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Summary of Contents for MBV Millipore MAS-100 NT
- Page 1 MAS-100 NT® Microbiological Air Sampler USER MANUAL...
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Page 2: Manufacturer
THANK YOU VERY MUCH! Dear customer congratulations and thank you very much for choosing a product from MBV AG. We are pleased to make a contribution to your success. MBV AG develops and produces precision mi- crobial air samplers for more than 20 years. Our... -
Page 3: Document History
MAS-100 Regulus introduced – Filter and filter kit introduced – Improved chapter structure for better understanding – Adapted to new CI/CD of MBV AG and Merck – Consolidated and/or removed redundant information (e.g. Feller correction tables…etc) – Improved overall picture quality –... - Page 4 Chapter 21: Updated CE-Certificate date 10.0 19.04.2011 – Chapter 13.1: Alarm IDs with cause and solution – Address MBV AG corrected (Industriestrasse 9) – Chapter 20: New Warranty from «AGB» of MT – Chapter 17: GWF according to EN 45004 / IEC 17025 –...
- Page 5 – Some wording changes – Charging inserted 30.07.2008 – Tripod inserted – CE/EMV pages removed and replaced by CE-Conformity Certificate 29.07.2008 – New Menu item template data in main menu: deletion of protocol data or complete templates possible – 2 Version: EMV test-numbers corrected to EMV Report 7E033-2 –...
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Page 6: Trademarks
This document may not be reproduced, in whole or in part, in any form or by any means electronic or mechanical (including photocopying, recording, or any other process), without the written permission of MBV AG, Switzerland. Information contained in this document may be subject to change without notice. -
Page 7: Abbreviations
ABBREVIATIONS The microbiological air sampler MAS-100 NT is designated hereafter as «Instrument». PC Software MAS-100 NT/NT Ex Portable Air Sampler - C&C communication and cali- bration) is designated hereafter as «PC Software». A comprehensive list of all used abbreviations can be found in Annex C – Glossary. APPLICABILITY The information in this manual is valid for the following configurations: Component... -
Page 8: Table Of Contents
TABLE OF CONTENTS MANUFACTURER DISTRIBUTION PARTNER DOCUMENT HISTORY TRADEMARKS ABBREVIATIONS APPLICABILITY RELATED USER MANUALS GENERAL INFORMATION 1.1. Safety information 1.1.1. Severity levels 1.1.2. Specific safety information for the instrument 1.2. General Provisions 1.2.1. Personnel qualification 1.2.2. Intended product use 1.2.3. Operating conditions 1.2.4. - Page 9 3.3. Optional accessories GETTING STARTED 4.1. Adjusting a Petri dish 4.2. Adjusting a contact plate 4.3. Battery charging 4.4. Firmware update tool 4.5. PC Software installation 4.6. Using the tripod OPERATION 5.1. User interface 5.2. Startup the instrument 5.2.1. Startup 5.2.2.
- Page 10 6.11.3. Contrast 6.11.4. Device info 6.12. System info 6.13. Printer configuration 6.13.1. Functionalities 6.13.2. Set printer settings 6.13.3. Other printers 6.13.4. Online printing activation via HMI 6.13.5. Online printing activation via PC Software ALARMS AND WARNINGS 7.1. Alarms 7.2. Warnings CARE AND MAINTENANCE 8.1.
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Page 11: General Information
ANNEX C – GLOSSARY GENERAL INFORMATION This chapter provides information of general interest regarding the instrument. 1.1. SAFETY INFORMATION IT IS IMPORTANT TO READ THESE INSTRUCTIONS BEFORE USING THIS INSTRUMENT. Please read the safety data sheet and the instrument-specific safety infor- mation in this manual carefully before using the instrument and/or any acces- sory supplied with this product. - Page 12 Hazard of damage to the instrument Read the instructions in this user manual carefully before any usage of the in- strument and pay attention to all warnings. Keep this manual in a designated place, accessible for all users for future ref- erence.
