Testeur de fluidité PF1

Galerie et schémas techniques

Description

Caractéristiques

• Support robuste avec deux bras facilement réglables
• La minuterie intégrée démarre et s’arrête automatiquement lors de l’ouverture/fermeture du volet
• Optimisé pour un nettoyage rapide
• Utilisation d’un agitateur ou d’un entonnoir de remplissage sans avoir à retirer des composants
• Mesure « Masse par Temps » simplifiée avec balance de laboratoire

Spécifications techniques

DT2

Manual disintegration tester (2 stations)

FT2

Friability tester (1 – 2 drums)

TD1

PF1 TM200 q-doc

™

Repeatability ± 0.03 mm

DISI

Automatic disintegration tester (1 – 4 stations)

DT50

MT50 FT2 ATS Xtend™ Semi-automated dissolution testing system*

HB43

Mettler Toledo®moisture analyzer

HR83

Mettler Toledo®moisture analyzer

HT10

Semi-automatic tablet testing system

LIMS

LIMS

MT50

Manual tablet hardness tester

ST50

Semi-automatic tablet testing system

WTDH

TDH+

p. 5

p. 17 p. 29

Depth

295 mm (11.6 inch) 395 mm (15.6 inch)

FT300

Flowability tester

Gauge

Preisser®(different models)

HS153

Mettler Toledo®moisture analyzer

HT100

Automatic tablet testing system

HX204

Mettler Toledo®moisture analyzer

Italy

India

Milan

Mumbai

SOTAX

SOTAX Europe SOTAX

TM200

Cap torque tester

US CA

CH DE FR GB TH IN CN

Width

–

p. 47

p. 59 p. 69

p. 79

p. 89 p. 99 p. 109

(1973)

Integration in USP (1996) (2005) (2006) (2011) (2018) (2019)

(1978)

(1993) (2002) (2008) (2013) (2014)

Audits

–

Convex

Oblong Oval Almond Hexagon Round Triangle

Europe

Americas

Height

190 mm (7.5 inch) 795 mm (31.3 inch)

Master

Client Media Preparation

Prague

Westborough, MA

Repair

–

System

32 bit, 64 bit

Tablet

Tablet

Weight

(without packaging) 11.5 kg (25.4 lbs) 20.5 kg (45.2 lbs)

intact

disintegrated

Balance

Sartorius®(different models)

Example

q-doc single workstation with three connected instruments

FT2 —

1 – 2 drums

Germany

Thailand (HQ Asia-Pacific)

Printer

LAN printer / Epson® 40col. Ethernet / RS-232 serial

q-doc®

q-doc®

AT50 —

For all your tablets

Accuracy

± 2 mm

Advanced

alarm signal for pH change

Americas

Middle East & Africa Asia-Pacific

Hardness

Units of measure N / Kp / Sc

Hardware

RAM min. 4 GB, better 8 GB

Lörrach

Bangkok

Managed.

Prevented.

Printer*

PostScript®3 (PS3) Ethernet

ST50 —

5 parameters

Services

Services (GMP) Services Services Services

Standard

Easy

Stations

2 independent stations

Trained.

Compliant.

optional

may include options or modifications not fitted as standard. No liability for errors and omissions.

required

Technical specifications are subject to change without prior notice. Products illustrated in this brochure

Built-in.

CPU min. 2 GHz, better Dual core / Quad core

Méthodes

écoulement à travers un entonnoir ou à travers un cylindre

Services.

Services.

Thickness

Units of measure mm / inch

operation

management

Analytical

Instrument

Cap Torque

Weight Dissolution Thickness / Length / Hardness optional may include options or modifications not fitted as standard. No liability for errors and omissions.

Controller

q-doc®data management software

Dimensions

267 x 356 x 608 mm

Drum types

Friability drum, anti-static

Foundation

Flow-Through Foundation Foundation Product Line Foundation Fully Automated Systems Acquisition

Friability

Weight Disintegration Thickness / Length / Hardness optional may include options or modifications not fitted as standard. No liability for errors and omissions.

Interfaces

2 x RS-232 serial

Job Import

LIMS Export LDAP Integration Data Trending Workgroups Extended

PVT / ASTM

–

Resolution

0.01 mm

Universal.

