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Analytical Product Program » Tablet Dissolution Testing» Media Preparation» Accessories and

Qualification Tools

www.pharma-test.com

Inner values do count, at the latest during maintenance.

the german gründlichkeit

Where quality comes as standardIn the pharmaceutical industry, quality and safety standards are extremely

high. Meeting these standards requires the use of reliable test equipment

and systems. As a globally renowned manufacturer and supplier of

pharmaceutical test equipment, we are committed to upholding these

standards. We continuously develop and optimise our product range

to offer our customers both cutting-edge technology and a standard of

quality that satisfies the most stringent requirements. Quality is simply

an integral part of what we do.

This commitment to quality is reflected in all our products. Every product

in our range is made of sturdy, high-quality materials and complies

with all the relevant safety standards. Crucial components are made of

stainless steel rather than plastic, which means our products contain

no plastic axle mountings or bearings. This makes them easier to clean,

more hygienic and more durable for everyday laboratory use. After all,

it's the tablets that should disintegrate, not the equipment.

We back on sustainability, so that our instruments will have long term effects for you.

We love high quality materials, because for us hygiene and cleaning are no empty rethoric.

Precision measurements throughout the lifetime of the machineAbsolute precision is vital in the pharmaceutical industry. Any errors in

measurement could have serious consequences and must be avoided

at all costs. Pharma Test is synonymous the world over with high-quality

test equipment that's designed to produce accurate analysis results.

We strive for perfection to give you the best results.

Complete flexibilityNo two laboratories are the same. That's why an increasing number

of our devices are designed to be installed both either lengthwise

and or crosswise. After all, bench space is always at a premium.

The interchangeable control units allow the devices to be adapted

to different circumstances for maximum flexibility in installation.

All-in-one solutionAny pharmaceutical production line requires regular testing of various

parameters. But why measure just one parameter? With our test devices

We think holistic, because everything always influences something else.

Any pharmaceutical production line requires regular testing of physical

properties and active pharmaceutical ingredient (API) content.

For over 30 years, Pharma Test has been synonymous with the development

and production of high-quality test devices and systems for quality-testing

tablets, capsules, suppositories, ampoules, bulk materials and other solid

dosage formats. We offer a complete product range from manual instruments

for physical testing to fully automated analytical test systems to analyse

the active chemical composition of a dosage form.

Our foremost priority is to develop products with the quality you would expect

from the “Made in Germany” label – “The German Gründlichkeit”.

you can measure tablet thickness, hardness, diameter and weight all

at the same time. Measuring all these parameters in the same unit

process saves time, space and the money that would otherwise be spent

on additional equipment. As well as being versatile, our products are

intelligent: every test specimen is accurately and automatically fed to

the right place in the machine with no change of format.

Commitment to sustainabilityPharma Test is continually working to improve sustainability, both in the

production process and in the life cycle of our products. We choose only

durable materials and operate a comprehensive maintenance programme

to keep our products working reliably. Our high standard of quality forms

an integral part of our commitment to sustainability, because the durability

and reliability of our products not only delivers economic benefits – it reduces

their environmental impact too.

Our fraction collectors are individually attuned, because the exact result is always the most important thing. Why work with only one value?

Test thickness, diameter, hardness and weight in one go.

Complete product rangeWe offer a complete product range designed to meet all of your laboratory

and QC needs. From high-quality test equipment and systems to software,

made-to-measure solutions, maintenance and service, we cover almost

every requirement. Your needs will be dealt with by a single contact person,

who is part of the fully trained Pharma Test Team. So contact us today and

tell us how we can help you.

From the very beginning, Pharma Test has set itself the goal of satisfying

the stringent requirements of the international pharmaceutical industry.

Our range of high-quality test equipment includes analytical products,

automated systems and galenical products.

Features› Fully USP <711/724> and EP <2.9.3/4> compliant, low head design

with pneumatic flip-back lift

› 7 stirred positons (4+3), additional vessel used for either blank or

standard medium or for pre-warmed media replacement in case

of fraction collector usage

› Print out of a run time report with information about actual stirrer

speed, bath temperature (only with PT-DL1)

› RS 232 output to connect a data logger or for remote control in

either on- or off-line applications

The standard serial port can also be used to connect a PT-DL data-logger

to print out reports. The reports include the instrument serial number,

date, time, tool speed and bath temperature and can be recorded at

programmable time intervals.

