Pharmaceutical - Mettler Toledo

THORNTON
Leading Pure Water Analytics
Pharmaceutical
Pure Water Analytics
A Step Ahead for Pharmaceutical Compliance

Pharmaceutical
Mettler-Toledo Thornton leading
Pharmaceutical Water measurement
Mettler-Toledo Thornton successes in the semiconductor industry helped establish our role as the paramount
worldwide supplier of instrumentation for pure and ultrapure water treatment systems. Leading pharmaceutical and
biotech facilities rely on Mettler-Toledo Thornton instruments to monitor and control their entire water treatment,
storage and distribution systems, providing a step ahead in implementing PAT (Process Analytical Technology).
Mettler-Toledo Thornton has expanded its capabilities to provide state-of-the-art conductivity, TOC, pH, dissolved
oxygen, ozone and temperature measurements to meet the current global requirements for pharmaceutical waters.
In 2001, Thornton joined the Mettler-Toledo Process Analytics group – gaining world-class technology, global distribution
and technical support capabilities.
Mettler-Toledo Thornton Industry Participation
As a technical leader in pure water measurements, Mettler-Toledo Thornton supports its staff
members' participation in the following pharmaceutical and biotech related organizations
and conferences:
United States Pharmacopeia, Pharmaceutical Water Expert Committee
Pharmaceutical Research & Manufacturers Association (PhRMA), Advisor
PDA Meetings and Conferences, participant and featured “Industry Expert"
ASTM D19 and E55 Commitees, Task Group Chair and Contributor
International Society of Pharmaceutical Engineers (ISPE) & INTERPHEX conferences,
active membership, participant and featured “Industry Expert”
Ultrapure Water Conference, participant organizer and conference leader
Mettler-Toledo Thornton instrumentation and sensors assure the best available technology to
comply with United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese
Pharmacopeia (JP). Validation, verification and service support from Mettler-Toledo
Thornton is second to none.
Mettler-Toledo Thornton –
the leader in meeting global pharmacopeial requirements
Thornton provides total conductivity, temperature and TOC measurement solutions
to meet worldwide regulatory requirements for Purified Water (PW), Highly
Purified Water (HPW) and Water for Injection (WFI). Thornton instruments &
sensors exceed all requirements of USP Water Conductivity, Total
Organic Carbon, and 2.2.44 Total Organic Carbon and conductivity tests
described in Ph.Eur. water monographs. These measurements are also in accordance
with ASTM D1125 and D5391 (conductivity) and D5173 (TOC).
2

Pharmaceutical Water conductivity
and total organic carbon requirements
Pharmaceutical water measurement requirements have been drastically revised in the last decade. To improve global manufacturing
efficiencies, the United States Pharmacopeia developed new requirements for Water for Injection (WFI) and for Purified Water, mandating
Water Conductivity and Total Organic Carbon tests to replace antiquated wet chemical methods.
USP initiated global HARMONIZATION efforts with the European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and Chinese
Pharmacopeia (CP) to help bring more consistency to worldwide pharmaceutical water quality requirements. Mettler-Toledo Thornton
is positioned as the global leader for HARMONIZATION activities for conductivity and TOC measurements.
Conductivity and TOC were introduced as compendial
tests for pharmaceutical waters originally in
USP 23 Supplement 5 (Nov 1996).
USP and EP 2.2.44 are the principal TOC
compendia that establish limits, system suitability
and limit of detection requirements.
USP Water Conductivity and conductivity
tests listed in EP water monograph's are the principal
conductivity compendia that establish limits and
calibration requirements.
Fundamental Goals for USP Purified Water & WFI
Maintain/Improve existing water quality
Improve the reliability of the testing
(using modern instrumentation)
Reduce the number of tests
Make allowances for on-line, in-line testing
Support PAT initiatives for on-line process control
Advantages of on-line testing:
Real-time process information, congruent with PAT
objectives. Data may be logged, providing historical
records
Easy and cost effective in-line measurements
Eliminates sample collection, handling and transportation
errors as well as costly Out of Specification
(OOS) investigations
Immediate alarms
In addition, temperature-compensated conductivity
remains an excellent technique to observe water
quality changes for process control
3

