MAS-100 NT Manual

MBV AG Tel. +41 44 928 30 80 MAS-100_NT_UM_01_e.doc Microbiology and Bioanalytic Fax +41 44 928 30 89 Laubisrütistrasse 24 Mail: [email protected] CH-8712 Stäfa www.mbv.ch

User Manual Hardware

MAS-100 NT™ Microbiological Air Sampler

MAS-100 NT™ Microbiological Air Sampler

MAS-100 NT™ Microbial Air Sampler: The Leading Microbiological Air Monitoring Systems

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Table of content

1 Warning notices 4 1.1 Important Safeguards 4 1.2 Operating the MAS-100 NT™ 4 1.3 Environmental Conditions 4 1.4 Warranty 4 1.5 Malfunction of Instrument 4 2 Introduction 5 2.1 General Description 5 2.2 Description of the MAS-100 NT™ 5 2.3 Sampling Head 6 2.4 Communication 6 2.5 Programming the MAS-100 NT™ 6 2.6 PC software MAS-100 NT™ Portable Air Sampler C&C 6 3 Basic Principle 7

4 Most Important Advantages of the MAS-100 NT™ 8 4.1 Comparison old MAS-100™ with new MAS-100 NT™ 9 5 First Time Use of MAS-100 NT™ 10 5.1 Adjusting Sampling Plates on the MAS-100 NT™ 10 5.2 Adjusting Petri dish 10 5.3 Adjusting Contact plates 10 5.4 First Time Connection to a PC 11 5.5 New: SQS- Sequential Air Sampling 11 6 General Functions 12 6.1 Overview 12 6.2 The Display 12 6.3 First Time Use of MAS-100 NT™ = Activation of Calibration Reminder 12 6.4 Switching ON and OFF the MAS-100 NT™ 13 6.5 Intro Screens 13 7 Operation 14 7.1 Switching on the MAS-100 NT™ 14 7.2 Starting the MAS-100 NT™ in STD or Standard Mode 14 7.3 Manual or Template Mode (HACCP-Plan) 14 7.4 Working with Templates 15 7.5 Example of Protocol Created by the Software 15 7.6 Process Settings 16 7.7 Standard or SQS Sampling Mode 16 7.8 Change the Sampling Volume 16 7.9 Working with the SQS or Sequential Sampling Mode 16 8 Menu Settings 17 8.1 Shut Down 17 8.2 Mode Selection 17 8.3 Process Settings: 17 8.4 Standard Volumes 18 8.5 Delay Data 18 8.6 User Selection 18 8.7 Print Settings 18 8.8 Sample Log 18


8.9 Alarm Log 19 8.10 Config Device 19 8.11 Time and Date 19 8.12 Language 19 8.13 Contrast 20 8.14 Device Info 20 8.15 System Info 20 9 Manual Adjustment of Flow Sensor 21 9.1 Definition of Adjustment and Calibration 21 9.2 Adjustment of the Flow Sensor 21 10 Manual Calibration of MAS-100 NT with DA-100 NT 23

11 Automatic Adjustment and Calibration of MAS-100 NT™ with DA-100 NT 24 11.1 Automatic Adjustment and Calibration of MAS-100 NT™ with DA-100 NT 24 12 Create a Calibration Certificate with DA-100 NT 27 12.1 Example : Calibration Certificate 28 13 Manual Calibration of MAS-100 NT™ with PC-Software 29

14 Create Test Protocol 30

15 Flow Adjustment Data 31 15.1 Printout Adjustment Data 31 15.2 Calibration Reminder 32 16 Service Menu 33 16.1 Reset Memory 33 16.2 Printer Configuration 33 16.3 Sensors 33 16.4 Pneumatic Test 34 16.5 Statistic 34 17 Alarm ID and Description 35 17.1 Alarm ID’s 35 18 Block Manual Interventions on the MAS-100 NT™ 36

19 Interpreting the Results 36 19.1 Feller Conversion Table for Sampling Head with 300 Holes 37 19.2 Feller Conversion Table for Sampling Head with 400 Holes 38 20 Technical Specifications 39 20.1 Environmental Conditions 40 21 Components Checklist 41

22 Care and Maintenance 41

23 Warranty 41


1 Warning notices

1.1 Important Safeguards

1.2 Operating the MAS-100 NT™ Read all instruction carefully before operating the instrument. The MAS-100 NT™ must be operated by specialized laboratory people only. They have to be aware and trained to work with laboratory instruments.

1.3 Environmental Conditions Please read the instructions in chapter 20.1

1.4 Warranty Only special trained people certified by the manufacturer (MBV AG, Switzerland) are aloud to calibrate and service the instrument. Instruments which are opened by unauthorized people will loose immediately their warranty.

1.5 Malfunction of Instrument If the instrument doesn’t work according to this instruction manual send it immediately back to the manufacturer.


2 Introduction Micro-organisms in the air are a potential risk for contaminating raw materials, semi-finished or end products and processes. Therefore the control of the contamination in the air is very important. The following industries are performing air monitoring as a standard procedure: • pharmaceutical industry • food industry • hospitals • cosmetics industry • environment

2.1 General Description According to the “The Rules Governing Medicinal Products1” and the International Standard Iso 14698-1/22 the air must be analyzed for the presence of micro organisms. The new MAS-100 NT™ is a new designed unit for microbiological air monitoring. The microbiological sampling is based on the well known and as standard method established impaction principle3. It works like all other MAS-Systems with standard 90mm Petri dishes. The MAS-100 NT™ is a further development of the standard MAS-1004 system. The major advantages are the compact design, the improved security features and the enhanced connection possibilities. The new sampler is very easy to handle. Hard- and software have been developed according to GAMP4. The total system is fully validated. Improved communication like RS-232, USB, are available. All functions and parameters as well as the calibration procedure may be done with the new MAS-100 NT™ calibration and communication-software. They may also be programmed directly on the unit. A big display on the unit allows the selection of all relevant factors. An alarm- and sample-log records the last 100 events and may be exported or printed at any time. As in other MAS-Systems the mass flow is measured and guarantees a flow of 100 liters/min. The MAS-100 NT™ is validated according to the EN ISO 14698 standard. 2.2 Description of the MAS-100 NT™ The MAS-100 NT™ is an improved version of the MAS-100. Improved electronic communication features, validated software, easy and automatic calibration and added safety feature makes this air sampler unique. The impaction speed was also improved and the system is now delivered with a sampling head of 300 x 0.6mm holes. All parameters are controlled and changed from the software ore may be programmed directly on the unit.

