Whether you have the best tablet press machine, a tablet friability tester is a must-have accessory.
You need to know tablet’s resistance to abrasion, breakage, aberration or capping.
Remember, in packaging and transporting tablet safely, friability testing is a critical quality control (QC) procedure.
Today’s guide covers everything about tablet friability testing – from quality standards, working principle, parts, classification, key features, etc.
By the end of this guide, you’ll know how to improve your quality control procedures.
Let’s dive right in.
- What is table friability tester?
- Why is Tablet Friability Testing Important?
- Quality Standards for Tablet Friability Tester Equipment
- Parts of Tablet Friability Tester
- Types of Tablet Friability Tester Machines
- Tablet Friability Tester Calibration Process
- SaintyCo Tablet Friability Tester Equipment
What is table friability tester?
Friability is the chipping or crumbling of a tablet due to compression during packaging or transit.
High quality vs low quality tablets
Tablet friability testing is carried out in pharmaceutical company laboratories.
A friability tester is a piece of equipment mainly used to determine how long tablets can last during transportation without having to break.
When this equipment is used, it raises a flag on quality issues of uncoated tablets.
Tablet friability tester
Tablet friability can be caused by several factors. Causes can include poor tablet design like:
- Sharp edges
- Low moisture content
- Insufficient binders.
When there is a weight loss on sample tablets of more than 1%, then we can say there is a problem with production quality.
In this case, the pharmaceutical company must find out the reason behind it.
There’s a possibility that the shape of the tablet is the cause, so that the design must be changed.
Sometimes it could be due to low moisture content in the tablets.
The test process involves dropping some tablets into a drum.
This is done using a rotating wheel with a baffle over a specified fixed time frame.
After that, inspection is done to find the broken tablets.
An example of a tablet friability tester is this diagram below.
Tablet friability tester equipment
Why is Tablet Friability Testing Important?
Some of the main reasons why you need a tablet friability tester include:
Tablets manufacturing and quality control
- Helps to determine the resistance of uncoated tablets to abrasion and shock during manufacturing, packing, and shipping.
- Provides pharmaceutical companies with an opportunity to carry out research. Knowledge about the cause of breakage of the tablets during testing could reduce company loses.
- Controls the stability of uncoated tablets in pharmaceutical industries, hospitals, and drug testing institutions.
- Provides data for sugar-coated tablets which is reliable.
- Protects the consumer right. Some tablets can lose 1% or less weight, and this is generally acceptable.
But if the sample tested has lost more than 1%, that particular batch of drugs is not recommended for use.
Quality Standards for Tablet Friability Tester Equipment
These qualities make the machine reliable, efficient and produce the expected results.
The tester has a drum of between 283 and 291 mm internal diameter.
This drum can have a depth of between 36 and 40 mm.
It is also made from a transparent synthetic polymer with a polished metal surface.
Inside the drum, there is a curved projection which has a radius of between 75.5 and 85.5 mm.
This projection extends from the middle of the drum to the outer wall.
The drum can be removed from one side when the tablets are being loaded into it and the machine is set to run.
It has a standard supply scope which contains AII IQ, OQ, and DQ/QC documentation.
Lastly, it has a program with an expected number of revolutions and duration for each revolution.
USP Specifications and Codes for Quality Standards for Tablet Friability Tester Equipment
|USP Standards||Maximum percentage difference allowed||BP/IP Standards|
|130 mg or less||10%||84 mg or less|
|130 mg-324 mg||7.5% or less||84 mg-250 mg|
|More than 325 mg||5%||More than 25 mg|
Codes for quality double tablet friability tester are
Here’s an example of double drum Tablet Friability tester codes:
- Part Number: 0401A00009 (A position)
- Part Number: 0403A00013 (B position)
- Tablet collector drawer (S.S)
- Part Number: 0401A00008 (A position)
- Part number: 0403A00012 (B position)
- Epson LX 300 and printer number 1501000001
Quality Standards for Tablet Friability Tester Equipment USP, EP and JP Pharmacopeia
USP means United States Pharmacopeia.
EP is European Pharmacopeia, and JP is Japanese Pharmacopeia.