- Page 13 MAS system accordingly. Update of PC Software 1.6.31 SP1 PC Software V1.6.31 contains type errors in the French and Spanish language translations. Operators of V1.6.31 may find on the USB memory stick or on the MBV AG homepage patch MAS100_NT_AirSampler_ver_1.6.31_UpdateSP1.exe to cor- rect this.
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Page 14: General Provisions
(within the «Terms and Conditions of Sale» applicable to your purchase transaction). For products listed in this publication purchased directly from MBV AG the applicable war- ranty terms may be found at: https://www.mbv.ch/about-us/gtc. 1.3.2. QUALITY STATEMENT The instrument has been designed and manufactured to the highest quality levels as de- scribed in our ISO 9001 processes. -
Page 15: Exclusion Clauses
The instrument shall only be serviced or repaired by qualified, trained and authorized technicians. – The instrument shall only be serviced or repaired as described in the MBV AG service manual. – The instrument shall only be serviced or repaired using original MBV AG spare parts. -
Page 16: Product Labeling
1.4. PRODUCT LABELING The label on the bottom plate of the instrument identifies the instrument and its manufac- turer. The information on the label includes: – Manufacturer’s name – Instrument type – Battery capacity – DC supply data – Regulatory information A unique serial number is printed on the handle of the instrument. -
Page 17: Instrument Description
2. INSTRUMENT DESCRIPTION 2.1. APPLICATION Microorganisms in the air represent a potential contamination risk for raw materials, semi- finished or end products or pose a threat to human or animal health. Based on a risk assess- ment or stipulated by application-specific guidelines the air in cleanrooms, associated con- trolled environments or other critical areas must be analyzed for the presence of airborne microbial contamination. -
Page 18: Working Principle
2.2. WORKING PRINCIPLE The instrument is an active microbiological air sampler, using the impaction principle predefined volume of air is aspirated through the small orifices of the sampling head. The air is accelerated and microorganism-carrying particles impact on an appropriate microbio- logical culture medium in a Petri dish. -
Page 19: Main Features
Sampling start delay to prevent influence of operator-generated air turbulence – Calibration reminder and out-of-calibration interval locking option – Fully validated system (hardware, software, firmware, consumables) MAS-100, Qualification of air sampler systems: The MAS-100, Meier R. und Zingre H., (Swiss Pharma 1-2/00) https://www.mbv.ch/media/microbialairsamplerqualificationmas100_1.pdf Page 19 of 70... -
Page 20: Perforated Lid
2.3.1. PERFORATED LID The sampling head is designed to accommodate one standard 90mm Petri dish. The instrument is delivered with one perforated lid. Additional lids are available as accesso- ries. Lids can be exchanged between instruments. The instrument’s standard sampling head configuration includes a perforated lid with 300 holes of 0.6 mm in diameter. -
Page 21: Change Of The Hepa Filter
2.3.2. CHANGE OF THE HEPA FILTER Attention The HEPA filter may pose a biological or chemical hazard. Wear protective clothing and gear. Exchange it using the appropriate safety precaution. Safely dispose of the used HEPA filter. Loosen the four screws on the exhaust plate with the Slotted screwdriver size 3 and detach it from the head of the Instrument... -
Page 22: Sqs - Sequential Air Sampling
A more detailed explanation with actual sampling data can be found in: SQS-Sequential air sampling. Validation of the microbial count in the air using the MAS-100. et al. Ewald (Swiss Pharma 26 (2004) No. 11, 9-11 mbv.ch/media/sqssamplingwithmas100nt.pdf Page 22 of 70... -
Page 23: Communication
2.3.4. COMMUNICATION The instrument features a comprehensive connectivity: USB interface, RS-232 to other sys- tems (PC, printers, MBV AG digitals anemometers). All functions can be programmed via the HMI on the instrument or by means of the PC Software delivered with each instrument. -
Page 24: Hardware Description
3. HARDWARE DESCRIPTION Hazard of injury The sampling head can be tilted. Fingers can get trapped whilst lowering the sampling head. 3.1. PARTS DESIGNATION The figures blow show the main components of the instrument as well as the location of the connection sockets. -
Page 25: Scope Of Delivery
If ordered, please check the accessories too. Contact your local representative immediately if items are missing or show signs of defect. Article No. Description Picture Merck KGaA MBV AG Portable case MAS-100 NT 1194980001 06.9048.01 MAS-100 NT 1.09191.0001 06.6200.01... - Page 26 Documents - Calibration certificate 06.6051.02 - Feller correction table 99.0047.01 - MBV Information Sheet USB memory stick 03.3120.01 Allen key No. 3 06.6053.01 Perforated lid 300 × 0.6mm 1.09195.0001 06.6020.01 Dust cover 1.09084.0001 06.6022.01 USB cable 1.5 m 1.19453.0001 06.7901.01 Battery charger 12V/2.5A with 1.19133.0001...