Note: The MAS-100 NT™ air sampler has been developed according to GAMP 45. The Soft- and Firmware are validated.


2.3 Sampling Head The new (300 holes x 0.6mm) sampling head is specially designed for standard Petri dishes and improved impaction speed. The sampling heads are exchangeable. You can use either the 300 x 0.6 or if you wish to continue to use 400 x 0.7mm lid. Please make sure that you select the appropriate lid in the Menu Device Info ( 8.14)

New 300 x 0.6mm Sampling head (perforated lid) Anodized in blue Impaction speed <20m/s

Old 400 x 0.7mm Sampling head (perforated lid) Anodized silver Impaction speed <11m/s

2.4 Communication Up to date communication USB, RS-232, with other systems (PC, Printer; DA-100 NT). 2.5 Programming the MAS-100 NT™ All functions may be programmed over the display or over the MAS-100 NT™ Software delivered with each system. This Manual will describe mainly the programming over the display. For more software programming, please consult software manual. 2.6 PC software MAS-100 NT™ Portable Air Sampler C&C The “MAS-100 NT™ Portable Air Sampler C&C” is a new validated communication and calibration software. It is delivered with the system. The software permits to select between 5 different access levels to set, read and program individual parameters in the MAS-100 NT™ (operating under Windows 95 or higher) A special calibration menu with the possibility of fully automatic calibration (adjustment of flow sensor, calibration of MAS-100 NT and printing calibration certificate) is available. A new alarm- and sample-log file is implemented and stored 100 events of each type. The may be printed or exported into Excel.

Note: The previous sampling head (400 x 0.7mm) is still available on demand

Note: The MAS-100 NT™ is validated to ISO 14698-1 and -2, 2003/09


3 Basic Principle The MAS-100 NT™ is a high-performance instrument that is based on the principle of the Andersen air sampler (see 2.1), which aspirates air through a perforated plate. The resultant airflow is directed onto a standard agar poured plate. After the collection cycle, the Petri dish is incubated and the colony forming units (CFU) are counted. The MAS-100 NT™ operates with a high-performance suction device, and the aspirated volume is continuously monitored. The system measures the inflow of air and regulates the aspirated volume to a constant value of 100 Standard6 liters per minute. The MAS-100 NT™ automatically regulates this volume according to pressure and temperature an thus give all the time comparable results. For measurement in pharmaceutical industry the recommended sampling volume – according to international guidelines – should be 1000 liters.

air inlet Petri dish Anemometer Blower Air outlet


4 Most Important Advantages of the MAS-100 NT™ • new: illuminated easy navigation display • new: multi lingual, implemented languages, English, French and German (other languages on

demand) (Spanish in preparation) • new: automatic calibration cycle and automatic printing of calibration certificate • new: validated hard and software for (HACCP7 , up to 100 tests programmable) • new: validation documents according to ISO 14698 • new: data logging for sample and alarms • new: USB communication for error-free results and automatic record-keeping • new: long live Lithium-ions rechargeable batteries • new: improved design • calibration reminder • Adapter-Kit for RODAC-Plates (5.3) • SQS-Cycle (see point 5.5) may be selected. If this cycle is activated, the desired volume may be

split up to 50 sequences over a period of total 24 hours • anemometer for mass flow control • indication of low airflow • real time clock and calendar • compact and easy to use • easy and automatic adjustment and calibration • adjustable for different Petri dish sizes • battery operation • according to international Guidelines: Isokinetic measurement, 0.45 m/sec, 100 liters/minute • sampling volume adjustable from 1 – 2000 liters


4.1 Comparison old MAS-100™ with new MAS-100 NT™

MAS-100™ New: MAS-100 NT™ Benefit:

New design with better view and access for programming the menu screen. Illuminated graphic display.

400 x 0,7mm Sampling head 300 x 0,6mm Sampling head (400 x 0.7mm Sampling head on request)

Higher collection efficiency through increased impaction speed

32 characters LCD display Graphic illuminated display better reading of display yes - no navigation Menu guided navigation with

up and down arrow and direct menu selection buttons

Straight forward navigation to menu points

Menu in English Menu in English, German and French pre programmed. Other languages on demand.

Multi lingual, user friendly

RS-232 communication USB communication Advanced communication HACCP-Software Improved HACCP-Software

with Windows login and reporting (FDA 21CFR part 11)

Through windows login reporting traceability of user

No alarm logging Alarm logging up to 100 Traceability of malfunction and error sampling

No audible alarm Audible alarm Audible error reporting Restricted sample logging Up to 100 samples are

logged with date, time, user and volume

Traceability of samples

Manual calibration Fully automatic calibration cycle with automatic editing of calibration certificate with DA-100 NT and PC

Unique for air samplers! Security, independent of person, easy to use, saving calibration cost and time!

Previous validation papers New validation papers according to ISO 14698-1/2

Validation according to ISO-Standard

NiMH-recharchable batteries Lithium-ion researchable batteries

No memory effect, improved recharging time

Non intelligent charging Intelligent charging Longer battery life Cost saving


5 First Time Use of MAS-100 NT™ If the MAS-100 NT™ is used for the first time or after a calibration the “calibration reminder" has to be set. (see 6.3) 5.1 Adjusting Sampling Plates on the MAS-100 NT™ Before using the MAS-100 NT™ for the fist time you will need to adjust the Petri dish support. 5.2 Adjusting Petri dish Lift off the perforated lid and place a Petri dish on the dish support. Use a 3 mm Allen key to adjust the three blue jaws until the Petri dish is securely supported and there is no play. Check that the Petri dish is properly supported by turning the sampling head to the horizontal position. The Petri dish support is now adjusted. The procedure need only be repeated at most if you change Petri dish manufacturer.

