QLA Validation Stopper, Sotax Compatible - CADSTP-ST *OBSOLETE*

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Validation Stopper (two holes for manual and auto cannulae)

QLA innovated product, used in Sotax Applications

The Cannula
Almost every dissolution test relies on samples being taken to produce a result. It is important that the sampling method does not adversely affect the accuracy of the dissolution test. Sampling errors are very common and are often the cause of erroneous results. The sampling position is critical but so too is the type of sampling cannula (also known as a probe) used.

Key Considerations

Sampling Position – The sampling position is important particularly for tests with baskets as there can be a concentration pro?le between the bottom of the vessel and the stirring element. It is less noticeable with paddles as the extra agitation provides for a more uniform ?ow pro?le. The sampling position is different for 500ml and 900ml tests. This can create problems for equipment that uses ‘through the shaft’ sampling.

Cannula Length – Cannulae vary in length from 4.75” (120mm) to 15” (380mm). These extended lengths are normally used for “through the head sampling” whereby the cannula passes through the drive head of the dissolution bath.

Cannula Material – The cannulae are made from either stainless steel or PEEK so that they do not adsorb or interfere with the active ingredient.

Stoppers – Cannulae can be used with stoppers during manual sampling to ensure that the sample is always taken from the same depth. Stoppers are attached to the cannulae and sit in a hole in the vessel cover. If these are to be used then it is important to get the stopper and cannula to match the vessel cover type or manufacturer. The range of self-tightening stoppers can be installed and positioned without the need for tools such as screwdrivers or
spanners.

Selecting a Self-Tightening Cannula Stopper

Self-tightening cannula stoppers offer a convenient method of setting the cannula sampling position in accordance with USP 711. Adjustable cannula stoppers are available for Distek, Hanson and VanKel cannulae.

Since there are numerous con?gurations of cannulae and dissolution instruments in common use, the speci?c application should be reviewed to ensure correct stopper selection.

The two factors which determine the speci?c stopper choice are:
1) Cannula outside diameter
2) Stopper outside diameter