Quality Lab Accessories – QLA – manufacture quality Dissolution Accessories and Consumables and Calibration Tools, and Jaytee are proud to distribute and support the range throughout the UK & Ireland.

Proud of being the only non-OEM company in the dissolution industry that have a fully staffed machine shop and modern manufacturing facility, they provide innovative designs and common sense solutions.

Quality

QLA operates a Quality Management System which complies with the requirements of the ISO 9001 current standard (certificate# FM595556). Our Lab Services division is ISO/IEC 17025 accredited (certificate#L15-277).

In addition to our commitment to ISO, we are also fully committed to all applicable regulatory standards, including:

• U.S. Pharmacopeia General Chapters 701, 711, 724, 1092 and others
• ASTM E2503 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
• Calibration tools and services are traceable to N.I.S.T. standards.

All QLA dissolution accessories and consumables have been manufactured in the USA and are U.S. Pharmacopeia compliant where applicable and meet machine manufacturer’s specifications. Information including QLA part numbers, descriptions, OEM part numbers and specifications are subject to change without notice.

Dissolution Baskets

Adopted in 1970, the rotating basket method of dissolution testing was the first official method. It essentially consists of an approximately 1 inch (25.4mm) × 1 3/8 inch (34.925mm) stainless steel, 40 mesh wire basket rotated at a constant speed between 25 and 150rpm. This method is now called Apparatus 1 (or Method 1).

The apparatus consists of a metallic drive shaft connected to the cylindrical basket. The basket is positioned inside a vessel made of glass or other inert, transparent material (see page 20). The vessel contents are kept at a constant temperature by being placed inside a water bath or heating jacket. The solution in the vessel is stirred smoothly by the rotating basket.

The USP Method 1 requires a 40 mesh screen unless otherwise specified in the monograph. Other meshes can be used to solve individual problems.

BASKET INSERTION & REMOVAL TOOL		BASKET STORAGE
The QLA Basket Tool provides a firm grip on baskets without damaging the basket during insertion and removal from shafts. The tool grabs hold of the lower rim and protects the delicate wire mesh for an easy fit of basket onto shaft.		The QLA Basket Holders provide a convenient way to organise and store baskets when they are not in use. The chances of accidentally damaging baskets are significantly reduced with the use of a good quality basket holder.
Key Benefits Can be used with any standard size dissolution basket Decreases contamination from hands Basket damage can result in excessive basket wobble and mechanical calibration failure Simple but effective design Can significantly increase the life of baskets and pay for itself in no time.		Key Benefits Compatible with all popular basket types (Agilent, Distek, Erweka, Hanson, Pharmatest, Sotax) To ensure your tests meet USP requirements, it is essential that all baskets are not bent or deformed O-rings ensure baskets are held firmly to the holder Fully stackable to maximize storage space and transport many baskets Low cost — it pays for itself by preventing damage to just one basket!
Part No.	Description	Part No.	Description
QLA-BSKTOOL	Basket Insertion/Removal Tool	QLA-BSKHLD-6	6 Position Basket Holder
QLA-BSKTOOL-DK	Basket Insertion/Removal Tool for thick rim baskets	QLA-BSKHLD-12	12 Position Basket Holder

FELODIPINE BASKETS
The USP Monograph for Felodipine Extended-Release Tablets specifies the use of a quadrangular stationary basket. The QLA Stationary Basket fully complies with the USP Monograph. The QLA Felodipine Basket is made from precision welded 316 stainless steel mesh and the basket is securely fixed to the shaft and will not easily bend or break off. The basket also features a small flap to prevent the tablet from escaping during testing. The flap is fabricated so that it will not fall off or be lost during use. USP 26 requires the use of a basket suspended a precise distance from the paddle shaft, which in turn requires the use of a modified vessel cover.
Key Considerations: The Felodipine Basket method offers a potential solution to problems associated with floating, sticking and swelling dosage form While the use of sinkers may solve similar problems, their final position in the dissolution vessel may vary, thus contributing to variations in test results — these variations can be eliminated by using the stationary basket Suitability for certain applications must be verified		STATIONARY BASKETS FOR AGILENT BATHS Can be used on most dissolution testers. A modified vessel cover may be needed.
Part No.           Description		Part No.	Description
QLA-STABSK-VK8    Basket Insertion / Removal Tool		QLA-STABSK-10	Stationary Basket Assembly with Basket Shaft and 10 Mesh Basket, 316 SS | Like 12-2061
		QLA-STABSK-20	Stationary Basket Assembly with Basket Shaft and 20 Mesh Basket, 316 SS | Like 12-2060
		QLA-STABSK-40	Stationary Basket Assembly with Basket Shaft and 40 Mesh Basket, 316 SS | Like 12-2063

Dissolution Basket Shafts

The basket shaft is the metallic drive shaft in Apparatus 1 which is connected to the cylindrical basket. All shafts are constructed from type 316 electropolished stainless steel.