5.3 Adjusting Contact plates New : The MAS-100 NT™may be used with commercially available contact plates. The use of a special Adapter No. 1.09214.0001 and Sampling head N0. 1.09213.0001 is necessary.

• Take the Allen key and exchange the 3

existing blue jaws by removing the Allen screw and replace with the 3 new blue jaws.

• Place the positioning template and mark the

centre (see picture) with a marker pen. • Remove the positioning template and put the

Adapter ring as shown in the picture bellow.

• Put now your contact plate in the adaptor and

tighten the 3 Allen screws. The marked point should be in the centre of the contact plate as shown in the picture.

Note: • Tighten the blue jaws and make sure that the

stainless steel adapter holds firmly .

Note: Do not over-tighten the blue jaws. If you do, the Petri dish may break and shed plastic debris in the aspiration unit and block the motor.


5.4 First Time Connection to a PC When connecting the MAS-100 NT™ the first time to a PC the USB driver has to be installed. The Driver is on the CD in the File “Driver FTDXX”. 5.5 New: SQS- Sequential Air Sampling8 A newly developed control system allows a measurement with the MAS-100 NT™ over a prolonged time with a single agar plate. Hereby, without any microbial loss, up to 50 air samples can be accumulated on the same Petri dish over a period of several hours. The main advantage of this method is that the risk of secondary contamination by the operators during the exchange of plates is reduced to a minimum. This is of very great importance for ambient air monitoring in sterile zones. In addition, by collecting sequential samples over a prolonged period of time the randomization is improved and thus a more reliable result obtained. Moreover, instead of several 90mm standard Petri dishes, only one dish has to be evaluated, thus reducing the expenditure on equipment and labor.

Volume Time 240

1000 216 192

700 168 144

500 120 96

300 72 48

100 24

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6 General Functions 6.1 Overview The MAS-100 NT™ has built-in multilingual dialog software. To navigate through the graphic display just follow the proposals indicated on the screen. There are four buttons, two underneath the screen for accepting the proposed action and the arrow flashes at the right side of the screen to navigate up and down the screen. 6.2 The Display

The MAS-100 NT™ has a illuminated graphic display. Follow the text on the screen by pushing the button or the arrow keys. The top line shows date, time and the status of the batteries. To start the instrument push the left down button (4) for about 1 second. The blue diode will light up.

6.3 First Time Use of MAS-100 NT™ = Activation of Calibration Reminder

The MAS-100 NT™ has a built in calibration reminder. If the MAS-100 NT™ is used the first time a screen comes up with the question of setting the time you want to be reminded that the instrument should be recalibrated. The manufacturer recommends to recalibrate the instrument at least once a year. Choose a value from 1 up to 12 month. 0 means, that the reminder is inactivated.

Accept by pushing OK. With Back the first screen is displayed again. After activation fill in the calibration certificate with the date on which the instrument was first used and the date for recalibration.

Note: You have to select a figure and push the “Accept” button in order to initialize the instrument. If you push not accept the MAS-100 will not work!

4 3

2

1


6.4 Switching ON and OFF the MAS-100 NT™ To switch on the MAS-100 NT™ push the left button (4) under the screen for about 1 second until the blue LED (run) illuminates. The program will start. To switch off push “Menu” select “Shut Down” and push “select” again and push the “ok” button for the question “Shut down device?” If no further manipulations are made on the Instrument and no run is started, the instrument will switch off automatically after 5 minutes. 6.5 Intro Screens After switching the MAS-100 NT on there are two screens appearing. Both of them may be canceled (see 8.14)

The first and second screen shows some information from the MAS-100 NT™.

Name: Each instrument may have a individual name. This may be programmed with the PC-Software. Dep.: Second possibility to specify the instrument for example “Department”. S/N: Serial number S. Head: The sampling head which has to be used for this instrument. Next Cal.: The time remaining until the next calibration is due. After about 5 second the screen moves to the start screen. By pushing the ok button it will move directly to the start screen.

Note: Both intro screen may be cancelled. (see 8.14)


7 Operation

7.1 Switching on the MAS-100 NT™ To switch on the MAS-100 NT™push the left button (4) under the screen for about 2 second until the blue LED (run) illuminates. The program will start. 7.2 Starting the MAS-100 NT™ in STD or Standard Mode Standard mode sample the selected Volume within one sampling process. (see SQS Sequential Sampling chapter 7.9 for splitting the selected volume into fractions)

Push “Start” to start sampling. Push menu to select menu If the Delay is deactivated (see 8.5) the Delay will not be displayed The screen will switch back to the first screen after 3 seconds If the User Selection is deactivated the User will not be displayed. (see deactivation of User in chapter 8.6)

7.3 Manual or Template Mode (HACCP-Plan)

Choose Mode selection and push Select. Choose Manual or Template Mode Template: Up to 10 templates (HACCP-Plan) may be programmed in the PC-Software and downloaded to the MAS-100 NT™ with USB cable. (see Manual for PC-software)

Note: Before operating the air sampler you will need to work through Section 6 “General functions”.

Note: If no templates are present on the MAS-100 NT™ the message: “There are no templates saved!” is displayed.


7.4 Working with Templates

With the software the user is able to create templates for the download to the MAS-100 NT™. Up to 10 templates or a total of 100 sampling places also called CCP, “critical control point” may be stored on the MAS-100 NT™.

The user can select a template for example “Template 1” and the Location and Device , all these names may be changed or renamed in the PC-software

Start the sampling on the MAS-100 NT™.After the test the values are uploaded to the PC and the values are used to create an automatic protocol. More about this read the Software Manual. 7.5 Example of Protocol Created by the Software


7.6 Process Settings

Push Menu and select Process Settings. Push Select to activate next screen.