In 2011, there was a 46thpharmacopeia discussion group meeting hosted by WHO.
The attendants of this meeting were the United States, Japan, and Europe experts.
They harmonize specifications for pharmaceutical preparations.
For example, they agreed that a tablet friability tester should have the following specifications:
- A drum with an internal diameter of between 283 and 291 mm and a depth of between 36 and 40 mm.
- It should be made from a synthetic polymer which has a polished internal surface.
- The drum should be removable from one side.
- Inside that drum, there should be a projection that is curved which has an inside radius of between 75.5 and 85.5 mm. This should extend from the middle of the drum to the outer wall.
- It should be connected to a horizontal axis of a device that rotates at a speed of 25 1 rpm.
- Tablets weighing more than 650 mg are put in samples of 10, dusted and weighed.
- Cleaved, broken and cracked tablets in a sample show that the sample has failed the test. The target value is always 1%. If the results of a test are less than the target value, the test should be repeated three times and the average calculated.
- If the shape or size of a tablet is causing Tambling to be irregular, the drum can be tilted at 10º.
As you can see, there is a clear procedure on how to assess the quality of tablets.
Parts of Tablet Friability Tester
Tablet friability tester is made up of different parts which include:
Fully assembled tablet friability testing machine
a) Calibration system
It quickly checks the machine to ensure it is ready for operation.
The machine has to be calibrated so that the test results desired can be reported.
b) Drum/ drums
This is where the tablets are loaded. It is made from Plexiglas.
Normally, it has two parts, that is, the drum and its cover.
The cover can be removed when you want to clean it or load tablet samples.
Also, it is made using high-quality stainless steel which meets the GLP requirements.
Once it is loaded, it is covered and ready for running.
Inside the drum, there is a curved scoop.
It pushes the tablets up and down at a predetermined height and speed.
c) Silent DC gear motor
Helps in rotating the drums at a fixed speed of 25 rpm or according to how it has been set.
It aids in settings of the time and rotation modes.
d) Click wheel navigator
Used to navigate the menu on the LCD screen.
e) Integrated report printer
Weight loss is calculated here automatically.
It generates reports for tests and copies of the reports are saved in a USB connected to it.
f) Discharge collector tray
Is made from clear Plexiglas and magnetically fixed to the base of the instrument.
It can be removed for cleaning and returned back easily.
Types of Tablet Friability Tester Machines
With the advancements in the pharmaceutical industry and equipment, today we have a range of tablet friability testing machine.
Some of the most common options to consider include the following:
· Single drum tablet friability tester
We shall now learn how this tester works, its merits and demerits and its features.
It has one drum just like the name suggests.
The drum has an internal curved projection which extends from the middle of the drum to the outer part of the drum wall.
How does single drum tablet friability tester work?
It operates at a fixed speed which is set to rotate twenty-five (25) times per minute.
Before you load the tablets into the drum, you should ensure the tablets are clean and weighed.
Once this is done, calibrate the instrument and load the sample of tablets into the drum.
You can now run the equipment.
This machine functions in such a way that when testing is complete, it automatically stops.
After that, you can remove the samples from the drum, de-dust, weigh and calculate friability.
The tablets are said to have passed the friability test if the average percentage weight loss is less than or equivalent to 1%.
Below is a picture of a single drum tablet friability tester.
Single drum tablet friability tester
Properties of single drum tablet friability tester
The drum is made from Plexiglas in compliance with USP, EP, and DAB.
It is also made of LED which displays information about time and speed rotation of the equipment.
This is because if there are any errors in the setting of the machine, then it can be seen and corrected.
Also, it has a program which shows the expected number of revolutions and duration for all revolutions.
Knowledge of how many revolutions and timing of a test is necessary to assist you in working with this tester.
Last but very important – it has a standard supply scope which contains AII IQ, OQ, and DQ/QC documentation.
Advantages of single drum tablet friability tester
It has an LED component which displays both target and actual setting used to run the equipment.
This gives an operator of the machine an ample time to set and run it.
Once it is set, the tablets are loaded into the machine drum and run.