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Page 27: Optional Accessories
3.3. OPTIONAL ACCESSORIES Article No. Description Picture Merck KGaA MBV AG Perforated lid 400 × 0.7mm 1.09088.0001 06.6021.01 Tripod for portable instruments 06.6054.03 of the MAS-100 product family Quick change adapter for tripod 1.09223.0001 06.6055.02 Digital anemometer MAS-100 1.19153.0001 01.2000.01 Regulus Perfor. lid alu 400 × 0.7mm for 1.09213.0001... -
Page 28: Getting Started
4. GETTING STARTED 4.1. ADJUSTING A PETRI DISH Before using the instrument for the first time, the Petri dish support may need to be ad- justed. To adjust the Petri dish support, proceed as follows: PROCEDURE 1) Lift off the perforated lid and place a Petri dish on the dish support. -
Page 29: Battery Charging
PROCEDURE 1) Aside of the 2D code, a power jack is available designed for use with MBV’s current DC plug battery charger. Multiport socket: 1) Align the red dot of the charging plug with the black dot of the handle. -
Page 30: Firmware Update Tool
Ex.. Update of PC Software 1.6.31 SP1 PC Software V1.6.31 contains type errors in the French and Spanish language translations. Operators of V1.6.31 may find on the USB memory stick or on the MBV AG homepage patch MAS100_NT_AirSampler_ver_1.6.31_UpdateSP1.exe to cor- rect this. -
Page 31: Operation
5. OPERATION Note Prior to operating the instrument, please study the general safety information (see chapter 1.1) and the user interface (see chapter 5.1). Note If the instrument is used for the first time or after a calibration, the «Calibra- tion reminder»... -
Page 32: Startup The Instrument
5.2. STARTUP THE INSTRUMENT 5.2.1. STARTUP PROCEDURE ❶ 1) Press the lower left button until the blue LED lights 2) The instrument starts up. ❶ 5.2.2. INTRO SCREENS After starting up the instrument, a sequence of screens will appear. FIRST SCREEN The first screen shows the instrument’s name. -
Page 33: Activation Of The Calibration Reminder
MBV AG suggests setting the calibration reminder to 12 months. Note Adjustment and calibration must only be performed by either qualified and authorized personnel or an authorized service center. For an optimal result, MBV AG suggests using the anemometer. Page 33 of 70... -
Page 34: Home Screen
MESSAGE «RECALIBRATION NEEDED» If the calibration reminder is activated and recalibration is due the instrument will display a warning before each run: Recalibration needed!. By default, the instrument can still be operated. Recalibra- tion should be performed as soon as possible. BLOCK SAMPLING UPON CALIBRATION EXPIRY If the calibration reminder is activated and the Block measurement if calibration validity ex-... -
Page 35: Start Sampling
5.5. START SAMPLING PROCEDURE 1) Press Start to initiate a sampling, or 2) Press Menu to check the process settings or access fur- ther functions. If the User selection is activated, a user may be chosen: 3) Toggle to the desired user with the buttons. -
Page 36: Operating And Sampling Modes
