bioMerieux Air IDEAL 3P Traceability Solution User Manual
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bioMerieux Air IDEAL 3P Traceability Solution User Manual

Aerobiocollector
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®
TM
Air IDEAL
3P
Traceability
Solution
AeroBioCollector
User's Manual
LCB 71260 La Salle France
bioMérieux SA Chemin de l'Orme
Distributed by :
69280 Marcy-l'Étoile - France
RCS Lyon 673 620 399
Tel. 33 (0)4 78 87 20 00
Fax 33 (0)4 78 87 20 90
www.biomerieux.com

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  • Page 1 AeroBioCollector User's Manual LCB 71260 La Salle France bioMérieux SA Chemin de l'Orme Distributed by : 69280 Marcy-l'Étoile - France RCS Lyon 673 620 399 Tel. 33 (0)4 78 87 20 00 Fax 33 (0)4 78 87 20 90 www.biomerieux.com...
  • Page 3 R e v i s i o n s The list of revisions below summarizes replacements or additional pages in your User’s Manual Date of Version Modifications Pages modified printing 2001/01 Bilingual (FR / EN) 2001/04 Multilingual (FR / EN / ES / IT / DE / PT) 2005/11 Update of the manual (FR / EN / ES)
  • Page 5 To ensure user safety, the instrument must be used in accordance with this manual. T r a d e m a r k s BIOMERIEUX, the blue logo, 3P, Air IDEAL and Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.

  • Page 7: Table Of Contents

    T a b l e o f c o n t e n t s How to use this manual ........................1-1 Finding topics and procedures ............................1-1 Glossary ..................................1-2 Typographic conventions ..............................1-3 ® Air IDEAL 3P™ Traceability keypad ..........................1-3 Functional description .......................... 2-1 Presentation .................................2-1 Principle of use .................................2-1 Operating principle ..............................2-2...
  • Page 8 Table of contents ® Air IDEAL 3P™ Traceability menus ........................3-16 ® Turning on Air IDEAL 3P™ Traceability ........................ 3-17 Standby .................................. 3-18 ® Turning off Air IDEAL 3P™ Traceability ........................ 3-18 Selection of one of the 4 pre-programmed sample volumes (Menu 1) ..............3-18 Programming a sample volume not in memory (Menu 2) ..................
  • Page 9 L i s t o f f i g u r e s Note: Screenshots and figures are given as examples only. 2. Functional description Figure 2-1: Principle of the impaction biocollector ......................2-2 3. Using Air IDEAL®3P™ Traceability ® Figure 3-1: Air IDEAL 3P™...

  • Page 11: How To Use This Manual

    H o w t o u s e t h i s m a n u a l IMPORTANT! Please read the "General safety and regulatory information" booklet provided with the instrument. F i n d i n g t o p i c s a n d p r o c e d u r e s This manual is divided into 7 chapters.

  • Page 12: Glossary

    How to use this manual Glossary G l o s s a r y Acrylonitrile butadiene styrene. ® Air IDEAL 3P™ Traceability, instrument used to collect and count viable bacterial and AeroBioCollector or fungal particles in a known and precise volume of air. Air sampler Number of Colony Forming Units read on the agar plate.

  • Page 13: Typographic Conventions

    How to use this manual Typographic conventions T y p o g r a p h i c c o n v e n t i o n s These conventions are used in the different chapters of the manual. •...

  • Page 15: Functional Description

    F u n c t i o n a l d e s c r i p t i o n P r e s e n t a t i o n "Pharmaceutical manufacturing evolves from an art to a science". This sentence alone from the FDA Guideline “Pharmaceutical cGMPs for the 21 century –...

  • Page 16: Operating Principle

    Functional description Presentation O p e r a t i n g p r i n c i p l e ® Air IDEAL 3P™ Traceability is an impaction AeroBioCollector used to detect the presence of viable micro-organisms in the environment to be tested, by precise sampling of a given volume of air.

  • Page 17: Collection Efficiency Validated According To The Iso 14698 Standard

    Functional description Presentation C o l l e c t i o n e f f i c i e n c y v a l i d a t e d a c c o r d i n g t o t h e I S O 1 4 6 9 8 s t a n d a r d ®...