Furthermore, it has a housing of GPL compliant stainless steel which is able to operate without rusting.
It can be adjusted to work in two ways, rotation and time mode.
Once the timing is complete, the number of revolutions set is also complete, and the machine then stops automatically.
Lastly, it is simple and easy to set and operate.
So long as the operator understands the setting techniques and has knowledge of the recommended settings, he can do it.
The table below shows some of the technical specifications of single drum tablet friability tester.
Friability tester machine technical specification
· Double drum table friability tester
It does both friability and abrasion test.
It is made in compliance with USP <1216>, EP <2.9.7> and JP<14> pharmacopoeias.
It automatically discharges the samples when testing is complete and then connects to an analytical balance.
See the diagram below for a double drum tablet friability tester.
Double drum friability tester machine
How does a double drum friability tester work?
Before you load the tablet samples into the drum, ensure that the samples ready to be loaded are cleaned.
This is get rid of any dust that might cause any foreign increase in weight of the tablets.
Adjust the weighing scale to start from zero weight and weigh the tablet samples.
It is to ensure that the weight results are correct as we begin the test.
Set the number of revolutions and the timing the test is required to take.
Load the tablets samples into the drum through a unique front loading drum system or discharge area.
In most cases, a recommended sample for a test can be of around 20 tablets.
When the tablet samples are in the drum, run the equipment.
Upon completion, the machine stops automatically.
The tested tablet sample is automatically discharged into some individual collector trays, and another sample is loaded for a new test.
Now, the last procedure is to inspect, de-dust, weigh and calculate friability of the sample.
Quality tablets will have an acceptable friability that does not exceed 1% although you can have less than that.
Advantages of a double drum tablet friability tester
With this friability testing machine, you can open, close or clean it easily.
For loading, there is an alternative for using the open discharge area.
Also, it has an LCD screen which displays the actual and the target settings of the machine.
Furthermore, this friability tester machine operates in two modes, time and rotation modes.
That is, it can either run with different drum rotation speed or locked speed mode.
More interestingly, it can stop and discharge the samples automatically when the test is complete.
It has a balance that automatically calculates the weight loss of tablet samples.
How is double drum tablet friability tester designed?
Double drum tablet friability tester has been designed in compliance with USP, Ph, and IP specifications.
It has an automated sample discharge with sample collector tray.
This makes the whole process of testing faster since many samples can be tested in a short while.
In addition to this, it can perform in a counter mode with a speed that can range from 20 to 60 rpm.
Not forgetting the unique loading drum system.
This loading system can open from one side to load tablet samples once a previous test is completed and discharged.
It can also be loaded through the discharge area.
During testing of the tablets, sometimes there could be tablet spillage.
The double drum has a positive engagement with the drive thus minimizing spillage.
A double drum is also tilted 10 degrees when tablets have sharp edges.
The specifications for double drum tablet friability tester are outlined in the table below.
|Number of rotations||25 ± 1 rpm|
|It’s accuracy||± 1 revolution|
|Number of resolutions||One revolution|
|The range||From 0-999 revolutions|
|Temperature range for operating||Between 10°C to 50°C|
|Power consumption||230 V ± 10%, 50 Hz.|
· Triple drum tablet friability tester
It is made in compliance with USP <1216, EP<2.9.7> and JP <14> pharmacopeias.
All triple drum tablet friability tester have automated discharge for tablet samples at the end of each test.
Besides, it connects to an analytical balance.
This instrument does both friability and abrasion tests.
Look at the diagram below.
It is an example of a triple drum tablet friability tester.
Tripple drum friability tester
How does triple drum friability tester work?
Triple drum tablet friability tester operates in the following manner.
The instrument is calibrated so that it can produce the expected results once the test is conducted.
Time and revolution mode are both set.
Tablets samples are loaded into the three drums either through a unique front loading system or open discharge area.
Do this after cleaning and weighing of the samples.
It is then covered, and the test is run in the equipment.
Upon completion, the machine stops automatically.
This prompts the automatic discharge of the tested tablets individual collector trays located below the drums.
No, do the inspection, de-dusting, weighing and calculation of tablet friability.
