If you’re in the solid dosage products manufacturing, then you need a disintegration tester.
In fact, it is an important quality control aspect in the tablet press industry.
So, today’s guide will focus on critical aspects of disintegration tester, from basic terms in the industry, classification, working principle, features, etc.
What is a Disintegration Tester?
Disintegration is the process where no residue of the unit under test remains on the surface of the apparatus after being broken down.
Or, if it does, contains remains of broken down tablets.
A good example is the pharmaceutical industry.
Practically, you can see how drug disintegrates in your stomach:
Complete disintegration is where any residue of the unit, except fragments of insoluble coating or capsule shell, remains on the screen of the test apparatus.
In simple terms, it is the breaking down of matter to minute particles.
A Disintegration Tester is, therefore, an instrument that is used in detecting the disintegration of solid dosage products.
It looks like this:
Other terms that you will frequently come across in this article are:
- Disintegration Time – This is the period required for dosage forms to break down into granules of specified sizes or smaller. This is carefully done under specified conditions.
- Disintegration test – It is a process of knowing the time it takes for a solid dosage form to completely disintegrate.
- Dissolution – It the process where solid substances enter a solvent, forming a solution. Dissolution in most cases is controlled by the affinity between solids and the solvent.
Today, we have some of the most advanced disintegration tester machines.
They feature the latest technology and development.
More importantly, they conform to international safety standards like the USP requirements.
Functions of the Disintegration Tester Apparatus in the Pharmaceutical Industry
As you will see in this section, this pharmaceutical instrument plays an integral role in the industry.
Below are some of the main reasons why you need a disintegration tester instrument:
Disintegration tester apparatus
i. To test the disintegration capability of tablets and capsules as per the pharmacopoeial standards like USP, BP, and IP.
If for instance the disintegration time within the set of samples varies or is too high or low then it wouldn’t correspond to the pharmacopeial standards.
ii. Monitor quality of different dosage forms and their performance, i.e. the time a formulation takes to disintegrate.
iii. Disintegration tester allows the researcher to analyze the in- vitro breakdown of powdered compounds for quality control.
iv. It can also be used to check the consistency and conformity of a batch of tablets or capsules in the industry. This also helps the production team to conform to the set standards such as USP requirement.
Generally, Disintegration Tester plays an important role in quality control.
Besides, it makes research easy and simple.
Types of Disintegration Tester Machines
Since the invention of Disintegration Tester, there have been many technological advancements.
Besides, there is a high demand for precise and efficient testing apparatus.
Depending on your manufacturing needs, you can choose any of the following:
Disintegration tester machine
Available in the market are the Fully Automatic kind of Testers, the Semi-automatic Disintegration Testers, and the Manual Testers.
Basically, the classification depends on the mode of operation.
These Disintegration Testers can be further classified depending on the number of stations they possess; for instance
i. Single Stationed Disintegration Tester
ii. Double Stationed Disintegration Tester
iii. Triple StationedDisintegration Tester
Here, the classification depends on the number of operating stations.
Remember, you can also find a 2-Station Semi-Automatic Disintegration Tester or an automatic type.
Below is some of the detailed information on the most common Disintegration Tester Machines you can find in the market.
1) Fully Automated Tablet Disintegration Tester Machine
This kind of Disintegration Tester automatically detects the individual disintegration times for a tablet or/ and other solid dosage forms.
As the word automatic states, they operate independently.
They have temperature sensors that enable them to operate within the required temperature limits.
The entire Fully Automated Tablet Disintegration Testers comply with the ESP / USP pharmacopeia requirements.
2) Semi-automated Tablet Disintegration Testing Machine
They are available as single, double, triple and four station systems among others.
Each Disintegration basket can be operated independently.
Besides, they are also fully equipped and complaint with the current USP and EP pharmacopeia standards.
3) Manual Tablet Disintegration Tester Machines
As the name suggests, these Testers are operated manually – by use of a hand.
These Disintegration Testers are used for manual testing of the disintegration time of tablets, capsules and other solid dosage forms.
4) Single Disintegration Tester Machines
The machine is referred to as a single because it has one basket.
It’s manually operated or automatically operated depending on the company.
This machine complies with the current USP, EP and other pharmacopeias.
It has clear baths to enable proper visual observation.
This helps the pharmacist /researcher to clearly see the outcome of the disintegration – has all the solid dosage forms been disintegrated?
The Disintegration basket which holds the glass tubes and discs are placed into a stainless steel holder.
Our company SaintyCo, has the BJ 1Disintegration Tester.
