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DOCUMENT HISTORY VERSION RELEASED HISTORY 2024-03-21 Page 2: Link to instrument website added Chapter 1.1.2: Hazard of damage to the instrument and/or wrong results updated Chapter 1.4.1: Type label updated Several links corrected Footer: Document name and version integrated Chapter 2.5: Transport Packaging updated & Article numbers added to parts 22.08.2022 Updated chapter 6.1 and 6.2...
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 pro- cess), without the written permission of MBV AG, Switzerland. Information contained in this document may be subject to change without notice.
ABBREVIATIONS The microbial compressed gas sampler MAS-100 Atmos ® is hereafter referred to as «instru- ment». A comprehensive list of all used abbreviations can be found in Annex D – Glossary. APPLICABILITY The information in this manual is valid for the following configurations: COMPONENT VERSION Application software MAS-100 Atmos...
TABLE OF CONTENTS Manufacturer Distribution partner (Worldwide except SWITZERLAND) 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. Operation 1.2.1. Personnel qualification 1.2.2. Intended product use 1.2.3.
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2.6. Accessories for MAS-100 Atmos 2.7. Parts designation 2.8. communication 2.8.1. USB type C port 2.8.2. Ethernet port 2.8.3. USB type A port 2.9. Local user interface 2.9.1. Power button 2.9.2. Touchscreen 2.9.3. Hardware key reader 2.10. Browser-based user interface 2.10.1.
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4.2. Setting up the optional user management 4.2.1. Initializing the MAS-100 user management 4.2.2. Creating new users 4.2.3. Blocking and unblocking a user 4.3. 21 CFR part 11 supporting instrument modes 4.3.1. Use case without LIMS/EM software 4.3.2. Use case with installed LIMS/EM software 4.4.
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7.4. Calibration service REGULATORY INFORMATION 8.1. ATEX 8.2. Substances subject to Chinese RoHS 8.3. Air transportation (IATA) TECHNICAL SPECIFICATIONS ANNEX A – BROWSER APP INSTALLATION Microsoft Edge Chromium Mozilla Firefox Google Chrome ANNEX B – FELLER CONVERSION TABLE ANNEX C – PHYSICAL SAMPLING EFFICIENCY The d50 value ANNEX D –...
Therefore, after such an incident, an instrument must be checked for correct functioning by trained person- nel or an MBV certified service centre. Any application other than the intended use is not covered by war- ranty.
Hazard of cross contamination The FDA considers the separation of penicillin production from other drug products for human use as a GMP requirement (21 CFR 211.46(d)), therefore MBV AG recommends taking any pre- caution for installing and handling the instrument accordingly. 1.2.
The manufacturer guarantees the instrument’s impeccable quality for a period of 24 months (starting from shipping date). The quality of original MBV AG spare parts is guaranteed by the manufacturer for a period of 3 months after the repair or service.
With the CE symbol the manufacturer declares conformity with the rel- evant directives of the European Union as stated on the «Declaration of Conformity» which can be found on the MBV AG website: Down- loads for compressed gas sampler MAS-100 Atmos (mbv.ch) Page 13 of 78 User Manual MAS-100 Atmos en, Version: 5.0...
With the EAC symbol the manufacturer declares conformity with the relevant directives of the Eurasian Trade Union as stated on the «Dec- laration of Conformity» which can be found on the MBV AG website: Downloads for compressed gas sampler MAS-100 Atmos (mbv.ch)
2. INSTRUMENT DESCRIPTION 2.1. APPLICATION/INTENDED USE The microbial compressed gas sampler is a highly accurate instrument used for tak- ing samples from compressed gases, such as air, Nitrogen (N ), carbon dioxide ), Argon (Ar) or a customer-defined gas (mixture) to assess the colony forming unit (CFU) count in a specific gas amount.
2.3.4. MASS-FLOW-BASED SAMPLING OF GAS VOLUME The instrument is equipped with a mass flow sensor in order to measure the amount of gas sampled, which is represented as a standardized volume. In this way, samples performed under different conditions (temperature, ambient pressure, altitude from sea level, etc.) are reproducible and comparable.
Unpack the instrument carefully and verify whether all items listed below are pre- sent. Contact your local representative immediately if items are missing or show signs of defect. DESCRIPTION ARTICLE NUMBER PICTURE MBV AG MERCK KGAA, DARMSTADT, GERMANY MAS-100 Atmos® sampler for 200162...
