BJ-1/2/3 Disintegration Tester

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BJ-1/2/3 Disintegration Tester

Disintegration Tester: The Ultimate FAQ Guide

In this guide, you will find all information you’re looking for about disintegration tester.

It covers everything including components, working principle, specification, safety features and features, just to mention a few.

So, if you want to be an expert in disintegration tester machine, read this guide.

What is Disintegration?

Disintegration is the physical process by which a substance mechanically breaks down into small pieces.

What is a Disintegration Tester?

A disintegration tester will test to find out the time it takes for a solid dosage to completely break into small pieces.

Disintegration testers usually measures the quality of dosages such as tablets and capsules.

Disintegration tester

Disintegration tester

What are the Technical Specifications of a Disintegration Tester?

The technical specifications of a disintegration tester vary from one tester to another.

Some of the technical specifications that a disintegration tester has include:

  • Nacelle back and forth frequency is between 29 to 32 per minute.
  • Nacelle back and forth range is 55 ±1 mm.
  • Temperature accuracy is between ±0.3 °C ±0.5 °C.
  • Power supply it needs is between 110 V or 220 V, 50 Hz OR 60 Hz, and 600 Watts.
  • Disintegration tester can weigh anything between 11 kg to 22 kg.
  • Volume of the water bath can go up to 8 liters.
  • Depending on the type of disintegration tester, it can come with one, two, or three nacelles.
  • Machine can flawlessly operate for over 24 hours in continuous mode.
  • It can achieve a stroke speed of up to 30 strokes per minute.

What are the Features of a Disintegration Tester?

The features of a disintegration tester will vary from one tester to the other.

This is because disintegration testing equipment come with various capabilities.

Some of the features of a disintegration tester include:

  • It comes with a splash proof panel that has an LCD display.
  • Some disintegration testers can come with fluorescent tube lights for a better view of the disintegration test.
  • Each of the test stations operates independently with an auto stop feature.
  • An MPU automatically controls the temperature, time, and frequency of the back and forth of the nacelles.
  • The liquid batch can have an even temperature throughout the disintegration test.
  • It has automatic features such as auto-test, auto-control, auto-alarm, and an auto-diagnose system.
  • It comes in a highly durable stainless steel body.

Why is it Important to Use a Disintegration Tester?

There are many reasons as to why it is important to use a disintegration tester.

A disintegration test is a pharmacopoeial testing requirement for many solid dosages such as IP, USP, and BP.

It will provide vital safety information on the bioavailability of a drug.

A disintegration tester will determine the safety of a drug without using in vivo methods.

It is cheaper and easy to use a disintegration tester than it is to use in vivo methods.

A disintegration tester will establish a consistent and uniform result across all the bathes that you will test.

Also, a disintegration tester complies to all quality standards meaning it will provide accurate and reliable information.

Besides, a disintegration tester comes in a wide range of prices that will ensure quality testing depending on your production capacity.

A disintegration tester can provide accurate results for a wide range of tablets and capsules.

It is easy to use and operate a disintegration tester.

What are the Components of a Disintegration Tester?

Parts of disintegration tester

Parts of disintegration tester

There are several components that make up a disintegration tester.

All these components work together to realize a successful and reliable disintegration test.

Some of the components of a disintegration tester include:

· Bath

The bath is the liquid solution that assists in the disintegration process.

The bath will help in achieving a constant temperature throughout the disintegration process.

Powerful pumps in the bath assist in circulating the liquid bath which helps in the disintegration procedure.

· Microprocessor Unit [MPU]

This is the unit that performs arithmetic and logic operations in the disintegration tester.

The MPU assists in controlling the time, temperature, and the frequency of the nacelles.

Also, the MPU will control all core elements of a computer on one cohesive circuit.

· Bath Cover

The bath cover simply seals all contents in the baskets from external environment.

Also, the seal will ensure that no contamination happens during the disintegration test.

This will lead to accurate and reliable results.

· Control Panel

The control panel enables one to easily operate the disintegration tester.

Different disintegration testers come with different control panel systems.

The control panel allows one to start and stop the disintegration test.

· Arm

A motor will drive the arm during the disintegration test.

The position of the arm allows one to easily remove and attach the baskets.

A non-corrosive element coats the stainless steel arm to ensure it does not contaminate the test solution.

· Heating System

A thermostat automatically controls the heating system.

The suitable temperature for the bath is 37⁰ C as it resembles the human body temperature.

