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The Manufacturing Process was created for companies and individuals to gain a com- plete understanding of the basic requirements needed to make tablets and capsules. The objective is that the read- er will gain a quick yet com- prehensive understanding of solid dosage operations used in the manufacturing process. The focus will be a step by step explanation of each unit dose operation common equipment and practical knowledge of each operation. The main topics are Formula- tion Blending Milling Granu- lation Drying Final Blending Tabletting Tablet Press Tool- ing Coating and Encapsula- tion. Common tablet capsule defects and problem solving are also part of the objective. Designed for new experi- enced employee training the expectation is that having this information will create a com- mon denominator thus pro- ducing an opportunity for better communication be- tween manufacturing groups. The company will no longer hear that the problem is the fault of another department. The reader should be able to understand each unit of oper- ation. They should under- stand how machines work and the usage of each piece of equipment and why one technology is preferred over another. T A BL ET A ND C AP SUL E M A NUFAC TU R I NG Objectives in learning • Understanding the principles of the manufacturing process • Designed for new employees recent transfers Managers QA RD Supervisors Leads and Operators • Gain a quick and compre- hensive understanding of tablet manufacturing • Get different departments on the same page I N S I D E T H I S I S S U E : Unit Operations 2-3 Formulating 3 Granulating 4-5 Milling 5 Blending 6 Tabletting 7 Coating 8 Encapsulation 9 Tablet Defects 10-11 Packaging 12 THE M ANUFACTURING P ROCESS S P E C I A L I Z E D T R A I N I N G I N - P L A N T A N D P U B L I C S E M I N A R S Michael Tousey has devel- oped a complete series of training programs. These programs can be pre- sented for everyone involved in the manufacturing pro- cess. Operators Leads Man- agers RD Engineering Maintenance Quality Assur- ance and packaging person- nel will all be able to gain knowledge and a better com- munication method between departments. Each of the programs can be tailored to meet the specific needs of the customers facili- ty and application. All training courses and semi- nars can include testing mod- ules. Copyright © 201 5 Techceuticals Volume 1 5 201 5

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Every separate manufacturing step is called a “Unit Opera- tion”. Weighing Blending and Tabletting are individual unit operations. A “Batch” of powder or granulation is pro- cessed in each unit operation. The objective is Batch to Batch Reproducibility in each Unit Operation. Unit Opera- tions are determined by what manufacturing steps are needed to combine the active ingredient with other needed ingredients to make a quality finished product. The three most common Unit Operation pathways are Di- rect Compression Wet Granu- lating and Dry Granulating. Which pathway is used de- pends on what is needed to do to make a tablet out of the active ingredient. Powders must Flow making a tablet or a capsule requires the powders to be somewhat fluid. Good flow can be com- pared to granulated sugar. Bad flow can be compared to powdered sugar. Products must flow freely to achieve proper dosage. Tablet press- es and encapsulation machin- ery do not actually weigh the individual dosage amount they fill by volume. Powders must Compress Particles must lock together. Overly wet particles will cause Sticking. Overly dry particles will cause Lamination. Fine particles escape during com- pression. Time under pressure is Dwell time. Tablet Press speed relates to compressibility and time under pressure. Tablets and capsules must also eject from the die after being com- pressed. Page 2 T H R E E P R I N C I P L E M E T H O D S OF D E V E L O P I N G P OW D E R S F O R T A B L E T M A K I N G U N I T DO SE O P ER ATI ON S maintained even after the liquid is dried and milled. There are many different types of binders that can be used. All powders have a variety of characteristics some may only require a very small amount of binder and some may require large amounts of binder. Many powders re- quire some level of intense mixing while adding a liquid binder actually comparable to kneading dough when mak- ing bread. Once the powder and binding solution are kneaded they are then milled for drying. The bonds that hold the particles together can withstand the milling process forming a uniform size “granule”. If we accom- plish these “unit operation” steps correctly pre-blending binder addition milling drying and final blending the result is a compressible powder called a granulation. A granulation is the formation of small agglomerates called “granules”. Each granule will contain a proper mix of the ingredients of the formula. We can control the final den- sity of the granules by the amount of liquid binding solu- tion and the mechanical ener- gy created by the type of ma- chine used. The machines used to blend powders and add liquid are called “granulators”. Some granulators have the ability to dry the excess mois- ture. Many granulators do not have the ability to dry the wet massed granulation therefore the wet granulation must be moved to the next unit operation which is called Drying. There are many types of Dry- ers that we will discuss later. When powders are sensitive to liquids heat or both we must blend the powders with a pre granulated “dry binder”. If the blended powders will not work with the addition of the dry binder and liquid or heat cannot be used then we Tablets made by blending the dry powdered ingredients together and then compress- ing into tablets is called “A Directly Compressible Formu- la”. We are saying that the characteristics of these pow- ders will blend together with the other ingredients and stay mixed. This combination of ingredients will flow com- press and eject from the tab- let press. Furthermore the tablet will have good hard- ness friability and will dis- solve quickly. If powders will not make a good tablet because they do not compress don’t flow well are too fluffy or separate after blending the particles need to be combined and attached using a pharmaceutical glue called a binder. When the binder is put into water or a solvent solution and is sprayed or metered into the powders this process is called “The Wet Granulation Pro- cess”. The solids within the liquid solution form bonds between particles which are The three principle methods of developing powders for tablet making are: Direct Compression Wet Granulating Dry Granulating Training Volume 15.0 Copyright © 201 5 Techceuticals

