1.25kg is 1.25kg - Mettler-Toledo

Pharmaceutical
Preparations
Industrial weighing and measuring
Peace of mind
with consistent tablet quality
At the CIMEX AG pharmaceutical manufacturing site, validated
weighing stations fitted with the dispensing software
FormWeigh. Net ® , guarantee formulation accuracy, failproof
material handling and compliance with cGMP/GAMP and
21 CFR part 11.
Analysis of the specific requirements
and close cooperation between
CIMEX AG and METTLER TOLEDO
led to the seamless and smooth upgrade
of CIMEX AG’s dispensing system
to FormWeigh. Net ® . Mohammed
Ibrahim, Production Manager of
non-penicillin based products manufacturing,
underlines that “a crucial
point was the integration of the
available devices into the new system
without suffering from production
loss during the changeover. The goal
was to bring the new system as close
as possible to the system already inplace
while introducing new functions.”
The customizable functions of
FormWeigh. Net ® made this a straightforward
task.
CIMEX AG decided to use the validation
service that METTLER TOLEDO
provides. The weighing stations were
qualified, the software validated and
all operators trained with no interference
to the on-going production. The
feedback after the Factory Acceptance
Test (FAT) was very positive: “We were
able to simplify the weighing procedure
considerably because the interface
is truly user-friendly”.
“The standard Computer System
Validation (CSV) packages tremendously
helped to minimize the validation
work.” The packages consist
of two manuals. Pac 1 contains all
relevant information and protocols
for a successful supplier Audit, while
News 3
Courtesy CIMEX AG

Dispensing room
2
Publisher
Mettler-Toledo AG
Industrial
Heuwinkelstrasse
CH-8606 Nänikon
Switzerland
Production
MarCom Industrial
CH-8606 Nänikon
Switzerland
MTSI 44099003
Pac 2 contains detailed protocols
for the Installation, Operation and
Performance Qualification (IQ, OQ,
PQ) as well as applicable SOPs for
disaster recovery, backup and system
security.
Subject to technical changes
© 01/2007 Mettler-Toledo AG
Printed in Switzerland
advantages for CIMEX AG
CIMEX AG is a leader in the manufacturing,
packaging and distribution
of solid pharmaceuticals for the
treatment of high blood pressure,
prostate problems and Parkinson‘s
disease. “Because of our global presence,
we require from our suppliers
not only good solutions, but also good
service and support, reliability, and
competitive prices”, says Dr. Thomas
Uhlmann, leader of the Production
and Technic Dept. of CIMEX AG.
METTLER TOLEDO is a qualified
partner of CIMEX AG.
METTLER TOLEDO Pharmaceutical Preparations News 3
®
Based on the great success of the
project with METTLER TOLEDO,
CIMEX AG plans to implement an additional
FormWeigh.Net ® system in its
penicillin production soon.
Key benefits of FormWeigh.Net ®
dispensing software
• User-friendly touchscreen
• Unique labeling system
• Graphical visualization of the
weight
• Electronic batch records and
e-signature
• Weighing and control at your
finger tips
• Fully 21 CFR Part 11 compliance
Network
Weighing station with ID30 industrial PC, barcode laser scanner, label printer and three scales connected.
Courtesy CIMEX AG
Warehouse, data and recipes
management-order generation
Courtesy CIMEX AG Courtesy CIMEX AG

Electronic batch documentation
All relevant batch information and the
operator’s “signature” are electronically
documented. Protected access
guarantees that sensitive data can only
be seen and/or changed by the authorized
people.
Secure process with unique
labeling system
Every raw material is identified uniquely
with a barcode. FormWeigh. Net ®
recognizes the raw material by reading
the barcode with a laser scanner,
verifies its quality status and the expiry
date.
The material information displayed
helps operators to prepare the right ingredients
for the batch. Furthermore,
safety precautions and handling procedures
are highlighted on the screen.
FormWeigh. Net ® confirms that each
quantity is correct before the operator
is allowed to start weighing.
A weight below the
limits is shown
in blue
A weight within the
target limits is shown
in green
Order overview: select your recipe
and start weighing
An easy-to-read order list is displayed
and the system is ready for production.
The weighing of the required
raw material can be started by simple
selection.
Visualization of the weight
FormWeigh. Net ® shows you graphically
and numerically how far you are
from the target weight. The required
tolerances are clearly displayed as limits
and weighing results that exceed
or fall below these limits are shown
in different colors. This helps to highlight
potential problems and prevent
mistakes.
ID30 user-friendly
touchscreen flat panel
The operators select or place the order
directly at the weighing station and
control it simply with a light touch of
the screen.
Weigh and control at your finger tips with the ID30 industrial PC
METTLER TOLEDO Pharmaceutical Preparations News 3 3