Pharmaceutical
Instruments that meet USP Purified Water,
Highly Purified Water & WFI specifications
Thornton 770MAX
The THORNTON 770MAX offers the highest quality and reliability for pharmaceutical and
biotechnology water systems to ensure compatibility and simplicity in calibration, validation
and verification of a high purity water system. One 770MAX instrument supports:
Up to 6 multiparameter sensor inputs
Up to 16 measurement types and 8 current outputs
Smart plug & play sensor connections
NIST and ASTM traceable standards for all conductivity sensor calibrations
NIST traceable certificates for instruments and calibrators
USP, EP, JP regulation conformance for calibration and performance
Certified 316L electropolished stainless steel sanitary sensors, USP Class VI compliant
User-programmable alarm setpoints, pre-programmed USP setpoints for PW and WFI, and
EP setpoints for PW, HPW and WFI (effective July, 2004)
THORNTON 770MAX optimizes cost-of-ownership with a reduced cost-per-measurement-point,
using multiple sensor types with patented Smart Sensor technology connected to one 770MAX
instrument. Multiple inputs for any combination of conductivity and/or resistivity, total organic
carbon, flow, pH, ozone, ORP, dissolved oxygen, pressure, level and temperature are possible.
Clean-In Place (CIP) & Steam-In Place (SIP)
Clean-In Place (CIP) and Steam-In Place (SIP) Applications are some of the most demanding
applications in pharmaceutical production. Steam and harsh chemicals are used to clean
piping systems prior to use and between batches. Sensors in this application must measure
accurately and also withstand contact with chemical cleaning agents and pressurized steam
without removal from the system.
Glassware and cage washers are commonly used in pharmaceutical and biotech research
and production to ensure cleanliness of glassware, and sanitary containment for animals.
Detergent concentrations and rinse water purity are measured for compliance.
The multi-channel 770MAX and two-channel M300 instrument systems are ideally suited for
these validated applications. With two and four-electrode conductivity sensors installed,
these instruments have the dynamic range to measure pharmaceutical water and the concentrations
of chemical cleaning agents, soap concentrations or pressurized steam. For some
washer applications, a pH sensor can also be used to measure detergent concentration.
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THORNTON M300 for Conductivity
Based on proven leadership
The M300 series comprises a complete family of conductivity/resistivity, pH, ozone
dissolved oxygen, temperature and flow instruments, with unmatched performance
and value. A wide range of conductivity measurements – include USP and EP
Purified Water, Highly Purified Water, and Water for Injection applications.
The M300 Conductivity Instruments feature:
One or two channel measurements for a wide conductivity measurement range
NIST and ASTM traceable standards for all conductivity and temperature sensor calibrations
NIST traceable calibration certificates for instruments and calibrator
USP, EP, JP regulation conformance for calibration and performance
Certified 316L electropolished stainless steel sanitary sensors, USP Class VI compliant
User-programmable alarm setpoints, including pre-programmed USP setpoints
for PW and WFI, and EP setpoints for PW, HPW and WFI
THORNTON M300 for pH
pH for demanding high purity water applications
The THORNTON M300 pH system includes a selection of pH sensors for pharmaceutical and biotechnology water
applications, plus a high purity pH sensor with a sealed flow chamber to prevent carbon dioxide contamination
from the air. This pH sensor ensures stable performance in high purity water.
THORNTON M300 for Ozone
Assures consistent sanitization
THORNTON M300 instrumentation provides consistent monitoring of ozonation levels to assure complete water
disinfection as well as complete removal of ozone after UV destruct units. Measurement at the end of the distribution
line can show when periodic sanitization has been achieved throughout the system.
5