7.7 Standard or SQS Sampling Mode

Select STD or SQS with arrow keys. Push Change and select STD for Standard sampling or SQS for Sequential sampling (see 5.5)

7.8 Change the Sampling Volume

Select Volume with up and down arrows. Push Change and select the desired volume with the up and down arrows. Push Save and twice Back to go to the Start screen.

7.9 Working with the SQS or Sequential Sampling Mode The SQS9 Sequential Sampling splits the selected volume into fractions over a selected time. The Standard mode samples the selected volume within one sampling process. (see chapter 5.5)

Select Menu and Process settings and then Change and select SQS (sequential sampling Mode) with the up or down arrows. Save to store new value. Push Change and select next parameter and change it to your requirements. Volume : 0 - 2000 l (selects the Standard Volumes, see 8.4) Fractions: 2 - 50 Duration: 23:59 h The screen shows now that the SQS Mode is selected with 10 fractions of a total of 1000l (100 l / fraction) and the sample is taken over the time of 4 hours beginning from start time. The sampling process may be stopped at any time pushing Abort.

Note: The minimum Volume for 1 Fraction is 20 liters

Back Change

Process SettingsMode: STDVolume: 1000l

Back Change

Process SettingsMode: SQS

1004:00h

Volume:Fractions:Duration:

1000l

Start Menu

01.01.2007

1000lMode:Volume:

SQS(10)

09:32

04:00hVolume:Duration:

Back Change



8 Menu Settings Push Menu on the start screen to access the 3 Main Menu screens.

All Menu position are explained below. 8.1 Shut Down

Choose the Shut Down menu. Push Select. Shut down device? is displayed. Confirm with OK. The device will shut down. OK

8.2 Mode Selection

Choose between Manual sampling or Template (HACCP-Plan) sampling. A Template may be created in the MAS-100 NT C&C software.

8.3 Process Settings:

Choose Standard (see chapter 7.2 ) or SQS Mode (see chapter 7.9) Move with the arrows , push Change to choose your values. Back Change


Back Change

Process SettingsMode: SQS

1004:00h

Volume:Fractions:Duration:

1000l


8.4 Standard Volumes

5 Volumes are pre set. All of them may be changed from 0 to 2000 l. If you choose 0 this volume will not be displayed any more. Choose the Volume with the arrow keys and push Change. Set the desired Volume with the arrow keys and push Save. Example: If you would only have one volume 1000l for selection, put the other volumes to 0.

8.5 Delay Data

If Delay is On (active) you may select a time between 1 and 120 min for a delayed start. If you don’t want to use this option leave it in the OFF position,

8.6 User Selection

It is possible to choose among 10 Users. With the PC-Software it is possible to rename the User. If it is in No position the user selection will not appear after the start. If it is in YES position after pressing the start button one has to choose a User before it is possible to start a sampling.

8.7 Print Settings

Chose Print settings and Select. If no printer is connected it will be displayed on screen. Push OK to quit.

8.8 Sample Log

Up to 100 samples are logged in the system. Each may be reviewed individually. After 100 logs the first one will be overwritten! You always get the last 100 logs If a printer is connected it is possible to make a printout of the sample log. Select the Nr of entries and then push Show. Scroll through the windows. Push Print for a hard copy.

Back Change

Standard VolumeVolume 1: 50l

250l500l

1000l

Volume 2:Volume 3:Volume 4:Volume 5:

100l

Back Change

Delay DataDelay: OffTime: 1 min

Back Show

Log SelectionNr of entries: 30Log ID:

Select Log ID toshow

30


8.9 Alarm Log

Up to 100 alarms are logged in the system. Each may be reviewed individually. After 100 logs the first one will be overwritten! You always get the last alarm 100 logs. (see chapter 17)

8.10 Config Device

In this menu the following parameters are selected and defined:

8.11 Time and Date

Select Time and adjust with the arrows Select Date and adjust with arrows Choose between EUR/JAP/USA date format Select between summer and wintertime by choosing ON/OFF

8.12 Language

3 languages are programmed. Choose between German, English and French (Spanish in preparation)

Back Show

Log SelectionNr of entries: 30Log ID:

Select Log ID toshow

30

Back Select

Config DeviceTime/DateLanguageContrastDevice Info

Back Change

Time/DateTime: 15:39

EUROn

Date:Format:Summer:

02.03.2007

English

Back Change

Language

Language:

02.03.07

02.03.0711:06

Back Next

Sample Log ID:31 2/3Start D. :Start T. :End D. :End T. :

11:06


8.13 Contrast

Contrast of the display may be regulated from 0 to 10

8.14 Device Info

Name: Name of device (can’t be changed) Location: may be renamed with the MAS-100 NT™ software. Dep.: may be renamed with the MAS-100 NT™ software. S. Head: Choose between 400 x 0,7 or 300 x 0,6 mm Sampling head Skip Intro:1 First Intro skipped 2 first and seconded Intro skipped, 0 both Intros will appear

8.15 System Info

Relevant information’s for the instrument. Push Back to quit.

Back Change

Contrast

0Contrast:


9 Manual Adjustment of Flow Sensor 9.1 Definition of Adjustment and Calibration Adjustment: Adjustment means to adjust a to a minimum deviation compared to a standard. Calibration: Is a comparison to a given value at defined conditions.

9.2 Adjustment of the Flow Sensor The instrument must be off. To get into the calibration Menu press and hold the 1 and 4 keys (see Display 6.2) simultaneously for about 3 seconds until the Fabtest menu is displayed. To adjust the MAS-100 NT™ Flow sensor you need a DA-10010 or a DA-100 NT11 Digital Anemometer.

Choose Adjustment Mode Choose Manual Adjustment and push Select.

Change the Cal. Flow with up or down arrows. Push Start Notice: To have always values above 100 L/min choose a value of 102.5 L/min. The accuracy of the MAS-100 NT™ is +/- 2.5%.