Ensuring reliable weighments
4
1.25kg is 1.25kg – Now and forever?
Our services keep your APIs active
Quality lies in consistently manufacturing to your exact formula, regardless
of when you make it, who the operator is, and despite any potential change
in manufacturing conditions.
Measurement reliability
and minimum weight
The accuracy of a precision instrument,
such as a scale, can be affected
by many factors. Accuracy and repeatability
of weighing operations are not
accidental – they result from wise
equipment choices and correct installation,
calibration and use.
Quality and consistency can be built
into your solids or liquids by ensuring
that your measurements are always
within acceptance tolerances. But how
do you get the peace of mind that your
weight measurements are reliable?
The flashing of this red icon on the new IND780 indicates
that the weight is below the minimum weight threshold.
Furthermore the weight is displayed in red as long as the
weight is below the minumum.
METTLER TOLEDO Pharmaceutical Preparations News 3
The relative uncertainty of a measurement
increases exponentially with
decreasing weight values. As a consequence,
a minimum weight limit exists
for every scale, below which the
measurement uncertainty becomes
larger than the tolerance specified for
the weighing process.
In every new METTLER TOLEDO indicator
is embedded the MinWeigh ®
function that warns the operator when
the weight is below the minimum
weight threshold. Ask your service
technician to activate MinWeigh ® for
increased safety in your processes.
The MinWeigh ® service also includes:
• On-site determination of measurement
uncertainty of the weighing
system within your process environment
conditions
• Calculation and documentation of
the minimum weight in relation to
the process tolerances
• Easy and fast recalculation of the
minimum weight, since tolerances
may change from one process to
the next

IPac means “in-spec” scale
performance
Equipment Qualification (EQ) is
much more than just complying with
GMP requirements. EQ ensures the
accuracy and consistency that you
require from your equipment. From
equipment selection, installation and
calibration, to thorough operational
qualification, IPac provides services
to ensure that your scale, in your
production setting, delivers certified
weighing performance to your specifications.
Furthermore, with IPac your
operators receive training to maximize
weighing efficiency while maintaining
accuracy and safety. IPac also
helps you document appropriate periodic
test procedures to confirm per-
formance during routine operation.
Finally, IPac provides ready-to-file
equipment qualification documents
designed to comply with your quality
system.
Great value for your money –
quality for your customers
• Certified weighing precision to
ensure the 1.25kg or any weight
that contributes to your product’s
success
• Determination of the minimum
weight ( MinWeigh ®)
• Improved productivity with correct
equipment set-up and user training
• Cost savings through use of an
OEM-developed qualification
protocol
• Best-practice documentation to
your quality system requirements
means smooth and timely cGMP
compliance
Courtesy Eisai
METTLER TOLEDO Pharmaceutical Preparations News 3

Product inspection
6
Unrivalled detection sensitivity,
easy GMP compliance
Metal detection plays a vital role in supporting
and ensuring the high standard of quality control.
There are a number of critical points
in the production process where contamination
may arise, including the
sifting process, the tablet pressing and
the packaging. Each of these steps
may demand a different type of metal
detection.
SSL International, a leading healthcare
company, which owns global
market brand leaders in foot care,
condoms and powder-free surgical
gloves, Scholl, Durex and Regent
Biogel respectively, has been using
METTLER TOLEDO Safeline metal
detection systems for many years. Due
to operational success, SSL purchased
three further METTLER TOLEDO Safeline
detectors to monitor solid dose
METTLER TOLEDO Pharmaceutical Preparations News 3
medicines for its OTC pharmaceutical
production plant in Peterlee, UK.
The highly sensitive Safeline Tablex
metal detectors consistently detect
fragments of metal contamination,
including non-magnetic stainless
steel and aluminium, at inspection
rates of more than 10 000 tablets per
minute.
These metal detectors also ensure
peace of mind by complying with
GMP regulations. Performance validation
software assists QA personnel
with step-by-step instructions through
the test routine. Evidence that QA procedures
have been followed can be provided
quickly and easily by downloading
and printing the data.
Key benefits:
• Unrivalled detection sensitivity
• High throughput
• Easy to operate
• Integrated reject systems including
side diverter and lift flap
mechanisms
• Mobile design allows for installation
in confined spaces
• Sealing to IP65 or IP66 standards
available
• Designed and manufactured for
21 CFR parts 210 & 211
• Ready for 21 CFR part 11
compliance
Courtesy Zambon Courtesy SSL International

