Water filtration consumables for Millipore Systems

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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.

QLA dissolution basket method

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.

All Baskets by Manufaturer
Agilent / VanKel
Caleva
Distek
Erweka
Hanson
Pharmatest
Sotax
Zymark / Caliper LifeSciences
OVERSIZE 40 MESH 24.5MM ID BASKETS & SHAFTS
Part No.DescriptionCategory
QLA-CUSTBSK-4040 Mesh Basket, Clip Style, 24.5mm ID, 316 SS, SerialisedBasket
QLA-CLIPHUB-DKDetachable Basket Hub for 24.5mm Basket, 316 SS, Serialized (Distek compatible)Hub
QLA-CUSTSHT-DK16.5” (420mm) Basket Shaft for 24.5mm Basket, 316 SS, Serialized (Distek compatible)
Shaft
QLA-CUSTSHT-EW2020” (508mm) Basket Shaft for 24.5mm Basket, 316 SS, Serialized (Erweka compatible)Shaft
QLA-CUSTSHT-HR16” Basket (405mm) shaft for 24.5mm Basket, 316 SS, Serialized (Hanson SR8-Plus compatible)Shaft
QLA-CUSTSHT-HRVBasket Shaft for 24.5mm Basket, 316 SS, Serialized (Hanson Vision compatible)Shaft
QLA-CUSTSHT-VK1515” (380mm) Basket Shaft for 24.5mm Basket, 316 SS, Serialized (VanKel/Varian compatible)Shaft
QLA-CUSTSHT-VK1314.5” (370mm) Basket Shaft for 24.5mm Basket, .316 SS, Serialized (V-Series compatible)Shaft
QLA-CUSTSHT-VK1919” (480mm) Basket Shaft for 24.5mm Basket, 316 SS, SerializedShaft
METFORMIN SAMPLE HOLDERS FOR AGILENT BATHS
Part No.DescriptionOEM
QLA-VERTHLD-500Vertical Sample Holder for Metformin 500mg, 316 Stainless SteelAgilent
QLA-VERTHLD-750-1KVertical Sample Holder for Metformin 750mg or 1000mg, 316 Stainless SteelAgilent
BASKET INSERTION & REMOVAL TOOLBASKET 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.DescriptionPart No.Description
QLA-BSKTOOLBasket Insertion/Removal ToolQLA-BSKHLD-66 Position Basket Holder
QLA-BSKTOOL-DKBasket Insertion/Removal Tool for thick rim basketsQLA-BSKHLD-1212 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.           DescriptionPart No.Description
QLA-STABSK-VK8    Basket Insertion / Removal ToolQLA-STABSK-10Stationary Basket Assembly with Basket Shaft and
10 Mesh Basket, 316 SS | Like 12-2061
QLA-STABSK-20Stationary Basket Assembly with Basket Shaft and
20 Mesh Basket, 316 SS | Like 12-2060
QLA-STABSK-40Stationary 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.
QLA spring clip or o-ring style
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

QLA shafts holders and wobble meters

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.

All Basket Shafts by Bath Manufacturer
Agilent / VanKel
Copley Scientific
Distek
Erweka
Hanson
Sotax
Zymark / Caliper LifeSciences

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.

All Paddles by Bath Manufacturer
Agilent / VanKel
Distek
Erweka
Hanson
Sotax

Key Considerations

Types of Paddles:

Electropolished 316 Stainless Steel — The 316 stainless steel (316 SS) shaft is strong and has a high resistance to bending. It is electropolished for removal of surface impurities and corrosion resistance.

PTFE Coated — The USP suggests that paddles may be coated with an inert coating. Most paddles are accordingly coated with PTFE or another inert coating. If peeling or flaking of the coating is observed then the paddles should be replaced.

Solid Fluoropolymer — The single piece molded design features a fluoropolymer blade and single piece stem molded onto an electropolished 316 SS shaft.
This innovative design features no paddle-to-shaft joint, thus eliminating potential cross-contamination and removing a probable corrosion path. Wobble is also considerably reduced in the solid fluoropolymer paddle because it is a single piece cast.

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.