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1 x perforated lid MAS-100 130.4457 1173570001 Atmos 300x0.6 mm 1 x pressure connection tub- 130.4285 1173540001 ing 2m PTFE with tri-clamp connector 1 x tri-clamp Ø34mm 130.4461 1173670001 1 x silicone gasket 34/10 mm 130.4318 1173640001 1 x dust cover (polypropyl- 130.4328 1173400001 ene, white)
2.6. ACCESSORIES FOR MAS-100 ATMOS DESCRIPTION PICTURE ARTICLE NUMBER MBV AG MERCK KGAA, DARMSTADT, GERMANY Wheeled case for MAS-100 130.4468 1173340001 Atmos Perforated lid 300x0.6 mm 130.4457 1173570001 (anodized aluminum) with blue sieve and individual black marking (3 letter code for lid type) Perforated lid 300x0.47 mm...
Instrument protection filter: 130.2652 1172780001 HEPA H13 (ISO 35H) Ø74 mm Nutrient plate holder 130.4190 1173350001 (stainless steel) for 90mm nutrient plates 1 x dust cover (polypropylene, 130.4328 1173400001 white) Filter cover (anodized alumi- 130.4159 1173360001 num) 2.7. PARTS DESIGNATION The figure below shows the main components of the instrument and their designa- tion: 2.8.
NOTE: According to regulatory, the length for the USB cable must not exceed 1m and that of the ethernet cable must not exceed 30m. 2.8.1. USB TYPE C PORT – To charge the internal battery of the instrument, the cable is connected with the USB Type-C to the instrument and with the USB-A to the power supply –...
2.9.1. POWER BUTTON The power button is used to switch between on, standby and off and has an inte- grated LED indicator: ACTION INSTRUMENT LED INDICATION STATUS Tap power button once Starting up Blue flashing Switched on Blue Connect instrument to power supply via USB-C cable Instrument is charg- Blue flashing (display switched off)
– Battery charging state [n]x Estimated number of sampling cycles that can be run with the remain- ing battery capacity (calculated by a default value of 1000 NL com- pressed air at 2 bar.a) Battery full Half of battery capacity remaining Battery almost empty Battery charging (instrument connected to power supply and display switched on)
The user will be prompted to present the hardware key. For programming and reading out, the hardware key is presented to the hardware key reader on top right of the touchscreen. Depending on the configuration set, the user must enter a personal PIN. This PIN is set dur- ing the first login on the instrument, whereby the user is prompted to set a personal PIN and to confirm it a second time.
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Support links available to every user Click on the headset symbol to call up the MBV service and support website. Click on the FAQ symbol to access the section of frequently asked questions. Click on the user manual symbol to download this user manual...
– If the black ‘system administrator hardware key’ that is supplied with the instru- ment got lost. Download a backup file key from the MBV website and copy it to a hardware key (see chapter «Other Troubleshooting») Open the submenu ‘Copy Key File’...
List of available submenus Submenu – – Description View and filter audit trail Configuration of the View sampling ar- instrument chive – – Set up the optional 21 Export/clear audit CFR part 11 compliant trail instrument mode Reference chapter 4.4.1 4.4.4 4.4.2-4.4.3 Submenu...
USE CASE NO USER 21 CFR PART 11 COM- 21 CFR PART 11 COMPLI- MANAGEMENT PLIANT USER MANAGE- ANT USER MANAGE- MENT ON INSTRUMENT MENT BY LIMS/ EM SOFTWARE User management None User management on in- User management of strument LIMS or EM software Instrument login con- No operator login...
Rem. user from list of blocked users Approve setting changes Export/import instrument settings file Service Export service file LUI and BUI Export calibration certifi- cate Diagnostics Run diagnostics Update application soft- ware 2.12. SUPPORTING A 21 CFR PART 11 COMPLIANT WORKFLOW In addition to a 21 CFR part 11 compliant user management, additional instrument settings are required to support a gas sampling workflow that is compliant with 21 CFR part 11 and meets data integrity requirements.
3. OPERATION 3.1. GETTING STARTED 3.1.1. INSTRUMENT POSITIONING The instrument shall only be stored, transported and used in an upright position. Use both handles when holding the instrument. 3.1.2. BATTERY CHARGING Make sure that the battery is charged before starting a sampling. Connect the mains charger to the USB type C port of the instrument to charge the battery.
Tap the power button once. The power but- ton indicator LED now flashes in blue color. 2. The instrument starts up. 3. The instrument displays the remaining cali- bration validity, both in text and with a color code: Green: valid (within the 12 months) Yellow: <1 month Red: <...