  • Page 19: Description

    ® U s i n g A i r I D E A L 3 P ™ Tr a c e a b i l i t y D e s c r i p t i o n ® Air IDEAL 3P™...

  • Page 20: Consumables

    Using Air IDEAL®3P™ Traceability Description C o n s u m a b l e s ® Air IDEAL 3P™ Traceability is adapted to all types of Petri dishes available on the market: 65, 70 and 90 mm. Moreover, the use of a large range of ready-to-use culture media – irradiated or classic – developed and manufactured by bioMérieux, the reference in this field, enables you to obtain the best possible performance from the instrument.

  • Page 21: 3 P ™ T R A C E A B I L I T Y

    Using Air IDEAL®3P™ Traceability Description ® F r o n t f a c e o f t h e A i r I D E AL 3 P ™ T r a c e a b i l i t y Figure 3-3: Front face ®...

  • Page 22: Keypad

    Using Air IDEAL®3P™ Traceability Sampling grid K e yp a d Figure 3-5: Keypad S a m p l i n g g r i d C o n f i g u r a t i o n f o r 6 5 , 7 0 o r 9 0 m m P e t r i d i s h e s Sampling grid for 65 or 70 mm Petri dishes Sampling grid for 90 mm Petri dishes ®...

  • Page 23: Tripod Assembly

    Using Air IDEAL®3P™ Traceability Sampling grid Stainless steel strip for attachment Aspiration orifice Seal Figure 3-7: Sampling head– 65, 70 or 90 mm Petri dishes T r i p o d a s s e m b l y Figure 3-8: Tripod assembly ®...

  • Page 24: General Specifications

    Using Air IDEAL®3P™ Traceability General specifications G e n e r a l s p e c i f i c a t i o n s E n vi r o n m e n t a l c o n d i t i o n s Normal storage conditions ................

  • Page 25: Technical Characteristics

    Using Air IDEAL®3P™ Traceability General specifications T e c h n i c a l c h a r a c t e r i s t i c s K e yp a d Key control. D i s p l a y Liquid crystal display (2 x 16 characters).

  • Page 26: Electrical Characteristics

    Using Air IDEAL®3P™ Traceability General specifications E l e c t r i c a l c h a r a c t e r i s t i c s Voltage......................7.4 VDC nominal Power supply ......................1 A max. ®...

  • Page 27: Unpacking Air Ideal®3P™ Traceability

    Using Air IDEAL®3P™ Traceability Unpacking Air IDEAL®3P™ Traceability ® U n p a c k i n g A i r I D E A L 3 P ™ T r a c e a b i l i t y The instrument is supplied in a carrying case and box.
  • Page 28 Using Air IDEAL®3P™ Traceability Recommendations for installation and use WARNING! The user’s manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

  • Page 29: Sampling Positions

    Using Air IDEAL®3P™ Traceability Sampling positions S a m p l i n g p o s i t i o n s     Figure 3-9: Sampling positions ® IMPORTANT! Air IDEAL 3P™ Traceability is delivered with a hook for suspending it in a glove box during decontamination phases.

  • Page 30: Screwing On The Sampling Grid

    Using Air IDEAL®3P™ Traceability Screwing on the sampling grid S c r e w i n g o n t h e s a m p l i n g g r i d CAUTION! Do not insert any foreign objects into the aspiration orifice located under the grid (see page 3-5).

  • Page 31: Low Battery Signals

    Using Air IDEAL®3P™ Traceability Electrical power supply L o w b a t t e r y s i g n a l s ∗ When the battery life has expired, the following low battery signals are output: Visual signal on the welcome message display: Flashing symbol Visual signal on the sample in progress display: Flashing symbol...

  • Page 32: Operation Using Mains Power

    Using Air IDEAL®3P™ Traceability Electrical power supply ∗ At the end of the operation, Disconnect the charger from the power outlet. • Disconnect the charger from the the instrument jack connector. • Install the protection cap. • Check that the battery life displayed is again 4 hours. •...

