lab products & solutions in pharma - mettler toledo ... solutions overview in... · lab...
TRANSCRIPT
1
Agenda
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- New Analytical Instruments
2
Agenda
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory Solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- Analytical Instruments
Pharmaceutical Processes & requirements
3
Raw Material Testing In Process Control Quality Control IPC for drying
Melting point Precision balances
Analytical balances Density/Refractometry
Thermal analysis General titration
Analytical balances Precision balances
DE/RE KF titration Melting point pH meters
Moisture analysers Analytical balances
Analytical balances KF titration
General titration Density/Refractometry
Melting point
Pharmaceutical Production and QC Primary Manufacture
Raw material A
Raw material B
Chemical reaction
Isolation, Purification Drying Isolation,
Purification Finalization
of API
4
Process development: • Precision
balances • Analytical
balances • pH meters • KF titration • Density /
Refractometry • Melting point
Stability testing: • Analytical &
Micro balances • pH meters • KF titration • General titration • Density /
Refractometry • Thermal
analysis
QC development: • Analytical &
Micro balances • pH meters • KF titration • General titration • Density /
Refractometry • Thermal
analysis
• Precision balances • Analytical balances • pH meters • Pipettes
• Precision balances • Analytical balances • pH meters • Pipettes • LabX software
Pharmaceutical R&D processes
Pharma- & Toxicology Phase I Phase II Phase III
Pre-clinical Development Clinical Development
Process Development
QC Development
Stability Testing
General Develop-ment
Molecular Targets ID
Target validation
Lead Discovery
(ID)
Lead optimization
Drug Discovery (Research)
Instruments
• Precision balances • Analytical balances • pH meters • KF titration • Density/Refractometry • Melting point • Pipettes
GLP GCP
ICH
21 CFR part 11
GMP
Legislation
• Pipettes • LabX software
5
Agenda
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- Analytical Instruments
Mettler Toledo Laboratory Solutions
6
Agenda
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
Weighing Solution
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- Analytical Instruments
- Weighing Solutions Mettler-Toledo Laboratory solutions
Solutions Overview: Lab Weighing
7
Precision Balances
Analytical Balances
Micro Balances
Automated Dosing
Moisture Analyzer
weight
Measure
0.000001g
Measure
0.00001g – 60g
Measure
0.1g – 64 kg
Automated,
accurate dosing of fluid
and solid substances
Measurement
of moisture contained in
solids
e.g. weighing of residues in
filters
e.g. weighing of active
substances
e.g. formulation of mixtures for
synthesis
e.g. capsule filling for clinical
trials
e.g. quality control in food
production
Lab Instruments & Solutions
Weighing Solutions - Micro balances
- Analytical Balances
- Precision Balances
- Automatic Weighing solutions
- Moisture Analyzers
- Mass Comparators
8
- Micro Balances
Weighing Solutions
9
XP6 6.1g / 1ug
XP2U 2.1g / 0.1 ug
XP6U 6.1g/ 0.1 ug
The choice for your valuable Samples
XP Micro Balance
XP6 6.1g / 1ug XP2U 2.1g / 0.1 ug XP6U 6.1g/ 0.1 ug
Lab Instruments & Solutions
Weighing Solutions - Micro balances
- Analytical Balance
- Precision balances
- Automatic Weighing solutions
- Moisture Analyzers
- Mass Comparators
10
- Analytical Balances
- Precision Balances
Weighing Solutions
Analytical & Precision Balances
11
Innovative and continuous renewed Weighing solutions
Introduction April 2015
Introduction July 2015
Introduction October 2015
Introduction January 2015
Follow the Green Light
StatusLightTM immediately shows the Balance Status
Green Ready to measure !