Cap adapters.

Worldwide.

service engineers

as needed.

ASTM B 527

test data.

Torque range 0 – 452 Ncm (0 – 40 lbin)

• Manual

• Manual Friability Tapped Density

AT Xtend™

Manual dissolution tester

Accessories

Capsules support, for 6-tube basket

Audit trail

Password security

By Experts.

Method automation –

Flowability

Cap Torque

Manage your

Test modes Open

Stand-alone

Online

Temperature

Range 25 – 40 °C, programmable

with funnel

with cylinder

ATF Xtend™

Fully automated dissolution testing system*

EasyTouch™

Program capacity 100 products –

For Experts.

R&D Services API screening & characterization –

For the lab.

Load up to 10 different

One for All.

Fast testing of

Pharmacopeia

USP <1174>, EP 2.9.36

Pharmacopée

USP <1174> EP 2.9.36

Power supply

100 – 240 V / 50 – 60 Hz 100 – 240 V / 50 – 60 Hz

Product Line

Fully Automated Dissolution Tester Product Line Acquisition Acquisition Product Line

SmartAdd —

Compact —

Test methods

USP <616> / Ph. Eur. 2.9.34, Method 1

Aesch / Basel

Westborough, MA

CE Conformity

The TM200 and MDU2 fully comply with all CE and EMC equipment guidelines relative to mechanical and electrical safety and

Configuration

10-magazine feeder, with SmartAdd™ –

Epson®40col.

RS-232 serial

Great Britain

China

Protocol your

Number of drums 1 – 2

RS-232 serial

–

Repeatability

± 1 N

Stroke height

Height 55 mm

Tablet press*

–

Weight (Mass)

Integrated weighing module Mettler Toledo®

dosage forms.

Operational qualification (OQ) –

re-validation

validation (CSV) • LIMS integration

test results.

Test modes USP <1216>

with cylinder

with funnel

Cylinder types

Glass cylinder, 250 mL volume

Czech Republic

Canada

Disintegration

Dissolution Hardness Dissolution Weight Moisture Hardness Hardness Friability Disintegration Tapped Density Weight

Master Station

Client Station Media Preparation Station

Noise emission

without optional noise reduction cabinet 78 dB (A)

Report results

Number of stations 1

Single or dual

Connect analytical

Tapped Density

Weight Moisture Friability optional may include options or modifications not fitted as standard. No liability for errors and omissions.

User interface

Program capacity 10

Width / Length

Units of measure mm / inch

do not connect

pins in disc

[email protected]

[email protected]

qualification.

Width

sotax.com/MT50

™

Angle of repose

Flow through an orifice — Flow through an orifice —

Calibration —

Weight (Mass) Integrated weighing module Sartorius®

Data Management

q-doc®software, for data collection

Data integrity.

Operating system (OS) Microsoft® Windows®7 / 10, Windows®Server 2008 R2 / 2012 / 2012 R2 / 2016

Free disc space

min. 20 GB

Integrated feet

–

Max. # stations

(per system) 1 3 1

Measuring range

2 – 800 N

Method transfer

–

Simply precise.

Measuring range up to 60 g

Smart. Smarter.

Tablet orientation with

Unit of measure

Ncm, Nm, kgcm, lbin, lboz

User interface*

Program capacity 100 products / methods

Version control

If there is no user action performed within

Your People —

Your Instruments —

Data Management*

q-doc®software, with full control of stations

External balance

Mettler Toledo®/ Sartorius®

Keep on running.

Minimum bench space.

LIMS integration

–

Tablet alignment

SmartAlign™with flap

Units of measure

mg / g

Your Project —

Your Problems —

characterization

and investigations • Qualification (IQ/OQ/PQ ) • Preventive maintenance

for your product

modifications not fitted as standard. No liability for errors and omissions.

Bottle dimensions

Diameter range 20 – 220 mm

Integrated wheels

–

Make life easier.

Weight (Mass) External balance Mettler Toledo®/ Sartorius®

Manage your data.

