AquaSense MB
AQUASense MB neu
Aqu@sense MB
AquaSense MB

AQU@Sense MB

 
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Product Id: P06170006

  • Fully Auto­mated In-​Process Control: Seam­lessly inte­grates into water purifi­ca­tion systems for auto­mated, real-​time moni­toring.
  • Trend Moni­toring: Early detec­tion of devi­a­tions or adverse trends in water purifi­ca­tion systems allows for proac­tive inter­ven­tion.
  • Rapid Phar­ma­ceu­tical Water Release: Enables PW or WFI systems to be released within 2-3 hours post-​sanitization.
  • Primary Vali­dated Instru­ment: Thor­oughly vali­dated according to Euro­pean Phar­ma­copeia, USP and PDA TR33
  • Proven Tech­nology: Utilizes Flow Cytom­etry with inte­grated dyeing, to reli­ably detect intact microor­gan­isms.

The Future of Micro­bial Moni­toring: AQU@Sense MB

Fully auto­mated In-​Process Control for enumer­a­tion of microor­gan­isms is avail­able today.

Gain compre­hen­sive insights into PW and WFI systems through regular measure­ments and trend moni­toring. Results are deliv­ered within 20 minutes, facil­i­tating rapid decision-​making and early trend detec­tion. Enhance product quality and process effi­ciency with an fully auto­mated instru­ment tool for micro­bi­o­log­ical moni­toring.

AQUASense MB neu 1280x640
AQUASense MB neu 1280x640

ICC instead of CFU: A new measure­ment

Intact Cell count is signif­i­cantly higher than Colony forming Units

Compar­ison of different methods to detect microor­gan­isms has shown that the number of indi­vidual cells is by far higher than the results of HPC. Scan RDI and fluo­res­cence microscopy have shown, that one colony on the plate typi­cally origins from many indi­vidual cells.

CFU, the «Gold Stan­dard» for micro­bial moni­toring has serious disad­van­tages.

 

  • Long time to result… minimum 3 to 5 days
  • Only considers growing organ­isms
  • Prone to human errors
  • Just an esti­ma­tion, not a real count for microor­gan­isms
  • VBNC organ­isms are invis­ible
  • Conglom­er­ates of cells will only generate only one colony
Plate R2A Agar

Cont­a­m­i­na­tion Control Strategy - A Guide for Phar­ma­ceu­tical Water Systems

Learn how to imple­ment a cont­a­m­i­na­tion control strategy for your water purifi­ca­tion system, compliant with EU GMP Annex 1.

Water is an essen­tial ingre­dient for the phar­ma­ceu­tical industry, but it also poses a signif­i­cant risk of micro­bial cont­a­m­i­na­tion. To ensure the quality and safety, a cont­a­m­i­na­tion control strategy (CCS) for the water purifi­ca­tion system should be imple­mented, as stated in the EU GMP Annex I. A CCS is a holistic approach that covers the design, oper­a­tion, main­te­nance, moni­toring and docu­men­ta­tion of your water system. It is based on a cont­a­m­i­na­tion risk manage­ment (CRM) that iden­ti­fies and miti­gates all poten­tial sources of cont­a­m­i­na­tion.

Product Details
Tech­nical Details
FAQ's
Down­loads

Seam­less Inte­gra­tion

Mechan­ical Inte­gra­tion:

Single Sampling Point
Multi Point with up to 4 Sampling points

The AQU@Sense MB can be combined with a valve system that can connect up to four sampling points to one AQU@Sense MB. The control of the measure­ment sequence is done by the control unit of the water system.

Measure­ment Modes:

  • Manual: The measure­ment can be started manu­ally with a minimum sampling interval of 30 minutes
  • Auto­matic: An auto­matic measure­ment interval between 30 minutes and 6 hours can be programmed in the AQU@Sense MB
  • Remote controlled: The measure­ment can be trig­gered via digital input signals with a minimum sampling interval of 30 minutes.

Data transfer:

  • 4 to 20 mA
  • Modbus
Product Details

Seam­less Inte­gra­tion

Mechan­ical Inte­gra­tion:

Single Sampling Point
Multi Point with up to 4 Sampling points

The AQU@Sense MB can be combined with a valve system that can connect up to four sampling points to one AQU@Sense MB. The control of the measure­ment sequence is done by the control unit of the water system.