The PT-DT70 is fully compliant to all major pharmacopoeias, like USP <717>,

EP <2.9.3> as well as the Japanese Pharmacopoeia. It is a low-head

dissolution tester, which provides a space saving, low cost entry into tablet

dissolution testing. Whether for a new laboratory or to meet tough budget

requirements, the PT-DT70 offers a lot of instrument for a comparatively

modest cost. It offers seven stirred positions as well as a pneumatically

supported lift off top for easy access to the dissolution vessels.

The vessels are arranged in two rows (4+3) and are easily accessible to

remove spent media and refill with solvent, simply by lifting up the

pneumatically assisted drive housing. To insert samples and withdraw

sample solutions, use the seven tube shafts which run through the top cover

of the instrument. Simply place your tablets next to the holes and introduce

them when ready to start. For easy sampling use the PT-MDS manual

sampling system which includes a stainless steel sampling tube, an in-line

filter and a 10ml disposable syringe. The PT-DT70 is already equipped

with all necessary interfaces for easy integration into automated systems.

Compact Dissolution Testing Instrument

PT-DT 70

the stirrer head of the Pt-dt70 can be easily flipped backwards

› Tablet Dissolution Testing

Advantages› Small footprint (approx. 65 × 55 cm), flip-back head and easy access

to all vessels

› Sampling channels through the head allow tablet drop and manual

sampling

› MonoShaft™ system to avoid re-adjustment of immersion after

tool exchange

› IQ/OQ documents included free of charge as standard

The new PTWS 100 is designed in compliance to the valid USP <711/724>

and EP <2.9.3/4> Pharmacopoeia. It features a bench saving six-vessel

design, including automated lift and staggered start. Furthermore, it offers

individual centering for all vessels.

The PTWS 100 exists in two versions: the PTWS 100D is equipped with a

single DC motor drive for all six stirring stations. The PTWS 100S includes

individual stepper motors for each one of the six stirring stations. This makes

is possible to run each station at a different stirring speed. Furthermore,

both versions of the PTWS 100 are also available in a 2 litre format.

For easy and fast maintenance, the pump and mains power are placed in

a separate housing. The special design, in which the blow-molded single

piece water bath is held in the instrument's chassis and the separated

heating system, virtually eliminates any vibration transfer from both within

the instrument and from external sources. Pump, heater, temperature

sensor and mains supply board are accessible without moving the bath.

This saves the need to perform a USP Suitability Test using after

instruments maintenance.

Features› Fully USP <711/724> and EP <2.9.3/4> compliant

› 6 stirred positons (2×3 or 3×2), stirrer speed and water bath

temperature are freely adjustable and are shown on the display,

programmable alarm times

› Print out of a run time report with information about actual stirrer

speed, bath temperature (only with PT-DL1)

› RS 232 output to connect a data logger or for remote control in

either on- or off-line applications

the PtWS 100d/S features optimal access for manual sampling


PTWS 100D/S 6-Station Dissolution Testing Instrument

Advantages› Modular design to minimize bench space requirements, excellent access

to all vessels

› Individual speed control for all stirred positions (PTWS 100S only)

› Individual vessel centering and staggered start feature for convenient

manual sampling

› MonoShaft™ system to avoid readjustment of the depth settings after

tool exchange


PTWS 310, PTWS 610, PTWS 1210 and PTWS D610 constitute the PTWS

series of tablet dissolution testing instruments. All instruments are

equipped with a central, automated pillar lift and an integrated protocol

printer. They each share to following features:

Method Storage and User ManagementThe PTWS series features large LC Displays, alphanumeric keypads and

a visual status information “traffic light”-system. The display always

shows the target settings and the actual measured parameters such as,

time, product and test information. Methods can be created directly

on the instrument and saved to a USB flash drive.

Water Bath and Vessel CenteringThe Plexiglass water bath is U-shaped and stabilized by a one-piece

frame. The bath cover is made from polypropylene. All vessels can

be individually centered.

