Tablet Compression Operation

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TABLET COMPRESSION OPERATION:

TABLET COMPRESSION OPERATION SHAIK ARIFA BEGUM, M.Pharm., (Ph.D.) ASSISTANT PROFESSOR CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES GUNTUR 1

Components of Tablet Presses:

Components of Tablet Presses Hoppers Dies Punches Cam tracks Feeding mechanism 1870 Wyeth Brothers, Invented the single punch press 2 SHAIK ARIFA BEGUM

Components of a Tablet Press:

Components of a Tablet Press There are 2 basic types of tablet presses. Single punch and Rotary tablet presses. A single punch tablet press has one station of tooling. It Typically operates at speeds from 1-60 tablets per minute. A rotary tablet press has multiple stations of tooling positioned on a rotary table. This rotary table is referred to as a turret. As the turret rotates, the tablet tooling is guided from one position to the next by cams. The objective of the operator is to keep this turret clean and properly lubricated. A press that has been properly prepared can run without being stopped around the clock. What causes a machine to be stopped is a need for cleaning, repair and lubrication as a result of a formula that is dusty, sticky, or abrasive. Rotary presses operate from 60-15,000 tablets per minute dependant primarily on the number of tool stations. 3 SHAIK ARIFA BEGUM

How a press operates……..?:

How a press operates……..? “A press must be cleaned and properly setup initially...whether it is manual or automated” Rotary tablet presses all work on the same principle of operation with few exceptions. The basics are adjust Weight, Compress and Eject within a speed range. 4 SHAIK ARIFA BEGUM

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Manual or Automated:

Manual or Automated A press must be cleaned thoroughly and properly setup whether it is a simple manually operated press, or a very sophisticated automated press. An improperly or poorly setup press will not produce quality tablets, will often break down and require more cleaning and maintenance and is less productive than one that is properly cleaned and setup. An automated press is capable of automatically monitoring and correcting itself through and entire batch of product, provided the press was setup , lubricated and cleaned properly 6 SHAIK ARIFA BEGUM

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Tablets What’s in them…..?:

Tablets What’s in them…..? 8 SHAIK ARIFA BEGUM

Tablet Weight is the Key:

Tablet Weight is the Key On the press tablet Weight is what determines potency of the tablet. High tablet weight means high potency and conversely low weight mean low potency, provided content uniformity is accurate. Therefore tablet weight control is critical. A tablet press does not weigh powders, it fills volumetrically. In other words the volume created by positioning the tooling for fill will determine the final tablet weight. Therefore if the powder density has variation then the final tablet weight will change even though the volume is the same. 9 SHAIK ARIFA BEGUM

Compression:

Compression The tablet press tooling is made so that the air is evacuated via the top of the die around the upper punch tip. The upper punch tip is actually made slightly smaller than the lower punch tip to control air release. One of the most common tablet defects is caused by improper air evacuation. As the powder is compressed the air is driven from between the particles of powder. If the product has a high percentage of fine particles they get pushed with the air. Some of the particles escape and the rest will be pulled to the edge of the upper punch tip, which creates a layer of fine dry light particles that do not compress well and are not likely to hold together, and they often split which is called Capping. 10 SHAIK ARIFA BEGUM

Tooling:

Tooling A set of punches and dies are often referred to as tooling. A station of tools consists of an upper punch, lower punch and die. The job of the upper punch is to control compression position within the die. Most modern tablet presses have adjust upper punch entrance which means that the machine can be adjusted to control how far the punch enters the die. Typically a good place to start is around 3mm upper punch penetration into the die. If the upper punch is set too high the product maybe pushed out of the die before the upper punch enters the die. Many machines allow punch entrance as deep as 6mm. The problem with being too deep in the die is that air may become entrapped contributing to a capping issue. Notice that the upper is smaller in diameter than the lower. 11 SHAIK ARIFA BEGUM

The Lower Punch :

