FAQ

Dissolution Testing

Which system for online dissolution testing do you offer?

We supply semi-automated systems as well as fully automated dissolution solution packages. The latest invention is the IDS-1000 In-Situ Fiber Probe system. As the new DTS-800 its world-wide a unique design because all equipment needed to perform an automated dissolution test is "on board".

Which type of spectrophotometer can you control with the WinDiss ARGUS dissolution software?

There are many drivers validated and available, like: Agilent 8453 Diode Array, SA500 Diode Array, PTAG T60 + T70, Perkin Elmer Lambda, Analytic Jena Specord, Cecil 3000 - 7200, Varian Carry 50, Shimadzu, and others.

Is there a driver available to run Pharma Test dissolution baths with the Agilent ChemStation software?

Yes, we offer a driver for Agilent ChemStation, which can controls all Pharma Test baths.

Do you offer any suitable attachment for UV sensible drugs?

Yes, we supply amber coloured vessels.

What is special about your PT-DDS4 media degasser?

Some of unique features of the PT-DDS4 are: a built-in calibration program to qualify and calibrate the dosing accuracy - no need for any external balance. Of course the calibration and validation results are printed using the built-in printer. Dosing correction by entering the MEDIA DENSITY is a big advantage offered by the PT-DDS4. A dosing report is printed including information of the media and the dosed weight or volume.

Why do you offer a media preparation system with a 25 litre tank?

Most of the users of the PT-DDS4 dearation system produce the dissolution media in batches to fill media either into more than one dissolution bath or to use the dearated media for several tests. As the media can easily be stored in the tank, the time saving is a valid point. As is the reproducability of the media quality.

What is the major advantage of the new PTWS 100?

It is probably the smallest dissolution bath available and it can be placed in two different ways on your laboratory bench, making optimal use of the available space. The display and keyboard can be attached by the operator into a position which makes it easy for him to see and use it.

Do you supply qualification equipment and PVT standards?

Yes, we supply all necessary equipment to perform mechanical and chemical calibration of any dissolution bath, as well as corresponding certification.

What does "media refilling" or "media replacement" mean?

Media refilling means, that the system automatically replaces the medium which has been removed from the testing vessels while sampling with fresh medium for all vessels. The reason for this is that the Pharmacopeia allow only a very small change in the volume of the vessels for the total dissolution run. This means when a certain volume is sampled or you sample multiple times in one run (a dissolution profiling test) the sampled medium needs to be replaced. An alternative method is to mathematically correct the volume in the vessels to reflect the change after sampling. In most cases of automated dissolution systems, media refilling is used.

Where should the sample be removed?

Samples always have to be removed at the same position within a dissolution vessel: midways between liquid level and tool, not less than 1 cm off of the inner vessel wall. Pharma Test offers the PT-MDS sampling device for manual sampling to make sure the operator always complies to this requirement. In automated dissolution systems, the EPE automated sampling manifold will always drive to the same position during sampling.

What does "staggered start and sampling" mean?

„Staggered start and sampling“ means that the stirring will only start when the tablet is already inside the vessel and down at the spherical bottom. If the stirrers start earlier, the tablet may start to flow and rotate, which will change the dissolution speed. „Staggered start and sampling“ instruments allow to start each stirring station individually. This means, the user can drop the 1st tablet and when it is down in the vessel, he starts the 1st stirring station. Now he waits for 30-60 seconds before starting the 2nd station, as this is the time he will need to withdraw a sample and refill the media. This process is repeated until all samples are inside the vessels. Parallel start is possible for all automated dissolution systems, which are connected to a fraction collector, auto sampler or spectrophotometer with a multiple cell changer.

For what are the extra vessels in some dissolution testing instruments used?

The two extra vessels of PTWS 310, 610, 1210, D610 and PTWS 4000 can be used to take blank media (USP buffer or water) and/or a reference standard (pure active dissolved in the dissolution media).

What does MonoShaft mean?

All stirrers of Pharma Test tablet dissolution testing instruments are MonoShaft design versions: the stirring tool consists of one common stirring shaft to be used for every available stirring tool and an adapter with the appropriate length for a certain stirring tool (such as for example baskets). This means that the stirring shaft can always remain inside the instrument, while only the stirrer adapter (paddle, basket or transdermal cylinder) has to be exchanged when switching from one tool to another. Because of this, there is no need for the operator to qualify immersion depth after a change of tools. The joint of the MonoShaft stirrers always remains outside the medium.

Why should I think about automating my dissolution testing?

Dissolution testing is probably the most time and human resource consuming test in a pharmaceutical company. In manual operation usually the user has to be present at the instrument in order to take the samples within a narrow time frame with just +/- 2% of tolerance. This means if he has, for example, to remove a sample every 5 minutes, he should not be more than 6 Seconds early or late. To test sustained release tablets which may take 6 hours, 8 hours or up to several days (transdermal patches) is usually impossible to handle with manually operated equipment.

Disintegration Testing

Do the automated disintegration test instruments meet the Pharmacopoeia requirements?

Yes, they do. Pharma Test has developped a system in which the disks still have the same weight as "manual" ones, also the basket design still meets the technical descriptions.

Is there any adjustment necessary to use your automated disintegration testing instruments?

No, automated detection does not need any adjustment at all.

Do you need a software to run the PTZ AUTO EZ series?

No, the PTZ AUTO EZ series have a built-in firmware program which can file up to 20 product methods and print the relevant result sheets. Even so we offer a 21CFR part 11 compliant PTZ32 software program to offer the possibility to run a batch statistic program etc.

Can the disinteration media temperature be measured?