5.6. OPERATING AND SAMPLING MODES The diagram shows the different modes in which the air samples can be taken. Operating modes Manual Template Sampling Sampling modes modes OPERATING MODES Manual mode: The instrument runs one single sampling. Template mode: The instrument runs a predefined sequence of samplings ac- cording to a sampling plan which is defined in a template. -
Page 37: Shutdown The Instrument
5.7. SHUTDOWN THE INSTRUMENT PROCEDURE 1) Return to the Home screen. (if not already there). 2) Press Menu. 3) Toggle with the buttons to Shut down. / 4) Press Select. 5) Press for the question Shut down device? Note If no sampling is running and interactions via HMI have ceased, the instrument will shut down automatically after five minutes of inactivity. -
Page 38: Settings And Configuration
6. SETTINGS AND CONFIGURATION 6.1. PROTECTED MODE The instrument can be locked via the PC Software to block manual interventions on the in- strument. By doing so, starting and stopping a sampling will be the only accessible func- tions on the instrument. Note Please refer to the Software Manual MAS-100 NT/NT Ex... -
Page 39: Operating Mode Selection
6.3. OPERATING MODE SELECTION Note Templates can only be generated using the Software. Please refer to the Software Manual MAS-100 NT&NT Ex for further details. 6.3.1. MODE SELECTION PROCEDURE 5) Go to the Main menu. 6) Press Mode selection. 7) Choose Manual or Template. -
Page 40: Template Data
6) Press Start to perform a sampling on the instrument. After sampling, the values can be uploaded to the PC where the values are used to create an automatic report. 7) Press Back to return to the Home screen. 8) Press Delete…... -
Page 41: Process Settings (Sampling Mode)
To ensure that no important data is deleted by accident, the instrument asks for verification to clear the template data. 6) Accept with or press Back twice to return to the Main menu. To ensure that no important data is deleted by accident, the instrument asks for verification to clear the template itself. -
Page 42: Std Mode (Standard)
6.4.1. STD MODE (STANDARD) PROCEDURE 1) Press Change and select with the buttons. / 2) Press Save to confirm. 3) Select Volume with the buttons. / 4) Press Change and select one of the predefined stand- ard volumes (see chapter 6.5) with the buttons. -
Page 43: Preset Standard Volumes
6.5. PRESET STANDARD VOLUMES – The instrument has 5 slots for storing preset standard volumes. – These preset volumes serve as parameters of the STD and SQS sampling mode. – Each slot contains a value between 0 and 2'000 ℓ. – An unused slot can be omitted for easier handling. To do so, enter the value of 0 ℓ in the slot to be omitted. -
Page 44: User Selection
6.7. USER SELECTION – The instrument can handle up to 10 predefined users (ID1 to ID10) – The users are created in the PC Software – Renaming the users is only possible in the PC Software – User selection is disabled, the user selection will not appear after the start. –... - Page 45 The message Printer not connected! will be displayed, if a printer is not connected to the instrument Press to return to the previous screen. PRINTOUT EXAMPLE Page 45 of 70...