The Lower Punch The job of the lower punch is more complex than that of the upper. The upper punch only controls penetration depth into the die. The lower punch first overfills the die with too much powder. Then to achieve final and proper tablet weight the lower punch is moved up to allow the scrapper to sweep the excess powder off the surface of the die table. Then the powder in the die is moved downward into the die which is called under fill to prevent the effects of centrifugal force from slinging powder back out of the die. This feature is not found on all rotary presses. Pre-compression is a feature found on most modern tablets presses. It’s designed to help tamp the powders together lightly compressing the powder and driving the air out of the die prior to final compression. Main compression is where the final tablet is compressed. Ejection is achieved by simply pushing the tablet up out of the die. 12 SHAIK ARIFA BEGUM

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Punch Length:

Punch Length Working Length: The most important dimension of the tooling is the working length variation within a set of punches. Working length is the distance from the bottom of the cup to the head flat. Working length is controlled to a very tight specification. Variations in this specification will result in weight, thickness and hardness variation. All companies should have the ability to inspect this dimension. When tooling is new the allowable variation is .002”. Using tooling with variations over .005” would be considered extreme. This variation must be maintained within the entire set. All upper punches must be the same length and all lowers must be the same as each other with the set. Uppers and lowers need not be the same. 14 SHAIK ARIFA BEGUM

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Overall length: The distance from the Cup edge (land) to the head flat is called the overall length. This dimension is not critical to the success of the tablet. It is acceptable for new tooling to have punch variations in the overall length by as much as .006” when new. 15 SHAIK ARIFA BEGUM

Head Configurations:

Head Configurations In the world of tablet press tooling there was a Standard tool head design and a different design used on European tooling. This meant that the tooling and cams used on a machine in the US was different than the tooling and cams used in Europe and the rest of the world. From that design a third design has been developed called the TSM Domed Head design. This design will not work into a Eurocam machine. It offers a larger more consistent head flat design and a radiused outside bevel for improved transition onto the pressure rolls. This design is becoming a standard and has proven to be a superior design. 16 SHAIK ARIFA BEGUM

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TSM:

TSM The TSM is an excellent guide to understanding tooling and the tooling influence on the compression operation. This manual has been put together by industry professionals that include Tablet press manufacturers, Tooling manufacturers, Tablet manufacturing companies. This group has put together the best reference available for tooling specification, terminology, and machine interchangeability. TSM is an excellent resource for new and experienced professional that work with tablet compression. Every company should have several copies in key departments and should reference this technology when ordering, inspecting, polishing, cleaning and repairing tooling 18 SHAIK ARIFA BEGUM

Dwell Time:

Dwell Time Dwell time is the actual amount of time that the powder is under pressure. The key factors to controlling dwell time are punch head flat diameter, number of compression points and rpm . To increase dwell time, simply slowing the machine down will provide more dwell. Conversely increasing rpm will decrease dwell time. It is important to recognize that all products are not dwell sensitive. Some products will recompress well at any given speed, others are very sensitive to even the slightest change. The punch head flat diameter is a contributing factor that is often overlooked. Look at the photo here on the left, you can see the many different diameters of head flats in this one set of tooling. Most up to date machines have pre-compression and main compression stations which mean that the tablet is being compressed twice. Using pre compression with a dwell sensitive powder will allow increased speed without sacrificing dwell. The bottom line is tablet hardness is (for most products— not all) directly effected by dwell. 19 SHAIK ARIFA BEGUM

Head profile:

Head profile The head of a punch is designed to match and follow the contour of the cams on the tablet press. It is important to be able to visually monitor wear of the punch head and the corresponding cams. The difference between a good operator and a great tablet press operator is the ability to look at wear of the cams and punches and be able to take corrective action to prevent further damage. Most companies use a simple gauge called a Go-No-Go gauge to determine acceptable punch head wear. 20 SHAIK ARIFA BEGUM

The inspection process :

The inspection process Tablet press tooling must be checked in-house. Tooling inspection should take place when the tools are first received from the vendor and then re-checked on a regular basis. If the product is abrasive causing advanced wear, then inspection should occur with great frequency. Products with a history will allow for less frequent inspection. Two inspections must take place after each cleaning; visual and working length. The operator must inspect tools before they are installed in the press and when removing from the press for cleaning. 21 SHAIK ARIFA BEGUM

