Manufactured from Pure Quality material, QLA filters are fabricated in special moulds in clean-room conditions to ensure the best manufacturing practices. Samples from each batch are then tested for dimensional accuracy and then further tested for heavy metal content, inorganic interference and other possible contaminants.
Genuine QLA filters are guaranteed suitable for dissolution testing and CERTIFIED to be compliant with USP standards. So you can be certain that every batch of every filter will be consistent and the same as every other batch.
Cannula Filters are used when high levels of particulate are present. They generally have a large surface area and may affect the hydrodynamics in the vessel. However they have a good flow rate and may be used to prevent particulates blocking the sample probes. A large porosity range is available. There are some points to take into consideration when it comes to choosing the right cannula:
Filter Discs have a lower surface area than a cannula filter. In-Line Filter Discs (or filter frit) are recommended for use of low volume sample probes. These filter discs are designed to keep the filtration process outside the vessel but may suffer from blocking due to the lower surface area. To avoid blocking, go for the Hi-Cap cannula which uses standard cannula filters outside the vessel.
Filter Tips are smaller than cannula filters. They fit on the end of larger diameter sample probes.
On 27th December 2013 the USP general chapter 232 was approved and becomes a requirement, with enforcement in 2015. Under this chapter, there is a requirement to show that pharmaceutical companies demonstrate that their compounds comply with strict limits for heavy metal and elemental levels determined by the USP. Previous testing for these is acknowledged to have been poor and this change is aimed to correct that anomaly.
In order to demonstrate that, it is necessary that no part of the dissolution system contributes any heavy metals into the system, and in particular the dissolution filters through which samples are taken.
From June1st 2013 all QLA dissolution filters are tested by ICP-MS and certified to be heavy metal free and therefore suitable for dissolution testing. To further re-enforce the quality of their filters, QLA are introducing their ‘Pure Quality’ label, and all filters labelled as such are traceable not to contain heavy metals. That coupled with their ISO9001 certification awarded by BSI ensure that QLA product remain at the highest quality level possible.