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Page 46: Sample Log
6.9. SAMPLE LOG – Up to 100 sample log entries are logged in the system. Each can be reviewed individ- ually. – After 100 entries the first one will be overwritten. Only the last 100 entries can be ac- cessed. – Log ID number will not reset to 1 after reaching 100 entries. -
Page 47: Alarm Log
6.10. ALARM LOG – Up to 100 alarm log entries are logged in the system. Each can be reviewed individu- ally. – After 100 entries the first one will be overwritten. Only the last 100 entries can be ac- cessed. – Log ID number will not reset to 1 after reaching 100 entries. -
Page 48: Config Device
6.11. CONFIG DEVICE PROCEDURE 1) Enter the menu item Config device. The menu contains the following sub-items: – Time/Date – Language – Contrast – Device info 2) Choose the desired sub item with the buttons. / 3) Press Select. 6.11.1. TIME/DATE Appearance of the date formats: –... -
Page 49: Contrast
6.11.3. CONTRAST The contrast value of the display can be adjusted in a range from 0 to 14. PROCEDURE 1) Press Change and select the desired contrast value. 2) Press Save to confirm. 6.11.4. DEVICE INFO Device info menu displays the following parameters: ➊... -
Page 50: System Info
6.12. SYSTEM INFO PROCEDURE 1) Enter the menu item System info. System info screen shows Hardware version Software version Serial number Date of last calibration Time to next calibration If the calibration validity is set to zero, the Last cali- bration Next calibration date are not displayed. -
Page 51: Printer Configuration
6.13. PRINTER CONFIGURATION 6.13.1. FUNCTIONALITIES The instrument is capable of printing directly via RS-232 port. The system can output: Summary Automatically after each sampling Instrument settings Manually, see chapter 6.8 Sample logs Manually, see chapter 6.9 Alarm logs Manually, see chapter 6.10 PRINTOUT EXAMPLES WITH EPSON TM-U220 Page 51 of 70... -
Page 52: Set Printer Settings
6.13.2. SET PRINTER SETTINGS If the printers are bought from MBV AG directly, the printers are preconfigured. To check or set the printer’s configuration, follow the steps below: PROCEDURE 1) Disconnect the power cord of the printer. 2) Remove the cover at the bottom of the printer to gain access to the DIP switches to adjust the printing parameters. -
Page 53: Other Printers
6.13.3. OTHER PRINTERS Although not supported by MBV AG, other printers might work. Adjust the communication settings to: – 9'600 Baud – 8 data bits – Parity even – 1 Stop bit – Handshake XON / XOFF If an emulator / interpreter setting can be selected, choose Epson. -
Page 54: Alarms And Warnings
7. ALARMS AND WARNINGS 7.1. ALARMS – The table below lists all alarms provided by the instrument. – All alarms are announced with an acoustic sound from the instrument and displayed on the screen. – Once an alarm occurs, the instrument is locked in an alarm state. –... -
Page 55: Warnings
– The selected volume is too – Increase the selected vol- low: ume or decrease the num- Volume is set too low! ber of fractions in the SQS 0 ℓ in STD mode or <40 ℓ per mode fraction in SQS mode. Sensor supply out of tol.! –... - Page 56 No calibration reminder active – Is displayed shortly after cali- – Calibrate device and set a bration validity is disabled (set calibration validity dura- to 0) . tion. Clear template data? – Is displayed if the function to – Confirm with or abort clear the template data is se- by pressing Back.
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Page 57: Care And Maintenance
8. CARE AND MAINTENANCE 8.1. GENERAL The instrument does only require moderate care and maintenance to remain in good work- ing condition. Please pay attention to the following aspects: – Follow the general safety information (chapter 1.1) – Always follow the cleaning and decontamination procedures (chapter 8.2) –... -
Page 58: Exterior
8.2.2. EXTERIOR The available cleaning /decontamination options are: Cleaning/disinfection solution Use a commercial product or a 70-90 % ethanol/water solution (or isopropanol/water). Spray the solution directly on the instruments exterior, then wipe with a sterile towel or spray the towel, then wipe. Vaporized hydrogen peroxide Use vaporized hydrogen peroxide with a concentration of up to 840 ppm. -
Page 59: Interior
8.2.3. INTERIOR PROCEDURE 1) Put the instrument in a laminar flow cabinet. 2) Use a cleaning/disinfection solution of 70-90 % ethanol/water (or isopropanol/water) in a spray bottle. 3) Run the instrument in the laminar flow cabinet for a minimum of 2 cycles at 1'000 L each. -