Stations 1 – 4 independent test stations

Power consumption

1’100 VA

Split sieve parts

Contact through

USP 1 / 2 / 5 / 6

USP 4 Hardness Disintegration

[email protected]

[email protected]

[email protected]

[email protected]

Balance connection

Mettler Toledo®/ Acculab®

Display resolution

1920 x 1080

Ingress protection

(against dust and water) IP52 IP52

Laboratory balance

–

Measuring accuracy

± 0.2 °C

Method development

–

Other basket types

6-tube basket, 18 mesh, automatic

Project management

–

Sample collection.

No dust inside the tester.

Strokes per minute

Frequency 30

edited or deleted.

authorized persons can perform certain tasks.

readily available.

with venturi system.

• Semi-Automated

• Semi-Automated

Analytical Services

Instrument Services

Dissolution Testing

Automated Sample Preparation Physical Testing

End-point detection

Technology Split sieves, discs with detection pins

Feasibility studies

–

Foston / Derbyshire

Shanghai

Measuring principle

Constant speed 0.05 – 5 mm/s, programmable

Networking and data

Calibration with traceable

Relocation services

–

Routine calibration

–

Temperature control

Dual control, built-in sensor / external sensor

included / required

Technical specifications are subject to change without prior notice. Products illustrated in this brochure

• Method transfer

• Relocation services

Complex dosage form,

Support Services Training (for different target groups)

Digital height gauge

– –

SOTAX in Switzerland

Method SOTAX in USA SPS Pharma Services Content Testing SOTAX in lndia ATF and AT50 Labserv and GNA Analytical

Static qualification

Measuring range 2 – 15 mm

Universal separator.

AutoAlign

the testing process.

of adapters.

DustX™brake cyclone

–

Linear force increase

10 – 200 N/s, programmable

We are there for you.

Global network of

management with q-doc

reference weights

[email protected]

[email protected]

• API screening and

• Troubleshooting • Installation • Training

• Method automation

• Audits and qualification • Project management

Preventive maintenance

–

Stirrer, for pivot arm

– –

• Method development

• Consulting • Routine calibration • Repair

Programmable rotational

from external analytical balance

Switzerland (HQ Europe)

USA (HQ Americas)

with cylinder or funnel

with stirrer and filling funnel

• Feasibility studies

• Training • PVT / ASTM • Troubleshooting

Fast. Precise. Flexible.

Special applications. Video monitoring.

Glass beaker, 1’000 mL

–

Routine re-qualification

–

The most suitable method

Technical specifications are subject to change without prior notice. Products illustrated in this brochure may include options or

Weight measuring station

Hardness measuring station

cylinder sizes / volumes

Small footprint

q-doc® network with FT2

Interfaces Ethernet, 2 x RS-232 serial

q-doc® network with TD1

Glass cylinder, 10 mL volume

static reference weights

Weight (without packaging) 32 kg (71 lbs) 30 kg (67 lbs)

Motorized drive unit MDU2

Electronic data

P Office + 41 61 487 5454

P Office + 1 508 417 1112

Repeatability (typically)

0.15 mg

common mistakes caused by

results, test run statistics, and redundant local user manage- module to analyze individual PCs, the workgroups module • Evaluate content uniformity

• Method validation and

• Computer system • FAT / SAT

DQD dynamic qualification.

Hardness

P Office + 39 02 8363 2641

P Office + 91 22 4295 0191

P Office + 420 246 039 260

P Office + 1 508 417 1112

P Office + 44 20 8349 6947

P Office + 8621-6135 6268, ext. 205

P Office + 49 7621 16 5635

P Office + 66 26 42 68 62

data strings. The powerful

party systems. Whether you q-doc with user groups in your a batch – or compare multiple by product, batch, or PC – inde- <USP 905>

q-doc® network with TM200

Printer Epson®40col. RS-232 serial

Modular additional stations

temperature monitoring

new test runs – and avoid

matically transfer individual any additional workload. Avoid integrated q-doc data trending large installations with multiple <USP 701> and Ph. Eur. 2.9.1

products. Wherever you are.

sotax.com/worldwide

such as registration of new

your test results? The LIMS password policy is “automati- results to perform batch com- “their” networked q-doc work- • Pass / Fail evaluation and

Acceptance tests (FAT / SAT)

–

Automate daily routine tasks

How do you want to evaluate Ensure that your company’s No need to export your test Limit what operators can see on

batch numbers or creation of

export module allows to auto- cally” followed without creating parisons. Use the seamlessly station. Particularly useful for automated re-test procedure

electronic data acquisition.

of repose.