3.2.2. APPLYING THE OPTIONAL GAS EXHAUST TUBING When sampling gases that can be potentially hazardous or toxic in high concentra- tions, it may be necessary to guide the sampled gas to a dedicated exhaust. For the safe removal of sampled gases from the room, a 5 meter long gas exhaust tubing (refer to chapter «Scope of delivery») can optionally be connected to the gas outlet of the instrument.
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3. Open the sampling head: Hold the long han- dle with your left hand and the short handle with your right hand and turn the head counter-clockwise until the long handle points to the “lock open” marking 4. Insert a new nutrient plate aseptically and remove its lid 5.
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13. To start a sampling, tap ‘START SAMPLING'. The sampling has started and the LED lights up in blue. 14. During the sampling cycle, the selected pa- rameters and the remaining sampling time are displayed inside the circle, a progress in- dicator is also displayed graphically around the circle in a clockwise direction.
23. The instrument has completed the sampling procedure and is now ready for the next sampling. At the end of the sampling day the nutrient plate is incubated under appropriate conditions for several days and finally the colonies (CFU) are counted. In case of ≥ 18 CFU per plate a statistical correction according to Feller must be performed.
3.5. SHUTDOWN Standby mode To put the instrument in standby mode (e.g. for a short break of operation), press the power button once. NOTE: A switch to the standby mode automatically logs off a user. Switching the instrument off To switch the instrument off completely, tap the power button twice. NOTE: During charging, the instrument cannot be switched off, it remains in standby mode.
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The default setting is English. Moreo- ver, German, French, Spanish, Italian and Russian can be selected. Defines the unit in which the pressure values are displayed and reported. The pressure values are represented in bar (100 kPa). The pressure values are represented in pounds per square inch (psi).
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interface and for reporting in the audit trail. Defines the tolerated time period of inactivity before the instrument switches to standby mode and logs off the user. 15 minutes is the default setting. Additionally, select between – 1, 5 or 30 minutes The instrument switches to standby mode after the specified time of inactivity.
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NOTE: The manufacturer recom- mends to calibrate the instrument in time and not to use it beyond the cali- bration validity. Defines if changes to the instrument settings made by a service engineer take a formal approval by the system administrator.
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used (see chapter «Setting up the optional user management»). NOTE: The user must take care to comply with local law. The instrument is not intended to take samples from oxidizing (O ), toxic, flammable or combustible gases or mixtures. This box defines the gas types that are available for selection on the local user interface.
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the instrument offers the option of halving the flow rate for sampling (50% mode). In this case the instru- ment needs the double time for sam- pling the selected gas amount, ac- cordingly. The system administrator can choose between 2 options: –...
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This information is also dis- played in the form of a scannable barcode. A matrix for the decom- position of the letter code can be found on our website: https://www.mbv.ch/me- dia/mbv_marking_of_perfo- rated_lids_black_marking.pdf – Sampling location The operator will be asked to scan...
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The selected data is both included in the displayed sampling barcode on the local user interface as well as in the sampling barcode that can be downloaded from the browser-based software (see chapter 4.4.4 «Viewing and exporting the sampling archive») (see pictures on the left).
NOTE: The certificates will not be up- dated when changing the custom in- strument label. The selected fields take effect only on the next calibra- tion certificates. This box allows to enter a company address which will be shown on the calibration certificates.
applies to advanced functions on the browser-based user interface. Users outside this user group have no access to the local user interface in case the optional opera- tor login has been configured according to chapter 4.1.2. Follow the following steps to set up a new user group on the instrument: On the browser-based user interface click on the submenu ‘DIAGNOSTICS’.
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Select the user role (User Administrator, system administrator or operator). 2. Select the instrument type (MAS-100 Atmos). 3. Enter the first name and last name in the corresponding boxes. Example for an operator: 4. Select the duration of the PIN validity according to your IT security guideline. Choose between 1 up to 12 months, or alternatively no limit if the validity shall not be restricted.
general and for the operator only if required by the instrument configuration (see chapter 2.11.1 «User management use cases» 4.1.2 «Changing instrument set- tings»). NOTE: After login, either on the local user interface of the instrument with a hard- ware key, or on the browser-based user interface with a key file, the page of the browser-based user interface reloads automatically to show the current login state.