Page 60: Interpretation Of Results
9. INTERPRETATION OF RESULTS The sampling results are typically interpreted by counting the colony forming units (CFU) on the incubated Petri dish. The discrete number of holes in the sampling head leads to the effect that as the number of CFU’s per sample rises, the chance that several CFU’s will enter the same hole in the perforated lid will also increase. -
Page 61: Adjustment And/Or Calibration Of The Instrument
FACTORY CALIBRATION CERTIFICATES The instrument is factory calibrated by a digital anemometer. The airflow of the anemome- ter itself is calibrated by the MBV calibration laboratory, which has been accredited by the Swiss Accreditation Service SAS according to ISO 17025:2017. -
Page 62: Regulatory Information
11. REGULATORY INFORMATION 11.1. SUBSTANCES SUBJECT TO CHINESE ROHS The instrument is compliant with the Chinese RoHS regulation SJ/T11363 2006. The table below lists the instruments’ hazardous substances and their concentration in milli- grams per instrument. 有害物质或元素 部件名称 Hazardous substances or elements Component 铅... -
Page 63: Technical Specifications
12. TECHNICAL SPECIFICATIONS General Flow rate Default: 100 SLPM ± 2.5 % Standard sampling volumes Out-of-specification limit selectable from 2.5 up to 25 % Freely definable sampling volumes 50, 100, 250, 500, 1'000 ℓ Sampling head Material Anodized aluminum Dimensions (D × H) Ø 109 × 32 mm Weight 190 g Lid geometry 300 × Ø 0.6 mm, or 400 × Ø 0.7 mm Sampling efficiency value 1.1 µm at 100 SLPM... - Page 64 Envoronmental conditions Altitude Up to 2'000 m above sea level Temperature Storage: -10 to +50 °C Operation: 5 to +40 °C Maximum relative humidity Max. 80 % RH for temperatures up to 31 °C, decreasing linearly to 50 % relative humid- ity at 40 °C; non-condensing EMC, ESD Equipment class A, industrial environment Miscellaneous Total aspiration volume...
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Page 65: Annex A - Physical Sampling Efficiency
ANNEX A – PHYSICAL SAMPLING EFFI- CIENCY ANNEX A.1 - D VALUE The physical sampling efficiency of an air sampler is influenced by the inlet or extraction ef- ficiency and by the separation efficiency. Inlet or extraction efficiency is a function of the inlet design of the sampler and its ability to collect particles from the air in a representative way and transport the particles to the im- paction nozzle or the filter. -
Page 66: Annex A.2 Iso 14698 Validation Statement
ANNEX A.2 ISO 14698 VALIDATION STATEMENT Note The instruments MAS-100 NT and MAS-100 NT Ex share an exactly identical mechanical layout in all components affecting the air flow path. Therefore, all data, results and conclusions shown hereafter – which were gathered with a MAS-100 NT –... - Page 67 BIOLOGICAL EFFICIENCY RESULTS The biological efficiency of a sampler is a measure of how effectively it can collect microor- ganisms on an agar plate in such a way the microorganism will subsequently form a colony. As suggested in the ISO 14698-1:2003, the common human derived environment contami- nant «Staphylococcus epidermidis»...
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Page 68: Annex B - Iso 14644-1 Cleanliness Statement
ANNEX B – ISO 14644-1 CLEANLINESS STATEMENT The instrument has been designed and validated for a very low particle generation rate and is compliant with the requirements of ISO 14644-1, Class 5. Operators committed to the highest degree of cleanliness are advised to prevent impurity traces inside the instrument (due to packaging, storage, transport…... - Page 69 ANNEX C – GLOSSARY Term Meaning Alternating Current ATEX European directive for equipment in explosive environments AUStralia European certification mark Code of Federal Regulations (USA) Colony Forming Units CI/CD Corporate Identitity/Corporate Design Direct Current Dual In-line Package (switch type) Eurasian conformity mark Electronic Commutated (electric motor) ElectroMagnetic Compatibility European standard...
- Page 70 Rich Site Summary Real Time Clock Service Information Letter (MBV AG) Chinese standard for electronic equipment SLPM Standard Liters Per Minute SoftWare Sequential sampling mode Standard sampling mode Serial Number Unified thread standard (standard, USA and Canada) User Requirements Specification...
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