High visibility and very easy

TouchControl sensor

Linear feeder prevents convex

with AutoAlign and SmartAlign

any operator action required.

flexibly adapted to your needs. current Windows password. identify trends. at hand. according to Ph. Eur. 2.9.5

directly from your LIMS, MES,

simply transfer recorded results – multiple passwords anymore – allows to view data in real-time only see the jobs, batches, • Pass / Fail evaluation based

import module allows to auto-

would like to export evaluated company’s Active Directory batch records over a defined pendently from general user • Calculate tensile strength

Intuitive icon-based EasyTouch

test results to USB flash drive Electronic data

Performance qualification (PQ)

–

matically transfer information

test runs (checked & judged) or (AD). No need to remember period of time. In IPC, the module rights. People within a workgroup <USP 1217>

or ERP system to q-doc without

the automated process can be operators can simply use their on a separate monitor to quickly and tests relevant for their tasks on Uniformity of Mass

or external analytical balance

23-position carousel

Cylinder, incl. set of 20 discs

–

Flow-Through Dissolution Tester

AT 700 Tablet Hardness Tester Zymark Automation Dr. Schleuniger®Pharmatron Xtend™Dissolution

Height (without glass cylinder)

270 mm (10.6 inch)

Linearity deviation (typically)

0.3 mg

P Tech Support + 41 61 487 5460

P Tech Support + 91 99 202 11 211

Platform, incl. collection tray

– –

Quick-change tongue with groove

Extended jaw for testing large

for child-resistant bottle caps

Calibration with traceable

manual transcription of complex

complete batch records to third ment and directly integrate results from all test runs within allows to flexibly restrict usage based on weight variation

Computer system validation (CSV)

–

Dr. Schleuniger®S-beam load cell

99.98 % linearity, over entire measuring range

Funnel, incl. 3 different nozzles

–

Method validation & re-validation

–

of test results to USB flash drive

SmartWay networking and data

Frequency (setting according to JP)

31

No modification of original records

User access restriction

efficient multi-parameter measuring

Configurable test reports and various

for easy alignment of convex shapes

objects up to 65 mm

Configurable test reports and various

control with user administration

with optional noise reduction cabinet

58 dB (A)

The base readily accepts an additional

Simplified “mass per time” measuring

platform for standardized measuring of

with laboratory balance

samples to large effervescent tablets.

(diameter)/hardness measuring.

stacking of several reference weights.

Dr. Schleuniger®S-beam load cell 99.98 % linearity, over entire measuring range

stored in an SQL database and cannot be

be defined and configured to ensure that only

The ST50 with patented SmartAlign tablet

Proven to master even the most unusual shapes, The ST50 can be optionally fitted with video

the complete measuring range on multiple

User administration

thickness gauge, the MT50 becomes a true

are presented in a clearly structured format.

“Flow through an orifice” type tests

Multi-purpose pivot arm for test setup

Sample collector, with 10 collection bins

–

When equipped with an analytical balance,

Angle of repose

a highly efficient data management system

AT4 Automatic tablet testing system

measure the opening and closing torque of

to the specific shape of a cap eliminate additional

measurements. Equipped with an integrated

tested parameters including statistical analysis

resistant weighing platform. Fragments or

measuring. An integrated TouchControl sensor

system setting, and reporting of results.

authorities all over the world.

Height 177 mm (7.0 inch); with FastTest™

207 mm (8.2 inch)

Quickly check the hardness station of your

Resolution 0.01 mm

Short cycle times and multi-batch handling

Compact and robust, the AT50 has a small

Width / Length (Diameter) Units of measure

mm / inch

continuously measures the force throughout

a flat top – minimizing the necessary number

double tablets are immediately discharged.

prevents compression during measuring.

