Microbial Detection

7000RMS Microbial Detection

Analyzer
Continuous, Real-time Analysis
Process Control & Transparency
High Measurement Sensitivity
Supports Regulatory Compliance

Real-time, On-line Microbial Monitoring

For Pharmaceutical Waters
 7000RMS
Microbial Detection Analyzer

Real-Time Microbial Analysis

METTLER TOLEDO Thornton’s 7000RMS™ is an on-line analyzer for real-time

measurement of microbial contamination (bioburden) in pharmaceutical water.
Laser-based technology enables immediate detection and quantification of
microorganisms directly from the water sample, overcoming limitations of
time-consuming growth-based methods.

Day 1 Day 3 Day 5

5 orcolonies
more 87microbes
An indirect estimate from plate counting Plate counting can only provide
Relies on the formation of a colony which a measurement like a snapshot
is dependent on incubation parameters and
culturability
5 -7 days after a sample is taken

A direct count using on-line monitoring

In the same 5 -7 day timeframe,
Advanced optical measurement technology
that counts individual microorganisms and the 7000RMS takes 216,000+
does not rely on growth measurements

Day 5
87microbes
87microbes
5 orcolonies
more
5 orcolonies
more
Day 5 Day 3 Day 1

Using traditional culture-based lab methods, measuring bioburden in Purified Water (PW)
and Water for Injection (WFI) is time-consuming and error-prone. Used in parallel with plate
counting, on-line microbial detection offers the potential to improve pharmaceutical water
system operations, reduce costs, and ensure water quality. With real-time, on-line measurement
an event can be detected immediately and remedied within hours.

2
Reduced risk of process upsets for Highly sensitivite technology to
maximized production efficiency control product quality

• Eliminate 5 - 7 day waiting period for plate • Count microorganisms as small as 0.3 µm
count results in size
• Release product / water without delay • Technology does not rely on the formation of a colony
• Real-time monitoring and trending data to react • Ability to detect viable but nonculturable (VBNC)
prior to an out of specification event bacteria

3
Microbial Detection Analyzer

Real-time Microbial Analysis for

Process Control and Transparency
The 7000RMS detects microbial presence within seconds after the sample
enters the analyzer. Measurements are continuously updated providing a
real-time profile of your PW or WFI system. This real-time information
enables the user to quickly divert contaminated water before it impacts
other locations within the water system.

Optimize sanitization frequency Real-time data allows immediate

and effectiveness reaction to contamination

• Trending data shows when sanitization is needed • View excursion details, including timing and severity
• Understand when sanitization is sufficient and • Trend information to proactively reduce and
release water immediately mitigate risk of releasing contaminated water
• Reduce sanitization cost and wear on water • Understand how water system changes impact
system components contamination risk

Photo credit (left): Bosch Packaging Technology

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Advanced Measurement Technology
Using Established and Trusted Techniques
Microorganisms such as bacteria and fungi contain metabolites such as NADH and riboflavin to
regulate growth and development. These metabolites fluoresce when exposed to light of certain
wavelengths. The 7000RMS utilizes two established optical measurement techniquies, Laser
Induced Fluorescence (LIF) and Mie Scattering, combining them in a unique manner to detect
microorganisms in high purity waters.

Excited State

Green Light
(lower energy)

Ground State
Blue Light
Blue Light
(high energy)

LIF: Molecule is excited to a higher energy level laser Mie Scattering: Molecule absorbs light/photons
light source, then releases that energy by emitting and scatters them at different distances based on their size
fluorescence

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 Pharmacopeia Guidelines
Microbial Detection Analyzer