Measure­ment Modes:

  • Manual: The measure­ment can be started manu­ally with a minimum sampling interval of 30 minutes
  • Auto­matic: An auto­matic measure­ment interval between 30 minutes and 6 hours can be programmed in the AQU@Sense MB
  • Remote controlled: The measure­ment can be trig­gered via digital input signals with a minimum sampling interval of 30 minutes.

Data transfer:

  • 4 to 20 mA
  • Modbus
Tech­nical Details

Tech­nical Details

Tech­nical Details
Product Id P06170006
Dimen­sions (W x D x H): 350x270x373mm
Weight: 14 kg
Degree of Protec­tion: IP65
Oper­ating Envi­ron­ment: Indoor, +5°C - +35°C, 10% - 90% RH
Measure­ment Prin­ciple: Flow Cytom­etry with DNA specific staining
Side Scatter and 2 Fluo­res­cence Signals
Sample Volume: 90 µl
Sampling: Online, offline single measure­ment or offline with sample manager for up to 30 samples
Analysis Time: 30 minutes (Time to result ~20 minutes)
Measuring interval:
min 30 minutes (manual, auto­matic or trig­gered with digital input)
Sani­ti­z­able:
Ozone up to 100 ppb / hot water up to 85 °C
Power Supply: 18 VDC, 1.4A, 20W
Commu­ni­ca­tion Output: 2x4 ... 20mA analog outputs (freely config­urable)
4 digital outputs
Modbus
TCP/IP
Commu­ni­ca­tion Input: 3 digital inputs (start-​​, stop-, abort measure­ment)
Data storage: Memory card 32GB
Data Export: USB 2.0, Ethernet
Elec­tronic Docu­men­ta­tion: 21 CFR Part 11 compliant elec­tronic docu­men­ta­tion
Audit Trail
Logbook
User manage­ment with 4 user levels
Compli­ance and Certi­fi­ca­tion: CE Certi­fi­ca­tion, Factory Vali­da­tion Certifi­cate

Stan­dard scope of delivery Item  Article No. P06170006
  AQU@Sense MB
Cartridge
Online Sampling Device
Manual Sampling Device
Power Supply / Cable

FAQ's

What are the differ­ences between Heterotrophic Plate Count (HPC) and AQU@Sense MB?

  Heterotrophic Plate Count AQU@Sense MB
Tech­nology Growth based, depen­dent on culture medium Fluo­res­cence analysis after DNA-​specific staining
Sampling Manual Auto­matic
Measuring unit Colony Forming Unit (CFU) Intact Cell Count (ICC)
Time to result 3-7 Days 20 Minutes (30 Minutes measure­ment interval)
LOD 1 Colony 1 ICC
Range 1-300 colonies per sample

1-1 000 000 ICC per sample

Iden­ti­fi­ca­tion

Colonies
Limited morpho­log­ical deter­mi­na­tion

Indi­vidual Cells
Dot-​plot / finger­print of a popu­la­tion
Inter­pre­ta­tion of the results according to different events (trend moni­toring)
Enumer­a­tion Visual counting by humans Auto­matic
Sample size 100 or 200ml 90µl

How can the AQU@Sense MB differ­en­tiate intact and damaged/dead cells in one sample?

The AQU@Sense MB employs two specific staining agents: SYBR Green I and Propidium Iodide. SYBR Green I pene­trates intact cell membranes and selec­tively binds to the cell’s DNA. In contrast, Propidium Iodide cannot pene­trate intact membranes and binds exclu­sively to the DNA of compro­mised cells.

To deter­mine whether only SYBR Green I or both SYBR Green I and Propidium Iodide are bound to a cell, the cells are passed through a very thin capil­lary and illu­mi­nated with a laser, stray light and fluo­res­cence light from is gener­ated and analyzed with a specific detec­tion system. As SYBR Green I and Propidium Iodide emit fluo­res­cence at distinct wave­lengths, the system can differ­en­tiate between intact or damaged cells.

Which advan­tages has AQU@Sense MB compared to other RMMs?

  • Primary-​validated tech­nology by inde­pen­dent scien­tists, ensuring high cred­i­bility and reli­a­bility
  • Clear and unam­biguous results, with differ­en­ti­a­tion between intact and damaged cells/debris
  • Repro­ducible results
  • High autonomy with a user-​friendly plug-​and-play setup, mini­mizing manual inter­ven­tion
  • Robust/indus­trial design
  • No direct user contact with chem­i­cals or waste
  • Minimal main­te­nance require­ments
  • Advanced detec­tion capa­bil­i­ties, iden­ti­fying indi­vidual cells, even within conglom­er­ates or biofilm frag­ments, enabling compre­hen­sive trend moni­toring.