Vibroban© Vibration AbsorbersIn order to protect the dissolution process from any internal or external

vibration, the bath is placed on to Vibroban© shock absorbers. Even the

built-in circulation pump is installed on a sprung-loaded platform to avoid

vibration transfer to the dissolution vessels. This unique design provides

system vibration immunity far below the recommended levels stated in

data from USP and various other publications.

“Easy Access“ to all Major ComponentsWhenever the heating system or power electronics need to be qualified or

serviced, the advantage of the easy access drawer design comes into

play. It is possible to service both components without moving the bath

from its qualified position. This means, you save the time and cost of a full

requalification and considerably reduce instrument down-time.

Optional FeaturesAutomationEvery PTWS instrument can directly control a PTFC-2 fraction collector

and a pump, for example in a typical “Off-Line”-application. All necessary

information for sample collection, medium replenishment and so on

is entered as a test description using the keypad and LC Display of the

dissolution tester. When the system is ready to be run, just press START

on the PTWS instrument and the automated sample collection sequence

begins. Furthermore, as the PTWS instruments are already equipped

with a communication port, they can easily be incorporated into a fully

automated online UV or UV/HPLC system controlled by the WinDiss

ARGUS software.

EPE Electronically Controlled Sampling ManifoldThe EPE auto sampling system only lowers the sampling probes into the

dissolution vessels during the actual sampling sequence. After the sampling

is complete, it is raised back into its upper home position. The user

can program the immersion depth and dwell time depending on the test

requirements.

TM Tablet Drop MagazineThe TM tablet drop magazine for synchronous insertion of the samples

into the dissolution vessels is also designed to effectively cover the

vessels as soon as the samples have been dropped. An automated tablet

magazine system is also available.

ITM Individual Temperature Monitoring DeviceIf the EPE auto sampling system is installed, it is possible to add the ITM

system to read and record the actual dissolution media temperature

during the sampling sequence. The results will be printed on the installed

printer or may be transferred and logged.


PTWS SeriesSeries of Tablet Dissolution Testing Instruments

The PTWS 310 combines compact design with state-of-the-art features

and a comprehensive supply scope, which includes a synchronous TM

tablet drop magazine. It is fully compliant to the valid USP <711/724> and

EP <2.9.3/4> Pharmacopoeia. The PTWS310 is secure in its handling

and features the Monoshaft™ stirrer tool design for all USP/EP stirring

tools. The vessels are arranged in two rows (4+4) and are easily removable

after driving up the instrument head. The Plexiglass water bath is

equipped with a water diffuser for an even temperature distribution.

The standard supply includes 1 litre vessels but smaller 250 ml mini

vessels and mini paddles can be used as well. Furthermore the

PTWS 310-2 instrument variant is equipped to handle 2 litre vessels.


› 8 stirred positions (4+4)

› Stainless steel instrument housing

› TM manual tablet drop magazine included in standard supply


PTWS 310 8-Station Dissolution Testing Instrument

Advantages› Water diffuser for even temperature distribution

› Individual vessel centering


tool exchange





› Vessels covered by individual lids

The PTWS 610 is fully compliant to the valid USP <711/724> and EP <2.9.3/4>

Pharmacopoeias. The six vessels "in line" design eases the manual

sampling and media refilling procedure, as the dissolution vessels are

lined up directly in front of the user. The two extra vessels in the back

row may be used to contain a placebo, blank or reference standard

media. The PTWS 610 is capable of staggered stirrer start. The vessels

are covered by individual lids. Each lid features openings for sample

withdrawal, temperature or pH measurements. For manual sampling we

offer the PT-MDS manual sampling device.

PTWS 6108-Station Dissolution Testing Instrument

Advantages› 6 vessels in the front row for optimal viewability and easy sampling access



tool exchange


The fully USP <711/724> and EP <2.9.3/4> compliant PTWS 1210 offers a

massive 12 sample throughput for busy labs and those wishing to complete

Q1 and Q2 result levels in one test. This bath design offers the same

physical conditions for all 12 samples inside the dissolution vessels: the

same tool speed, same temperature and the same immunity to both

internal and external potential vibration sources. The testing positions

are arranged in two rows (6+6) and offer staggered start capability.

The vessels are covered by individual lids. Each lid features openings

for sample withdrawal, temperature or pH measurements. For manual

sampling we offer the PT-MDS manual sampling device.