4.3. 21 CFR PART 11 SUPPORTING INSTRUMENT MODES The instrument offers two optional instrument modes for and without LIMS or EM software, that can support a workflow that needs to be compliant with 21 CFR Part 11 and needs to meet data integrity requirements: 4.3.1.
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Audit trail display The audit trail display lists all messages in chronological order. The newest entry ap- pears on top. Each entry consists of the following information: HEADER INFORMATION Local date / time Date and time stamp, indicated in local time zone (currently selected) and in the format yyyy-mm-dd hh:mm defined according to ISO 8601 Category Each entry is divided into one of the ten different categories...
Settings approval If the corresponding setting is activated according to chapter 4.1.2 «Chang- ing instrument settings») this category lists all activities of formal approval of setting changes. User Shows all events pertaining to the user management. Action Shows messages that represent an action, such as «sampling started», etc. Technical Shows messages that are related to internal technical aspects of the instru- ment, such as «battery charging started».
The export file is a .zip archive with the file name «instrumentSerialNumber_Audit- Trail_yyyyMMdd-hhmmss.zip». This .zip file contains .xml files of the audit trail and the sampling and error/warning list. It also contains a signature and a public-key file which protect the complete archive from manipulations. This .zip archive is recom- mended for archiving at the customer’s site.
Make sure that you do not need the local data on the instrument anymore and that you have exported and saved the .zip file at a safe place for archiving before irrevo- cably clearing the data from the instrument. Tap on the activated ‘CLEAR AUDIT TRAIL’ button and confirm to clear all audit trail data from the instrument.
NOTE: Scale the page in the browser with ctrl+scroll or in the menu in the upper right corner if the displayed barcode is too big or too small. 4.5. DATA TRANSMISSION TO AN INSTALLED LIMS OR EM SOFTWARE The prerequisite for using this function is that a LIMS or EM software is installed and that a connected device is available which can read barcodes/QR codes.
The sampling barcode is available for later display and scanning by accessing the submenu ‘SAMPLING ARCHIVE’ on the browser-based user interface. The data of the sampling barcode can also be exported as .CSV or .XML file (can be configured according to chapter 4.1.2 «Changing instrument settings»).
If there are setting changes to be approved, it is neither possible to change instru- ment settings nor to perform a calibration and adjustment. The corresponding tiles are locked on the browser-based user interface. It is recommended to perform the approval as soon as possible: Therefore, open the submenu ‘SETTINGS APPROVAL’: 1.
4.8.1. VERIFYING THE SAMPLING TIMER This function is used to verify the correctness of the time base for the sampling timer. There are two optional methods to carry out the test: – With the automated timer verification procedure the instrument compares the internal system time with the computer system time.
It does not contain any user information or other sensitive information such as the au- dit trail. MBV advises the system administrator to attach a service file of the instru- ment when issuing a service request, for simplified error analysis.
Follow the instructions on the screen. After a firmware update has been carried out, it is necessary to reload the page manually with «Ctrl+F5» to see the updated data on the browser-based user interface. 4.8.5. RESETTING THE USER MANAGEMENT This function is used to initialize the 21 CFR part 11 compliant user management on the instrument or to apply the already initialized user management on a new instru- ment of the fleet.
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Example of a calibration certificate: It shows all tests that have been performed and the corresponding results. The cer- tificates can be printed our or saved as pdf by tapping the ‘PRINT’ button in the top left corner. NOTE: The print function of the browser may automatically add a header and a footer (showing the URL address, for example), which is not desirable.
5. CARE AND MAINTENANCE 5.1. GENERAL The instrument does require moderate care and maintenance to remain in good working condition. Please pay attention to the following aspects: – Follow the general safety information (see chapter 1.1) – Always follow the cleaning and decontamination procedures (see chapter 5.2) –...
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The perforated lid Remove the perforated lid from the instrument. The perforated lid (anodized alumi- num) can be disinfected or autoclaved with the following techniques: METHOD ACTIVE INGREDIENT CONCENTRATION CONDTIONS (V/V) – – – Dry or moist heat Moist heat (steam) Saturated 121°C for 20 mins or sterilization (auto-...
5.2.3. ACCESSORIES The available accessories can be cleaned and decontaminated as follows: ACCESSORY MATERIAL METHODS – Dust cover Polypropylene Steam sterilization (autoclaving) at 134°C for 5mins or 121°C for 20 mins NOTE: The dust cover will slightly shrink af- ter the first autoclaving cycle, resulting in some clearance.