A control sensor will allow one to adjust the temperature with ease.

Automatic disintegration testers come with an auto-switch that turns off the heater if the temperature goes beyond the optimal temperature.

This ensures reliability of the disintegration test.

· Safety System

The safety system ensures safety of the operator and that the machine works in the best conditions.

The machine has automatic features that can take control of the test if some parameters are off.

For instance, an auto-switch will minimize the chances of the machine or liquid bath from overheating.

· Connection Unit

The connection unit enables one to connect other external components to the tester like printers.

Also, the printer will enable the operator to print out the final results of the disintegration test.

Sharing a printout is easy and enables different personnel to analyze the results.

All the data that relates to the disintegration test is printable.

The data can be the temperature of the bath and frequency of the stroke.

· Baskets

Baskets, sieves, and discs all make up the basket.

All baskets have to comply with pharmaceutical quality standards.

A disintegration tester can come with more than one basket system.

· Input Panel

The input panel is where you will key in information that will determine how the test will run.

For instance, you can key in the target disintegration time, bath temperature, median temperature, etc.

The input panel can have buttons or it can be an intuitive touch screen.

· LCD Screen

The LCD screen will show all information of the test once disintegration begins.

It displays information such as time, temperature, frequency, etc.

· Basket Rack

The basket tack is rigid and supports the cylindrical glass tubes

How does a Disintegration Tester Work?

Disintegration testers may come with one or more baskets where the disintegration test will take place.

Here is the basic principle of how a disintegration tester will work.

Parts of disintegration tester There are several components that make up a disintegration tester. All these components work together to realize a successful and reliable disintegration test. Some of the components of a disintegration tester include: • Bath The bath is the liquid solution that assists in the disintegration process. The bath will help in achieving a constant temperature throughout the disintegration process. Powerful pumps in the bath assist in circulating the liquid bath which helps in the disintegration procedure. • Microprocessor Unit [MPU] This is the unit that performs arithmetic and logic operations in the disintegration tester. The MPU assists in controlling the time, temperature, and the frequency of the nacelles. Also, the MPU will control all core elements of a computer on one cohesive circuit. • Bath Cover The bath cover simply seals all contents in the baskets from external environment. Also, the seal will ensure that no contamination happens during the disintegration test. This will lead to accurate and reliable results. • Control Panel The control panel enables one to easily operate the disintegration tester. Different disintegration testers come with different control panel systems. The control panel allows one to start and stop the disintegration test. • Arm A motor will drive the arm during the disintegration test. The position of the arm allows one to easily remove and attach the baskets. A non-corrosive element coats the stainless steel arm to ensure it does not contaminate the test solution. • Heating System A thermostat automatically controls the heating system. The suitable temperature for the bath is 37⁰ C as it resembles the human body temperature. A control sensor will allow one to adjust the temperature with ease. Automatic disintegration testers come with an auto-switch that turns off the heater if the temperature goes beyond the optimal temperature. This ensures reliability of the disintegration test. • Safety System The safety system ensures safety of the operator and that the machine works in the best conditions. The machine has automatic features that can take control of the test if some parameters are off. For instance, an auto-switch will minimize the chances of the machine or liquid bath from overheating. • Connection Unit The connection unit enables one to connect other external components to the tester like printers. Also, the printer will enable the operator to print out the final results of the disintegration test. Sharing a printout is easy and enables different personnel to analyze the results. All the data that relates to the disintegration test is printable. The data can be the temperature of the bath and frequency of the stroke. • Baskets Baskets, sieves, and discs all make up the basket. All baskets have to comply with pharmaceutical quality standards. A disintegration tester can come with more than one basket system. • Input Panel The input panel is where you will key in information that will determine how the test will run. For instance, you can key in the target disintegration time, bath temperature, median temperature, etc. The input panel can have buttons or it can be an intuitive touch screen. • LCD Screen The LCD screen will show all information of the test once disintegration begins. It displays information such as time, temperature, frequency, etc. • Basket Rack The basket tack is rigid and supports the cylindrical glass tubes How does a Disintegration Tester Work? Disintegration testers may come with one or more baskets where the disintegration test will take place. Here is the basic principle of how a disintegration tester will work.

Tablet disintegration testing equipment

· Preparation Stage

In the preparation stage, you will ensure that you have all the materials for the disintegration test.

The materials include the solid dosage which can be a tablet or a capsule.

The other material is the liquid bath.