› 12 stirred positions (6+6) for testing of two batches




PTWS 1210 12-Station Dissolution Testing Instrument


› 12 stirred positions (6+6) for testing of two batches



The PTWS D610 is fully USP <711/724> and EP <2.9.3/4> compliant.

It offers the possibility of performing two sets of six tests each with either

the same or variable stirrer speed settings or even with different tool

sets. A 2 in 1 dissolution tester for the same footprint. Identical speed

setting is possible as well. This bath design offers the same physical

conditions for all 12 samples inside the dissolution vessels: the same tool

speed, same temperature and the same immunity to both internal and

external potential vibration sources. The testing positions are arranged

in two rows (6+6) and offer staggered start capability. The vessels are

covered by individual lids. Each lid features openings for sample withdrawal,

temperature or pH measurements. For manual sampling we offer the

PT-MDS manual sampling device.

PTWS D610Dual Speed Dissolution Testing Instrument

Advantages› Identical test conditions for comparative tests of two batches

(for example Biowaiver)



tool exchange


Advantages› Individual stirrer speed control for front and back stirrer rows



tool exchange



The PTWS 4000 is a specialised 4-litre dissolution tester version that

enables the user to perform either pooled tests, or test for dosage forms

that contain high concentrations of active material. The instrument is

supplied with six stirred 4 litre and two unstirred 1 litre dissolution vessels.

This instrument can also be easily adapted to handle 2 litre and 1 litre

vessels. The instrument control is the same as for all other PTWS

instruments described above but the frame work is substantially different.

Two lift pillars are used to move the upper head housing. Staggered

and synchronous stirrer start is possible. The system comes in a stainless

steel design which is one of the highlights of this instrument.


› Equipped with 4 litre vessels



PTWS 4000Pool Test Application Instrument

Features› Insert to test dissolution of suppositories

› Described in Japanese Pharmacopeia

› Driven by stirrers of dissolution testing instrument

› Active ingredient diffuses through membrane

The PTSW 0 can be used to test the dissolution rate of suppositories and

other lipophilic samples as well as gel capsules. It can not only be

incorporated into any PTWS tablet dissolution bath offering the staggered

stirrer start option (PTWS 610, 1210, D610 and 4000), but also into the

PTWS 310. The drive of the rotating cell is attached to the individual stirrer

shafts of the dissolution bath while the built-in gearbox of the PTSW 0

reduces the nominal tool speed by a ratio of 4:1.

The sample is placed into the cell together with about 5 ml of dissolution

media. The cell is sealed and the complete instrument is placed into a

standard USP/EP dissolution glass vessel. This is usually filled with water

at 37°C. The active material will diffuse out through the membrane which

covers the cell into the outer media, leaving bulking agents, such as

wax or cocoa butter, behind. Sampling and measuring of the active content

can be carried out by using a standard stainless sampling probe;

no additional filter needs to be used.

PTSW 0Rotating Dialysis Cell

Advantages› Larger volumes for highly concentrated formulations



tool exchange


Advantages› Usable in all instruments of the PTWS series

› Broadens the capabilities of existing dissolution testing instruments

› Simple to install and remove

The USP reference standard tablets, are used to perform a dissolution

instrument suitability test after a successful physical parameter qualification

(OQ). During this suitability test, the quality of degassing has a significant

effect upon the test results obtained; as does vibration. Naturally, the

mechanical “fitness” of the instrument has to be established and is usually

achieved by performing the OQ prior to the USP suitability test.

Low vibration levels, low wobble, correct tool centering and precise tool

depth settings are just some of the factors which may affect a successful

qualification – but media degassing is one of the most influential factors.

The PT-DDS4 media preparation system has proven in many tests and

in general operation, that its automated degassing and dosing procedure

fulfills the requirements of both the FDA and USP and that the USP

Prednisone qualification test (PVT) will successfully be achieved.

The prepared media (water or buffer) can either be filled directly into the

media tank or it can be automatically primed using the on-board vacuum

pump and the internal liquid level sensor which controls the pre-filling

volume. Select your method of choice and enter the maximum volume.

It is also possible to mix a buffer using de-mineralised water and a buffer

concentrate, if the on-line buffer mix option is installed.