MT50 before starting daily tasks. Sometimes

Measuring range 2 – 35 mm / optional: up to 65 mm

With little practice, operators can execute

Report templates can be easily configured to

load cell, the entire hardness range can be

User administration

of resources. From URS to implementation in

Our certified service engineers inspect your

range of tablet sizes and shapes. Optimized

specifically designed for your application. position during width, length / diameter, and hard-

systems, and seamlessly protocol everything

Instrument

with any other manual tester on the market.

test protocols to very basic reporting needs.

Receive a new lot from production for urgent

The open test area ensures that measuring

double-sided presses and bulk collection are

both single and double-sided tablet presses

multi-parameter runs quicker and easier than

individual requirements – from comprehensive

precision load cell located in the main unit

cap adapters can be utilized for caps with

to vary test conditions in a repeatable way.

Flow through an orifice, with cylinder

weight, thickness, width, length / diameter,

printout includes all specifications and indicates

Simply the fastest way to perform a series of

printed at the end of each test. Results for all

The patented SmartCal™ system uses a single

Resolution 0.01 mm

The self-adjusting high-speed feeder reliably

Two counter-rotating rollers accurately align

automated routine allows to adjust and verify

Data Management q-doc®software, with SmartWay™networking –

lab? No problem, the SmartAdd magazine feeder

operators can easily perform routine cleaning

multi-purpose testing system that accumulates

If pre-programmed products have been used, the

planning and coordination. Many projects fail

preventive maintenance programs. Avoid costly

All relevant user interactions and changes are

Even without LDAP integration, q-doc

Calibration (Adjustment / Verification) Static

with reference weights; dynamic: with DQD™

Record weight measurements from your balances,

Weight (Mass)ThicknessWidth Diameter / LengthHardnessDisintegrationFriabilityTapped DensityFlowabilityMoistureCap TorqueDissolution

are proven to find solutions for even the most

support by experienced professionals and product

bottle caps. Its universal holder accommodates

pressure typically caused by clamping or other

can be easily searched, filtered, printed, and

rules according to your company policy.

documented. In case of investigations, entries

allows to define several password security

external probe can be mounted on the basket to

(Apparatus A / B)

measured using a special “sensitive mode”.

Quick-change tongue with flat surface Clip-on jaws for 3-point bending strength test

Full traceability of product and method modifi-

a configurable time period, q-doc will auto-

Getting the most out of your equipment requires

From first installation to qualification and regular

The TM200 is specifically designed to precisely

Molded cap adapters that are custom-made

and hardness results in a single test protocol.

whether limit violations (T1 / T2 / PL) have occurred.

ensures precise temperature control of the test

End-point detection Manual detection mode, per sample

general feasibility check or need assistance in

help in troubleshooting, and coordinate activities

individual bins. Different collection modes for

and dust is completely removed. Ideal for

medium. A built-in sensor continuously monitors

Manual detection mode, all samples

simply due to inadequate preparation and a lack

machine downtime and keep performance high.

your tests. Whether you would like to perform a

and Asia find solutions to your technical problems,

“sensitive mode” for breaking forces as low

require any tools. Because settings are stored sample – marked with tablet ID# and time stamp for

allows flexible interaction and avoids downtime.

of the stations.

alternatively the operator simply checks whether

Bath capacity 5.5 liter

certified reference weight in multiple positions

Measuring range 2 – 25 mm

positioning system handles an exceptionally wide

the ST50 can be fitted with a custom carousel monitoring to automatically record the tablet

tablets up to 800 N, and even large effervescent

correct custom parameters are automatically it provides great observation possibilities for better

unusual tablets shapes and special applications.

specialists whenever you require assistance.

Shortest warm-up times with induction heating and

(individual or per test run). Printout of test reports. a laboratory balance. Printed test reports or electronic

a laboratory balance. Printout of test reports or

funnel or cylinder, as well as determination of theangle acquisition. and flexible configuration according to individual SOPs.

address the various challenges on the road ahead.

maintenance according to standardized checklists.

as 2N allow testing of small mini-tabs, very hard

individually for each product and method, the easy retrieval in case of OOS investigations. In R&D,

be qualified using the DQD™ qualification tool.