Key Considerations – Clip or Clipless?

Spring Clips
The USP standard dissolution basket is designed to attach to the basket shaft using spring clips. Over time these clips can lose strength and fail to grip the basket securely. Baskets that are not gripped securely are likely to exhibit excessive wobble. Only QLA clips are made from special spring tempered 316 stainless steel. Competitors’ clips are made from annealed 316 stainless steel. Spring tempered 316 stainless steel clips will maintain its gripping strength much longer than annealed 316 stainless steel clips.

O-Ring
The clipless basket fastens to the shaft using an O-ring instead of clips. While it can be argued that this design reduces wobble and is easier to use, the USP still specifies the use of clips and proof of equivalence may be required if a clipless alternative is to be used.

Care & Maintenance

Shaft Storage
Bent or scratched shafts fail to comply with USP regulations so it is essential not to store shafts on a desk or loose in a drawer where damage or corrosion can occur. Proper storage in a basket shaft/paddle holder can prevent damage from occurring. View the range.

Wobble
A Wobble Meter (QLA-WOBMET-MI) is available to monitor basket shaft wobble.

Dissolution Paddles

The Paddle Method

Apparatus 2, commonly known as the paddle method, has similar physical specifications to those of Apparatus 1 with a paddle substituted for the rotating basket.

Some of the dimensions and tolerances for the paddle are critical if consistent results are to be obtained from vessel to vessel. The USP specifies that the paddle must rotate smoothly without significant wobble. The arc of the paddle blade creates considerable flow and any wobble will have an exaggerated effect on the flow profile. The contours of the paddle blade must not include any sharp edges — at the tips for instance — that could produce turbulent instead of laminar flow patterns.

All QLA paddles are certified U.S. Pharmacopeia compliant where applicable and meet machine manufacturer specifications.

Dissolution Spin Shaft Accessories

Spin on / off shafts for Apparatus 1 & 2 offer a quick, convenient change between paddle and basket methods without the need to
reset the shaft height.

These two-piece basket / paddle / cylinder shafts join above the media to prevent potential contamination.

Dissolution Capsule Sinkers

Floating tablets rarely dissolve at a reproducible rate. Using a sinker in Apparatus 2 fixes the tablet to a certain point and aids reproducibility. Sinkers can also be useful where tablets may stick to the sides of the vessel.

USP 711 States: “A small, loose piece of non-reactive material such as not more than a few turns of wire helix may be attached to dosage units that would otherwise float. Other validated sinker devices may be used.”

Once a sinker design is selected for a particular application, the dimensions and drawings should be recorded to ensure uniformity in the procedure.