  • Page 33: Operation In Slave Mode

    Using Air IDEAL®3P™ Traceability Operation in slave mode O p e r a t i o n i n s l a v e m o d e ® − In slave mode, the Air IDEAL 3P™ Traceability is used with a RUID. −...

  • Page 34: A I R I D E A L ® 3 P ™ T R A C E A B I L I T Y M E N U S

    Using Air IDEAL®3P™ Traceability Operation in manual mode ® A i r I D E A L 3 P ™ T r a c e a b i l i t y m e n u s Turning on.  WELCOME Last sample taken.
  • Page 35 Using Air IDEAL®3P™ Traceability Operation in manual mode ® T u r n i n g o n A i r I D E AL 3 P ™ T r a c e a b i l i t y ∗...
  • Page 36 Using Air IDEAL®3P™ Traceability Operation in manual mode S t a n d b y ∗ To put the instrument on standby, • <ON/OFF> Briefly press , the indicator light must not go off. • Wait for 5 minutes. ∗ To reactivate the instrument, •...
  • Page 37 Using Air IDEAL®3P™ Traceability Operation in manual mode Example: ∗ To select stored volume No. 2 from menu 1, • < + > Press twice. Wait 2 seconds. • Note: If you did not wait for the end of the first timeout, in other words if you pressed another button before the 2 seconds, the new value selected ( ) is not recorded.
  • Page 38 Using Air IDEAL®3P™ Traceability Operation in manual mode ∗ To program a new volume, < > or < > Press until the desired volume is displayed. • < > or < > program a new IMPORTANT! It is imperative to press the buttons immediately to volume.
  • Page 39 Using Air IDEAL®3P™ Traceability Operation in manual mode ∗ To program a new volume for program 1, < > or < > Press until the desired volume is displayed. • < > or < > IMPORTANT! It is imperative to press the buttons immediately to program a new volume.
  • Page 40 Using Air IDEAL®3P™ Traceability Operation in manual mode ∗ To program a new volume for program 4, < > or < > Press until the desired volume is displayed. • < > or < > IMPORTANT! It is imperative to press the buttons immediately to program a new volume.
  • Page 41 Using Air IDEAL®3P™ Traceability Operation in manual mode ∗ To program a delay value, < > or < > Press until the desired delay value is displayed. • < > or < > IMPORTANT! It is imperative to immediately press to program a new volume.
  • Page 42 Using Air IDEAL®3P™ Traceability Operation in manual mode ∗ Total sampling time must be less than 5 hours otherwise an error message will appear. ∗ To select menu 5, • <MENU> Press 5 times. The following message appears and the 1 line flashes: The unit volume is shown on the lower left and cannot be modified in this menu.
  • Page 43 Using Air IDEAL®3P™ Traceability Operation in manual mode B a t t e r y a u t o n o m y t e s t ( M e n u 6 ) This menu is used to verify that the battery is still compliant with specifications of new material (battery life ≥...

  • Page 44: Starting Sampling

    Using Air IDEAL®3P™ Traceability Starting sampling S t a r t i n g s a m p l i n g ® CAUTION! Before starting, check that Air IDEAL 3P™ Traceability is fitted with a sampling grid and not its protective cover otherwise it could undergo irreversible damage which is not covered by the bioMérieux warranty.
  • Page 45 Using Air IDEAL®3P™ Traceability Starting sampling − A buzzer indicates the end of sampling (6 short buzzes) and the display returns to the original message with automatic correction of the remaining battery life. The indicator light changes to constant green. The instrument is free to perform a new sampling cycle.

  • Page 46: Stopping The Motor

    Using Air IDEAL®3P™ Traceability Starting sampling S t o p p i n g t h e m o t o r • <START/STOP> Press <START/STOP> Note: It is always possible to stop a sampling operation in progress by pressing If the motor is stopped during the program, i.e.