SPIN SHAFT TIGHTENING AND LOOSENING TOOL

  • Provides for a secure connection and ensures the 2 piece shaft doesn’t come loose or detached during operation
  • Rubber lined for extra grip and will not scratch or damage the shaft
  • Use two tools for best results

BUY HERE

Spin Shaft Features:

  • Spin On/Off Shafts may be used on any Agilent/VanKel, Distek, Erweka, or Hanson dissolution instruments
  • Distek’s primary design is the bottom detachable basket hub and paddle blade but QLA also manufactures Spin On/Off Shafts for Distek 2100 and 2500 baths as well.
  • It is unnecessary to remove the shaft when changing from APP 1 to APP 2.
  • There is no need to readjust shaft height or the locking mechanism.
  • The attachment connection for Spin On/Off Shafts is located outside the media, eliminating any chance of contamination.
  • Precision manufacturing has assured USP compliance and detachable components meet USP specifications.
  • Spin On/Off Shafts are engineered to minimize the risk of cross-threading and ensure a secure connection.
  • Wobble data is well within USP tolerance

All Compatible Spin Shafts by Bath Manufaturer
Agilent / VanKel
Distek
Erweka
Hanson SR8-Plus
Hanson Vision
QLA UltraCenter™

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.

All Capsule Sinkers by Manufaturer
Agilent / VanKel
Sotax

Key Considerations

Inevitably, home-made sinkers tend not to be reproducible and so commercially available sinkers are quite popular. The choice of sinker will depend on the tablet or capsule.

General Guidelines

  • Sinker Size – The sinker should have minimal surface contact with the tablet as this can affect the dissolution rate. Sinkers are available in different sizes to accommodate most capsule/tablet dimensions.
  • Sinker Weight – Should be heavy enough to ensure that the tablet sinks to the bottom of the vessel and doesn’t move for the duration of the test.
  • PTFE Coated Sinkers – Can be used where there may be a reaction between steel and the tablet. They also work well with magnetic retrievers.
  • Uncoated – 316 stainless steel sinkers are more durable than coated sinkers.
  • Basket Sinkers – Ideal for coin shaped tablets but care should be taken that the outer coating of the tablet does not clog the mesh.
  • Wire Spirals – Should be as wide as practically possible to avoid clogging which would affect the dissolution rate.

 PART NO.OEM REFSTYLEMATERIALCOATINGI.D. (mm)LENGTH (mm)WIRE I.D. (mm)MAX CAPSULE SIZENO. COILS
BASKET

QLA-CUSBSK-JPAgilent 12-3070Basket, JP316 SS-11.925.41.0000-
QLA-BSK008-01-Basket, 8 Mesh316 SS-15.726.90.71000-
QLA-BSK008-JP-Basket, 8 Mesh316 SS-12.922.90.711-
QLA-SNK008-VKAgilent 12-3062Basket, 8 Mesh316 SS-20.212.70.7100-
QLA-SNK010-VKAgilent 12-3060Basket, 10 Mesh316 SS-20.212.70.6400-
QLA-SNK020-VKAgilent 12-3063Basket, 20 Mesh316 SS-20.212.70.4100-
QLA-SNK040-VKAgilent 12-3064Basket, 40 Mesh316 SS-20.212.70.2500-
QLA-SNK080-VK-Basket, 80 Mesh316 SS-20.212.70.1800-
 
PRONGED

QLA-CAPWHT-VKAgilent 12-30503 ProngNylon / PP-9.525.4-1 (min=3)-
QLA-MAGWHT-VKAgilent 12-30563 ProngNylon / PP-9.525.4-1 (min=3)-
QLA-CAPWHT-SV-3 Prong316 SS-7.025.4-1 (min=3)-
 