Flashing Green Please wait – proFACT is adjusting the balance
Yellow Task is waiting, such as proFACT
Red Do not use the balance ! Error must be corrected
Your Benefits Immediate checking if the balance is ready for use – Save time! The Quality Control / Quality Assurance can see which balance needs attention – Save money by reducing incorrect weighing results
Follow the Guide
Redesigned LevelGuideTM
Level bubble displayed on the Terminal
Large bubble for immediate indication
Your benefits Intuitive instructions Quick response
New Large Display
Effortless display reading
Prevents tired and strained eyes
Direct access to function icons is possible
New XPE Analytical At-a-Glance
Firmware Improvements Large digits display with function key availability Improvements to Pipette Check, Dosing Guide (SmartTrac) and more! New "rugged" filter set for customers with low level vibrations, causing unstable readings at >50% load
StaticDetect Eliminate OOS SmartGrid, ErgoClips compatible Compact AntiStatic Kit ready
LevelGuide Level the balance in seconds
Built-In Ergonomics Simplest small sample
handling with ErgoClips New ErgoClip SmartPrep
Micro Touchless left- and right-
handed operation
EasyScan Compatible Pipette testing down to 1µl Built-in application
New XS Analytical At-a-Glance
Full Process Control LabX ready
Embedded applications TestManager™
SmartGrid & ErgoClips Fast settling times
ErgoClips for direct dosing Large, accessible dosing area
New Portfolio Introducing:
¬ XS105 ¬ XS225DU
¬ XS304
Ergonomics Large digits display
Left and right handed door operation
ErgoSens for Zero/Tare/Print
Easy Cleaning as Standard SmartGrid
Dishwasher safe materials Dismantles in seconds
SmartPan Performance Harsh conditions (worst case) : Air conditioning draft and strong turbulence Balance tested : XPE6003SD5 (6100 g – 5mg)
Standard Pan SmartPan Settling Time (s) 3,6 sec 1,7 sec Repeatability sd (mg) 14,7 mg 6,2 mg
Test weights 400 g 20 repetitions 2 Kg 20 repetitions 5 Kg 20 repetitions
Average values
The new ErgoStand
Adjustable terminal holder for individual
comfort
Easy mounting and dismounting
Quick lock for faster mounting and dismounting
Cable slot for an easier and tidier cable positioning
Optimized arm height for better
ergonomics
The new ErgoStand
Correct posture
Correct viewing position
Prevents pain in the back, hands and neck
23
MS - Small and Large precision platforms
MS-TS Precision balances with draft
shield and small platform
MS-TS Precision balances with small
platform MS-L Precision balances with
large platform
Max. capacity: 320 g – 1'020 g Readability: 1 mg
Max. capacity: 1'600 g – 12 kg kg Readability: 10 mg – 1 g
Max. capacity: 8 kg – 32 kg Readability: 0.1 g – 5 g
Trusted Results at Your Fingertips
Lab Instruments & Solutions
- Micro balances
- Analytical Balances
- Precision balances
- Moisture Analyzers
- Mass Comparators
24
- Automatic Weighing solutions
Weighing Solutions
Automated Weighing solutions
25
Automated Dosing & Weighing Solutions
from XPE and XS Analytical models
Anytime upgradeable to Automatic Solutions
QB-PS QB-P(L)
XPE
QA-L
Lab Instruments & Solutions
Weighing Solutions - Micro balances
- Analytical Balances
- Precision balances
- Automatic weighing solutions
- Moisture Ana
- Mass Comparators
28
- Moisture Analyzers
Weighing Solutions
Safe Results
Instant Comfort
HE53 HE73 HC103 HS153 HX204
Easy Compliance
Easy Reporting
Moisture Pharma Optimized Solutions
Pharma Excipients Method Collection
31
Special Methods Collection Pharma Excipients Brochure for Moisture
Weighing Solutions - Micro balances
- Analytical Balances
- Precision balances
- Automatic Weighing solutions
- Moisture Analyzers
-
32
- Mass Comparators
Weighing Solutions
Lab Instruments & Solutions
Calibration Solutions meeting Your Needs
METTLER TOLEDO Your Partner of Choice
Addressing Your Need
Manual Comparators
Automated Comparators
Robotic Comparators
Software & Accessories
www.mt.com/comparators
34
Agenda
Introduction Mettler-Toledo Group & Sales Int.
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- Analytical Instruments
- Analytical Instrumentation
Mettler Toledo Laboratory Solutions
Solutions Overview: Analytical Instruments
35
Melting and Dropping Point
Titration General & KF
pH Cond Ion Meters
Density- and Refractometry
Thermal Analysis
Measure pH, Conductivity,
dissolved oxygen and specific Ions
Determine the
accurate content of a
certain chemical in a
substance
Use the precise
density or refractive index to characterize a substance or
measure a content
Use the
dropping or melting point to determine the
purity of a substance
Measure the behavior of substances
versus temperature
Lab Instruments & Solutions
Analytical Instruments - Meters : pH / Cond / Ion / DO
- Titration : General & KF Solutions
- Density & Refractometers
- Melting & Dropping Point Analyzers
- Thermal Analysis Instruments
36
- Meters : pH / Cond / Ion / DO
Analytical Instruments
37
Meter portfolio in pH / Cond / Ion / DO
Benchtop meters Portables
SevenExcellence™
SevenGo Duo™
New Seven2Go™
SevenGo Duo pro™
New Seven2Go pro ™ Professional
Level
Routine Level SevenCompact™
Entry Level New FiveEasy Plus™
New FiveEasy™
New FiveGo™
38
InLab Sensors & Solutions
Superior quality sensors
Long years know-how and experience (INGOLD since 1948)
Innovation leader in development
Strict quality controls applied in manufacturing
Comprehensive range available to suit all possible applications
39
A dedicated sensor for your application
Select easily your electrodes on www.electrodes.net
Lab Instruments & Solutions
- Analytical Instruments - Meters : pH / Cond / Ion / DO
- Titration : General & KF
- Density & Refractometers
- Melting & Dropping Point Analyzers
- Thermal Analysis Instruments
40
- Titration : General & KF Solutions
Analytical Instruments
41
Karl Fischer Titration
Only sensitive to water from 1 ppm to 100% water Small footprint and automation possibilities Result documentation
V30/V20 Volumetric KF T50/70/90 Volumetric KF C30/C20 Coulometeric KF
42
General Titration
Simple interface Flexible methods Easy to use Result documentation Data integrity
T90/T70/T50 G20 Automation
45
Standardization with Titration Excellence
Prevention of errors, simple operation
Intelligent burettes Automatic burette RFID recognition. Titrant name, concentration, titer and expiry data.