This particular test has six tubes in its basket.
5) 2- Station Semi-automatic Disintegration Tester Machines
They have individual heating of the beaker.
This allows testing of products at two different temperatures.
Like other apparatus, they comply with the USP/IP Pharmacopoeia standards.
In most cases, they possess programmable timer with alarm and temperature controls.
We can have the bathless Disintegration Testers and those that have the bath.
2 –Station bathless Semi-Automatic Disintegration Tester are most preferred.
This is because the media temperatures are attained faster and visual observation is enhanced more as compared to the one with a bath.
6) 3 Station Disintegration Testers
These Testers possess 3 stations/baskets that are used in testing the disintegration time of the tablets.
Like all machines, they also comply with USP/IP /EUH standards.
7) 2 and 4 Disintegration Tester Machines
They come with an individual sensor that measures each bath and beaker temperature.
The machine supports 4 USP baskets that are controlled independently.
The Disintegration Testers have a magnetically coupled pump for water circulation in the bath.
8) 6 Station Disintegration Testers
This 6 station Disintegration Tester comes with 3 pairs of baskets that are controlled by independent timers and motors.
Main Parts of a Disintegration Tester
Now we will look at the parts that make a Disintegration Tester perform its functions.
Look at this example:
Parts of disintegration tester machine – Photo courtesy: Total Laboratory Services
MPU helps to automatically control the temperature, time and frequency of the nacelle back and forth.
The MPU is an acronym for Microprocessor Unit or a Microprocessing unit.
It is a device that implements the core elements of a computer system on a single integrated circuit.
Or, as a few integrated circuits operating as a cohesive circuit.
b) A large LCD screen Display
Test screen shows run-time information once a disintegration test starts.
The total testing time for each station or the single station is indicated at the end of the test.
c) Alpha–numeric keyboard
This helps in editing product and test information such as target disintegration time for each station.
Take for example in 2 or 3 Station Disintegration Testers.
Bath and median temperature can also be keyed in with the help of the keyboard and noted from the LCD Display.
The keyboard can be in the form of control buttons or LCD screen.
This helps in working out the disintegration time of the particular dosage particle being tested.
Other parameters can also be worked on using the calculator.
It can be optional in some Disintegration Testers.
It all depends on the manufacturer.
It is the medium for the disintegration process.
Normally, the bath liquid (water) helps in achieving an even temperature for the disintegration processes to take place.
In the bath, there can be a powerful pump that helps to circulate water.
f) Bath cover
It covers the bath, acting as a shield from external temperatures and conditions that would otherwise alter the process and ultimately the results.
g) Basket Assembly
As the name suggests, these are groups of baskets.
A complete basket design comprises of a basket, sieves, and discs.
They all comply with the USP, EP and other standards.
For automatic disintegration tester, the equipment parks out the beater once the process is complete.
Normally, this occurs in the top most position.
h) Reciprocating arm
Its motor driven hence provides long and quiet reliable operation.
This arm allows for the rapid attachment and removal of the basket assemblies
i) Control Knob
It enables the machine to operate easily with very little knowledge.
This is the START button that the operator uses to start the machine manually.
Of course, you can also use it to stop the operation.
However, this will depend on the design of the disintegration tester apparatus.
j) A Built in Heating System
This system is thermostatically controlled.
It warms the water in the bath up to 37⁰ Celsius.
This pre-selected temperature is automatically adjusted by a control sensor.
In some Disintegration Testers, there may be a second sensor that acts as a safety device.
It switches off the heater should the temperature rise above the optimal temperature.
k) Printer Connectivity
This is connecting the Disintegration Tester to a printer.
This enables the operator to print out the test results shown on the LCD screen for reference.
Remember, the test report printed can show a minimum and maximum disintegration time, statistics.
Other information includes bath and media temperature, stroke frequency and product data for each sample tube.
Of course, you will get data relating to all testing stations.
l) Overheating Protection System
Some of the main safety features include:
- Pressure gauge to monitor the pump flow
- Thermo-switch and a thermo-fuse to cut off power supply in case of an electrical fault
- Heating system sensor – Secures the automatic shutting down of the pump and heater. This is in the event that no water flow is detected or the electronic control fails.
How a Disintegration Tester Machine Works
The test may be run with either 1 or 2 beakers and basket assemblies simultaneously.
Disintegration tester machine
Each disintegration basket can be operated independently.
The solid dosage material, capsule or tablet is placed in one of the beakers for the test to be run.