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The Manufacturing Process Three Principle Methods continued must “Dry Granulate”. The Dry Granulation method uses mechanical force to densify and compact powders togeth- er which forms dry granules. This compaction can be done on a tablet press using “slugging tooling”. Slugging tooling or slugging punches dies are a method to dry com- pact powders into granules. The other method is to use a machine called a Roller Com- pactor or Chilsonator. This is basically the same kind of machine used to make the charcoal briquettes for our outside grill. The slugged or roller compacted powders are then milled final blended and compressed on a tablet press. Of these three principle meth- ods the “Wet Granulation” method is the most common. It is also the most demanding and requires many unit opera- tions. In The Tablet Capsule Pro- cess we will discuss each of the principle methods and discover the unit operations required for each method. We will define each pro- cessing step and the common equipment types used in each unit operation. The final goal is to make a quality tablet with the follow- ing attributes: ▪ Good Weight Control ▪ Good Thickness Control ▪ Good Hardness Control ▪ Good Ejection ▪ No Capping ▪ No Lamination ▪ No Sticking ▪ Good Friability ▪ Good Disintegration ▪ Good Dissolution As we go through each unit operation we will refer to one of these three principle pro- cessing methods.  Direct Compression  Wet Granulating  Dry Granulating  To improve powder flow.  To improve compressibility.  To reduce fines.  To control the tendency of powders to segregate.  To control density.  To capture and fuse small quantities of active material. The average tablet press speed in the pharmaceutical industry produces 3000 tpm tablets per minute or 50 tablets per sec- ond. Tablet press speeds can exceed 10000 tpm or 166 tps. Page 3 THE F O R M U L A WHY G R A N U L A T E of the tablet to eject from the tablet press without falling apart. Excipients also en- hance the hardness disinte- gration appearance color taste and the overall perfor- mance of the tablet. As stated previously a formu- la that is designed on a slow speed tablet press may not work on a high speed press. Even the best tablet press with all the best design fea- tures may not be able to com- press a formula at any speed. Each formula has a limit to how fast it can be com- pressed. In order to increase the speed the formula must be changed. We have determined that a formula contains many ingre- dients other than just the active ingredient. The ingredi- ents within the formula in addition to the active are called excipients. Excipients are needed to make a good quality tablet at the required tablet press speed. They help the flow compressibility and the ability “ All formulas have a limit to how fast they can work on a tablet press. Even the best tablet press cannot improve this limitation without changes in the formula” Copyright © 201 5 Techceuticals

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Most of the early research in granulating took place in pans and drums and some of the theory and knowledge gained using that equipment is not directly applicable in all tech- nologies. There are however at least three theories which have been accepted by aca- demics as applicable. These three mechanisms are: 1 Nucleation 2 Transition in the funicu- lar and capillary stage 3 Ball growth. In nuclea- tion the formation starts with loose agglomerates or single particles which are wetted by the binding solution and form small granules by pendular bridging. Continued addition of binding solution and tum- bling action consolidates and strengthens the granules through the funicular stage and into the capillary stage. In this transition stage the granules continue to grow by one of two mechanisms: 1 single particle addition and 2 multiple granule for- mation. Theoretically at the end of the transition stage there are a large number of small gran- ules with a fairly wide size distribution. Two of the four tests Loss on Drying LOD and Particle Size Distribution are com- monly performed by opera- tors on the production floor. In some cases the operator only performs the LOD and the other three tests are performed in the laboratory. The practice varies depend- ing on the situation. There are four standardized tests which are commonly performed on either milled or finished granules: 1. LOD- water content 2. Bulk Density mg/ml 3. Particle Size Distribution 4. Angle of Repose flow gradient. Page 4 WET G R A N U L A T I N G P R O C E S S S T E P S G R A N U L E FO R MAT I O N IN TH E WET G R A N U L AT I N G P RO C E SS HOW G R A N U L E S A R E T E S T E D the “LOD” or loss on drying test. The finished granulation is then milled to reduce the size of any caked material into a standardized particle size distribution. This distribu- tion is usually measured us- ing a series of screens lined up top to bottom from largest screen to a pan to collect the dust. In the final blend the lubri- cant is added to the granula- tion producing the final blend. Granulation is actually caused by a complex interac- tion of several variables and knowledge of each is neces- sary to control the granule formation process. If we es- tablish which variables are critical to granule formation we will have the basis to con- trol granule growth for a re- producible process. In the pre-mix step the pow- ders to be granulated are added and mixed prior to the introduction of the binder. In the wet massing step the binder is added to the mixture and the components are massed to a predetermined end point. In the drying step the wet mass is dried to a predeter- mined end point commonly measured with a test called Wet Granulating is the most common processing method used in pharmaceutical manufacturing Training Volume 15.0 Moisture Balance for checking LOD...Loss on Drying Copyright © 201 5 Techceuticals