  • Page 47: Setting Air Ideal®3P™ Traceability Parameters (Summary Diagram)

    Using Air IDEAL®3P™ Traceability Setting Air IDEAL®3P™ Traceability parameters (summary diagram) ® S e t t i n g A i r I D E A L 3 P ™ T r a c e a b i l i t y p a r a m e t e r s ( s u m m a r y d i a g r a m ) Menu 1: Selection of one of Menu 2: Selection of a...
  • Page 48 Using Air IDEAL®3P™ Traceability Setting Air IDEAL®3P™ Traceability parameters (summary diagram) Menu 4 : Programming Menu 5 : Programming Menu 6 : Battery autonomy delayed start-up. sequenced samplings. test. Press < > or < > until the Press < > or < >...

  • Page 49: Maintenance Menu

    Using Air IDEAL®3P™ Traceability Maintenance Menu M a i n t e n a n c e M e n u N a vi g a t i o n u s i n g < + > a n d < - > k e ys STORED VOL: ZZZL NEXT CALIBRATION FSE (Field Service...
  • Page 50 Using Air IDEAL®3P™ Traceability Maintenance Menu Welcome message Date of next calibration (Month/Day/Year) ID of operator who performed calibration Serial number of RUID used for calibration Flow Rate Measurement Bench serial number Date of last calibration ® Air IDEAL 3P™ Traceability firmware version ®...

  • Page 51: Procedure

    P r o c e d u r e P r i n c i p l e Implementation and following of a procedure to measure aerobiocontamination corresponds to a process based on prevention, which involves: Evaluating the current level and standard of hygiene and controls. •...

  • Page 52: Procedure

    Procedure How to obtain a good quality sample H o w t o o b t a i n a g o o d q u a l i t y s a m p l e P r e c a u t i o n s o f u s e Check the condition of the instrument and sampling grid.

  • Page 53: Sampling Plan

    Procedure Sampling plan S a m p l i n g p l a n The sampling plan must be drawn up very carefully and followed strictly. The aim is to guarantee that the values obtained are comparable. Any discrepancy between values should reveal a variation in aerobiocontamination.

  • Page 55: Maintenance

    M a i n t e n a n c e P r e v e n t i v e m a i n t e n a n c e CAUTION! No preventive maintenance needs to be performed by the user. If an anomaly occurs on your instrument, call bioMérieux or your local distributor.

  • Page 56: Decontamination Of External Parts

    Maintenance Routine servicing D e c o n t a m i n a t i o n o f e x t e r n a l p a r t s All the external parts of the instrument can be decontaminated with most of the usual disinfectants at the usual effective concentration (70% isopropanol, hydrogen peroxide, 70% ethanol, quaternary ammonium).

  • Page 57: Troubleshooting

    Tr o u b l e s h o o t i n g Indicator light Action Action Error message Possible cause status in MANUAL mode in SLAVE mode Press <MENU> to return to Press <MENU> to return to LAST SAMPLING Sampling is Flashing red interrupted in...
  • Page 58 Troubleshooting Routine servicing Indicator light Action Action Error message Possible cause status in MANUAL mode in SLAVE mode MOTOR JAMMED Sampling has been Inspect the black grid under Inspect the black grid under interrupted as the the Petri dish retaining claws. the Petri dish retaining claws.

  • Page 59: Appendix

    A p p e n d i x U s i n g t h e r e a d i n g t a b l e The following reading tables indicate the most probable number of micro-organisms collected per plate (MPN collected) with respect to the number of agglomerates of colonies counted on the agar (CFU read).

  • Page 60: Reading Tables

    Appendix Reading tables The probability pi decreases as i increases. It is therefore particularly relevant to apply the statistical correction using FELLER’s law when high CFU values are read, i.e. close to N, i.e. in the case of agar plates almost completely saturated with colonies.
  • Page 61 Appendix Reading tables corrected corrected corrected corrected count count count count 209,340144 288,153475 400,832773 600,854201 211,548478 291,131003 405,401739 610,669016 213,775369 294,142367 410,050862 620,861324 216,021131 297,188344 414,783004 631,461324 218,286089 300,269739 419,601186 642,502990 220,570571 303,387386 424,508594 654,024729 222,874919 306,542148 429,508594 666,070184 225,199481 309,734919 434,604748 678,689231...

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