Push Start Change the Blower PWM value until you get a mean flow value which is +/- 0.5 l close to the indicated mean flow value. Push Next

Note: The values in L/min are always standard Liters. Liter at 1013.25 mbar and 20°C

Note: The manufacturer suggests to calibrate the instrument using the DA-100 NT together with the MAS-100 NT™ software.

Note: If you use a DA-100 please don’t forget to calculate standard Liters. See DA-100 Manual


Perform 3 measurements and take the mean value. Enter this value in the Adj. Flow: field with the up and down arrows. Push Next to continue

Sensor successfully adjusted will appear on the display if everything was correctly adjusted. Enter with the + or – key the validity of the adjustmentn (0 – 12 month) Push Exit to get out of this Menu

Note: If wrong values are introduced a probability calculation is verifying the values and does give a error if the entered values is wrong!

Abort Next

Flow SensorEnter mean flow

Cal.Flow: XX.Xduring calibration


10 Manual Calibration of MAS-100 NT with DA-100 NT The instrument must be off. To get into the calibration Menu press and hold the 1 and 4 keys (see Display 6.2) simultaneously for about 3 seconds until the Fabtest menu is displayed. To calibrate the MAS-100 NT™ Flow sensor you need a DA-10012 or a DA-100 NT13 Digital Anemometer.

Choose Adjustment Mode Choose Calibration and push Select.

Connect the DA-100 NT to Device (MAS-100 NT) Push Start, Starting up blower, please wait… is displayed. The DA-100 NT automatically starts to measure the volume and displays the values and the Deviation of the Calibration. Note the values.

Note: The manufacturer suggests to calibrate the instrument using the DA-100 NT together with the MAS-100 NT™ software.

Note: If you use an old DA-100 perform the Manual Adjustment and don’t forget to calculate the Volume into Standard liters. Run the MAS-100 in the manual Standard mode for 1000 litres. Read the values from the DA-100 and put them in the certificate. A certificate is on each product CD delivered with the system.


11 Automatic Adjustment and Calibration of MAS-100 NT™ with DA-100 NT 11.1 Automatic Adjustment and Calibration of MAS-100 NT™ with DA-100 NT

Automatic Procedure (SOP): 1. Visually check the lower edge of the perforated sampling head to make sure that there are no

notches or unevenness. This could lead to a leak between the lid and the sealing ring. If the sampling head is damaged replace it with a new one.

2. Stand the DA-100 NT on the perforated lid of the MAS-100 NT™ and connect the cable between the two instruments. Connect the MAS-100 NT™ with the USB-cable also to the PC.

3. Start the Software on the PC and start the MAS-100 NT™

4. Start the Software on the PC and put the MAS-100 NT™ on.

Choose Calibrator in the Access level menu. Type in “mascal” in the Password box and quit with OK

Note: Take care that no miss measurement occurs due to turbulences of the air. If possible protect the anemometer from any air currents which could directly affect it.

If checking the MAS-100 NT™ yields that the values deviate by more than ± 2.5 % of the calibration flow, the instrument has to be recalibrated. The MAS-100 NT™ is equipped with an anemometer regulating a constant mass flow.


5. Calibration Menu

6. Select Sampling head

Choose the sampling head you are working with. (see 2.3)

7. Set the validity of the Calibration

Chose between 1 – 12 month. If you select 0 the calibration reminder is deactivated. If you push the Set calibration Validity button, the reminder will be activated through the software.


8. Flow Adjustment

9. Select Calibration Flow (to avoid mass flow

lower then 100 Liter/min choose 102.5 Liters)

10. Select Calibration Span: Select 10.0 l/min in order to select a calibration span from 97.5 to 107.5 l/min. (If you have selected the calibration flow to 100.0 l/min the curve would be 95.0 to 105.0 l/min)

11. Select “Automatic + Calib. with certificate”, push Start and confirm the Calibration window with yes.

12. Push Next: The DA-100 NT will automatically be switched on and the calibration process works automatically through its steps.

13. If the calibration has passed an automatic

calibration certificate is printed and stored in the path according the settings in this window.

14. It is possible to block the measurement with the

MAS-100 NT™ if the calibration date is expired. Activate the box to enable measurement after expiration of calibration date.

15. If a calibration is not accepted by the system displays Calibration Error: invalid sensor gain. Make sure everything is correctly connected, the DA-100 NT is positioned on the MAS-100 NT™ sampling head and retry the Automatic calibration cycle. If again the calibration Error occurs control if the system allows to aspirate the total Calibration flow. (Calibration Flow + ½ of Calibration span) If the System doesn’t reach its total flow it has to be calibrated manually. (see chapter 9)


12 Create a Calibration Certificate with DA-100 NT

Start the “Flow Calibration Test. If the Deviation from the Air Flow is within the ± 2.5 % (green field with the mean value of 3 measurements) see picture below a new calibration certificate may be printed.

Note: If the Deviation from the Air Flow is bigger than ± 2.5 % (red field with the mean value of 3

measurements) see picture below, a new calibration has to be performed.

Print calibration certificate: Press the “Create Calibration Certificate” button. Enter the Certificate Nr: ……………and press ok. An automatic PDF-file is created. Print out the certificate and sign it. (See example next page)

Note: If you have an old DA-100 fill in the values in the calibration certificate delivered with the product CD.


12.1 Example : Calibration Certificate


13 Manual Calibration of MAS-100 NT™ with PC-Software Note: Take care that no miss measurement occurs due to turbulences of the air. If possible protect the

anemometer from any currents which could directly affect it.

If checking the MAS-100 NT™ shows that the standard litres deviate by more than ± 2.5 %, the of the calibration flow instrument has to be calibrated.

Manual Procedure (SOP): 1. Visually check the lower edge of the perforated sampling head to make sure that there are no

notches or unevenness. This could lead to a leak between the lid and the sealing ring. If the sampling head is damaged replace it with a new one.