What is the corre­la­tion between the two measuring units CFU and ICC?

Intact Cell Counts (ICC) and Colony Forming Units (CFU) do not exhibit a direct corre­la­tion. Primarily due to the pres­ence of Viable but Non-​Culturable Cells (VBNC), which are not detected on HPC but easily detected in flow cytometer. Secondly, due to differ­ence in time and envi­ron­mental factors between two methods. Flow cytom­etry provides an instan­ta­neous snap­shot of cell pres­ence. There­fore, cells that may not thrive under HPC condi­tions might still be detected by flow cytom­etry.

Conse­quently, when the AQU@Sense MB is employed as a tool in Quality Control (QC), a perfor­mance qual­i­fi­ca­tion (PQ) is neces­sary at the customer's site to estab­lish para­me­ters, including base­line, warning, and action levels.

What are Viable But Non-​Culturable (VBNC) organ­isms? Are they of big impor­tance for patients’ safety?

For microor­gan­isms, entering the VBNC (viable but non-​culturable) stage is a survival strategy in response to stress condi­tions like unfa­vor­able envi­ron­ments, nutrient deple­tion, and temper­a­ture fluc­tu­a­tions, which are main features of PW/WFI water systems.
These VBNC bacteria remain alive and meta­bol­i­cally active but are unable to grow in stan­dard labo­ra­tory condi­tions. Recent studies have shown that the VBNC state is reversible, meaning these microor­gan­isms can return to a multi­plying state, posing a poten­tial bioburden, and in turn, health risk. Flow cytom­etry helps detect VBNC microor­gan­isms in phar­ma­ceu­tical water because it uses non-​growth-based methods.

Is it possible to iden­tify the strain with AQU@Sense MB?

No, the AQU@Sense MB does not iden­tify the strain. However, since flow cytom­etry is applied, a finger­print of the distri­b­u­tion of the cells is given which can give more infor­ma­tion about the state of the micro­bial popu­la­tion.

How to use AQU@Sense MB in daily moni­toring?

There are two possible fields of appli­ca­tion for daily routine analysis. In-​Process Control (IPC) and Quality Control (QC).
For IPC it can be can be inte­grated into the water system as an online control system for moni­toring bioburden. When oper­ating at its maximum capacity, the AQU@Sense MB can perform batch­wise contin­u­ously up to 48 measure­ments per day (minimum measure­ment interval: 30 minutes). The measure­ment interval is adjustable according to the needs and stan­dard oper­a­tion of water system. The bene­fits of frequent measure­ments are notice­able - for rapid detec­tion of even minor changes, in contrast to the conven­tional plate count method. This system can be utilized not only to contin­u­ously monitor bioburden levels in the plant but also e.g., to release the water system after sani­ta­tion or main­te­nance for tech­nical water release.

Is it possible to make QC releases with the AQU@Sense MB?

Yes, it is possible to perform a QC release using the AQU@Sense MB. However, to incor­po­rate it into current QC release process, customers must conduct a perfor­mance qual­i­fi­ca­tion (PQ) to confirm its suit­ability for the intended purpose. According to regu­la­tory guide­lines, the AQU@Sense MB or any other Rapid Micro­bi­o­log­ical Method (RMM) can be vali­dated as a QC release method. Since the AQU@Sense MB is already primary vali­dated the perfor­mance qual­i­fi­ca­tion proce­dure is much simpler.

An equiv­a­lence testing must be conducted using appro­priate para­me­ters, followed by statis­tical analysis, since it indi­cates a new measuring unit (Intact Cell Counts, ICC) instead of Colony Forming Units (CFU). The results of the testing must demon­strate that the results of the AQU@Sense MB allow for an unequiv­ocal deci­sion regarding compli­ance with the stan­dards outlined in the mono­graphs, even when compared to the conven­tional HPC.

Is AQU@Sense MB acknowl­edged by the author­i­ties (EMA, USP, FDA etc.)?

The AQU@Sense MB, along with other RMM devices (Status November 2023), is not specif­i­cally autho­rized by name by any regu­la­tory body. However, it can be vali­dated and qual­i­fied as a QC release method, since the EU GMP Annex I strongly recom­mend to incor­po­rate RMM’s.

At BWT, we are working on obtaining autho­riza­tion for the applied method (flow cytom­etry).

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AquaSense MB

AQU@Sense MB