all functions are disabled.
“SAS Super IAQ” Rev. 1 Pg. 2
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SECTION TWO
• OPERATING INSTRUCTIONS
1. PRINCIPLE OF SURFACE AIR SYSTEM
The Surface Air System (SAS) encompasses several models which use the same principle.
Air is aspirated at a fixed speed for variable time through a head which has been machined
with a series of small holes of a special design. The resulting laminar air flow is directed onto
the agar surface of a “RODAC Plate” (or a Petri dish) containing medium consistent with the
microbiological examination to be made. When the preset sampling cycle is completed, the
plate is removed and incubated. The organisms are then visible to the naked eye and can be
counted for an assessment of the level of contamination.
2. THE BASIC IDEA
The major points of the Surface Air System (SAS) are:
A. To use a simple and inexpensive “Contact Plate” (“SURFAIR PLATE”, “RODAC”) for
surface, hands or air control. These plates are very well known and easily available. They
can be purchased ready poured with different media.
B. To sample a known volume of air for a variable time to provide a range of sampling
volumes.
C. To aspirate air in a laminar flow pattern with sufficient velocity to impact organisms onto
an agar surface.
D. To accumulate data on the level of hygiene in each environment so that fluctuation can be
monitored.
E. To take advantage of advanced electronics for more reliable results in different operating
conditions.
F. To have the flexibility to choose between 55 mm Contact Plates, 84 mm Maxi Contact
Plates or 90 mm Standard Petri Dishes.
G. To apply cGLP and cGMP to air
sampling operations.
H. To organize sequential sampling
to obtain a more representative
sample under actual operating
conditions.
“SAS Super IAQ” Rev. 1 Pg. 3
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3. INSTALLATION
3.1 The practical use of contact plates
THE PRACTICAL USE OF “CONTACT PLATES” FOR AIR CONTROL
SAS SUPER IAQ
SAS SUPER IAQ FLOW SCHEME
1. Remove the aspirating head.
2. Insert an identified, closed and prepared Contact Plate and remove plate lid.
3. Replace the aspirating head.
4. Select the required air volume and start the unit. The air flow is directed onto the agar
surface of the Contact Plate.
5. At the end of the cycle, remove the aspirating head.
6. Close and remove the Contact Plate.
7. Incubate the Contact Plate
8. Count the colonies, record the results on the microbiological air sampling report and
analyze the results.
“SAS Super IAQ” Rev. 1 Pg. 4
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3.2. LIST OF MENU AND UTILITY SUB-MENU
MENU DESCRIPTION
START FOR XXX This message indicates the air sampler is ready to sample the
volume shown
USER MODE With this function the air sampler can be set to select one of eight
programmable sampling volumes
PROGRAM MODE With this function you can to modify the eight programmable
sampling volumes
DELAY MODE With this function the air sampler can be set to start after a
programmable delay
UTILITY MODE This function led to the following Sub-Menu:
SET TIME
To adjust date and time
SAMPLING SITE
To identify the sampling point
IDENTIFY
To identify the operator’s name
LANGUAGE
To display text in different languages
CLEAR RECORD
To clear the recorded sampling data
DISPLAY RECORD
To show the recorded sampling data
AUTO SWITCH OFF
To disconnect the automatic switch off when the “Infrared
Remote” is used
“SAS Super IAQ” Rev. 1 Pg. 5
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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 working properly.
The battery pack of the instrument must be charged for at least 4 hours before the test (14 hours
if slow battery charger is used).
SAS SUPER IAQ
After the ON/OFF button is pressed an automatic visual presentation will be displayed.
In the following displays, the entry of “XX” indicates numerical figures.
ACTION DISPLAY
I N T E R N A T I O N A L Switch on the ON/OFF
switch (black button)
P B I
S N X X X X
P R E S S A R R O
W
S F O
R
NEW ME N U S ELECT.