Safety cover (anti-static)

tests to method programming, user administration,

ensure results that are accepted by regulatory

trained and qualified operators, supervisors, and

calibration – SOTAX on-site services give you

various tests performed on different instruments.

Method 2 3 mm, ± 0.2 mm

Measurement data (“raw data”) is automatically

User groups and their access rights can

anything from small bottles to large jugs. A high-

cap fixtures. Alternatively, universal membrane

finding optimum process parameters – our experts

with field service if needed. Friendly, uncomplicated

jaw movements, powerful electronics, and a special

Change-over only takes seconds and doesn’t ness measuring. Video clips are created for each

non-broken tablets are automatically diverted into

are gently decelerated as they arrive at the tester

require any (partial) disassembly of the tester or

Repeatability ± 1 N

separates all sizes and shapes – from very small

even the most convex shapes for width / length

Robust manual hardness tester with Dr.Schleuniger®

Smart, Smarter, SmartTest. Semi-automatic tablet testing Robust tablet testing system for fully automated

Standardized determination of the tapped density of

Standardized characterization of powders, granules Tester for manual or motorized inspection of the More than “just” data integrity. Automated data collection

administrators. Standardized training modules allow

ease of regulatory compliance throughout the life

all samples have disintegrated within the specified

User interface Program capacity 10 methods

different types of powder flow tests – and allows

Test methods Flow through an orifice, with funnel

functions within your organization. From performing

and documentation by certified service engineers

make the AT50 a true workhorse for your laboratory.

footprint and fits on a standard laboratory bench.

managed phases, qualification, and training – our

instruments in regular intervals, exchange critical

project managers help your organization to actively

parts before failure occurs, and execute routine

qualified using the DQD qualification tool. A fully

Xport™option (export on USB flash drive) –

testing or a new stability timepoint comes into the

processes remain fully visible at all times and that

the circulating water temperature and an additional

Baskets 6-tube basket, 10 mesh, manual

Collect samples at regular time intervals for future

Prevent dust from entering the AT50 using our Dimensions Width 450 mm (17.8 inch) 580 mm (22.8 inch)

Larger installations and networked solutions require

Extend the life time of your equipment with SOTAX

Tablets are automatically centered on the vibration-

arrive on their convex side for correct thickness

and DIN EN ISO requirements. Suitable for connecting

(USP, Ph. Eur.). Powder flow through an orifice with caps. Printout of test reports or electronic data over 30 test devices, central database, LDAP integration,

of various tests performed on different instruments.

Balance connection Mettler Toledo®/ Acculab®

reference or for further testing in the lab. Tested,

unique DustX brake cyclone. Diverted samples

specialists will assess possibilities for automating

Our SOTAX support teams in Europe, North America,

A fully automated routine allows to adjust and verify

EasyTouch™ Program capacity 100 products 100 products

configurations are readily available for establishing

AT50 Automatic tablet testing system

powder and granules according to USP, Ph. Eur., ASTM,

and other bulk materials according to Pharmacopoeia cap torque of various screw caps incl. child-proof and evaluation of all batch tests. Standardized drivers for

run time. If baskets are lifted out during a test for

Printer Epson®40col. IEEE 1284 parallel

Dimensions Width 404 mm (15.9 inch); with 65 mm option

434 mm (17.1 inch)

continuous temperature measurement of the test medium.

data management with q-doc®software.

measuring technology for fast and precise recording of

system with SmartAlign™for reliable alignment of various measuring of 5 physical parameters. Operate stand-

tablets up to 25 mm diameter – all on the same unit.

loaded when starting a test run. understanding of breaking characteristics.

up to 5 parameters. Simple operation with EasyTouch™

tablet shapes. 5parameters with integrated weighing alone on your lab bench to load multiple batches or

Bathless disintegration tester with 1 – 4 stations for

Disintegration tester with 2 independent test stations Friability tester with 1 – 2 drums and integrated 10 ° tilting

and optimized test sequences for different requirements.

module and Dr. Schleuniger®measuring technology. integrate online with your tablet press for automated IPC.