	PART NO.	OEM REF	STYLE	MATERIAL	COATING	I.D. (mm)	LENGTH (mm)	WIRE I.D. (mm)	MAX CAPSULE SIZE	NO. COILS
BASKET	QLA-CUSBSK-JP	Agilent 12-3070	Basket, JP	316 SS	-	11.9	25.4	1.00	00	-
	QLA-BSK008-01	-	Basket, 8 Mesh	316 SS	-	15.7	26.9	0.71	000	-
	QLA-BSK008-JP	-	Basket, 8 Mesh	316 SS	-	12.9	22.9	0.71	1	-
	QLA-SNK008-VK	Agilent 12-3062	Basket, 8 Mesh	316 SS	-	20.2	12.7	0.71	00	-
	QLA-SNK010-VK	Agilent 12-3060	Basket, 10 Mesh	316 SS	-	20.2	12.7	0.64	00	-
	QLA-SNK020-VK	Agilent 12-3063	Basket, 20 Mesh	316 SS	-	20.2	12.7	0.41	00	-
	QLA-SNK040-VK	Agilent 12-3064	Basket, 40 Mesh	316 SS	-	20.2	12.7	0.25	00	-
	QLA-SNK080-VK	-	Basket, 80 Mesh	316 SS	-	20.2	12.7	0.18	00	-
PRONGED	QLA-CAPWHT-VK	Agilent 12-3050	3 Prong	Nylon / PP	-	9.5	25.4	-	1 (min=3)	-
	QLA-MAGWHT-VK	Agilent 12-3056	3 Prong	Nylon / PP	-	9.5	25.4	-	1 (min=3)	-
	QLA-CAPWHT-SV	-	3 Prong	316 SS	-	7.0	25.4	-	1 (min=3)	-
O-RING	QLA-CAPWHT-S99	Sotax 8399	O-Ring	316 SS	-	5.8	22.9	-	0	-
SPIRAL	QLA-CAPWHT-TR	-	Butterfly	316 SS	-	5.4	9.5	0.76	-	-
	QLA-CAPWHT-PC	-	Strip Film	316 SS	-	10.8	10.8	0.94	-	-
	QLA-CAPWST-15	Sotax 8280	Helix	316 SS	-	5.0	15.5	0.41	5	6
	QLA-CAPWHT-04	-	Helix	Music Wire	PTFE	9.8	21.3	1.09	0	5
	QLA-CAPWHT-4S	-	Helix	316 SS	-	9.8	21.3	1.19	0	5
	QLA-CAPWHT-LG	-	Helix	Music Wire	PTFE	10.4	27.9	1.09	000	6.5
	QLA-CAPWHT-XL	-	Helix	Music Wire	PTFE	11.8	29.2	1.09	000	5.5
	QLA-CAPWHT-XLS	-	Helix	316 SS	-	11.8	29.2	1.09	000	5.5
	QLA-CAPWHT-XLSS	-	Helix	316 SS	-	11.8	22.5	1.09	Special	3
	QLA-CAPWST-18	Sotax 7349	Helix	316 SS	-	6.0	18.0	0.41	3	8
	QLA-CAPWST-19	Sotax 8283	Helix	316 SS	-	7.0	19.3	0.41	2	8
	QLA-CAPWHT-2S	-	Helix	316 SS	-	9.4	21.3	1.09	0	8.5
	QLA-CAPWHT-02	-	Helix	Music Wire	PTFE	9.4	21.3	1.19	0	8.5
	QLA-CAPWHT-XS	-	Helix	316 SS	-	14.6	22.5	1.19	Special	8.5
	QLA-CAPWST-23	Sotax 6881	Helix	316 SS	-	8.0	23.0	0.41	0	9
	QLA-CAPWST-31	Sotax 7349	Helix	316 SS	-	11.0	31.0	0.78	000	11
WIRE	QLA-WIRESK-VK	Agilent 12-3000	Sinker Wire 50 feet	316 SS	-	-	-	0.81	-	-

Dissolution Vessels

Good dissolution vessels are critical in obtaining correct and reproducible results and are sometimes overlooked as a key element in the dissolution test.

All vessels meet the physical dimensions of the USP and have a hemispherical bottom which means that they should be perfectly rounded with no obvious defects of the glass on the inside. Wall thicknesses should be even and reproducible.

Although the USP states the dimensions for vessels, the tolerances are actually quite wide, meaning vessels associated with various dissolution baths are not dimensionally the same. Replacing a vessel with one not specifically designed for the instrument could impair vessel centering and paddle height. Also larger or smaller inside diameters can affect vessel hydrodynamics.

Note: QLA vessels are acid etched, or laser marked on plastic rim, with a unique serial number and come with a Certificate of Conformance (COC), where applicable

QLA ULTRACENTER™ PRECISION VESSELS

Dissolution Vessel Covers

The loss of media due to evaporation can be considerable. Vessel Covers should reduce these problems and provide openings to accommodate cannulas and stoppers. Cover styles include all common one-piece and hinged covers, as well as a unique rotary configuration.

Dissolution 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 USP defines the sampling point as: “A zone half way between the top of the media and top of the paddle or basket not less than 1cm from the vessel wall. The sampling position is critical but so too is the type of sampling cannula (also known as a probe) used”.

Dissolution Cannula Filters

Almost every dissolution test relies on samples being taken to produce a result. Filters are used to prevent particles of tablet from getting into the sample and affecting the spectrophotometer or HPLC results.
Filters should be shown not to absorb any compounds of interest.
All filters are U.S. Pharmacopeia compliant where applicable and meet machine manufacturer specifications.