Make sure you connect the power cable to the disintegration machine and that the machine is on.

Key in the measurement parameters such as the temperature of the liquid bath and the speed cycle of the arms.

Pour the liquid bath in the basket or baskets

Ensure the liquid bath is in the correct temperature.

Suspend the tablet or capsule above the baskets that have the liquid bath.

· Disintegration Stage

Once the liquid bath reaches the optimum temperature, lower the tablet or capsule in the liquid bath.

The arms in that connect to the beaker will perform this function in the disintegration basket.

The arm will move back and forth within the time frame on the display panel.

Automatic adjustment of the stroke rate happens after every few seconds.

Once the time is up, the disintegration tester will turn off.

For manual disintegration testers, the operator has to shut down the machine by themselves.

· Final Stage

Once the test in complete, take measurements from the disintegration test.

Automatic disintegration testers can print the results.

For manual disintegration testers, the operator can take down the readings manually.

What is Disintegration Time?

Disintegration time is the time a solid dosage will take to break down into small particle sizes.

What are the Factors that Affect the Disintegration of Tablets?

There are a number of factors that will affect the disintegration of tablets.

Some of these factors include:

Tablets disintegration equipment

Tablets disintegration equipment

· Lubricants

Many lubricants are hydrophobic.

This means you will use the lubricants in small sizes than any other ingredient that formulates the tablet.

When you mix them, the particles of the lubricants may stick to the surface of other particles.

The hydrophobic coating that results from all this will hinder the wetting of the tablets.

This will consequently affect the disintegration of the tablets.

The lubricant will increase the disintegration time since it decreases the wettability of the tablets.

Lubricants will place a negative effect on the water uptake if the tablets have no disintegrants.

The lubricant will also negatively affect the water uptake if tablets have a high concentration of swelling disintegrants.

If the tablet has some strongly swelling disintegrants, this will hardly affect the disintegration time.

· Fillers

Solubility and compression properties of fillers affect the disintegration of tablets.

If you use soluble fillers, this may increase the viscosity of the fluid that penetrates the tablets.

This will in turn reduce effectiveness of swelling disintegrating agents since they are soluble in water.

This means they are likely to dissolve and not disintegrate.

An insoluble diluent will produce a faster disintegration when you have an adequate amount of disintegrants.

· Binders

When the binding capacity of the binder increases, the disintegration time of tablets will increase.

In addition, the concentration of the binder will affect the disintegration time of the tablets.

· Surfactants

The type of surfactant you use will affect the disintegration time of tablets.

Surfactants are efficient when in specific concentration levels.

Surfactants will lower the hydrophobicity of tablets.

This means the more hydrophobic a tablet is, the greater the disintegration time.

Examples of good surfactants include:

  1. Sodium lauryl sulface [On various drugs]
  2. Polysorbate 80
  3. Polysorbate 20

Some examples of poor surfactants include:

  1. Sodium lauryl sulface [on various drugs]
  2. Polysorbate 40
  3. Polysorbate 60
  4. Tweens
  5. Poly ethylene glycol

· The Compression Force

If the compression force of tablets is high, it will lead to the formation of hard tablets.

This will in turn affect the disintegration time as the density of the tablets will he hig.

· The Granulation Process

The granulation process will affect the physical properties of the granules hence affecting the disintegration time.

· Humidity

Tablets with high humidity content will have a decrease in the disintegration time.

This is because the high humidity will soften the tablets making them soft.

What is the Difference Between Disintegration and Dissolution?

Dissolution tester machine

Dissolution tester machine

Disintegration is the physical process by which a substance mechanically breaks down into small pieces.

Dissolution tester will determine how a substance dissolves in a liquid medium.

A dissolution and disintegration test will both use a liquid bath to conduct the tests.

A disintegration test will determine the therapeutic effectiveness of different drugs.

Also, a dissolution test will assist in determining the in-vitro breakdown of solid and powder substances.

Dissolution and disintegration are both vital in determining the quality of various pharmaceutical dosages.

A dissolution and disintegration test are important as they comply with all pharmacopeia standards such as BP, IP, and USP.

A dissolution and disintegration testers can have more than one basket in the machine to conduct the tests independently.

Binders and fillers can both affect a dissolution and disintegration test.

Disintegration uses time value to measure the disintegration of many pharmaceutical dosages.

Dissolution uses the Q value when measuring the dissolution of various pharmaceutical dosages.

A basket assembly is available in both a dissolution test and disintegration test.