It then automatically generates and prints out a report through an inbuilt printer.
Depending on the design, it also stores a soft copy of the report in a USB flash drive which is also connected to the machine.
This report can then be used for future reference.
Properties of triple drum tablet friability tester
The following are the properties of a triple drum tablet friability tester.
It is designed in compliance with USP <1216>, EP <2.9.7> and JP <14> Pharmacopeia.
Drums can easily be opened and closed when there is a need for loading of tablets and cleaning.
Once the tablets are clean, they are weighed.
Calibration of the machine is done to ensure the instrument is ready to perform the tests.
Time and revolution mode are then set.
After that, the tablet samples are then loaded into the drums and the test is run.
When the test is complete, the instrument stops automatically.
Samples tested are automatically discharged into a collector tray.
The printer then prints the test reports once the friability test has been calculated.
The table below illustrates the technical specifications for triple drum tablet friability tester
|Parameter||Technical Specification for triple drum tablet friability tester.|
|The number of drums used in testing friability of tablets||Three drums located on the right side.|
|Speed range for drum rotation||Is between 15 – 100 r.p.m|
|The accuracy of speed||Can be ±1 r.p.m|
|Rotation numbers||Can be adjusted from 2 to 9999, switchable to time mode.|
|Time for testing||It can be adjusted from between 2 to 9999 switchable to rotations mode.|
|Management criteria||A maximum of 256 descriptions of tests can be stored in the instrument.|
|How it is managed||A maximum of 32 different users who have selective user right levels can be stored in the instrument.|
|Data storage||It connects to a USB flash drive for data storage|
|It’s Display||It has LCD which changes with backlight color.|
|The Keyboard||It has Keypad with function keys and clicks wheel|
|The housing of the instrument||It is stored in a stainless steel housing that is polished and has a plastic frame.|
|The Power consumption||It consumes about 110/230 Volt, 50/60 Hz|
|Dimensions of the instrument||Approximately 50cm x 56cm x 47cm. That is the width x depth x-height|
|Dimensions for packaging||Approximately 60cm x 60cm x 50cm. That is width x depth x-height.|
|Weight- both net and gross||Approximately 22 / 25 kg|
|Certification||USP / EP certification requirements are met|
|Certification for CE / EMC||Certification provided for All CE / EMC|
Please note that some of these specifications will vary from one tablet friability testing machine to another.
Advantages of triple drum tablet friability tester
The drums can be opened when you want to load or clean them.
For loading, there is an alternative for using the open discharge area.
It also has an LCD screen which displays the actual and the target settings of the machine.
Also, it operates in two modes: time and rotation modes.
That is, it can either operate with different drum rotation speed or locked speed mode.
When the test is complete, it stops and discharges the samples automatically.
It has a balance that automatically calculates the weight loss of tablet samples.
Additionally, it an in-built printer which generates detailed reports with weight loss calculations and test result assessment.
Lastly, it is programmed to remind the operator to carry out instrument calibration.
This is to ensure the instrument generates acceptable results all the time.
· Automated Friability Tester
This refers to any tablet friability tester that tests numerous samples at a time.
It has an in-built program of test algorithms for tablets that are tested frequently.
Examples of automated tablet friability testers include:
- Double drumtablet friability testers
- Triple drumtablet friability testers
- Four drumtablet friability testers
- Six drum tablet friability testers
Most of their functions are done automatically once the machine has been calibrated.
The time and rotation modes are set, and the instrument is run.
Once the time and number of rotations set are complete, the automatic tablet friability tester automatically stops.
Tests samples are automatically discharged into the collection trays.
In addition to these, the integrated printer automatically prints out the sample test results.
This is followed by an automatic saving of the report to a USB flash drive connected to the printer.
Therefore, almost every process here is automated.
Working Principle of Tablet Friability Tester Equipment
All these tablet friability testers that we have discussed in our previous subtopic have almost the same working principles.
The differences could be very slight.
Nevertheless, let us look at some of these principles.
As a rule of thumb, a tablet friability tester operator must check if the instrument is in a calibrated state.