Pharmaceutical
Total organic carbon (TOC)
in pharmaceutical Waters
Total Organic Carbon (TOC) measurement conformance is clearly defined within the USP and EP
2.2.44. as a replacement for the Oxidizable Substances Test. TOC measurement systems are required to pass
specified tests to ensure system suitability performance for compliance in pharmaceutical water systems.
Thornton Installation Qualification (IQ) and Operation Qualification (OQ) documentation simplifies the compliance
process. Thornton provides the fastest in-line TOC measurements, without additional chemicals or
reagents, to meet global regulations and PAT objectives.
5000TOC Sensor
With the addition of the 5000TOC Total Organic Carbon Sensor, the 770MAX is the only on-line transmitter to offer
multiple TOC and conductivity measurements on a user-configurable multiparameter instrument platform.
The 5000TOC Sensor is designed for all pharmaceutical water requirements. Low detection limits, fast, continuous
response, and no chemicals are key features that simplify meeting industry requirements. The 5000TOC Sensor is in
compliance with USP/EP for both TOC and conductivity tests.
Continuous flow design, no batch measurement cycle
770MAX Smart Sensor interface
Two TOC Sensors connect to one 770MAX, with four more channels
remaining for additional sensors
Real-time continuous monitoring for precise data trending and better
process control
No gases or reagents to handle, store or replace and no moving parts
minimize routine maintenance
Meets USP , and EP 2.2.44 requirements for the
Pharmaceutical industry
550TOC Analyzer
Accurate, validated TOC measurements for compendial requirements or
process control – either in-process or in the laboratory
Truly continuous analysis and rapid measurement updates
Display TOC, resistivity or conductivity and temperature from one unit
No chemicals, reagents, or membranes required
Small, portable analyzer
Quick and simple system suitability tests for global regulations compliance
6

Outstanding training & technical services
empower the Thornton user.
On-Site Instrument Operation &
Calibration Training Workshops
Thornton’s Operator Training Courses are
tailored to each customer’s requirements.
The course is conducted in a classroom
setting where interaction between instructor
and participants is encouraged. Each
attendee is supplied with material detailing
the course content. Instruments are
provided for hands-on participation.
The areas covered in this training program
focus on Thornton instrumentation,
calibration, and maintenance specific to
your facility. Additional technical topics
may be added or substituted as
requested.
Traceable Instrument Calibration
Thornton offers instrument calibration and
validation services traceable to national
standards, industry guidelines, and/or
regulatory requirements (including USP
, USP , and EP 2.2.44).
Services using factory-trained technicians
are available at our facilities in Bedford,
Massachusetts or on-site at your location.
Each calibrated/validated instrument is
supplied with the appropriate calibration
documents.
Specialized Conductivity Calibrations
Choose one of seven unique conductivity
calibrations to fit your application needs,
from standard calibrations to customerspecified
temperature and ASTM verification
points. System calibrations are also
available where the instrument and sensors
are calibrated together, optimizing
system accuracy.
Service & Calibration Contracts
A Thornton representative will provide onsite
service for items covered under the
agreement. These services include, but
are not limited to:
Calibration/validation of instrument and
sensor system
Issuance of appropriate documentation
Identification and verification of all software
revisions
Minor repairs or adjustment of instruments
at a discounted labor rate
Installation and validation support
services
TOC System Suitability Test services
Traceability Lineage
THORNTON Meters
THORNTON Sensors
THORNTON Calibrators
Precision Multi-meter
THORNTON Reference
Sensors
Calibration Lab
National Institute of
Standards & Technology
(NIST)
American Society of
Testing & Materials
(ASTM) Solutions
7

