Quality Lab Accessories

08/01/2025

David Cuevas, Latin American Sales Manager, joined the BioAnalytical Instruments team representing QLA products at PRChem 2025.

06/10/2025

QLA is excited to bring the Merel product line to our US and Puerto Rico customers!

🌎 We are proud to announce our new distribution partnership with 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐋𝐚𝐛 𝐀𝐜𝐜𝐞𝐬𝐬𝐨𝐫𝐢𝐞𝐬 (𝐐𝐋𝐀)! 📢 With their extensive experience and strong reputation in the pharmaceutical laboratory sector, QLA is the ideal partner to r...

12/09/2024

QLA Korea had the honor of presenting QLA products at the Korea Lab Autumn 2024 Exhibition! Great turnout!

01/25/2024

ASTM/Enhanced Mechanical Calibration vs Prednisone PVT- Which is better for my lab?

The debate about the prednisone performance verification test (PVT) versus the ASTM enhanced mechanical calibration has gone on since the inception of ASTM chapter 2503. Both are different means of providing an answer to the same question,” Is my dissolution tester suitable for use and can I trust the data from it?”
The prednisone PVT is typically performed after a mechanical qualification of the dissolution tester which, if one follows USP 711, has wider tolerances for passing than ASTM 2503. However, if one follows the suggestions in USP Guideline on Procedures for Mechanical Calibration and Performance Verification Test Apparatus 1 and Apparatus 2 (Mar 2023), then the recommended mechanical tolerances are largely in line with those in ASTM 2503. Another note is that prednisone tablets have both a specification for a geometric mean, as well as a coefficient of variation; so having a vessel which has centering at the edge of the tolerance but passing, combined with other vessels which are centered nearly perfectly can potentially cause a failure as if the vessel was out of tolerance.
So where is the advantage to running a PVT? Unlike an ASTM enhanced mechanical qualification, a PVT provides a wholistic test of the dissolution tester, the laboratory, and (if performed with in-house staff) the operator. The prednisone calibrator tablets are designed to fail if any aspect of the dissolution tester, or the process of the testing (e.g. sampling, deaeration, dissolution media, standard preparation) is out of tolerance.
However, the PVT is time consuming. For a trained operator to perform both a mechanical qualification as well as the PVT the instrument will typically be unusable for 2 to 3 days. There are also chances for failure completely unrelated to whether the dissolution tester is within all necessary specifications. The test can fail due to operator errors or errors with equipment unrelated to the dissolution tester.
The ASTM enhanced mechanical qualification has the advantage that it focuses only on the dissolution tester. The operator or other equipment present in the lab do not factor into whether the dissolution tester is suitable for use. There are some key advantages to this, one of the chief ones being the time it takes to perform a mechanical qualification on a dissolution tester is typically only a few hours. The measurements can be performed by most metrology groups without the need for special training on performing dissolution tests.
Without a calibrator tablet though, the ASTM calibration needs a means to determine whether the paddles, baskets, and vessels are within specification. The ASTM calibration checks this by means of either measurement of the dimensions of the apparatus, or alternatively certification from the supplier that the items met all specifications at time of manufacture. This is not required with the PVT because the calibrator tablet performs that check; if the items are within specification the test should pass, if they are out of specification the test should fail.
Which method of qualification is largely dependent on what works best for the lab. The ASTM calibration allows for faster turnaround during the qualification process. The PVT provides proof that not just the dissolution tester, but the lab itself is capable of running dissolution tests correctly, which can be of benefit if the lab is regularly audited. Ultimately both are acceptable by the FDA, and both will answer the question of whether or not your dissolution tester is producing data you can trust.

08/28/2023

When to use a sinker:
The following article has been authored by John Heaney.
Not all tablets, capsules, and gelcaps behave the same in dissolution media. In some cases, a dosage may be buoyant enough to move far more than normal when subjected to the turbulence caused by a paddle (Apparatus 2) if not float all the way to the surface. Either of these would be considered unacceptable if they were observed during a test.
The case of a dosage form floating to the surface is obvious. It’s far out of position from the bottom of the dissolution vessel and is not subject to the same hydrodynamic forces as a dosage which stays in place.
In the case of a dosage form that is moving around when subjected to the forces beneath the paddle, the issues may be less obvious. Yes, the dosage is still at the bottom of a dissolution vessel, but it’s moving, and each vessel may have a dosage that is moving differently from another. More specifically, the hydrodynamic forces that each dosage is subject to is likely to be different; perhaps significantly. This in turn could lead to more variability with the results for each vessel which would make it more difficult to discern if there are problems with that batch.
As with any dissolution test, the initial method development of a test for a new tablet, capsule, or gelcap should include observation. The analyst should be present and recording observations for each vessel. In some cases if the dosage is sufficiently buoyant, placing it in a small beaker of media would show that a sinker may be required. If possible, or practical, calculating the density of the dosage prior to performing a dissolution test may be sufficient to determine if a sinker is needed if the density is sufficiently lower than that of the media.
In a QC environment, the dissolution method should be well defined. If a dosage form suddenly needs a sinker and one is not called for in the method, it may be indicative of a problem at best with that individual dosage form, or at worst, the batch as a whole. While a dosage suddenly floating that did not float before is indicative of a serious problem, a dosage moving around more than usual at the bottom of the vessel while using Apparatus 2 (paddles) can also be indicative of poor deaeration. If the media has been poorly deaerated then it is most likely that bubbles will appear on the surface of the dosage. If enough of them adhere to the surface of the dosage, they can cause the tablet to become more buoyant as well as serve as a barrier against the diffusion of the drug away from the surface of the tablet. Sinkers are not a solution to poorly deaerated media.
Generally speaking, it’s not difficult to determine whether or not you need a sinker. Determining how to pick a sinker will be covered in a future blog.