What is a Disintegrating Agent?

A disintegrating agent is a substance that will increase the disintegration of tablets or capsules.

It increases the surface area of the dosage hence promoting a rapid release of the dosage substances.

How can I Calibrate a Disintegration Tester?

Calibrating a disintegration tester will ensure it gives accurate and reliable results.

Here are some ways of calibrating a disintegration tester:

Tablet disintegration tester

Tablet disintegration tester

· Number of Cycles

Start by recording the frequency of how the basket assembly moves up and down.

Record in intervals such as 0-5, 15-20, 30-35, 45-50, and 60-65 minutes.

Manually record the cycles the basket assembly makes in relation to the time set.

Make sure you are not stopping the machine between the readings.

Record all the readings as per the time intervals above.

For more than one basket, measure the readings independently.

The number of cycles for every minute should be between 29 and 32 in the entire calibration test.

· Calibrating Temperature Maintenance

Start by setting the temperature to 37 °C.

Fill the beakers with liquid bath, such as water.

Fix the basket rack assembly.

Start the even frequency of the up and down motion.

Use a calibrated thermometer to measure the temperature of the liquid bath in the beakers.

Relax until the temperature is between 36 °C and 38 °C.

When the temperature is in this range, start recording the readings.

Record the initial temperature reading.

Then continue making temperature readings after 15-minute interval.

Continue this until you reach the 120-minute mark.

Perform this test independently on each basket rack assembly.

When taking temperature readings, insert the thermometer 2 to 3 minutes before you make the measurements.

This ensures you get stable readings.

Throughout the entire calibration test, the temperature should remain with 37 °C with a variation of +/- 1 °C.

· Calibrating Distance Travelled

Firmly fix the basket assembly rack.

Proceed by attaching a white paper on the instrument.

Ensure the paper has no kinks.

The paper has to be parallel to the path of the arm of the basket assembly.

Mark the position of the assembly when not moving at its highest position.

Press the START/STOP key to start the test.

Press the key timer as well.

When the assembly reaches the lowest position, make a mark of the paper.

Take the measurement between the highest and lowest mark using a calibrated ruler.

Take the paper out.

Perform the test in three stages.

Perform it at the beginning of the test, after 60 minutes, and after 120 minutes from the start.

Make sure you perform the test independently on different basket rack assemblies.

The distance the basket rack assembly should move has to be between 53 mm and 57 mm.

Conduct the calibration test once a month.

What Types of Tablets can you Test with a Disintegration Tester?

There are a number of tablets you can test with a disintegration tester for quality control purposes.

Some of the tablets you can test using a disintegration tester include:

  • Compressed tablets
  • Sugar coated tablets
  • Film coated tablets
  • Enteric-coated tablets
  • Effervescent tablets
  • Buccal tablets
  • Sublingual tablets
  • Chewable tablets
  • Lozenges
  • Dispersing tablets
  • Multiple compressed tablets
  • Layered tablets
  • Compression coated tablets
  • Gelatin-coated tablets
  • Inlay tablets
  • Extended-release tablets
  • Rapid release tablets
  • Immediate release tablets

How does Disintegrations Tester help Boost Tablet Compression Business?

A disintegration tester will boost your tablet compression business in many ways.

Here are some reasons as to how a disintegration tester will boost your compression business:

· Accuracy and Reliability

A disintegration tester is accurate and can perform the tasks over and over again making it reliable.

· Increase in Sales

A disintegration tester will guarantee high quality tablets which in turn will increase your sales and profit margins.

· Increase Production Capacity

It is easy to operate a disintegration tester.

This enables the operator to perform multiple tests within a short time increasing your production capacity.

· Time Saving

A disintegration tester performs the disintegration test in a fast and efficient manner.

This makes it possible to meet your production needs for a large number of batches.

How does a Tablet Friability Tester compare to a Disintegration Tester?

A tablet friability tester measures how a tablet will fracture into small pieces when under mechanical stress.

Tablets friability tester

Tablets friability tester

A disintegration tester will test to find out the time it takes for a solid dosage to completely break into small pieces.

Besides, a friability tester will help determine the shelf life of a solid substance during packaging and transportation.

Also, a tablet friability tester has drums that rotate the tablets.

A disintegration tester uses beakers with a liquid bath to test the disintegration of solid dosages.

Tablets disintegration tester

Tablets disintegration tester

When using a tablet friability tester, the tablets and the environment should be completely dry.