The DT50 integrates seamlessly with q-doc data management

Manual detection mode, per sample

required, a report including “pass / fail” evaluation

Dr. Schleuniger®S-beam load cell 99.98 % linearity, over entire measuring range

targeted knowledge transfer – tailored to the different

cycle of your instruments. Standardized execution

automated detection of the disintegration time per sample.

for manual protocolling of the disintegration time function according to USP <1216>. Suitable for connecting

Extend your DT50 to a disintegration system with up to four

Easy handling.

From method development to stability studies and commercial

Friendly and competent local service is the cornerstone of

Modular documentation packages for qualification / computer

Database MS-SQL®(Express or full version) 2008 R2, 2012, 2014, 2016

SOTAX offers unique specialist knowhow in close cooperation

Routine Analytical QC analysis –

Test protocols including weight loss and percent friability

Rotation Speed 20 – 100 rpm, programmable

with q-doc data management for consolidated batch reporting

10° tilting function

automatically consolidates all testing data into one clearly

3-tube basket, 10 mesh, manual

challenges associated with release testing of pharmaceutical

Installation qualification (IQ) –

From version control to advanced user access right management

Mouse

a single test protocol. For efficient batch analysis, q-doc®

Basket types 3-tube basket, 10 mesh, automatic

batch release in a US-FDA-inspected, certified Pharmaceutical

our business. A global network of service engineers and certified

possible, results from multiple stations can be combined into

6-tube basket, 10 mesh, manual

Additionally, the qualification procedure is fully menu-guided

Test modes Time

Based on decades of experience and unique application knowhow,

training, to preventive maintenance, regular re-qualification,

assistants helps companies worldwide in overcoming the various

Compliance Services Installation –

for implementation of a fully 21 CFR part 11 compliant system.

Communication ports Depending on connected instruments / systems

services are a one-stop solution for Pharmaceutical companies.

instrumentation – from on-site installation, qualification, and

with SPS Pharma Services. Set in an independent cGMP-compliant

Stability studies –

with q-doc data management for consolidated batch reporting of

Stroke height Method 1 14 mm, ± 2 mm

completion of a test. If needed, the TD1 can also be integrated

User-defined 50 – 300, programmable

of large tablets and re-tests according to USP <701> as easy as

Basket types 6-tube basket, 10 mesh, automatic

Station. Retrofit is simple with a standard Ethernet connection.

been optimized for fast and ergonomic handling.

The TM200 allows programming of up to 10 different products. For

Max. bottle height* 330 mm

and users with q-doc . Use the same method on different systems,

21 CFR part 11

electronic signatures, audit trail, and advanced user management

Consolidated batch

capabilities. Test protocols with automatic calculation of Tapped

Strokes per minute Method 1 300

each test, up to 100 measurements can be protocolled and reported

Motorized drive unit MDU2

Establishment with GMP-compliant quality system – our analytical

SOTAX partners assists you throughout the life cycle of your

To document testing sequences, the TD1 features built-in reporting

User-defined

by connecting a printer. Alternatively, the TM200 can be connected

Cap adapter* Molded cap adapter, for bottle caps (custom)

calculations can be conveniently printed directly from the tester.

Accuracy ± 1 rpm

software. Each station is controlled individually. To make testing

Manual detection mode, all samples

Density, Compressibility Index, and Hausner Ratio can be printed on

Method 2 250

Static qualification with a single SmartCal™reference weight that

Epson®40col. RS-232 serial

and FDA-inspected facility, a team of scientists, analysts, and lab

Clinical & Commercial batch release –

batch reporting from multiple instruments in different departments.

Universal membrane cap adapter, Ø small

with q-doc software for electronic data collection and consolidated

Molded cap adapter, for pump caps (custom)

Dynamic qualification of the entire hardness range without requiring

Video monitoring

and a human readable audit trail – q-doc fulfills all requirements

Keyboard

including a printed report. If needed, the FT2 can also be integrated

Revolution count

our team of experts will find a solution for your specific challenge.

and uncomplicated troubleshooting support in case of problems.

can be printed on completion. Calibration (Adjustment / Verification) Static

with reference weights; dynamic: with DQD™

Conformités et normes