Dissolution Transdermal Testing

With paddle over disk, a transdermal patch is placed either between a glass disk and an inert PTFE mesh (QLA-APPFIVE-HR), or directly onto a stainless steel mesh (QLA-APPFIVE-V35, QLA-APPFIVE-V56 and QLA-APPFIVE-V80). This is placed at the bottom of the vessel, with the release side facing upwards, under a rotating paddle.

Transdermal testing is carried out at 32°C to reflect the temperature of the skin.

Other variables such as the height setting and sampling requirements are the same as for USP Method 2.

QLA’s USP Apparatus 5 products are compatible with all brands of dissolution baths.

KEY CONSIDERATIONS

Shaft Storage
The QLA-APPFIVE-HR watch glass patch holder is a borosilicate watch glass with a 17 mesh PTFE screen, held together by Kynar clips. Patches up to 90mm in diameter can be tested. It is compatible with all brands of dissolution baths and conforms exactly to the USP specification.

The QLA-APPFIVE-V35, QLA-APPFIVE-V56 and QLA-APPFIVE-V80 patch holders have stainless steel screens and can accommodate various patch sizes. Various mesh sizes are available.

Dissolution Rotating Cylinder

USP Apparatus 6 rotating cylinder is similar to USP Method 1 (the rotating basket). However, the basket assembly is replaced by a solid 316 Stainless Steel cylinder.

The transdermal patch is fixed to the outside surface of the cylinder. Transdermal testing is carried out at 32°C to reflect the temperature of the skin.

Other variables such as the height setting and sampling requirements are the same as for USP Apparatus 1.

QLA’s Rotating Cylinders and Extensions are serialized, come with a Certificate of Conformance and are compatible with most brands of dissolution baths.

Dissolution Calibration Tools

CONTROLLING HARDWARE VARIABLES
It is important to ensure the dissolution bath is working as intended, and giving precise and reproducible results. To do this it is important that the bath meets the USP or ASTM physical specification. The ASTM variables are tighter as they rely only on the physical measurement whereas the USP also requires a test using calibrator tablets.

QLA provides a comprehensive set of validation tools to measure these variables. All tools (except the verticality meter) are serialized and supplied with a traceable 1 year certificate of calibration.

Wobble Meter – The Wobble Meter uses a special vessel cover that fits securely inside the top of the vessel. The gauge is firmly attached to this cover then placed against the shaft or basket. The shaft is then rotated at a slow speed and the wobble (displacement) is displayed on the easy to read dial. The gauge works with all open dissolution baths (where you can access the vessel during the test).

Vibration Meter (QLA-VIBMET-UN) – This simple Vibration Meter allows you to quickly assess vibration levels and ensure that low levels are maintained when new equipment is introduced into the lab or after routine bath maintenance. It uses digital electronics but is equipped with an analog needle display. For this type of device, an analog display is better than a digital one because it gives a much better feel for the nature of the vibrations.

The meter uses an accelerometer probe that is calibrated to themeter as a matched set. The probe end has a custom mounting block that is compatible with most dissolution instruments.

Universal Level (QLA-LEVEL-UN) – The bath’s vessel plate must be level to ensure the bath has been properly set up. Baths are equipped with adjustable feet which may be adjusted while observing the Universal Level to achieve vessel plate levelness. The certified level is a simple circular, bubble level that allows quick and easy verification of the vessel plate level in all directions at once.

Verticality Meter (QLA-VERTMET-MI) – This digital Verticality Meter is a highly precise device which permits accurate measurement of shaft and vessel verticality as required by the ASTM Specification. The meter is suitable for any open dissolution bath where vessels and shafts are accessible. The meter requires a simple user calibration at each time of use and for this reason is not supplied with a certificate of calibration (Available on request only).

Depth Setting Tools (QLA-DEPSET-25, QLA-DEPSET-25A, QLA-DEPSET-MI, QLA-DEPGAG-VK, QLA-ASTMBALL-25, QLA-DEPSET-45, QLA-DEPSET-PK, QLA-DEPSET-SB) – QLA offers multiple tools for setting the height of the basket/ paddle (use QLA-DDAPT-Plus to measure the height). See descriptions and pictures to identify which style will best suit the needs of your laboratory. To set the correct depth, simply place the gauge at the bottom of the vessel, lower the basket or paddle until it touches the spacer and lock the shaft into position.