Batch variations and changes:

Batch variations and changes When a machine starts-up the operator must understand that the tablet press is cold. As the press runs it will warm-up. If a press becomes too warm the product may stick to the die table resulting in densified material which will migrate into the tablet creating a visual defect, a gray or dark spot. As the product runs on the press some segregation usually take place. Fines migrate one way and larger particles another. At some point these groups of fines or large particles will enter the die causing a big increase or decease in weight or compressibility. If a group of fine particles enter a die cavity the result maybe capping. The point is that segregation is not only possible, but it is very likely with products that have a wide variety of particles sizes with various densities. A poorly blended batch will result in many variations on the tablet press. 22 SHAIK ARIFA BEGUM

Instrumented Single Station Tablet Press:

Instrumented Single Station Tablet Press The CPR-6 Tablet Press. The detection of the data concerning the compression force of both the lower and upper punches, and the ejection force of the tablet. 23 SHAIK ARIFA BEGUM

CPR–18 Rotary Tablet Press:

CPR–18 Rotary Tablet Press The CPR-18 is a bench top rotary press developed to be used for R&D and medium production batches. B-10 – 10 stations handling punches up to 16 mm in diameter D-8 – 8 stations handling up to 22 mm in diameter Up to 18,000 tablet per hour 24 SHAIK ARIFA BEGUM

IN-PACK Semi-Automatic Blistering Machine:

IN-PACK Semi-Automatic Blistering Machine The IN-PACK is a pneumatic blistering machine, ideal for clinical trials, stability testing, package development, and low volume production runs. The machine does thermoforming, sealing, coding and cutting blisters in PVC/ALU and/ or ALU/ALU . 25 SHAIK ARIFA BEGUM

Processing Problems:

Processing Problems Making tablets batch after batch without an occasional defect would be unusual. Some products start up with problems and end with them. Tablet to tablet weight variations create tablet defects. Consistent tablet weight is essential to making a good tablet. Without solving other defects will be difficult (if not impossible) because of how a tablet press operates. 26 SHAIK ARIFA BEGUM

Some of the most common tablet defects are: :

Some of the most common tablet defects are: Weight variation Friability variation Picking & Sticking Capping Laminating Chipping Mottled Double pressing 27 SHAIK ARIFA BEGUM

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Often problems with compression can be associated with many root causes. One very common issue is machine start up. The tablet press is cold. The steel is cleaned and bare metal can allow granules to stick to these metal surfaces. The reason a lubricant is in the product is to prevent granules from sticking. Many companies are very accustomed to a double start up. The first one distributes powders which begin to stick, especially to the punches and to the die table. The operator will often remove the stuck granules and then at second start up no sticking occurs because the working surfaces are now protected by the lubricant. 28 SHAIK ARIFA BEGUM

Weight variation & Friability Variation:

Weight variation & Friability Variation Tablet weight is the key to controlling hardness and friability. Controlling tablet weights within a tight range will contribute to better tablet hardness and friability. Many variables can influence weight fluctuations. The key weight control factors are product uniformity in particle size and density, proper tablet press set-up, and control of flow rates into the die cavity. However, the importance of weight control cannot be over emphasized. Weights must be uniform in order to trouble shoot most other tablet defects. 29 SHAIK ARIFA BEGUM

Picking & Sticking:

Picking & Sticking Picking and Sticking occurs when granules stick to the punch faces during compression. Punch face design and debossing can be modified to eliminate the problem. Granules are not dried properly. They become case hardened during the drying process, which means that the granules are wet on the inside. During compression these granules break open and the wet product sticks to the punch faces. If this occurs, the drying process must be improved. To overcome sticking on the press, increase hardness by making the tablet thinner and Increase dwell time to make the wet granules adhere to other granules rather than the punch face. Also, if a blend is incomplete this could mean that the lubricant in the formula is not protecting the granule from sticking to the punch cup surface. If all else fails polish the punch cup surface. 30 SHAIK ARIFA BEGUM