2. Stand the DA-100 NT on the perforated lid of the MAS-100 NT™. Switch the DA-100 NT on with the blue knob.

3. Connect the PC with USB cable and start the MAS-100 NT™ software. 4. Select Access level, then Calibrator (default

password: mascal) and Manual Calibration. Select Calibration Flow (to avoid mass flow lower then 100 Liter/min choose 102.5 Liters)

5. Select Adjustment Span: Select 10.0 l/min in

order to select a calibration span from 97.5 to 107.5 l/min. (If you have selected the calibration flow to 100.0 l/min the span would be 95.0 to 105.0 l/min)

6. Select Manual Adjustment, push Start and

confirm the Calibration window with yes.

7. Adjust the Speed in % in order to reach the set calibration flow. Take 3 values, calculate the mean value and push next. Adjust the mean value in the Mean flow [l/min] window.

8. Push Next

9. If the calibration was successful the following window is displayed. Push the OK Button to accept the calibration and transfer the values to the MAS-100 Iso NT.

10. Make now 3 measurements with the DA-100 NT and fill in the results in your own certificate.


14 Create Test Protocol In the “Flow calibration Test” (Calibration Menu) it is possible to make a test protocol for the MAS-100 NT™. Connect the DA-100 NT and the PC to the MAS-100 NT™ and push the button Create Test Protocol. With this option it is possible to make a control measurement of the MAS-100 NT™ at any time without changing the calibration data and values. The title of the document will be “Test Protocol” instead of “Calibration Certificate” (see chapter 12)


15 Flow Adjustment Data In the following window , it is possible to get some technical information on the last and the actual adjustment of the flow sensor. Choose Actual or Last Adjustment and make a printout with the “Print Adjustment Data” button:

15.1 Printout Adjustment Data


15.2 Calibration Reminder The MAS-100 NT™ issues a calibration reminder. The calibration reminder can be set to a figure of between 0 and 12 months. If 0 months is selected, no calibration reminder is issued. If, for example, you select 6 months, a 6 month period is calculated from the date you exit this menu. Once the defined period is up, the following message is displayed: Calibration expired

Note: The reminder has to be set by the user, at the time of first use of the MAS-100 NT™. (see 6.3)


16 Service Menu The Service menu is a menu only for service people for checking some key values on site. It should not be used by untrained people. To get into the Service Menu of the MAS-100 NT™ push and hold the arrow keys 1 and 2 simultaneously for about 2 seconds while the unit is on. (see Display 6.2)

16.1 Reset Memory

Select Sample or Alarm log to clear the logged data. Select All to clear both the Sample and Alarm data. Push select and OK.

16.2 Printer Configuration

Select Printer Config. Select Onl. Printer: to ON/OFF. If it is ON and a printer is connected after each run a printout is printed. Printer: Select a pre configured printer. Samsung Bixolon SRP-275 or Epson TM-U220 Printer settings shows values. Push Back to main Menu

16.3 Sensors

Push Select on Sensors. The two screens are displayed for information on different sensors and values. For information only!


16.4 Pneumatic Test

In this position the blower may be switched on and off manually.

16.5 Statistic

In the statistics menu it is possible to see total working hours of Device (Instrument) and blower.


17 Alarm ID and Description In the list you will find all the alarms which could appear if the MAS-100 NT™ doesn’t work properly. The alarms will be announced with an acoustic sound from the MAS-100 NT™ and displayed on the screen. It will be logged in the alarm log file of the MAS-100 NT™ and also be displayed in the alarm log file of pc-software. (see chapter 8.9 ) Quit the alarm by pressing the quit button on the instrument. If a remote switch is connected the LED became red during alarm. Press the remote button once to quit the alarm. The LED turns to green. 17.1 Alarm ID’s

Alarm ID Description 91 Blower did not reach minimal rotation, blower does not start 92 Minimal flow for starting measurement not reached 93 Flow to high 94 Target flow not reached 95 Flow to low 97 Device temperature too high 98 Last measurement/sterilisation was interrupted by power down 99 Sampling duration to low 100 Calibration not valid 101 Calibration required 102 Target Volume to low 103 High Flow Sensor Power Supply out of tolerance 104 Measurement stopped 105 Battery discharged


18 Block Manual Interventions on the MAS-100 NT™

The MAS-100 NT™ may be locked from the PC-Software. (see Menu Process and device settings in the PC software). Only start and stop functions are active. All other functions are deactivated.

To change any of the parameters the advanced user has to deactivate the “Protected Mode” in the software.

19 Interpreting the Results First, the total microbial count is corrected based on Feller’s14 statistical correction table (see Section 19 “Appendix”), then it is converted to contaminant particles per cubic meter. The correction table is based on the principle that as the number of organisms per sampling rises, the chance that several organisms will enter the same hole in the perforated lid also increases. (A table of statistical corrections according to Feller for the MAS-100 in a plastified cover is provided separately with each sampler). Important: With the new MAS-100 NT™ a sampling lid of 300 x 0.6mm is delivered as standard. If you wish to have a sampling lid 400 x 0.7 please specify when ordering the system!


19.1 Feller Conversion Table for Sampling Head with 300 Holes Positive hole conversion table MAS-100 Impaction Lid 300 x 0.6 MBV AG, 8712 Stäfa r = Number of colony forming units counted on 90 mm Petri dish Pr = Probable statistical total

r Pr r Pr r Pr r Pr r Pr r Pr

1 1 51 56 101 123 151 209 201 332 251 541 2 2 52 57 102 124 152 211 202 335 252 547 3 3 53 58 103 126 153 213 203 338 253 553 4 4 54 59 104 127 154 216 204 341 254 560 5 5 55 61 105 129 155 218 205 344 255 566 6 6 56 62 106 131 156 220 206 347 256 573 7 7 57 63 107 132 157 222 207 350 257 580 8 8 58 64 108 134 158 224 208 353 258 587 9 9 59 66 109 135 159 226 209 357 259 594

