In today’s ever-advancing technological landscape, an increasing number of instruments are replacing manual intervention, reducing human impact on results, and directing the focus toward evaluating the parallelism of data right at the heart of the instruments themselves.
Recently, a client approached us seeking advice, expressing concerns about the subpar parallelism in the testing data obtained from a certain brand of hardness tester they were using. Intrigued by their inquiry, we offered our Copley TBF 100i hardness tester as a potential solution. To substantiate our claims, we invited the client to send us some samples for testing with our hardness instrument, recognizing that persuasive evidence lies in the actual data obtained.
01 The Protagonists of Today
Client Samples: The confidential samples provided by our client along with the Copley TBF 100i hardness tester.
02 Regarding Sample Collection
Generally, before the samples reach the hands of the quality control personnel, they may undergo friction and falls on conveyor belts, collisions with sampling containers by the sampling personnel, and potential compression during transportation. These external factors can have a certain impact on the originally dense internal structure of the samples. Therefore, it is crucial to handle the sampling process with care, aiming to avoid situations like the incomplete sample shown in the figure below.
03 About Sample Shape
Rarely do samples possess a perfectly regular circular shape, and even if they are circular, factors such as grooves or imprints can influence their stress distribution. To ensure data parallelism, our first step is to address the sample orientation:
- Ensure that circular tablets with grooves/imprints have consistent groove/imprint orientations.
- Ensure that irregularly shaped tablets are placed at angles relative to the hardness tester that are consistent among them.
- Ensure consistency in the orientation of the tablets, ensuring they are placed identically, with the same side facing the hardness tester.
Now that we have addressed the above considerations, let us proceed with today’s testing.
04 About Sample Placement
For this particular set of samples, which are elongated in shape and feature both grooves and imprints, special attention should be given to their positioning:
- Place the sample (D) as close to the fixed jaw (B) as possible, to prevent any angle deviation caused by the movement of the electric clamp (E).
- Orient the sample horizontally in parallel with the direction of the electric clamp’s movement.
- Ensure that each time the sample is replaced, the position and orientation of the imprints on the sample remain consistent.
By adhering to these guidelines, we can proceed with the testing, ensuring accuracy and consistency in our results.
05 About the Testing Process
- Before conducting the initial measurement of the new specification of samples, it is necessary to set the diameter/length of the samples.
- Decide whether to simultaneously measure the thickness and weight of the samples.
- Adjust the batch size of the samples to be tested (default is 3; for this testing session, it has been set to 10).
Below is the testing process:
Between each sample switch, be sure to carefully clean any powder or debris from the pharmaceutical tablets.
06 About Sample Quality and Thickness Measurement
TBF100i is capable of simultaneously conducting measurements for both the quality and thickness of pharmaceutical tablets, requiring the procurement of additional accessories such as a thickness gauge and balance.
The thickness gauge and balance are connected to the hardness tester via data cables, enabling the activation of weight and thickness detection functions. By utilizing the “Run” button on the instrument, measurements are carried out in sequence, and data is collected.
The instrument first measures the sample’s weight, followed by thickness, and finally, it measures the diameter and hardness.
This comprehensive measurement capability provides a more holistic approach to quality control and analysis of samples, enabling users to accurately assess the characteristics and performance of the pharmaceutical tablets. Furthermore, integrating these functionalities into a single device streamlines the operation process, enhancing testing efficiency and convenience.
07 About the Testing Results
In this experiment, I conducted consecutive measurements of hardness and diameter (length) for ten samples. Below is a comparison of the testing results obtained from this batch of samples with the results obtained by the client’s instrument:
From the comparison of their average values and standard deviation (SD), it can be observed that the two sets of results are quite close, indicating accuracy in both cases. The TBF100i exhibits a smaller SD, suggesting excellent data reproducibility. The client has expressed approval and affirmation regarding the measurement results we provided.
Copley TBF100i consistently delivers precise testing results, exhibiting superior data reproducibility.
08 Product Ordering Information
| Material Number | Product Name |
|---|---|
| 2532 | TBF 100i Hardness Tester |
| 2505 | IQ/OQ Confirmation Document Package |
| 2507 | Sartorius Quintix 224-1CEU Balance |
| 2508 | Mitutoyo Thickness Measurement Gauge |
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