Endorse Alternative Microbial Methods

The General • Continuous monitoring capability advantages in terms of accuracy,
Information Chapter of the 7000RMS enables a more sensitivity, precision, selectivity, or
<1231> Water accurate and constant surveil- adaptability to automation or com-
for Pharmaceutical Purposes, the lance of water system status. puterized data reduction, or in other
United States Pharmacopeia (USP) special circumstances.” USP <1223>
• On-line monitoring enables early
has long supported on-line, continu-
indication of microbial excur-
ous monitoring of pharmaceutical The USP <1223> and the EP
sions so that process and quality
waters so that historical in-process (5.1.6) are informational documents
groups can ensure water used for
data is recorded to ensure the water which detail validation procedures of
manufacturing is in compliance
system is in control and continues to alternative microbiological methods,
and in control.
produce water of acceptable quality. which detail validation procedures
for different technologies and proce-
General Chapter <1223> Valida-
Grab sampling provides incomplete dures. In addition, the FDA and the
tion of Alternative Methods encour-
information. European Medicines Agency (EMA)
ages selection, evaluation and use of
have also published guidelines for
technologies such as 7000RMS as
In USP <1231> compendial limits the deployment of alternative micro-
alternatives to compendial methods.
of 100 cfu/mL for Purified Water biological measurement methods.
Chapter <1223> provides guidance
(PW) and 10 cfu/100 mL for Water
and methods for the specification,
for Injection (WFI) are the traditional
qualification and implementation of USP is a trademark of the United States
microbial requirements for water Pharmacopeia
alternative methods.
quality. However, “water sampling
1) Novel Concept for Online Water Bioburden
protocols are limited in their abil- Analysis: Key Considerations Applications and
“Alternative methods and/or proce-
ity to identify changes in ongoing Business Benefits
dures may be used if they provide American Pharmaceuticals Review, July 2013
water system performance mak-
ing it difficult to provide ongoing
trend analysis, as ‘grab’ samples
can only provide a snapshot of the
dynamic water system.” 1

6
7000RMS Analyzer
Specifications
General Specifications
Flow rate 30 mL/min
Detection limit 1 AFU (Auto Fluorescent Units)
Minimum detection size ≥ 0.3 µm
Measurement range 0 -10,000 AFU / mL
Analysis time Continuous
Response time 2 seconds (1 mL)
Data communication - Ethernet - standard RJ 45 / Wi-Fi capable
- SCADA connectivity via Modbus TCP
- Analog output channels; 4 - 20 mA standard, with configurable output ranges
- USB
Water Requirements
Temperature (non-condensing) 5 - 90 °C (41-194 °F)*
Inlet pressure 20 - 80 psig (2 - 5.5 bar(g))** 1
Type / Quality Purified Water (PW), Ultrapure Water (UPW), Water for Injection (WFI)
Power/Installation/Enclosure
Power requirements 100 - 240 VAC 50 - 60 Hz 5A
Use the power cord included with the instrument
8.2' (2.5 m) cord length provided standard
Monitoring location At-line to drain
Ambient temperature (non-condensing) 0 - 37 °C (32 - 98.6 °F)*
Inlet connection 0.125" (3 mm) O.D.
Outlet connection 0.125" (3 mm) O.D.
Wall mount Anti-vibration shelf required (P/N 58 079 700)
Enclosure material Stainless steel
Physical dimensions (WxHxD) 22.2"(56.4 cm) W x 24.25"(61.6 cm) H x 12"(30.5 cm) D
Weight 73.4 lbs (33.3 kg)
Environmental Conditions
Use Indoor use
Altitude Up to 6562' (2000 m)
Environmental Temperature 5 - 35 °C (41- 95 °F)
Environment Pollution degree 2
Humidity (non-condensing) 80% maximum relative humidity up to 31 °C (87.8 °F)
decreasing linearly to 50% relative humidity at 40 °C (104 °F)
Voltage MAINS supply voltage fluctuations up to ±10% of the nominal voltage of
100 - 240 VAC 50 - 60 Hz
TRANSIENT OVERVOLTAGES: up to levels of OVERVOLTAGE CATEGORY II
TEMPORARY OVERVOLTAGES occurring on the MAINS SUPPLY
* Temperature below 15 °C or above 45 °C requires Sample Conditioning Coil (included)
** Process pressure above 80 psig (5.5 bar(g)) requires optional High Pressure Regulator (P/N 58 091 552)
1
Calibration, cleaning and grab sample requires sample pressure of 0 psig (0 bar(g))

The 7000RMS analyzer is certified as a Class 1 laser product.

The 7000RMS unit contains a Class 3B Laser System, as
specified by IEC 60825-1 Ed.3 (2014).

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Ordering Information
Description Order Number
7000RMS Microbial Detection Analyzer 58 045 001

METTLER TOLEDO Thornton provides complete on-line

measurements for Pharmaceutical Water Systems.

UniCond ® 7000RMS

Regulated
Measurements
for WFI and
Purified Water

pureO3
TM

1500RV

6000TOCi

www.mt.com/thornton
For more information

METTLER TOLEDO Group

Process Analytics Division
Local contact: www.mt.com/pro-MOs

Subject to technical changes

©04/2019 METTLER TOLEDO. All rights reserved
7000RMS is a trademark of the METTLER TOLEDO Group.
PA2029EN Rev B 04/19