Lab Products & Solutions in Pharma - METTLER TOLEDO ... Solutions Overview in... · Lab Products & Solutions in Pharma ... Agenda Pharmaceutical Processes & requirements ... manual

Lab Products & Solutions in Pharma

Pharma conference Cairo - November,18 2015

Frédéric Poix

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


Mettler-Toledo Laboratory Solutions



- Pipettes



- Analytical Instruments


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





- Pipettes




Mettler Toledo Laboratory Solutions

6

Agenda



Weighing Solution


- Pipettes




- 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

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- Micro Balances

Weighing Solutions

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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



- Analytical Balance

- Precision balances



- Mass Comparators

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- Precision Balances

Weighing Solutions

Analytical & Precision Balances

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Innovative and continuous renewed Weighing solutions

Introduction April 2015

Introduction July 2015

Introduction October 2015

Introduction January 2015

The Excellence Line

A suitable solution for all your needs

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

New MS-TS Balances

21 21

New MS-TS – Trust and Comfort

22 22

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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


- Micro balances




- Mass Comparators

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Weighing Solutions

Automated Weighing solutions

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http://ch02wiki01.eu.mt.mtnet/images/9/98/Quantos_QS30_XPE_Terminal.jpg

Quantos HPD

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Automated Dosing & Weighing Solutions

from XPE and XS Analytical models

Anytime upgradeable to Automatic Solutions

QB-PS QB-P(L)

XPE

QA-L

http://ch02wiki01.eu.mt.mtnet/images/7/7d/QB1_QBL_diag_CutOut_02_def.jpg

http://ch02wiki01.eu.mt.mtnet/images/9/98/Quantos_QS30_XPE_Terminal.jpg





- Automatic weighing solutions

- Moisture Ana

- Mass Comparators

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Weighing Solutions

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HX204 / HS153 HE53 / HE73 HC103

Moisture Analyzer Portfolio

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






-

32

- Mass Comparators

Weighing 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.





- Pipettes






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


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™

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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

http://www.electrodes.net/


- Analytical Instruments - Meters : pH / Cond / Ion / DO

- Titration : General & KF




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- Titration : General & KF Solutions


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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

43

Titration Excellence A fully modular concept

Still very compact

44

Titration Excellence Expandable to the max

Connect up to 8 burettes

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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.



- Titration : General & KF solutions

Density & Refractometers



46



Density & Refractometers

47

Density meter DM40/45/50

Refractometer RM40/50 Automation



- Titration : Potentiometric & KF solutions




48



Melting and Dropping Point

49

MP50/70/90 DP70/90



- Titration : Potentiometric & KF solutions




50



Thermal Analysis Instruments

51

MODULAR

EVOLUTIVE

COMPACT & INNOVATIVE TECHNOLOGY

MULTI COUPLAGE with MS, FTIR, GC/MS…

DSC TGA DMA

52

Agenda






- Pipettes




- Pipettes


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






- Pipettes



- Autochem 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






- Pipettes


Automation and Software solutions


- Automation and Software Solutions


Automation with InMotionTM

57

Put Your Lab InMotionTM

InMotionTM Autosampler at a glance

One Automation Platform 58

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

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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

61

LabX Software

Connect the system to your existing IT

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






- Pipettes



-

UV/ VIS Spectrophotometers


65

Adaptable to your needs

66

Semi Automation

Heating and cooling thermostat

Automation

Standard cuvette

Long pathlength cell holder

Solid sample

Cuvettes (glass, quartz)

Certification

New UV/VIS Portfolio

67

UV7

UV5

UV5Nano

UV5Bio

Complete presentation during the WS

OneClickTM interface and LabX Software Uniform Use

UV/VIS pHmeter

Pharma Laboratory Solutions

69

Thanks for your attention

Documents

Lab Products & Solutions in Pharma - METTLER TOLEDO ... Solutions Overview in... · Lab Products & Solutions in Pharma ... Agenda Pharmaceutical Processes & requirements ... manual