O-RING

QLA-CAPWHT-S99Sotax 8399O-Ring316 SS-5.822.9-0-
 
SPIRAL

QLA-CAPWHT-TR-Butterfly316 SS-5.49.50.76--
QLA-CAPWHT-PC-Strip Film316 SS-10.810.80.94--
QLA-CAPWST-15Sotax 8280Helix316 SS-5.015.50.4156
QLA-CAPWHT-04-HelixMusic WirePTFE9.821.31.0905
QLA-CAPWHT-4S-Helix316 SS-9.821.31.1905
QLA-CAPWHT-LG-HelixMusic WirePTFE10.427.91.090006.5
QLA-CAPWHT-XL-HelixMusic WirePTFE11.829.21.090005.5
QLA-CAPWHT-XLS-Helix316 SS-11.829.21.090005.5
QLA-CAPWHT-XLSS-Helix316 SS-11.822.51.09Special3
QLA-CAPWST-18Sotax 7349Helix316 SS-6.018.00.4138
QLA-CAPWST-19Sotax 8283Helix316 SS-7.019.30.4128
QLA-CAPWHT-2S-Helix316 SS-9.421.31.0908.5
QLA-CAPWHT-02-HelixMusic WirePTFE9.421.31.1908.5
QLA-CAPWHT-XS-Helix316 SS-14.622.51.19Special8.5
QLA-CAPWST-23Sotax 6881Helix316 SS-8.023.00.4109
QLA-CAPWST-31Sotax 7349Helix316 SS-11.031.00.7800011
 
WIREQLA-WIRESK-VKAgilent 12-3000Sinker Wire 50 feet316 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

All Vessels by Bath Manufacturer
Agilent / VanKel
Distek
Erweka
Hanson
Pharmatest
Sotax

Key Considerations

  • Glass Vessels benefit from good thermal conductivity (it is often necessary to have the temperature of the water bath as much as 2°C higher than the analysis temperature when using plastic vessels). Another advantage of using glass vessels is their high resistance to scratching, which means they have to be replaced less frequently.
  • Amber Vessels can be used if light sensitive compounds are being tested. They are available in glass and plastic.
  • Plastic Vessels are very reproducible because they are made from a mold rather than hand formed. They also have feet which allows them to stand upright independently. The biggest disadvantage is that plastic is very prone to scratching and cracking, requiring frequent replacement. Plastic vessels have the advantage over glass in that they are very reproducible. The vessel is made from a mold rather than hand-formed. This reduces possible errors in setting the paddle height and centering and can give very reproducible results. Another advantage of plastic vessels is that they have feet so they can stand upright independently.
  • Plastic Rim Vessels were developed to help minimize glass rim breakage that can occur during normal laboratory use. They are produced by a unique proprietary bonding method using high impact plastic which eliminates rim breakage and safety concerns. All QLA Plastic Rim Vessels are dishwasher safe. Plastic Rim Vessels come in both Standard and UltraCenter™ Precision versions. Serial numbers are laser marked on the plastic rim only.
  • Peak Vessels are designed to prevent cone formation at the base of the vessel. An undesirable poorly stirred cone shaped region can develop under the paddle during USP Apparatus 2 dissolution tests. Peak vessels have a cone shape molded into the bottom of the vessel that improves the hydrodynamics around the dosage form and leads to more reproducible dissolution rates. The peak effectively displaces the unstirred cone, forcing the material tested into the region of appropriate hydrodynamics, where all surfaces of the dosage are constantly and uniformly exposed to the moving medium. Peak vessels do not comply with USP specifications and cannot be substituted in existing applications.

QLA ULTRACENTER™ PRECISION VESSELS

QLA ultracenter vessels

UltraCenter&trade Precision Vessels are available in clear and amber, Glass Rim, Plastic Rim and PEAK versions. QLA’s molded PEAK vessels are Patent Pending.
Small variations in vessel dimensions have been shown by the USP and others to contribute to excessive changes in dissolution rates. UltraCenter&trade Precision Vessels are produced using a unique molded process which provides a precise and consistent inside diameter and spherical radius resulting in a more reproducible dissolution profile. They are compatible with most dissolution baths and have been adopted as a standard by many major pharmaceutical companies.

QLA Certificates

  • COC – All serialized QLA parts — like baskets, paddles and vessels — come with a Certificate of Conformance (COC) at no extra charge.
  • COA – Certificate of Analysis (COA) is available for all QLA serialized parts — like baskets, paddles and vessels – for an additional fee.

QLA certificates

QLA UNIVERSAL VESSEL STANDS

For the safe transportation and storage of vessels
Due to their shape, dissolution vessels are difficult to hold securely. This can often result in scratched, chipped or even smashed vessels.

The noncorrosive rigid ABS plastic stands are available in 6 or 8 vessel capacities and can hold vessels from any dissolution bath manufacturer.