10 10 60 67 110 137 160 228 210 360 260 601 11 11 61 68 111 138 161 230 211 363 261 609 12 12 62 69 112 140 162 232 212 367 262 616 13 13 63 71 113 142 163 235 213 370 263 624 14 14 64 72 114 143 164 237 214 374 264 632 15 15 65 73 115 145 165 239 215 377 265 641 16 16 66 74 116 146 166 241 216 381 266 649 17 17 67 76 117 148 167 243 217 384 267 658 18 19 68 77 118 150 168 246 218 388 268 667 19 20 69 78 119 151 169 248 219 391 269 677 20 21 70 80 120 153 170 250 220 395 270 686 21 22 71 81 121 155 171 253 221 399 271 696 22 23 72 82 122 156 172 255 222 403 272 707 23 24 73 83 123 158 173 257 223 407 273 717 24 25 74 85 124 160 174 260 224 410 274 728 25 26 75 86 125 161 175 262 225 414 275 740 26 27 76 87 126 163 176 264 226 418 276 752 27 28 77 89 127 165 177 267 227 422 277 765 28 29 78 90 128 167 178 269 228 427 278 778 29 30 79 92 129 168 179 272 229 431 279 791 30 32 80 93 130 170 180 274 230 435 280 805 31 33 81 94 131 172 181 277 231 439 281 820 32 34 82 96 132 174 182 279 232 444 282 836 33 35 83 97 133 175 183 282 233 448 283 853 34 36 84 98 134 177 184 284 234 452 284 871 35 37 85 100 135 179 185 287 235 457 285 889 36 38 86 101 136 181 186 289 236 462 286 909 37 39 87 103 137 183 187 292 237 466 287 931 38 41 88 104 138 184 188 295 238 471 288 954 39 42 89 105 139 186 189 297 239 476 289 979 40 43 90 107 140 188 190 300 240 481 290 1006 41 44 91 108 141 190 191 303 241 486 291 1036 42 45 92 110 142 192 192 306 242 491 292 1069 43 46 93 111 143 194 193 308 243 496 293 1107 44 47 94 113 144 196 194 311 244 501 294 1150 45 49 95 114 145 198 195 314 245 507 295 1200 46 50 96 115 146 200 196 317 246 512 296 1260 47 51 97 117 147 202 197 320 247 518 297 1335 48 52 98 118 148 203 198 323 248 523 298 1435 49 53 99 120 149 205 199 326 249 529 299 1585 50 55 100 121 150 207 200 329 250 535 300 1885

The values in the table are calculated from the basic formula (Feller, 1950 ) Pr = N [1/N + 1/N-1 + 1/N-2 + 1/N-r+1]


19.2 Feller Conversion Table for Sampling Head with 400 Holes Positive hole conversion table MAS-100 Impaction lid 400 x 0,7mm MBV AG, 8712 Stäfa r = Number of colony forming units counted on 90 mm Petri dish Pr = Probable statistical total

r Pr r Pr r Pr r Pr r Pr r Pr r Pr r Pr

1 1 51 54 101 116 151 189 201 279 251 394 301 557 351 836 2 2 52 56 102 118 152 191 202 281 252 397 302 561 352 844 3 3 53 57 103 119 153 193 203 283 253 400 303 565 353 853 4 4 54 58 104 120 154 194 204 285 254 402 304 569 354 861 5 5 55 59 105 122 155 196 205 287 255 405 305 573 355 870 6 6 56 60 106 123 156 197 206 289 256 408 306 578 356 879 7 7 57 61 107 124 157 199 207 291 257 411 307 582 357 888 8 8 58 63 108 126 158 201 208 293 258 413 308 586 358 897 9 9 59 64 109 127 159 202 209 295 259 416 309 591 359 907

10 10 60 65 110 128 160 204 210 297 260 419 310 595 360 917 11 11 61 66 111 130 161 206 211 299 261 422 311 599 361 927 12 12 62 67 112 131 162 207 212 301 262 425 312 604 362 937 13 13 63 68 113 133 163 209 213 304 263 428 313 608 363 947 14 14 64 70 114 134 164 211 214 306 264 431 314 613 364 958 15 15 65 71 115 135 165 212 215 308 265 433 315 618 365 969 16 16 66 72 116 137 166 214 216 310 266 436 316 622 366 981 17 17 67 73 117 138 167 216 217 312 267 439 317 627 367 992 18 18 68 74 118 140 168 218 218 314 268 442 318 632 368 1005 19 19 69 76 119 141 169 219 219 317 269 445 319 637 369 1017 20 20 70 77 120 142 170 221 220 319 270 449 320 642 370 1030 21 22 71 78 121 144 171 223 221 321 271 452 321 647 371 1043 22 23 72 79 122 145 172 224 222 323 272 455 322 652 372 1057 23 24 73 80 123 147 173 226 223 325 273 458 323 657 373 1071 24 25 74 82 124 148 174 228 224 328 274 461 324 662 374 1086 25 26 75 83 125 150 175 230 225 330 275 464 325 667 375 1102 26 27 76 84 126 151 176 232 226 332 276 467 326 673 376 1118 27 28 77 85 127 153 177 233 227 335 277 471 327 678 377 1134 28 29 78 87 128 154 178 235 228 337 278 474 328 684 378 1152 29 30 79 88 129 156 179 237 229 339 279 477 329 689 379 1170 30 31 80 89 130 157 180 239 230 342 280 480 330 695 380 1189 31 32 81 90 131 158 181 241 231 344 281 484 331 701 381 1209 32 33 82 92 132 160 182 242 232 346 282 487 332 706 382 1230 33 34 83 93 133 161 183 244 233 349 283 491 333 712 383 1252 34 35 84 94 134 163 184 246 234 351 284 494 334 718 384 1276 35 37 85 95 135 164 185 248 235 353 285 497 335 724 385 1301 36 38 86 97 136 166 186 250 236 356 286 501 336 730 386 1327 37 39 87 98 137 167 187 252 237 358 287 504 337 737 387 1356 38 40 88 99 138 169 188 254 238 361 288 508 338 743 388 1387 39 41 89 101 139 171 189 255 239 363 289 511 339 749 389 1420 40 42 90 102 140 172 190 257 240 366 290 515 340 756 390 1456 41 43 91 103 141 174 191 259 241 368 291 519 341 763 391 1496 42 44 92 104 142 175 192 261 242 371 292 522 342 769 392 1541 43 45 93 106 143 177 193 263 243 373 293 526 343 776 393 1591 44 47 94 107 144 178 194 265 244 376 294 530 344 783 394 1648 45 48 95 108 145 180 195 267 245 378 295 534 345 791 395 1715 46 49 96 110 146 181 196 269 246 381 296 537 346 798 396 1795 47 50 97 111 147 183 197 271 247 384 297 541 347 805 397 1895 48 51 98 112 148 185 198 273 248 386 298 545 348 813 398 2028 49 52 99 114 149 186 199 275 249 389 299 549 349 820 399 2228 50 53 100 115 150 188 200 277 250 391 300 553 350 828 400 2628