Yes, using the new PTZ AUTO EZ series you can always read and record media as well as bath temperature as long as the basket is immersed into the media.

Is the disintegration basket still immersed in media at the end of a run?

This depends on the instrument type you are looking for. The PTZ AUTO and PTZ AUTO EZ series lifts the baskets completely out of the media at the end of test run. PTZ S and DIST 3 do not offer this feature.

Which type of printer can be used with the PTZ AUTO instruments?

Any PCL capable printer is suitable, we suggest to use a Laser Jet as it is document proof.

Can a manual (semi-automated) disintegration testing instrument be upgraded to a fully automated system?

Yes, PTZ AUTO instruments can be upgraded to the fully automated PTZ AUTO EZ version. All you need is the detection electronics and the electronic PT-MKT baskets. Pharma Test offers an update kit for that purpose. Please contact your local Pharma Test representative for more information.

How many individual operateable testing stations do your disintegration instruments feature?

You can select everything from a single station unit to an instrument which includes four individually operateable testing stations.

Do you supply manually operateable disintegration test instruments?

Yes, the PTZ AUTO instruments can be supplied as strictly manually operated units. Also PTZ S and DIST 3 are completely manual instruments.

Suppository Testing

Is there a tool available to test dissolution of suppositories?

Yes, for this purpose we offer the PTSW0 suppository dialysis cell which is placed into a standard USP dissolution testing instrument.

Do you manufacture a single station suppository disintegration testing instrument?

Since the Pharm.EUR aks to always test three suppositories, we only offer three station suppository disintegration testing instruments.

What is the SPT-6 used for?

The unique SPT-6 is used for testing of the softening time of suppositories. This time gives information about the "hardness" of the fat based drug.

Tablet Hardness Testing

Do your hardness testing instruments operate on speed mode?

All our hardness testing instruments can be set to either linear force or linear speed increase mode. The rate is also programmable.

Do all tablet hardness testing instruments show the same results?

Yes, all Pharma Test hardness testing instruments show the same results, if the operation settings are the same. Different force increase mode, different force increase rates and different ways of touching the tablet will cause different results. Pharma Test hardness testing instruments allow adjustment of all these settings.

Which tablet shapes can your 4 in 1 WHT 3ME handle?

The WHT 3ME is the only automated tablet testing system which can reliably correct the position of capsules or oblong shaped samples. This instrument is equipped with the unique "sample orientation flap" system. No need to change any tool to keep a capsule shaped sample at the correct position while height, length and hardness are tested.

How do Pharma Test tablet hardness testing instruments fulfill the calibration requirements from the current USP Pharmacopeia?

The current USP Pharmacopeia requires the force sensor of a tablet hardness testing instrument to be calibrated periodically over the complete measuring range (or the range used for measuring samples) with a precision of 1N. All Pharma Test tablet hardness testing instrument can be statically calibrated over the complete measuring range by the use of different tracebale counterweights. All instruments support the checking of at least three different points during calibration to prove the linearity of the force sensor. Furthermore, Pharma Test offers the PT-MT magnetic tablets to calibrate the breakpoint detection of the whole tablet hardness testing instrument (force sensor and mechanics of the instrument). All Pharma Test tablet hardness testing instruments are fully compliant to the requirements of the current USP Pharmacopeia.

Friabilty Testing

Are the friability drums made of anti static material?

No, there is no Perspex or Acrylic material available which is anti static, but we offer drums with anti static coating.

Do you offer automated friability testing instruments?

Yes, we do. The PTF DR series includes a RS232 interface to connect an analytical balance directly to the friabilator.

What is the "abrasion" drum used for and is it described in any Pharmacopeia?

The standard friability drum is used to test "rolling and impact" durability, while the abrasion drum simulates the mechanical stress for the samples during transportation. Currently the abrasion drum is not described in any Pharmacopeia.

Powder Testing

Which testing acccessories are included with the new PTG-S4?

The PTG-S4 is fully equipped to test cone-angle, flow-time, flowability, cone density and weight, weight increase curve. Also the stirrer which is needed to test powders having high amount of fine particles is included in the system.

Does the PTG-S4 powder testing instrument meet the specification of the Pharm.Eur.?

Yes, the PTG-S4 is equipped with the EUR flowability test set.

Are the PTG 2 or PTG-S3 still available?

No, it is replaced by the powder charaterisation solution package which is offered by the PTG-S4 as this system also includes a built-in balance and printer as well as all necessary test equipment. The technical specifications of PTG-S3 and PTG-S4 are the same but the PTG-S4 features a fully integrated dust protection cover in the standard scope of supply. This dust protection is held in place by magnets and can easily be removed for cleaning.

How can you qualify the tapping height of the PT-TD200 tap density testing instrument?

For this purpose we offer a "wobble" meter. The PT-TD200 tap density testing instrument has a special qualification program, which allows to measure the tapping height at a reduced operating speed.

What is the principle of the tapping height measurement?

The PT-TD200 program offers a "qualification setting" which slows the speed of the tapping mechanics down to enable the operator or an automated gauge to accurately measure the tapping height. This is a unique feature of the PT-TD200 instrument.

Do you offer cylinder types than 250ml.?

Yes, we offer also the 100 ml cylinder including the cylinder dish and holder. The smaller cylinder can easily be exchanged within the PT-TD200.

Can the PT-TD200 be used to test tapping density (apparent volume) as per USP 616 (apparatus 1+2) and also as per EP 2.9.15?

Yes, the PT-TD200 features two seperate testing positions. The instrument automatically detects in which one of the two testing positions the cylinder is placed into and automatically adjusts speed and tapping height accordingly.