They can also be stacked together to save bench space and enable you to transport many vessels at a time.

qla-vessel-stands

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.

All Vessel Covers by Bath Manufacturer
Agilent / VanKel
Distek
Erweka
Hanson

Key Considerations

  • Evaporation Losses are reduced by using vessel covers with a minimal open area during the test. Slots and holes for temperature
    verification, sample introduction and sample collection should be closed when not in use. These losses are further reduced when
    using conical shaped low evaporation covers.
  • Cannulas Stoppers – Cannulas can be used with stoppers during manual sampling to ensure that the sample is always taken from the same depth.
  • Vessel covers must have the appropriate hole for the stopper (which is attached to the cannula) to sit in. The stopper and cannula must match the vessel cover type. See page 28 for sampling cannula and stoppers.

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”.

All Sampling Cannula by Bath Manufacturer
Agilent / VanKel
Distek
Erweka
Hanson
Pharmatest
Sotax

Key Considerations

  • Sampling Position – The sampling position is important particularly for tests with baskets as there can be a concentration profile between the bottom of the vessel and the stirring element. The sampling position is different for 500mL and 900mL tests. This can create problems for equipment that uses ‘through the shaft’ sampling.
  • Cannula Length – Cannula vary in length: 4.75” (120mm) is used for 900mL, 7.75” (195mm) is used for 500mL and 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 cannula are made from either stainless steel or PEEK so that they do not absorb or interfere with the active ingredient.
  • Stoppers – Cannula 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 cannula 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. The range of self-tightening stoppers can be installed and positioned without the need for tools such as screwdrivers. See below for more details.

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.

All Cannula Filters by Bath Manufacturer
Agilent / VanKel
Distek
Erweka
Hanson
Pharmatest
Sotax

Key Considerations

Most manufacturers use a filter on the end of the sampling cannula. These cannula filters are made of Ultra High Molecular Weight (UHMW) Polyethylene and are completely inert to most compounds.
With filters, porosities are nominal and represent an average pore size rather than an absolute pore size. Thus a 35μm and 40μm filter will perform in much the same way.

If in-line filters are used it is important that a small amount of media is pushed back in the reverse direction to wash particles off the filter back into the vessel. Particles are part of the tablet and as such should be kept inside the vessel dissolving with the rest of the tablet.

Failure to do this results in the particles staying on the filter. The effect of this is not only to remove the particles from the media but next time a sample is taken, the media is pulled through the particles stuck to the filter which can give erroneously high readings.

When selecting a filter, it is wise to conduct some tests to ensure that there is no sample absorption onto the filter. If this is a problem then alternative filters and materials are available but external filtration may be required.

Types of Filters:

  • Cannula Filters – Cannula Filters 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 when high levels of particulates are present to prevent particulates blocking the sample probes. A large porosity range is available. Different manufacturers recommend different filters for use with their sampling cannula and not all are interchangeable because of differences in cannula diameter.
  • Filter Discs – Some low volume sample probes require an In-Line Filter Disc (or filter frit) which has a lower surface area than a cannula filter. These are designed to keep the filtration process outside the vessel but may suffer from blocking due to the lower surface area. These are designed to keep the filtration process outside the vessel but blockages may occur due to the lower surface area.
  • Filter Tips – Filter Tips are smaller than cannula filters and fit on the end of larger diameter sample probes.

Dissolution paddle over disk

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

Mesh sizes

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.

