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"SAS SUPER IAQ" -
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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
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
th
USP 23-NF 18 8
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
Code n. 90578
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REFERENCES
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www.internationalpbi.it
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Summary of Contents for PBI SAS SUPER IAQ
- Page 1 “SAS SUPER IAQ” - Code n. 90578 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 –...
- Page 2 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.
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Page 3: Table Of Contents
SUMMARY SECTION ONE PAGE Brief Operating Instructions Visual Display Presentation SECTION TWO Operating Instructions Principle The basic idea Installation 3.1 The Practical Use 3.2. List of MENU and SUB-MENU 3.3. Preliminary Inspection 3.4. 55 mm Contact Plate holder adjusting 3.5. 84 mm Maxi Contact Plate use (optional) 3.6. - Page 4 SECTION TWO (continued) PAGE 4.9. Sanitation of Air Sampler 4.10. Contact Plate 4.11. Contact Plate Preparation 4.12. Total Bacterial Count and/or Micro-organisms Identification by Dilution 5. Final Operation 6. Result Calculation and Recording 6.1. CFU/1000 Litres SECTION THREE 7. Specifications 7.1.
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Page 5: Section One
SECTION ONE • BRIEF OPERATING INSTRUCTIONS FOR SAS SUPER IAQ The air flow is displayed after the automatic presentation each time the instrument is switched Press ON/OFF switch. Press START button to sample the same air volume of the last sampling cycle. -
Page 6: Section Two
To have the flexibility to choose between 55 mm Contact Plates, 84 mm Maxi Contact Plates or 90 mm Standard Petri Dishes. To apply cGLP and cGMP to air sampling operations. To organize sequential sampling to obtain a more representative sample under actual operating conditions. “ SAS Super IAQ” Rev. 1 Pg. 2... -
Page 7: Installation
The practical use of contact plates THE PRACTICAL USE OF “CONTACT PLATES” FOR AIR CONTROL SAS SUPER IAQ SAS SUPER IAQ FLOW SCHEME Remove the aspirating head. Insert an identified, closed and prepared Contact Plate and remove plate lid. Replace the aspirating head. - Page 8 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. 4...
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Page 9: Preliminary Inspection
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. - Page 10 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.
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Page 11: Tripod Installation (Optional)
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. -
Page 12: User Mode
X X X X to confirm 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. 8... -
Page 13: Program Mode
X X X X X X X 0 to select the tens of litres Press ENTER and then “ ” X X X X X X X X to select the units of litres “ SAS Super IAQ” Rev. 1 Pg. 9... -
Page 14: Utility Mode Program
This data is memorized in the file “DISPLAY RECORD” (see paragraph 4.4.6). The site identification should be changed for samples taken at different sites especially if the results are to be printed. Select UTILITY MODE Program. “ SAS Super IAQ” Rev. 1 Pg. 10... -
Page 15: Operator Identification
D E N T I F Y “ to select the IDENTIFY Sub-Menu Press ENTER to select “ I D E N T I F Y “ operator identification X X X X “ SAS Super IAQ” Rev. 1 Pg. 11... -
Page 16: Language
This option is used to delete all the data memorized in the “DISPLAY RECORD”. Before starting this procedure, please be certain that existing data is not required or that it has been downloded. Select UTILITY MODE Program. “ SAS Super IAQ” Rev. 1 Pg. 12... -
Page 17: Clear Record
Select UTILITY MODE Program. ACTION DISPLAY Press ENTER and then “ ” to select the “AUTO S E T A U T O S W I T C H SWITCH OFF” Sub-Menu. “ SAS Super IAQ” Rev. 1 Pg. 13... -
Page 18: Autoswitch Off
Press ENTER to confirm and then press START. The message “DELAY” will flash until the selected time is reached: the display flashes to confirm delayed start has been selectes. ACTION DISPLAY S T A R T F O R “ SAS Super IAQ” Rev. 1 Pg. 14... -
Page 19: Low Battery Message
(black button) 4.7. “REMOTE SWITCH” USE The SAS SUPER IAQ microbiological air samplers can be fitted with an Infrared Remote Control (optional). The instrument, in normal operating conditions, automatically switches off after 4 minutes, to save the battery, if the unit is not being used. It is therefore necessary to disable the “autoswitch off”... - Page 20 The automatic switch off option is reactiveted by switching off the air sampler with the Main Switch (black button). CAUTION! When the auto switch off option is disabled, remember to switch off the instrument after use to save the battery charge. “ SAS Super IAQ” Rev. 1 Pg. 16...
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Page 21: Sanitation Of Air Sampler
ADJUSTABLE “CONTACT PLATE” HOLDERS The SAS SUPER IAQ air samplers are designed for use with standard “Contact Plates”. The plate holders are adjustable to allow different brands of Contact Plate to be fitted. 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. -
Page 22: Contact Plate Preparation
SAS System. 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. “ SAS Super IAQ” Rev. 1 Pg. 18... -
Page 23: Total Bacterial Count And/Or Micro-Organisms Identification By
Contact head, the 84 mm Maxi-Contact head and the Petri head. The probable count (Pr) is then used to calculate the Colony Forming Unit (CFU) per cubic metre of air sampled. “ SAS Super IAQ” Rev. 1 Pg. 19... - Page 24 IMPACTOR USING 55 mm CONTACT PLATES AND 90 mm PETRI PLATES Colo Colo Colo Colo Colo Colo nies nies nies nies nies nies 1088 1307 r = colony forming units counted Pr = probable count “ SAS Super IAQ” Rev. 1 Pg. 20...