The values in the table are calculated from the basic formula (Feller, 1950 ) Pr = N [1/N + 1/N-1 + 1/N-2 + 1/N-r+1]


20 Technical Specifications General: Specification: Flow rate:100 Liters / Min 100 liters / min. ± 2.5%, Standard sampling volumes: 50, 100, 250, 500, 1000 liter Freely definable sampling volumes: 1 to 2000 liters ,volumes individually selectable

between 0 and 2000 liters. 0 volumes are not displayed

Sampling head : Diameter: Ø 10.9 cm Weight: 1.5 kg Material: Aluminium anodized Autoclavable: 20 minutes at 121°C MAS-100 Iso NT™ Height: 25.0 cm Length: 28.3 cm Weight: 2.3 kg Carrying case Plastic

Additional information: Tripod screw For use with normal camera tripod Battery pack Li-Ion Motor 6V Battery charger input: 110-240 Volt, 1.5A 50-60Hz Charger output 12 V DC /2.5 A Display: Alphanumeric graphic display Lifetime RTC Battery: Approx. 10 years Processor: Micro-Processor Gas regulation: Mass flow meter Guidelines: 73/23/EEC, 89/336/EEC, DIN EN 61326-1:1997,

DIN EN 61010-1:2001, GAMP 4.0:2001 CE approval : Emission: EN 61326-1:2006, EN

55011:1998+A1:99 Immunity EN 61326-1:2006, EN 61000-4-2:1995 EN 61000-4-3:1995:2002, EN 61000-4-4:1995 EN 61000-4-5:1995, EN 61000-4-6:1996 EN 61000-4-8:1993, EN 61000-4-11:2004


20.1 Environmental Conditions Altitude: Up to 2000 m or above if specified by

manufacturer Temperature: 0 to 40°C Maximum relative humidity: 80 percent for temperatures up to 31°C,

decreasing linearly to 50 percent relative humidity at 40°C;

Mains supply-voltage: Fluctuations must not exceed ± 10 percent of the nominal voltage; other supply voltage: fluctuations as stated by the manufacturer

Transient over-voltage: Acc. to INSTALLATION CATEGORIES (OVERVOLTAGE CATEGORIES) I,II, and III and normal category is II;POLLUTION DEGREE 1 or 2 in accordance with IEC 664


21 Components Checklist 1 x 06.6200.01 MAS-100 NT™ 1 x 06.9048.01 Carrying case 1 x 06.8001.01 Battery charger and plugs 1 x 06.7901.01 USB cable 1.5m 1 x 06.6052.01 CD with PC-Software and User-manual, USB Driver and

Excel certificate for old DA-100 1 x 06.6053.01 3mm Allen key Optional accessories: 1 x 06.6014.01 Cable: RS-232 to Lemo –socket for MAS-100 NT

22 Care and Maintenance The MAS-100 NT™ should be periodically calibrated (see chapter 9 - 11). The perforated lid and dust cover are autoclavable (15 min/121 °C). Make sure that the holes in the perforated lid are not clogged. Dirt may be removed from the exterior of the MAS-100 NT™ by wiping with a cloth moistened with a mixture of 60-80% alcohol/water or with one of the commonly used disinfectants. The outside of the instrument may also be cleaned with alcohol/water solution. Avoid spilling liquid into the electrical/electronically connections.

23 Warranty The MAS-100 NT™ has a 2 years warranty against failure due to malfunction of electrical and electronic components (see invoice date). The MAS-100 NT™ is a precision instrument for industrial and laboratory use and should only be operated by qualified personnel.


1 The Rules Governing Medicinal Products In The European Community Vol. IV: Guide to Good Manufacturing practice for medicinal products, 199207 2 ISO EN 14698-1 and 2 Clean rooms and associated controlled environments- Biocontamination control Part 1 and Part 2 (Ref. Number: Iso 14698 -1:2003(E)) 3 New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne Particles, A. Andersen, U.S. Army Chemical Corps Proving Groung, Dugway, Utha., 1958 4 MAS-100, Qualification of air sampler systems: The MAS-100, Meier R. und Zingre H., (Swiss Pharma 1-2/00) 5 Good Automated Manufacturing Practice GAMP 4 December 2001 6 Standard Liter = volume at 1013.25 mbar and 20°C 7 HACCP Hazard Analysis and Critical Control Points (http://www.cfsan.fda.gov/~lrd/haccp.html 2008/05/02) 8 SQS-Sequential air sampling; Validation of the microbial count in the air using the MAS-100; Swiss Parma 26 (2004) No.11,9-11 9 SQS- Sequential air sampling, Validation of the microbial count in the air using the MAS-100, Swiss Pharma 26 (2004) No. 11, 9-11 10 DA-100 Digital Anmometer indicating Volume 11 DA-100 NT New Digital Anemometer with Volume and Mass Flow as well as Temperature and Ambient Pressure indication. 12 DA-100 Digital Anmometer indicating Volume 13 DA-100 NT New Digital Anemometer with Volume and Mass Flow as well as Temperature and Ambient Pressure indication. 14 An introduction to probability theory and ist applications, Volume One (W. Feller) Page 174-175 (d) A sampling problem / Feller et al. 1950

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MAS-100 NT Manual

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