Tablet friability tester has a display screen where setting information is displayed.
Therefore, from the function key on the instrument, select the mode of operation which is time and counts down modes.
Ensure that you clean the tablet samples, the instrument, and the weighing machine.
This helps in ensuring that there is no extra weight loaded into the drum.
Once the machine is set, load the samples into the drum, enter the weight of the samples and select the start key to run the test.
When this is done, the tested sample is removed from the drum.
After this, inspect for capping or breaking of the tablets.
Finally, inspect, weigh and calculate friability of the sampled tablets.
Key features of tablet friability tester
Tablet friability tester has the following features.
i. A drum/drums which are clear.
ii. Single drum runs one test while double and triple can run two and three tests simultaneously respectively.
iii. Each drum has a curved projection inside it that tumbles the tablets up and down during testing.
iv. They all conform to testing standards set by USP <1216>pharmacopeia.
v. The drum/ drums are driven by the silent DC gear motor.
vi. It can easily be disassembled for loading, unloading, and cleaning of the drum.
vii. Those with many drums have automatic discharge and tablet collector tray where tasted samples are discharged into.
viii. Multi-drum tablet friability testers like a triple, four and six drums have printers and a connection for USB.
Tablet Friability Tester Calibration Process
As a rule of thumb, before using any pharmaceutical instruments, ensure it can record or display accurate results.
To do this, it measurements must conform to certain set standards.
That’s exactly what you’re going to learn here.
What is Tablet Friability Tester Calibration?
It is configuring the tester to provide sample results within an acceptable range.
It eliminates or even minimizes factors that may cause inaccuracy in measurements.
Normally, it is a primary process of maintaining the instrument.
It tests samples of values of a calibrator.
Friability test apparatus
Tablet friability tester calibration involves two sub-processes which are discussed below.
Number of rotation in 1, 2 and 4 minutes calibration
To calibrate the instrument in a rotation of 1, 2 or 4 minutes, on the function key, set the time mode.
If you want it to run for 1 minute, select 1 minute mode.
You can then start the instrument and see the revolution numbers in a minute.
Repeat the same process for 2 and 4 minutes and after that, record the results.
All these three tests must be performed three times to ensure reliability and accuracy.
Below is an example of an acceptable number of rotations in 1, 2, and 4 minutes.
- Number of rotations acceptable for 1 minute are Between 24 to 26 rotations.
- Number of rotations acceptable for 2 minutes are Between 48 to 52 rotations.
- Number of rotations acceptable for 4 minutes are Between 96 to 104 rotations.
Calibration for 25, 50 and 100 rotations for time
Here, you calibrate the equipment to rotate 25, 50 and 100 rotations and select the count mode.
You can then start the apparatus and use a stopwatch to stop at 25, 50 and 100 rotations.
This will help you determine the time each set of rotations takes.
Upon completion of each three calibrations, record all the results.
Below is an example of an acceptable time in minutes for 25, 50 and 100 rotations.
- It is acceptable to have 25 rotations in a time duration of between 0: 57 00 to1:03 00 minutes
- For 50 rotations, the time duration can be between 1: 54 00 to2:06 00 minutes
- When it comes to 100 rotations, the durations can range between 3: 48 00 to4:12 00 minutes.
SaintyCo Tablet Friability Tester Equipment
SaintyCo is a leading company in processing and equipment packaging of pharmaceutical, cosmetics, and other products.
Our latest tablet friability tester is the CS-1/2/3 series.
This instrument detects friability and abrasion of uncoated tablets.
It is more advanced than all the tablet friability testers.
Besides, it conforms to the USP specifications and codes.
SaintyCo friability tester
For easier operation, our tablet friability tester equipment features MPU, high speed and revolutions.
Besides, the friability tester equipment has key function option, with an LED and display.
Depending on the tablet quality testing needs, SaintyCo offers a perfect solution for all testing needs.
Tablet friability tester is a very important equipment, particularly to pharmaceutical companies.
It is also useful in hospitals and tablet testing industries.
Its quality and state at the time of use are very important for the successful production of tablets.
Remember, it determines whether the tablet will reach the end user in good condition or not.