The instrument’s keyboard and LC-Display are used to file product and

de-aeration information. Enter and file descriptive data for the number of

media doses required, user data, media information and so on. All method

related data as well as the dosage reports can be saved to hard copy

using the built-in printer. A maximum of 16 product and de-aeration

method files can be saved. As soon as all data is entered, the de-aeration

process can start. While the media is heated, it is constantly circulated

under vacuum within the tank. The de-aeration process needs about 30 to

45 minutes for approx. 25 litres of media. Thereafter, 25 litres of deaerated

and pre-heated media are available for either gravimetric or volumetric

dosing. Volumetric dosing will allow on-line dispensing directly into the

dissolution vessels. The PT-DDS4 is equipped, as standard, with a built-in

load cell which is used to precisely measure the dosing volume. It is also

used to qualify and adjust the dosing accuracy. A dissolution vessel holder

supports the empty vessel beneath the dosing tube. The number of

medium dosages as well as the actual dosed volume and any deviation

from target volume is reported via the built-in printer.

Features› Complies to USP/EP/FDA requirements

› De-aerated and pre-heated medium stored for approximately

24 UPS vessels

› User friendly menu systems and method storage

› Optional equipment for volumetric dosing and online buffer mixing

› Dissolution Media Preparation and Dosing

PT-DDS4Media Preparation System

Advantages› Considerable time saving compared to manual media preparation

› Moveable instrument for flexible usage

› Integrated cleaning, calibration and adjustment program


› Accessories and Qualification Tools

Pharma Test offers a variety of tools and accessories as described in the international Pharmacopeias.

MonoShaft™ System and Stirring ToolsAll vessels, stirrers and stirring tools are individually marked and batch coded. The stirring shaft is

attached to the drive system with a safety chuck. The required stirring tool is screwed onto the

stirring shaft without any change to the total length of the tool assembly. In case the currently installed

stirring tools (paddle, mini paddle, basket, transdermal cylinder, etc.) needs to be exchanged,

the operator does not need to re-qualify the immersion depth. Apparatus 1 Baskets are available with

various mesh sizes or even gold plated.

Test VesselsAll standard dissolution vessels feature an approximate volume scale and are individually coded.

The vessels are manufactured with a high level of precision and fully compliant to the strict tolerances

of the valid EP and UPS Pharmacopeia. We offer 250 ml, 1 litre, 2 litre, 4 litre vessels in clear glass

and alternatively in amber coloured format for UV sensitive tests.

SinkerWe offer a large variety of tablet and capsule sinkers in various forms and finishes. A range of paddle

and basket depth gauges, manual sampling systems, in-line filters with 5 or 10 micron pore sizes, water

diffusers for even heating of the water baths are also available.

SWT2 Test Insert for Bath and Vessel CenteringIn addition to this selection of accessories, we offer a full range of qualification tools for tablet dissolution

testing instruments, for example this SWT2 test insert to measure stirrer wobble and vessel centering.

dissolution vessels

monoShaft system and stirrer tools

Accessories and Qualification Tools

SWt2 test insert for bath and vessel centering

Over 70 distributors and agents serve your

interests world-wide, with fully qualified and

trained staff to service and maintain your

investment.

Pharma Test Apparatebau AGSiemensstraße 5

63512 Hainburg/Germany

T +49 6182 9532-600

F +49 6182 9532-650

[email protected]

www.pharma-test.com

Pharma Test Limited

12 Bell MeadCM21 9E Sawbridgeworth, Hertfordshire/Great Britain

[email protected]

PharmaTest Trade KFT

Nagyszalonta u. 13/b.1118 Budapest/Hungary

[email protected]

Pharma Test North Africa

97, Kournish El Nile – Rood El FaragCairo/Egypt

[email protected]

P.T. Pharma Test Indonesia

Komplek Mutiara Taman Palem Blok H2/19, Cengkareng11730 Jakarta Barat/[email protected]

Pharma Test Instruments India Pvt. Limited

No.2, 2nd. Floor, Sree Datri Niwas, Nagwara Circle,

Outer Ring Road Opp. Manyata Softech Park560045 Bangalore/[email protected]

Current as of May 2012

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