6. ERRORS AND WARNINGS The instrument issues warning and error messages to alert the user of conditions that may have an impact on the sampling results. This information can also be help- ful for troubleshooting purposes. 6.1. WARNING LIST All warnings are displayed on the local user interface. All warning events indicated as [W-XXXX] are logged in the audit trail of the instrument (see chapter «Audit trail and sampling archive»).
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[E-74716] Failed to start process be- Restart MAS-100 Atmos and try cause instrument is not idle again. If the error persists please contact your local service contact. [E-74726] Failed to start decompres- Restart MAS-100 Atmos and try sion because instrument is again.
(black, deliv- ered with in- strument) – The PIN of the de- Go to the MBV website to download a backup ‘file key’ fault ‘system ad- for the system administrator: ministrator hard- https://www.mbv.ch/en/expert-center/downloads/mas- ware key’ was for- 100-atmos/ –...
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Operator or sys- The user administrator can overwrite the affected user key by tem administrator following the process of creating a new user (see chapter forgot personal 4.2.2). User administrator The second user administrator can overwrite the affected forgot the PIN user admin key by following the process of creating a new user (see chapter 4.2.2).
FACTORY CALIBRATION CERTIFICATES The instrument is calibrated by means of a dedicated reference instrument that is calibrated in the MBV calibration laboratory for airflow. The MBV calibration labora- tory has been accredited by the Swiss Accreditation Service SAS according to ISO 17025:2017.
NOTE: The membrane packaging received at the time of purchase might be reused if handled with care. However, it is recommended to use the robust wheeled case, available as accessory (MBV article number: 08.8105.01, Merck KGaA, Darmstadt, Germany article number: 1173340001), for repeated shipping.
9. TECHNICAL SPECIFICATIONS GENERAL Gas types Default: Compressed air, Nitrogen (N ), car- bon dioxide (CO ), Argon (Ar) Advanced: customized gas type (no oxidizing or combustible gases) if the gas factor is known Gas flow rates Default: 100 L/min Optional: 50 L/min Optional: Automatic fallback from 100 to 50 L/min (if needed)
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Perforated sieve geometry 300 orifices, Ø0.6mm Ø109 x 90mm Dimensions perforated sieve Physical sampling efficiency Nominal d value of 1.1μm (e.g. according to (nominal d value) ISO 14698/ EN 17141) at 100 L/min using the 300x0.6mm perforated lid Nominal d value of 1.6μm at 50 L/min using the 300x0.6mm perforated lid value of 1.1 μm at 50 L/min using...
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Charging time Full recharge time approx. 7.5 hrs Sampling time Minimum sampling time approx. 2 hrs Maximum sampling time approx. 5 hrs Depending on the chosen settings and the valve opening. Environmental conditions Altitude Up to 3'000 m above sea level Temperature Storage: -10 to +50 °C Operation:...
ANNEX A – BROWSER APP INSTALLATION MICROSOFT EDGE CHROMIUM STEP IMAGE DESCRIPTION Go to the browser tab http://192.168.254.1/dashboard with the name MAS-100 Atmos. Click on the three dots (…) > Apps > ‘Install this site as an app’. Define the application name (for exam- ple “MAS-100 Atmos”) and tap ‘install’.
GOOGLE CHROME STEP IMAGE DESCRIPTION Go to the browser tab http://192.168.254.1/dashboard with the name MAS-100 Atmos. Click on the three dots (…) > Apps > ‘in- stall this site as an app’ Define the application name (for example “MAS-100 Atmos”) and tap ‘create’ Open chrome//:apps in a new tab.
ANNEX B – FELLER CONVERSION TABLE Positive hole conversion table according to Feller for perforated lids with holes r = Number of colony forming units counted on nutrient plate Pr = Probable statistical total 1006 1036 1069 1107 1150 1200 1260 1335 1435...
ANNEX C – PHYSICAL SAMPLING EFFICIENCY THE D50 VALUE The physical sampling efficiency of an air sampler is influenced by inlet or extraction effi- ciency and by 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.
Normal Liters per minute Personal Identification Number QR (code) Quick Response code (2D barcode) RoHS Restriction of Hazardous Substances (directive) Service Information Letter (MBV AG) Chinese standard for electronic equipment Serial Number Page 76 of 78 User Manual MAS-100 Atmos en.docx, Version: 5.0...
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User Requirements Specification United States of America Universal Serial Bus WEEE Waste Electrical and Electronic Equipment (European directive) Page 77 of 78 User Manual MAS-100 Atmos en, Version: 5.0...
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