PADDLE OVER DISK (Apparatus 5)
Part No.DescriptionOEM Reference
QLA-APPFIVE-HRTransdermal Patch Holder includes watch glass, (1) 17 mesh screen, (4) Kynar Clips65-190-092 (Hanson)
QLA-APPFIVE-HRCLIPKynar Clip for QLA-APPFIVE-HR65-190-205 (Hanson)
QLA-APPFIVE-HRSCR17 mesh screen for QLA-APPFIVE-HR
65-190-190 (Hanson)
QLA-APPFIVE-V35Paddle over Disk Assembly, 35mm opening, 40 mesh screen, 316 SS12-4200 (Agilent)
QLA-APPFIVE-V56Paddle over Disk Assembly, 56mm opening, 120 mesh screen, 316 SS12-4230 (Agilent)
QLA-APPFIVE-V80Paddle over Disk Assembly, 80mm opening, (2) 16x16 mesh screens, 316 SSQLA
QLA-APP5S16-3516 Mesh Stainless Steel Screen for APPFIVE-V35 (Pack / 25)QLA
QLA-APP5S20-3520 Mesh Stainless Steel Screen for APPFIVE-V35 (Pack/25)QLA
QLA-APP5S30-3530 Mesh Stainless Steel Screen for APPFIVE-V35 (Pack/25)QLA
QLA-APP5S40-3540 Mesh Stainless Steel Screen for APPFIVE-V35 (Pack/25)QLA
QLA-APP5S20-5620 Mesh Stainless Steel Screen for APPFIVE-V56 (Pack/25)QLA
QLA-APP5S40-5640 Mesh Stainless Steel Screen for APPFIVE-V56 (Pack/25)QLA
QLA-APP5S120-56120 Mesh Stainless Steel Screen for APPFIVE-V56 (Pack/25)QLA
QLA-APP5S16-8016 Mesh Stainless Steel Screen for APPFIVE-V80 (Pack/25)QLA
QLA-TRANDE-SCCustom Transdermal Screen, 316 Stainless SteelQLA

Dissolution rotating cylinder

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.

KEY CONSIDERATIONS

If an extension (QLA-APPSIX-EX) is needed, it should be ordered at the same time as the main cylinder (QLA-APPSIX-01 / QLA-AP6CYL-DK / QLA-SPNAP6-01).

Rotating cylinder extension

Other shaft lengths are available on request.

ROTATING CYLINDER (Apparatus 6)
Part No.DescriptionOEM Reference
QLA-APPSIX-01Rotating Cylinder for Transdermal Patches, 316 SS, SerializedQLA
QLA-AP6CYL-DKDetachable Rotating Cylinder for Transdermal Patches for Distek, 316 SS, Serialized3200-0142 (Distek)
QLA-SPNAP6-01Spin ON/OFF Rotating Cylinder for Transdermal Patches, 316 SS, Serialized (Upper Shaft available separately)
QLA
QLA-APPSIX-EXRotating Cylinder Extension for QLA-APPSIX-01 / QLA-AP6CYL-DK / QLA-SPNAP6-01, 316 Stainless Steel, SerializedQLA
QLA-74-105-240Rotating Cylinder for Transdermal Patches for Hanson Vision, 316 SS, Serialized74-105-240
QLA-74-105-241Rotating Cylinder and Extension Set for Hanson Vision, 316 SS, Serialized74-105-241

QLA biodissolution accessories

BIODISSOLUTION ACCESSORIES (AGILENT Apparatus 3 - Includes VanKel)
Part No.DescriptionAgilent Reference
QLA-GLA100-VBIO100mL Outer Glass, Clear, Non-Graduated27-5110
QLA-GLA300-01300mL Outer Glass, Clear, Non-Graduated27-5100
QLA-GLA300-02300mL Outer Glass, Clear, GraduatedQLA
QLA-GLA300-03300mL Outer Glass, Clear with Class A 250mL markQLA
QLA-740300mL Outer Glass, Amber, Non-GraduatedQLA
QLA-EVACOV-05Evaporation Cover for 300mL Outer Glass, PVC27-1500
QLA-GLAIST-01100mL Glass Inner Sample Tube with threaded ends, Clear27-5000
QLA-GLAIST-AV100mL Glass Inner Sample Tube with threaded ends, AmberQLA
QLA-LOWCAP-03Lower Cap for 100mL Inner Sample Tube27-1020
QLA-LOWCAP-05Lower Cap for 100mL Inner Sample ube, Wider Style for improved mixing27-1050
QLA-UPPCAP-03Upper Cap for 100mL Inner Sample Tube27-1000
QLA-MSHSCR-1010 Mesh Screen, Stainless Steel, 1.25” diameter. (Pack/25)27-2099
QLA-MSHSCR-2020 Mesh Screen, Stainless Steel, 1.25” diameter. (Pack/25)27-2100
QLA-MSHSCR-3030 Mesh Screen, Stainless Steel, 1.25” diameter. (Pack/25)27-2103
QLA-MSHSCR-4040 Mesh Screen, Stainless Steel, 1.25” diameter. (Pack/25)27-2105
QLA-POLSCR-2020 Mesh Screen, Polypropylene, 1.25” diameter. (Pack/25)27-2000
QLA-POLSCR-3030 Mesh Screen, Polypropylene, 1.25” diameter. (Pack/25)QLA
QLA-POLSCR-4040 Mesh Screen, Polypropylene, 1.25” diameter. (Pack/25)27-2005
QLA-POLSCR-7878 Mesh Screen, Polypropylene, 1.25” diameter. (Pack/25)27-2010
QLA-POLSCR-1K100 Mesh Screen, Polypropylene, 1.25” diameter. (Pack/25)27-2015
QLA-VESSTD-APP3/1414 Position Vessel Stand for 300mL Outer GlassQLA
QLA-VESSTD-APP3/20Position Vessel Stand for 300mL Outer GlassQLA