Capping & Lamination:

Capping & Lamination Capping is often referred to as air entrapment. During compression, air is evacuated from between the granules to allow the granules to lock to one another. If the “air” does not escape during the compression process the top of the tablet (the tablet cap) wants to come off. The tooling (punches and dies) are designed to allow air to escape during compression along the upper punch tip and die wall. This is why capping occurs on the top “cap” of the tablet. Capping is not just air entrapment. During compression air evacuation pushes the very fine dry granules out with the air. It is these dry and light particles that do not want to lock together, resulting in tablet “caps” wanting to come off the tablet. 31 SHAIK ARIFA BEGUM

Capping & Lamination:

Capping & Lamination Lamination is when the tablet splits apart anywhere except at the upper cap. Lamination is often blamed on over compressing. Too much compression force flattens out the granules and they no longer lock together. Lamination can also occur when groups of fine and light particles do not lock together. These groups of fine and light particles simply will not compress well. Reducing thickness and increasing dwell time will give these particles more of a chance. Dwell time can be increased by adding pre-compression or slowing the machine speed down. 32 SHAIK ARIFA BEGUM

Chipping :

Chipping Many tablets are sensitive to chipping after compression. First make certain that the punch tip edges are not damaged. Some punch tip designs are more sensitive to damage from handling than others. Once confirmed that the chips are not being created by damaged punches then make certain that the “take off blade” is set correctly for proper ejection off the machine. If the blade is too high it will allow the tablet to wedge under the blade causing chipping. If the tablet is friable the tablet can become chipped as the tablet travels off the press, down the tablet chute, through the tablet metal detector, Tablet Deduster and finally into the collection bin. Transferring finished tablets must be done carefully. Many times investigations into chipped tablets discover poor handling and transfer of tablet bins from compression to storage and then onto the packaging floor. Packaging machinery can also cause chipping. 33 SHAIK ARIFA BEGUM

Double impressions:

Double impressions Double Impressions will happen on a tablet press when the punches are allowed to twist or jump. Round punch tips want to twist naturally due to the rotation of the press. Double impressions usually occur on the bottom of the tablet from the lower punches. It usually means that the lower punch retainers are loose and the punches are jumping during compression. Make certain the lower punch retainers are clean and not worn. They do need to be replaced often. When a machine starts up it is cold. As it warms up, lower punch retainers can become loose and may need to be tightened to prevent double impressions. Therefore, it is important to check them often at start-up. Also, many newer machines now use punch seals. As seals become worn they will allow the punches to bounce or twist during compression. 34 SHAIK ARIFA BEGUM

Fines:

Fines A press can run as long as it stays clean and the tooling is lubricated. Another way to say this is that dust is what causes us to stop and clean the machine. If we had a formula with very little dust the machine would run cleaner and longer because the dust was not present and therefore unable to make the machine dirty. Many companies must stop the press and perform partial or complete cleanups in the middle of a batch. This immediately tells us that they have contamination issues and the lubricant on the punches or lack of lubricant is the issue due to variations in fine dusty products... also commonly referred to as Fines. Fines are the dust in the formula that can cause capping, dust can become airborne and land on the lubricant and dry it up, resulting in possible black specks on the tablet. 35 SHAIK ARIFA BEGUM

Mottling:

Mottling Unequal distribution of color on a tablet. One cause of mottling is a drug whose color differs from the tablet excipients or a drug whose degradation products are colored. A dye can cause mottling by migrating to the surface of a granulation during drying if the dye is not well dispersed or if its particle size is too large Change the solvent system Reduce drying temperature Grind to a smaller particle size Use of non-aqueous solvents . 36 SHAIK ARIFA BEGUM

Poor Mixing:

Poor Mixing Uneven distribution of lubricants & glidants Inadequate mixing after addition of lubricants (Poor flow) Bridging Rat-holing 37 SHAIK ARIFA BEGUM

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