Worldwide Offices
Ensure prompt, local sales support.
Australia Mettler-Toledo Ltd., 220 Turner St., Port Melbourne, Victoria 3207
Tel. + 61 3 9644 5700, Fax + 61 3 9645 3935, info@mtaus.com
Austria Mettler-Toledo GmbH., MT-A, Südrandstrasse 17, A-1230 Wien, Austria
Tel. + 43 1 604 19 80, Fax + 43 1 604 28 80, info.mtat@mt.com
Brazil Mettler-Toledo Ltda., Al. Araguaia, 451-Alphaville, Barueri São Paulo, Brazil 06455-000
Tel. + 55 11 4166 7400, Fax + 55 11 4166 7401, info@mettler.com.br
China Mettler-Toledo (Shanghai) Co. Ltd., 589 Gui Ping Road, Shanghai PRC 200233, China
Tel. + 86 21 6485 04 35, Fax + 86 21 6485 33 51, mtcs@public.sta.net.cm
France Mettler-Toledo Analyse Industrielle, 30, Bd. de Douaumont, BP949 75829 Paris Cedix 17, France
Tel. + 33 1 47 37 06 00, Fax + 33 1 47 37 46 26, mtpro-f@mt.com
Germany Mettler-Toledo GmbH, Ockerweg 3, P. O. Box 11 08 40, D-35396 Giessen, Germany
Tel. + 49 641 507 0, Fax + 49 641 52 951, info.mtd@mt.com
India Mettler-Toledo India Pvt Ltd, Amar Hill Compound, Saki Vihar Road, Powai Mumbai 400 072 India
Tel. + 91 22 2857 0808, Fax + 91 22 2857 5071, sales.mtin@mt.com
Italy Mettler-Toledo S.p.A., 20026 Novate Milanese (MI), Via Vialba, 42, Italy
Tel. + 39 02 33 332 1, Fax + 39 02 356 29 73, customercare.italia@mt.com
Japan Mettler-Toledo K.K., 4F Izumikan Sanbancho Bldg, 3-8 Sanbancho, Chiyoda-ku, Tokyo 102-0075, Japan
Tel. + 81 3 3222 7106, Fax + 81 3 3222 7121, sales.admin.jp@mt.com
Korea Mettler-Toledo (Korea) Ltd., Yeil Bld 1&2F, 124-5, YangJe-Dong SeCho-Ku, Seoul 137-130 Korea
Tel. + 82 2 3498 3500, Fax + 82 2 3498 3555. info_MTKR@mt.com
Malaysia Mettler-Toledo (M) Sdn. Bhd., Unit 1-01, (1st Floor), Lot 8, Jalan Astaka U8/84, Seksyen U8 Bukit Jelutong, 40150
Shah Alam, Selangor, Malaysia, Tel. + 603 7845 5888, Fax + 603 7845 8773, MT-MY.CustomerSupport@mt.com
Mexico Mettler-Toledo S.A. de C.V., Pino No. 350, Col. Sta. MA. Insurgentes, Mexico, D.F. 06430
Tel. + 52 55 5547 5700, Fax + 52 55 5541 2228, ventas,lab@mt.com
Russia Mettler-Toledo C.I.S. AG, Sretensky blvd. 6/1, office 6, 10 1000 Moskau
Tel. +7 495 621 92, Fax 7 495 621 63 53, inforus@mt.com
Singapore Mettler-Toledo (S) Pte. Ltd., Blk 28 Ayer Rajah Crescent #05-01, Singapore 139959
Tel. + 65 6890 0011, Fax + 65 6890 0012/13, Ashley.Kong@mt.com
Spain Mettler-Toledo S.A.E., Miguel Hernandez, 69-71, L'Hospitalet de LI., E-08908 Barcelona, Spain
Tel. + 34 932 237 600, Fax + 34 932 237 601,Tere.Pares@mt.com
Sweden Mettler-Toledo AB, Virkesvägen 10 , S-120 08 Stockholm, Sweden
Tel. + 46 8 702 50 22, Fax + 46 08 642 45 62, info.se@mt.com
Switzerland Mettler-Toledo (Schweiz) AG, Im Langacher Postfach CH-8606 Greifensee
Tel. + 41 1 944 45 45, Fax + 41 1 944 45 10, info.ch@mt.com
Thailand Mettler-Toledo (Thailand) Ltd., 272 Soi Soonvijal 4, Rama 9 Rd., Bangkapi, Huay Kwang, Bangkok 0320 Thailand
Tel. + 662 723 0300, Fax + 662 719 6479, MT-TH.CustomerSupport@mt.com
United Kingdom Mettler-Toledo Ltd., 64 Boston Road, Beaumont Leys, Leicester, LE4 1AW, United Kingdom
Tel. + 44 116 235 7070, Fax + 44 116 236 5500, enquire.mtuk@mt.com
United States Mettler-Toledo Thornton, Inc., 36 Middlesex Turnpike, Bedford, MA, 01730 USA
Tel. + 1 781 301 8600, Fax + 1 781 301 8701, thornton.info@mt.com
For all
other countries
please consult our web site
www.mt.com/thornton
For more information
Mettler-Toledo Thornton, Inc.
36 Middlesex Turnpike, Bedford, MA 01730 USA
Tel. +1-781-301-8600, Fax +1-781-301-8701
Toll Free +1-800-510-PURE
Subject to technical changes
© Mettler-Toledo Thornton, Inc.
ML0100 Rev.C 07/07