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.

KEY CONSIDERATIONS
The variables are:
SPECIFICATIONASTMUSP
Shaft Wobble 1.0mm Max.No significant Wobble
Shaft VerticalityMust be vertical, bubble within the linesNot defined
Basket Wobble1.0mm Max. at bottom rim1.0mm Max. at bottom rim
Vessel Centering1.0mm Max.2.0mm Max.
Paddle/Basket Height+/- 8% or +/- 2.0mm+/- 2.0mm
Rotation2% or +/- 2 rpm+/- 4%
Temperature+/- 0.5°C+/- 0.5°C
VibrationNo significant vibrationNo significant vibration
Vessel verticality1° from vertical Max.Not specified

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

CALIBRATION TOOLS
Part No.DescriptionAgilent Reference
QLA-CNTGAG-MIVessel Centering Gauge, Multi-InstrumentQLA
QLA-EUROINDC-M10mm Shaft for QLA-CNTGAG-MIQLA
QLA-WOBMET-MIWobble Meter, Multi-InstrumentQLA
QLA-DDAPT-PLUS25mm Digital Depth Gauge with Case, Multi-InstrumentQLA
QLA-ASTMBALL-2525mm Calibrated BallQLA
QLA-DEPSET-2525mm Depth Set Tool, Black AcrylicQLA
QLA-DEPSET-25A25mm Depth Set Tool, Carbon FiberQLA
QLA-DEPSET-MI25mm Ball Style Depth Set ToolQLA
QLA-DEPGAG-VK25mm Depth Set Gauge, Stainless Steel, VanKel Style12-7300
QLA-GNGDEPGo/No Go 25mm Depth GaugeQLA
QLA-DEPSET-4545mm Ball Style Depth Set ToolQLA
QLA-DEPSET-PKDepth Set Tool for PEAK VesselsQLA
QLA-DPSPBK-VK25mm Basket Height Spacer for Legacy VanKel Baths12-7210
QLA-DPSPPD-VK25mm Paddle Height Spacer for Legacy VanKel Baths12-7200
QLA-DEPSET-SB1cm Stationary Basket Spacer for Legacy VanKel BathsQLA
QLA-LEVEL-UNUniversal Precision Bubble Level, Multi-InstrumentQLA
QLA-VERTMET-MIDigital Verticality Meter, Multi-InstrumentQLA
QLA-THERMD-LCCalibrated Digital Thermometer, Multi-InstrumentQLA
QLA-TACHOM-UNOptical Tachometer, Multi-InstrumentQLA
QLA-TACHCLIPTacometer Target Clip for 3/8” OD ShaftQLA
QLA-VIBMET-UNVibration Meter includes probe and case, Multi-InstrumentQLA
QLA-VALTOL-ASTMASTM Validation Tool Kit includes Centering Gauge, Wobble Meter, 25mm Depth Set Tool, Go/No Go Gauge, Adapters, Digital Verticality Meter and Manual Verticality Tools (Not for use on Hanson Vision or Sotax)QLA
QLA-VALTOL-KT2Standard Validation Tool Kit includes Centering Gauge, Wobble Meter, 25mm Depth Set Tool, Go/No Go Gauge, Adapters and Precision Bubble Level (Not for use on Hanson Vision or Sotax)QLA

Dissolution calibration tools

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.