- Page 25 CORRECTION TABLE TO ADJUST COLONY COUNTS FROM A 401-HOLE IMPACTOR USING STANDARD 90 mm PETRI PLATES Colon Coloni Coloni Coloni Coloni Colo nies “ SAS Super IAQ” Rev. 1 Pg. 21...
- Page 26 = Colony Forming Units per 1000 litres (= 1 cubic metre) of air 80 x 1000 x = ------------------------- = 400 CFU per 1000 litres of air (1000 litres=1m To express the final result in CFU/ft multiply the CFU/m value by 0,02832 “ SAS Super IAQ” Rev. 1 Pg. 22...
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Page 27: Section Three
Housing: polyurethane resin Sampling Efficiency: The effective sampling efficiency of the SAS SUPER IAQ, in a controlled environment, with aerosol of known particle size is 100% over 4 microns in size. Considering the normal range of environmental micro-organisms is between 4 and 20 microns, the SAS SUPER IAQ is suitable for all normal air monitoring testing (V.LACH –... - Page 28 SAS Super IAQ Upper Panel 10. 11. 12. Feet for sampling in upright position 13. ON/OFF switch (black button) 14. Printer connection (not used in SAS SUPER IAQ) 15. Battery charger connection 16. Flashing LED during air sampling 17. Instrument Serial Number 18.
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Page 29: Messages Shown On Display
SAS Super IAQ Bottom Panel 29. Protecting screw cap for tripod connection 30. Instrument Brief Instructions 31. Battery pack and PC Board 32. 33. 34. 35 Instrument feet 7.1 Messages shown on display The following messages can be displayed: INTERNATIONAL PBI Name of producer S.N. -
Page 30: Sampling Time Requested For Different Air Volumes
NOTES The correct metal hydrate battery charger must be used to charge the SAS SUPER IAQ ! If the air sampler has not been used for several weeks, check the battery status! The efficiency of the battery is reduced when operating at temperatures below 0°C. -
Page 31: Automatic Switch Off
The instrument will automatically switch off after 4 minutes to save the battery. The ON/OFF switch (black button) must be pushed twice to switch on the unit to start a cycle if the automatic switch off has operated. “ SAS Super IAQ” Rev. 1 Pg. 27... -
Page 32: Section Four
Calibration Certificate that is traceable to know standard such as the NIST 8.3 Performance routine monitoring The SAS SUPER IAQ should be checked monthly / bimonthly (depending how often they are used) using the “Pitot Kit” or “Propeller” units to monitor that they are working correctly and their performances has not been affected by bad handling or damage. -
Page 33: Trouble Shooting
Take out the old battery, replace it with a new one, and connect the new battery. Reassemble the control block to the instrument body in the reverse order. Be sure the rubber sealing ring (Position 4) is correctly positioned. “ SAS Super IAQ” Rev. 1 Pg. 29... -
Page 34: Accessory And Spare Part List
With “Sabouraud Dextrose Agar” for fungi (yeasts and moulds) count and neutrilizing agent for total viable count 7427 Gram 60 With “Violet Red Bile Agar” for gram negative count 20 Cat.n. 19810 Surfair Plate - Empty Contact Plates “ SAS Super IAQ” Rev. 1 Pg. 30... -
Page 35: Section Five
SECTION FIVE 9. BRIEF INSTRUCTIONS FOR SAS SUPER IAQ TO START WITH THE SAME AIR VOLUME AS THE PREVIOUS SAMPLE ACTION DISPLAY Switch on the ON/OFF switch (black button) T A R T (Last aspirated volume of air) Push “START”... - Page 36 7427 Gram 60 With “Violet Red Bile Agar” for gram negative count Empty “Contact Plates” ∅ 55 mm 7066 Empty Maxi Contact Plates ∅ 84 mm 4474 “ SAS Super IAQ” Rev. 1 Pg. 32...
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Page 37: Section Six
XXXX Company / Institute XXXX Laboratory XXXX Name of Instrument Microbiological Air Sampler Model SAS SUPER IAQ Serial Number XXXX Name of Producer International PBI Name of Distributor XXXX Condition at the moment of arrival (X) new; (x) used; (x) reconditioned... - Page 38 (specify) NOTE OF MALFUNCTIONING ELECTRONICAL PART MECHANICAL PART NOTES: ATTENTION: THE INSTRUMENT MUST BE SENT TO INT.PBI C/O STATIM VIA SAN GIUSTO 85 20153 MILANO ITALY SIGNATURE NAME DATE Mod. PQ09.9 “ SAS Super IAQ” Rev. 1...
- Page 39 “ SAS Super IAQ” Rev. 1 Pg. 35...
- Page 40 WARRANTY WARRANTY CONDITIONS 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: Faulty components free replacement The labour is always at customer's expense...
- Page 41 Via Novara, 89 - 20153 Milano HEREBY DECLARES under its sole responsibility that the following product “SAS Super IAQ” code: 90578 ♦ the following harmonized standards have been applied EN 61010-1/2001, EN 61326-1/2000 ♦ and conforms with the technical requirements of the...