A test screen shows the run time information once the disintegration test is started.
The total testing time for the station is also indicated at the end of the run.
Individual disintegration time of each sample can easily be logged by pressing the corresponding numeric key.
Of course, this is after visual detection.
The Disintegration Testers which are USP/EP complaint use baskets with mesh (which can also be referred to as sieve) bottoms or beakers with a mesh bottom.
Here is how a Single basket Disintegration Tester works.
The reciprocating arm slowly moves the disintegration basket up and down over a distance.
Let’s say 50 millimeters each way, over a time period of 30 minutes each.
The stroke rate is automatically readjusted after every few seconds.
Also, the rate at which the arm moves is dependent on the motor drive mechanism.
After pressing the start button, the disintegration basket is smoothly moved to the testing medium.
The testing procedure may vary in machines.
It can be automatic, semi-automatic or manual depending on the manufacturer.
Tester machine will, therefore, stop automatically if the pre-set time for the disintegration has elapsed and the timer alarm alerts.
In a Manual Disintegration Tester, the Operator can stop the machine if he/she has seen that all the samples are disintegrated.
Features to Consider when Buying a Disintegration Tester Machine
Just like we choose the best fruits or vegetables in the market stores when buying a machine we also consider some factors.
With the advancement of technology and the need to have a market, most companies do produce machines that are similar in operation.
As a result, there’s a need to take note of details as well as specifications that make your choice the ideal.
Specifications of disintegration tester
Below are some of the most important features to take note:
The machine should be able to autotest, auto diagnoses, and auto alarm.
Each test station should be driven independently and it stops at the end of a test.
This will only happen if one buys an automatic Disintegration Tester
ii. Using MPU
Disintegration Testers use an MPU to control all operations.
So it’s important for the buyer to be on the lookout for Disintegration Testers fitted with an MPU.
iii. Control knobs
There should be buttons you can conveniently use in starting or halting the process.
iv. LCD Screen
This screen is an important aspect to consider when purchasing a Disintegration Tester.
It helps to monitor the process.
As a researcher, you can easily take note of the time elapsed, read the disintegration time and keep an eye on the temperature readings in case they flare up.
In as much as the machines are auto, to err is to humans and machines, right?
v. LAN connectivity
This is also a feature to consider in the purchase of a Disintegration Tester
It allows for the convenient connection of the gadget to the internet.
The LAN connectivity can be of use to Researcher in further analysis of the end test results.
vi. USP and EP Standards
The design of choice should be of high quality.
This quality is guaranteed if and when the manufacturers use materials that beat or meet the stipulated standards.
Instrument and its components should be made from materials that meet the approved USP and EP Standards.
Weight of the machines should be easily accommodated.
For example, Disintegration Tester machine can weigh 33lbs /11kg,16 kg /44lbs or 22kg/55lbs.
In addition to weight, you must consider the dimensions (length, width, and height).
Portable test equipment is the best option.
When purchasing a Disintegration Tester, you have to be 100 % sure that the results you will receive at the end are exact and accurate.
This can happen if one tests a machine before purchase.
But be rest assured, USP compliant test equipment provide accurate results.
A disintegration tester should be connected to a power supply for it to perform its role efficiently.
A good Disintegration Tester can work continuously if connected to the right power supply.
A Single Basket Disintegration Tester, for example, can work under less voltage, compared to a 3 Basket Disintegration Tester.
Why SaintyCo Disintegration Tester
From this guide, I have highlighted various critical aspects of Disintegration Tester.
To make it easier for you to acquire the best disintegration testing apparatus, SaintyCo has a solution for you.
SaintyCo Disintegration Testers are fully compliant with the United States Pharmacopoeia standards.
Take for example:
BJ 1/2/3 Series of the Disintegration testers have been developed and built using the latest and most advanced technology.
They are accurate and very efficient in their use.
With integration systems software, the Disintegration Testers can test the disintegration time of dosage.
Besides, the results can further be analyzed by the researcher upon connection of the Testers to computers.
SaintyCo Disintegration testers come in 3 varieties a buyer can choose from.
This gives the buyer a wide selection to choose from.
It will depend on the buyer’s unique specifications.
SaintyCo disintegration tester
Click here in case you want to learn more about SaintyCo Disintegration Testing Equipment.
I know by now you appreciate the role the Disintegration Tester plays in the Pharmaceutical industry.
And, this guide explores everything you need to know about Disintegration Testing Equipment.
For any questions or inquiries on disintegration tester, don’t hesitate to contact us.