07/12/2023

Precision Molded vs Standard Glass Vessels

Variability is a fact of life in any manufacturing process. That is the reason there are acceptance ranges and tolerances as well as QC departments to measure finished product ensuring that everything is acceptable. The tools used by any QC department need to be as consistent as possible. A pair of calipers that gives a slightly different reading each time when measuring an NIST standard block is not particularly valuable. The same is true of dissolution testers, or more specifically vessels, that have high variability. High variability in the vessel size and shape will increase the variability of the results.
Most accessories used in dissolution testing are machined which allows for the relatively tight tolerances of about 0.13 mm or 0.005 inches. Historically, the vessels have not fallen into this category. At the start of dissolution testing back in the 1960’s, vessels were hand formed from glass tubing by master craftsmen. A good craftsman would be able to keep the vessels similar, but they do this by working on the outside of the glass, not the inside where ultimately the tablet and dissolution media reside. And imperfections could form, whether it be to differences in craftsmen from the same facility, differences in the glass, or differences in how the flames were applied.
The hemisphere of the vessel is the most critical part of the process, but until the past 2 decades, has shown some of the highest variability. For Apparatus 2 especially, the hydrodynamics near the tablet would be determined by the hemisphere of the vessel. In some cases, deformities may be easy to find. One vessel has a shallow hemisphere compared to a deeper one, visibly obvious when the vessels are side by side. Or a vessel may have a slight bulge in one direction causing it not to match others that can be felt when inspected by hand. In other cases, it may not have been obvious until a performance verification test is done.
Vessel manufacturing technology has improved significantly though, and while higher variability was a requirement before, it is now optional. While the specifics of the process vary from manufacturer to manufacturer, high precision vessels can be manufactured using a process similar to molding. This allows for the dissolution vessels to move away from tolerances typically used for items made by hand, and closer to that of machined items.
And the results in many cases are obvious. Numerous studies have shown that vessels like QLA’s UltraCenter™ Precision Glass Vessel are much more consistent both mechanically and during testing. In every case the adoption of high precision vessels has resulted in better centering results for ASTM based mechanical qualifications and lower variability with the USP Prednisone PVT. The reason for this is clear – the vessels are more similar, so the hydrodynamics are similar, so the results are similar.
In QLA’s own testing the variability dropped from over a %CV of 6 to a %CV below 3. That’s an immense change from altering a single component on a dissolution tester. It also further shows how critical the vessels are in dissolution testing.
Additional studies also show the benefits of these vessels:
• Effect of the Irregular Inner Shape of a Glass Vessel on Prednisone Dissolution
Results (Makoto Tanaka, Hiroyasu Fujiwara and Morimasa Fujiwara, Dissolution
Technologies November 2005, pgs 15-19)
• Dissolution Testing Variability: Effect of Using Vessels from Different
Commercial Sources (Mark R. Liddell, Gang Deng and Walter W. Hauck- US
Pharmacopeia. American Pharmaceutical Review)
• Evaluation of Glass Dissolution Vessel Dimensions and Irregularities (Mark R.
Liddell, Gang Deng, Walter W. Hauck, William E. Brown, Samir Z. Wahab and
Ronald G. Manning, Dissolution Technologies February 2007, pgs 28-33)
• Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment
Approach (Joseph Eaton, Gang Deng, Walter W. Hauck, William Brown, Ronald
G. Manning and Samir Wahab, Dissolution Technologies February 2007, pgs
20-26)

The adoption of vessels similar to QLA’s UltraCenter™ Precision Glass Vessels are not just useful for passing the qualifications, but they show that the variability is present with the tablets or capsules rather than within the system. This makes determining if there’s a QC problem and if a batch needs to be stopped far easier and more reliable than handmade Standard Glass Vessels. They provide results you can count on.

05/03/2023

QLA Korea showcased QLA products from April 18th - 21st at Korea Lab 2023. The exhibition was very successful, and we are pleased to have such an enthusiastic representation of the QLA brand in Asia

04/27/2023

QLA being represented by our distributor in Mexico, Canitec, at ExpoFarma held at the World Trade Center in Mexico City from April 19th - 21st. Our Latin American Sales Manager, David Cuevas, was very happy to be part of this event and very appreciative of the hospitality shown by Canitec.

03/01/2022

QLA celebrated 25 years in business this past year. Each member of our team plays a major role in making QLA the industry leader in product quality and positive customer experience. We are so proud of our success and want to thank all of our customers for their loyalty and support over the years. Here’s to the next 25 years!

10/15/2021

AIT France was recently at Forum Labo Paris representing QLA! Can anyone spot Qually, our pill shaped mascot? Thanks to AIT for their continued support!

08/25/2021

Not only is this an interesting article about basket mesh sizes and how they affect hydrodynamics, QLA was mentioned in regard to our Precision Baskets and Basket Removal Tool! This is why it is critical to handle these items with care.

The USP Apparatus 1 (rotating basket), typically used to assess drug product reproducibility and evaluate oral solid dosage forms performance, consist…