VESSEL CENTERING SYSTEM ACCESSORIES
Part No.DescriptionAgilent Reference
QLA-ACCUBKT-VKAccuCenter Bracket for Legacy VanKel and Agilent 708-DS BathsQLA
QLA-EZLBKT-01Vessel Centering Bracket with 6 Replaceable Pins for Legacy VanKel Baths12-6050 (Agilent)
QLA-EZLKIT-01Vessel Centering Bracket Repair Kit (Set/12 Pins)QLA
QLA-EZLPEG-01Vessel Centering Bracket Peg12-6065 (Agilent)
QLA-ACCUBKT-DKAccuCenter Bracket for Distek 2100 BathsQLA
QLA-ACCUBKT-DK2500AccuCenter Bracket for Distek 2500 BathsQLA
QLA-ACCUBKT-IKIT2500AccuCenter Bracket Installation Kit for Distek 2500 BathsQLA
QLA-RING01-DKAcculign Vessel Centering Ring for Distek3350-0096 (Distek)
QLA-RING-UCEWVessel Hold Down Ring for UltraCenter Vessels on Erweka DT BathsQLA
QLA-ACCUBKT-HRAccuCenter Bracket for Hanson SR8-Plus BathsQLA

Vessel centering accessories

AGILENT VK8000 AUTOSAMPLER ACCESSORIES
Part No.DescriptionAgilent Reference
QLA-RINSETRAY66 Position Acrylic Rinse Tray17-1300
QLA-RINSETRAY88 Position Acrylic Rinse Tray17-1310
QLA-REPNED-VLLong Replacement Needle for VK800017-6100
QLA-REPNED-VSShort Replacement Needle for VK800017-6110
QLA RINSTRAY8 ACRYLIC

WATER BATH PRESERVATIVE

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

Got Green Water? Try EVER-CLEAR

Ever-clear preservative
  • 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.

TUBING
Part No.DescriptionOEM Reference
QLA-PPTUBV-01Peristaltic Pump Tubing, Santoprene, Coded Purple & White (Set/8)17-6000 (Agilent)
QLA-PPTUBV-02Peristaltic Pump Tubing, Silicone, Coded Purple & White (Set/8)17-6010 (Agilent)
QLA-PPTUBD-01Peristaltic Pump Tubing, Santoprene (Set/6)5640-0337 (Distek)
QLA-TAATUB-HP3 Collar Auto Analyzer Tubing, Tygon, .081” (2.06mm) ID (Set/12)QLA
QLA-TEFTUB-HPFEP Tubing for HP, PTFE, 1/32” (.8mm) ID x 1/16” (1.6mm) OD (500' (152m) Roll)QLA
QLA-TEFTUB-8VColor-Coded Sample Tubing, PTFE, .040” (1.02mm) ID x .066” (1.68mm) OD [8 Lengths of 50' (15m)]QLA
QLA-TUBINGTygon Tubing, 1/16” (1.6mm) ID x 1/8” (3.2mm) OD (Sold by Foot)QLA
QLA-CANFER-UNFlangeless Ferrule for 1/16” (1.6mm) TubingQLA
QLA-CANFLN-UNFlangeless Nut, 1/4-28 for 1/16” (1.6mm) TubingQLA
Dissolution tubing

PAPER ROLLS FOR AGILENT / VANKEL
Part No.DescriptionAgilent Reference
QLA-PAP100-01Plain Paper Rolls for Report Center II (Pack/25)12-9995
QLA-TPP082-70XDSThermal Paper Rolls, 2.25” wide (Pack/25)12-9988
QLA-TPP100-01Thermal Paper Rolls, 1.5” wide (Pack/25)12-9994

SHAFT COLLARS
Part No.DescriptionOEM Reference
QLA-TUMSCR-DKShaft Collar w/Thumb Screw for Distek 2100 Series2821-0094 (Distek)
QLA-SHTCOL-DKShaft Collar & Hex Key for 3/8” OD Shaft5570-6077 (Distek)
QLA-SHTCOL-EWLocking collar for 10mm OD ShaftQLA

PTFE SUSPENSION CUPS
Part No.DescriptionAgilent Reference
QLA-SUSPC-BASEWeighted Holder, 57.2mm OD, 5.2mm ID.12-4050
QLA-SUSPC-17.5Insert cup, 17.5 x 8.2mm, use with QLA-SUSPC-BASE12-4055
QLA-SUSPC-20Insert cup, 20 x 8.2mm, use with QLA-SUSPC-BASE12-4060