Depth Measuring Gauges, Digital Depth Gauge (QLA-DDAPT-Plus) – The new Digital Depth Gauge is an extremely precise instrument used to accurately measure the basket/paddle distance from the vessel spherical bottom. This allows basket or paddle height to be determined within .01mm. The QLA-DDAPT-Plus Digital Depth Gauge is made to fit most open access dissolution baths.

Optical Tachometer (QLA-TACHOM-UN) – The most accurate method of measuring the rotational speed is by using an Optical Tachometer. A reflective sticker is placed on the shaft or shaft drive, the Optical Tachometer shines an infrared light on to the shaft at this point. The reflection is then measured at every rotation, giving an accurate reading of the rotational speed. The tachometer can be used on all dissolution baths.

Centering Gauge (QLA-CNTGAG-MI) — The Centering Gauge comes with a 3/8” OD surrogate shaft that fits directly into the shaft drive. A 10mm OD surrogate shaft (QLA-EUROINDC-M) is also available separately. The gauge may be placed near the vessel top and bottom (beginning of the spherical radius). This allows the impact of vessel verticality on centering to be evaluated. The spindle is rotated slowly and the measuring arm follows the inside of the vessel perimeter. Deviation from the center position can be directly read from the dial, which always faces the operator.

The gauge works on most open access baths. For bathless systems where the shaft cannot be easily removed, the gauge fits directly onto the bottom of the shaft once the basket hub or paddle is removed.

Calibrated Thermometer (QLA-THERMD-LC) – The digital Calibrated Thermometer is an extremely accurate thermistor-based low cost thermometer. It is ideal for validating dissolution bath and media temperature as well as general lab use. A simple switch lets you set the digital display to show either Celsius or Fahrenheit readings. The thermometer is supplied with a certificate of calibration.

Validation Tool Kits (QLA-VALTOL-KT2 & QLA-VALTOL-ASTM) – Our Validation Tool Kits contain everything necessary to make a complete calibration of a dissolution bath.

• The QLA-VALTOL-KT2 standard tool kit contains a Centering Gauge, Precision Level, Wobble Meter, Go/No Go Gauge (this is used to verify that the height is more than 23mm but less than 27mm) and a 25mm Depth Set Tool.
• The QLA-VALTOL-ASTM Tool Kit is the same as the KT2 kit but also includes the verticality meter and manual verticality tools.

Both kits contain instruction

Dissolution Accessories

VESSEL CENTERING SYSTEM ACCESSORIES
Problems with vessel centering? We have THE solution for that! The QLA AccuCenter™ Bracket provides ultimate centering accuracy on most dissolution instruments (both old and new).

• Cost effective replacement for OEM centering systems
• Spring loaded, rotary knobs secure the vessel firmly in place and eliminate floating when empty

This innovative bracket is adjustable and designed to center the vessel from the inside diameter and not the outside. When used in conjunction with QLA’s UltraCenter™ Precision Vessels, extreme centering accuracy can be achieved. Many older baths were not designed to meet the new tighter centering requirements of Enhanced Mechanical Calibration and/or ASTM. When Pharmaceutical Labs adopt these stricter mechanical guidelines, there is no need to run USP calibrator tablets! This generally results inconsiderable cost and time savings for your lab.

WATER BATH PRESERVATIVE

Part No.	Description	OEM Reference
QLA-EVERCLEAR	Ever-Clear Dissolution Bath Algaecide, Single Dose	QLA
QLA-EVERCLEAR-12	Ever-Clear Dissolution Bath Algaecide, Single Dose (12 pack)	QLA
QLA-EVERCLEAR-48	Ever-Clear Dissolution Bath Algaecide, Single Dose (48 pack)	QLA

Got Green Water? Try EVER-CLEAR

• Highly soluble water preservative crystals.
• Extremely effective against the formation of bacteria and fungi.
• Non-hazardous and its environmentally friendly formula does not require any special disposal instructions.
• Regular use will reduce the effect of microorganism build-up inside the bath and within the pump and heater.
• Use with DEIONIZED water.
• Single dose will protect a bath for up to 8 weeks.
• Time saving! No need to empty the bath while using Ever-Clear; just add one container to your bath every 8 weeks.

GLASS ACCESSORIES