Customised checkweighing solutions
AstraZeneca and METTLER TOLEDO in partnership have developed
a leading-edge checkweighing, print and verification solution for
use on a brand new product packaging line.
Already the preferred checkweighing
technologies provider for AstraZeneca
in Macclesfield, METTLER TOLEDO
has installed fifteen Checkweighers
for the company over recent
years. AstraZeneca returned to
METTLER TOLEDO requesting a system
that would scan, batch/date print
and checkweigh “prescription-sized”
packages of their Zomig ® migraine
medicine.
Highest levels of accuracy and
integrated solution
AstraZeneca required a solution that
ensured the highest levels of scanning
accuracy, cost-effective print capability
and a checkweighing tolerance of
+/- 200mg; a level sufficient to determine
whether the correct dosage instructions
were contained within the
packaging.
Working together, AstraZeneca and
METTLER TOLEDO developed a customised
solution to suit their needs.
The solution consists of the already
proven S2 Pharma checkweigher with
top and bottom belt system, which
guarantees the highest reliability of
feeding. This is integrated with a sensor
able to recognise the given number
of pixels in a specified print area and
an appropriate printer, chosen for
its cost-effective replacement print
heads.
The system implemented ensures
that only correctly-filled and batch/
date-printed Zomig ® packs progress
toward shipping, with any pack that
fails to contain dosage instructions
being ejected for re-filling. “Developing
this highly innovative solution
for AstraZeneca, requiring the highest
levels of accuracy and technology,
was a very rewarding challenge for
METTLER TOLEDO and AstraZeneca”,
so comments Steve George, Sales Account
Manager of METTLER TOLEDO
Product Inspection.
Key benefits
Specially developed for the pharmaceutical
environment, the S2 Pharma
Checkweigher features:
• Easy-to-use with touchscreen color
display
• Great flexibility for easy integration
into every production line
• Secure operations with reject catch
bin and open flap detection options
• Quality assurance with unique statistics
and data storage capability
• Equipment qualification and validation
support
The top and bottom belt system
ensures highest reliability of feeding
METTLER TOLEDO Pharmaceutical Preparations News 3 7
Courtesy Weleda

Moisture determination
fully pharmacopeia-compliant
METTLER TOLEDO moisture solution package provides fast
and reliable moisture analysis in compliance with GMP.
According to the pharmacopeias, e.g.
USP, moisture determination with drying
oven is the established reference
method. However, process time is very
long and requires many complex process
steps. In contrast, moisture determination
with the METTLER TOLEDO
Halogen Moisture Analyzer HR83 is a
significantly faster and easy-to-use
solution.
Cross-validation experiments have
shown that moisture results obtained
with the HR83 method excellently
match the pharmacopeia-compliant
drying oven results. This solution is already
in use and approved by an FDAinspected
pharmaceutical company.
Mettler-Toledo AG
CH-8606 Greifensee
Switzerland
Tel. + 41 44 944 22 11
Fax + 41 44 944 30 60
Your METTLER TOLEDO contact:
Key benefits
• Time to result is reduced from
hours to minutes
• Save 3-5 hours of process time for
the majority of all measurements
• Outstanding results reproducibility
and reliability
• High resolution of 0.1mg – same
resolution as required by Pharmacopeia
for balances when using
reference method
METTLER TOLEDO provides the entire
solution for the HR83, including:
• Reference SOP & documentation
• Exemplary methods for the 10 most
often used pharma excipients covering
the majority of all moisture
measurements
• Qualified installation (IQ, OQ,PQ)
with IPac moisture
• Temperature calibration of HR83
exactly at point of use
www.mt.com/ind-pharma For more information