GLASS ACCESSORIES

VOLUMETRIC FLASKS
Part No.DescriptionOEM Reference
QLA-VOLFLK-05500mL Volumetric Flask, Class A, Calibrated at 20ºC, Round BottomQLA
QLA-VOLFLK-09900mL Volumetric Flask, Class A, Calibrated at 20ºC, Round BottomQLA
QLA-VOLFLK-1K1000mL Volumetric Flask, Class A, Calibrated at 20ºC, Round BottomQLA
QLA-VOLFLK-X5500mL Volumetric Flask, Class A, Calibrated at 37ºC, Round BottomQLA
QLA-VOLFLK-X9900mL Volumetric Flask, Class A, Calibrated at 37ºC, Round BottomQLA
QLA-VOLFLK-X11000mL Volumetric Flask, Class A, Calibrated at 37ºC, Round BottomQLA

TAPPED DENSITY
Part No.DescriptionOEM Reference
QLA-GLA010-0110mL Graduated Cylinder, Funnel Top, Hexagonal Base52-5000 (Agilent)
QLA-GLA100-01100mL Graduated Cylinder, Funnel Top, Hexagonal Base52-5010 (Agilent)
QLA-GLA1CA-01100mL Graduated Cylinder, Funnel Top, Hexagonal Base, Class A, Calibrated at 20ºCQLA
QLA-GLA250-01250mL Graduated Cylinder, Funnel Top, Hexagonal Base52-5020 (Agilent)

ROTATING BOTTLE APPARATUS FOR AGILENT
Part No.DescriptionOEM Reference
QLA-RBAASSY-01100mL Clear Glass Bottle and Cap with Viton LinerQLA
QLA-RBAASSY-02100mL Clear Glass Bottle and Decant Cap with 40 Mesh SS ScreenQLA
QLA-RBSCRN-4040 Mesh SS Screen for 100mL Decant Cap32-1221 (Agilent)

MISCELLANEOUS GLASS ACCESSORIES
Part No.DescriptionOEM Reference
QLA-FLEAK-150150mL Glass Fleaker, GraduatedQLA
QLA-FLEAK-300300mL Glass Fleaker, GraduatedQLA
QLA-FLEAK-500500mL Glass Fleaker, GraduatedQLA
QLA-FLEAK-01K1000mL Glass Fleaker, GraduatedQLA
QLA-FLEAKCAP-UNFleaker Cap fits 150mL, 300mL and 500mL fleakersQLA

DISINTEGRATION TESTING FOR AGILENT / VANKEL
Part No.DescriptionOEM Reference
QLA-DISASY-03Basket Assembly with 3 Glass Tubes and 10 Mesh Stainless Steel Screens37-3030
QLA-DISASY-06Basket Assembly with 6 Glass Tubes and 10 Mesh Stainless Steel Screens37-2001
QLA-DISASY-P6Basket Assembly with 6 Plastic Tubes and 10 Mesh Stainless Steel ScreensQLA
QLA-DISTUB-06Glass Replacement Tubes for 6 Tube Assembly, 25mm (Set/6)37-5000
QLA-DISTUB-P6Plastic Replacement Tubes for 6 Tube Assembly, 25mm (Set/6)QLA
QLA-DISTUB-03Glass Replacement Tubes for 3 Tube Assembly, 38mm (Set/3)37-5005
QLA-FDISC-VKUSP Fluted Plastic Disks for 6 Tube Assembly (Set/6)37-4000
QLA-DISDISK-03USP Fluted Plastic Disks for 3 Tube Assembly (Set/3)37-4010
QLA-DISSCR-VK1010 Mesh Stainless Steel Screens for 6 Tube Assembly (Set/6)37-2200
QLA-DISSCR03-VK1010 Mesh Stainless Steel Screens for 3 Tube Assembly (Set/3)QLA
QLA-GLA900-DB900mL Clear Glass Disintegration Beaker, Flared Top37-5200
QLA-GLA905-DB900mL Clear Glass Disintegration Beaker, Flat Top37-5305

QLA disintegration testing