After titer determination titer automatically stored, with date and time.
Monitoring Titer value (Limits)
Useable life (Expiry date titer)
Life span (Expiry date of the titrant)
Warning levels: none, warning, block.
Lab Instruments & Solutions
- Analytical Instruments - Meters : pH / Cond / Ion / DO
- Titration : General & KF solutions
Density & Refractometers
- Melting & Dropping Point Analyzers
- Thermal Analysis Instruments
46
- Density & Refractometers
Analytical Instruments
Lab Instruments & Solutions
- Analytical Instruments - Meters : pH / Cond / Ion / DO
- Titration : Potentiometric & KF solutions
- Density & Refractometers
- Melting & Dropping Point Analyzers
- Thermal Analysis Instruments
48
- Melting & Dropping Point Analyzers
Analytical Instruments
Lab Instruments & Solutions
- Analytical Instruments - Meters : pH / Cond / Ion / DO
- Titration : Potentiometric & KF solutions
- Density & Refractometers
- Melting & Dropping Point Analyzers
- Thermal Analysis Instruments
50
- Thermal Analysis Instruments
Analytical Instruments
Thermal Analysis Instruments
51
MODULAR
EVOLUTIVE
COMPACT & INNOVATIVE TECHNOLOGY
MULTI COUPLAGE with MS, FTIR, GC/MS…
DSC TGA DMA
52
Agenda
Introduction Mettler-Toledo Group & Sales Int.
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
- Analytical Instruments
- Pipettes
Mettler Toledo Laboratory Solutions
RAININ - Manual Liquid Handling Solutions
53
Bioclean Tips
Electronic Pipettes
Manual Pipettes
Automated Pipetting
Tubes and Plates
Very accurate manual Dosing of very small amounts of
Liquid down to 1 microliter
Automated dosing of precise
amounts of liquids in a
programmable way
Automatically
and very accurately dose
up to 96 dosings at once
Highest purity
pipette tips that avoid
contamination even for
demanding applications
Liquid handling containers for Life Science applications
e.g. preparation of samples for DNA analysis
e.g. accurate and automated mixing of liquids
e.g. PCR preparation
e.g. plates for PCR
54
Agenda
Introduction Mettler-Toledo Group & Sales Int.
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Automation and Software solutions
- Analytical Instruments
- Autochem Solutions
Mettler Toledo Laboratory Solutions
Autochem - Solutions Overview
55
Synthesis workstations increase the number of successful
experiments
Track key reaction
components in-situ and in real time
Track the rate and degree of change of particles in real time
Understand reaction hazards for safe scale-up
of a chemical process
Transform data into key process
information
e.g. determine process
scalability
e.g. real time end point
determination
e.g. real time determination
of target particle size
e.g. determine safety criticality
factors
e.g. understand effect of
temperature on reaction rate
Reaction Calorimetry
Chemical Synthesis
Particle Size and Count
Data Capture and Analysis
Chemical Reaction Analysis
56
Agenda
Introduction Mettler-Toledo Group & Sales Int.
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
Automation and Software solutions
- Analytical Instruments
- Automation and Software Solutions
Mettler Toledo Laboratory Solutions
InMotionTM – Increase efficiency
Standard Rack # of samples Beaker size [mL]
Flex (420 mm W) Single Row
50 25 27 80 18 100 15 180
11 250
Pro (420 mm W) Multiple Row
182 25 69 80 34 100 23 180
Max (570 mm W) Multiple Row
303 25 113 80 55 100 43 180 24 250
Water Bath Rack Flex 18 100
Pro 61 80 29 100
59
InMotionTM – SmartSampleTM
60
Secure and Efficient Weighing with SmartSampleTM
Balance stores sample weight and more on RFID chip on sample beaker
Instrument reads out the weight automatically
Benefits Avoid transcription errors
Samples placed in wrong position
Sample ID associated to wrong weight
LabX - Streamline your Lab workflow
62
A unique software in with respect to instrument, data and workflow management.
One software platform
63
Pharma Regulations
Full Compliance with
Secure DB Regulation option
(audit trail)
E-signature User management
System Validation ONE system; not many
64
Agenda
Introduction Mettler-Toledo Group & Sales Int.
Pharmaceutical Processes & requirements
Mettler-Toledo Laboratory solutions
- Weighing Solutions
- Analytical Instrumentation
- Pipettes
- Autochem solutions
- Automation and Software solutions
-
UV/ VIS Spectrophotometers
Mettler Toledo Laboratory Solutions
Adaptable to your needs
66
Semi Automation
Heating and cooling thermostat
Automation
Standard cuvette
Long pathlength cell holder
Solid sample
Cuvettes (glass, quartz)
Certification