A tablet friability and disintegration tester can both test a number of similar tablets.

Moreover, a tablet friability and disintegration tester are both important in the pharmaceutical industries.

Also, a tablet friability and disintegration tester both comply to pharmacopoeia standards.

A tablet disintegration tester has one or more beakers while a tablet friability tester has a circular drum with a scoop.

A tablet friability tester usually tests the friability of tablets.

A disintegration tester can test the disintegration of tablets, capsules, suppositories, or boluses pessaries.

How does a Tablet Hardness Tester compare to a Disintegration Tester?

A tablet hardness tester determines the breaking point and structural integrity of a tablet.

Tablets hardness tester

Tablets hardness tester

A disintegration tester will test to find out the time it takes for a solid dosage to completely break into small pieces.

A tablet hardness tester determines how the tablet will change under conditions such as transportation, packaging, handling, and storing.

A tablet hardness tester uses units of measurement such as Newton or Kiloponds.

A tablet hardness tester will use a caliper to measure the breaking point of a tablet.

A disintegration tester uses beakers with a liquid bath to test the disintegration of solid dosages.

A disintegration tester uses a liquid bath while a tablet harness tester has to be completely dry.

Tablets disintegration tester

Tablets disintegration tester

What Types of Disintegration Testers are available in the Market?

There are a number of disintegration testers available in the market.

Also, the one you choose has to meet your production needs and budget.

Besides, the number of stations will vary on these disintegration testers.

The classification of disintegration testers in terms of number of stations include:

· Single Station Disintegration Tester

Single station disintegration testers come with one basket.

· Double Station Disintegration Tester

Double station disintegration testers come with one pair of baskets.

· Triple Station Disintegration Tester

Triple station disintegration testers come with three baskets.

· Four Station Disintegration Tester

Four station disintegration testers come with two pairs of baskets.

· Six Station Disintegration Tester

Six station disintegration testers come with three pairs of baskets.

The main disintegration testers available include:

· Semi-Automatic Disintegration Tester

A semi-automatic disintegration tester can come with one, two, three, or four baskets.

The baskets can operate independently.

This tester is much affordable than a fully automatic disintegration tester.

It comes with some level of automation.

· FullyAutomatic Disintegration Tester

A fully automatic disintegration tester can come with one, two, three, four, or six baskets.

This machine is the most expensive when you compare it to semi-automatic and manual disintegration testers.

It performs all the tests by itself requiring minimal to none human involvement.

· Manual Disintegration Tester

A manual disintegration tester operates manually.

The operator has to use their hand to drive the components during the disintegration process.

Manual disintegration testers are generally cheaper than fully automatic and semi-automatic disintegration testers.

What are the Quality Standards that a DisintegrationTester should Conform to?

Disintegration testers have to comply to quality standards for quality and health purposes.

Some of the quality standards that a disintegration tester should conform to include:

  • USP pharmacopeia requirements.
  • EP pharmacopeia requirements.
  • IP pharmacopeia requirements.
  • BP pharmacopeia requirements.
  • EUH standards.
  • Current Good Manufacturing Practices.
  • CE mark.

How do you Maintain a Disintegration Tester?

Maintaining a disintegration tester ensures that it gives reliable results and will last for a long time.

Here are some steps on how to maintain a disintegration tester:

  • Clean the baskets after use.
  • Drain the water bath after the disintegration test is complete.
  • Store the machine properly after each use.
  • Replace faulty electrical components.
  • Repair and replace worn out parts.
  • Use genuine parts when replacing to avoid future break downs.

How do you Troubleshoot a Disintegration Tester?

Here are some ways you can troubleshoot a disintegration tester:

· Tester does not Turn ON

Ensure the power switch is on.

Check and connect the power cable.

· Display is not Working

Power the machine off and then on.

· Heater will not Turn ON

Connect the power cable.

Power the machine off and then on.

· Basket Arms are not Moving

Check the power unit and error log.

What are the Safety Features of a Disintegration Tester?

A disintegration tester comes with automatic features such as:

  • Auto-alarm feature.
  • Auto-stop feature.

Which Material is a Disintegration Tester made of?

The material that makes up the bulk of the disintegration tester is stainless steel.

How much does a Disintegration Tester Cost?

A disintegration tester can cost anywhere between 400 USD to 10000 USD.

At SaintyCo we have a range lab instruments to increase your production needs.

Contact us today for all your disintegration tester needs.