S A S S U P E R I A Q
“SAS Super IAQ” Rev. 1 Pg. 6
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I D X X X X
SI TE XXXX
S T A R T F O R X X
M/ D / Y - H: M
Push START button
to start air sampling
with last cycle
( X X ) X X
M/ D / Y - H : M
The motor will run until the figures in brackets reach the same figure as displayed to the right
and then it will stop. During the sampling the two red leds are flashing (see position 16 and 28
in the figures at page 24).
3.4 “55 mm CONTACT PLATES” HOLDER ADJUSMENT
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 the figure in the
Chapter 4.10).
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 IAQ using a special
adaptor (Cat.n. 19123). For more details see Application Note N. 89.
“SAS Super IAQ” Rev. 1 Pg. 7
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3.6. TRIPOD INSTALLATION (OPTIONAL)
The SAS SUPER IAQ can be fixed to a table tripod or a floor tripod. The threaded connection
is located under the unit, between the two front feet. When not in use, the screw is protected by
an threaded plug.
4. OPERATIONS
Push the Main switch (black button) once to switch on the unit.
The Main switch (black button) must be pushed twice to switch on the unit if the automatic
switch off timer operated when last used.
Press “CLEAR” at any time to return to the initial “START FOR” configuration.
The air sampler is provided with eight programmable air volumes (“User Mode”) selectable 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.
The following volumes of air are suggested:
- Contaminated areas (communities, processing rooms, etc.) 10-200 litres of air
- Normal areas (laboratory benches, houses, etc.) 200-500 litres of air
- Sterile or high risk areas (operating theatres, etc.) 500-1000 litres of air.
“SAS Super IAQ” Rev. 1 Pg. 8
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4.1. TO START WITH THE SAME AIR VOLUME AS THE PREVIOUS SAMPLE
ACTION DISPLAY
Switch on the ON/OFF
switch (black button)- wait
6 seconds
S T A R T F O R X X
(Last aspirated volume of
air)
M / D / Y - H / M
Push “START” (after the
visual
( X X ) X X
display presentation) M / D / Y - H / M
4.2 TO START WITH ONE OF THE EIGHT OPERATOR PROGRAMMABLE
SAMPLING VOLUMES MEMORISED IN THE “USER MODE” PROGRAM
Up to eight volumes, can be programmed into the unit.
ACTION DISPLAY
Switch on the ON/OFF switch
STAR T FOR XX
(black button)
M/ D/ Y - H/ M
Press “¿” to select
USE R MODE
the USER MODE
M/ D/ Y - H/ M
Press “ENTER” to select the
S . PR OG XXXX
pre-memorized volumes
M/ D/ Y - H/ M
Press “¿” to select the chosen
S . PR OG XXXX
pre-memorized volumes
M/ D/ Y - H/ M
Press ENTER
START FOR XXXX
to confirm
M/ D/ Y - H/ M
Press START to run the sampling cycle.
The total number of available “USER MODE” programs is eight.
The maximum volume of air for each sampling cycle is 1999 litres.
“SAS Super IAQ” Rev. 1 Pg. 9
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4.3 “PROGRAM MODE”: MODIFICATION OF AN EXISTING “USER MODE”
PROGRAM
Using this procedure, it is possible to memorise up to eight differen t volumes (from 1 to 1999
litres of air). (See chapter 4.2.)
ACTION DISPLAY
Switch on the ON/OFF
S T A R T F O R X
X
switch (black button)
M / D / Y - H / M
Press “¿” to select
P R O G R A M M O D
E
PROGRAM MODE
M / D / Y - H / M
Press ENTER and then “¿”
S. PR OG XXXX
to select the volume
of air to be modified
M / D / Y - H / M
Press ENTER
X X X X - 0 0 0 0
M/ D / Y - H/ M
Press “¿” to select
X X X X - X 0 0 0
the thousands of litres
M / D / Y - H / M
Press ENTER and then “¿”
X X X X - X X 0 0
to select the hundreds of litres
M / D / Y - H / M
Press ENTER and then “¿”
X X X X - X X X 0
to select the tens of litres
M / D / Y - H / M
Press ENTER and then “¿”
X X X X - X X X X
to select the units of litres
M / D / Y - H / M
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