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The Manufacturing Process Dry granulating also called Slugging Chilsonating or Roll- er compaction involves the pressing of mixed powders into an object to be reground into a precise powder. This action increases particle den- sity improves powder flow and captures fines. The Dry Granulating method is used over other technolo- gies for one or more of the follow reasons: 1. Granulate materials which are sensitive to heat and/or moisture. 2. Produce a uniform particle size range. 3. Improve flow properties. 4. Control dust. 5. Control bulk density. 6. Produce uniform blends 7. Control particle hardness. 8. Improve wetting or disper- sion rates. Powders can be compacted using a tablet press this is called Slugging. Once slug- ging is completed or powders are compacted on a Chilsona- tor or Roller Compactor they are milled. It is best to Mill densified powders using a low shear mill for best results. Using a high shear mill may over-mill or result in an over production of fine particles. impede the flow do not com- press well and can become air born. The air born dust can be witnessed on filters walls cabinets and machine compo- nents. Besides affecting yields the dust will combine with oil and grease on the tablet press causing the punches to become tight requiring more frequent cleaning cycles. Common milling Generally we want to be as gentle with powders as possi- ble. Some powders have high moisture content and they may be subject to compaction within the mill others are very hard and friable and are subject to pro- ducing “fines”. Fines are powders that are very small and “dusty” which will pass through a 200 mesh screen. Fine dusty particles equipment: Low Shear Mills Oscillators and Comils. Medi- um Shear Mills Quick Sieves and Hammer Mills. High Shear Mills Pulverizes and Hammer Mills. Many companies do not have designated milling rooms which requires moving single mills from location to location. In this event you must always check motor rotation before operating any milling equipment. Page 5 M I L L I N G DRY G R A N U L AT I N G M I L L A P P L I C A T I O N shear force. Therefore mill- ing machinery is defined by Low Medium and High shear applications. Some milling machines allow for changes in the type of mechanical action used to reduce the powder to the proper final particle size range. Mills can be used to de-lump powders without actual particle size reduction. Often different mills are used within different unit opera- tions throughout the com- plete manufacturing process: At weigh-up for de-lumping before blending for proper particle size distribution after wet granulating to enhance drying and after dry granulat- ing to prepare powders for final blending and tablet com- pression. Milling equipment is used to Improve flow reduce segrega- tion enhance drying and limit wide particle size distri- bution. Milling machinery used in the preparation of tablet cap- sule formulations can be cate- gorized as to their mechanical energy Low Medium or High energy mills will impart a force on the powders called “Fines” are small dust like particles that do not flow or compress well and also contribute to lower yields and more frequent cleaning. Copyright © 201 5 Techceuticals

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There are at least ten 10 different variables that can contribute to the success or failure of powder flow on a tablet press. In addition to the well studied particle size shape and distribution. There are also particle surface tex- ture cohesivity surface coat- ing particle interaction static electricity recovery from com- paction and wear/attrition while in the holding container. These other non-traditional measurements studied and appreciated shed significant light on flow issues heretofore not fully understood: Particle size Size distribution Shape Surface texture Cohesivity Surface coating Particle interaction Electro-static charge Compaction recovery Wear/attrition characteristics Most powders without the aide of granulation and flow agents simply cannot flow at speeds required for high speed tabletting. All powders have the capacity to form bridges create rat holes and stick to contact surfaces. To some extent most powder mixes exhibit some degree of each problem situation above. The issue becomes critical when any or all of the situa- tions begin to affect unwant- ed change in powder flow. Bottom line: Recognize that a “good” final blend is often viewed as such because it has good content uniformity and potency not by its ability to flow. However good flow is impera- tive to attaining a good tablet. Understanding powder char- acteristics will contribute to accurate blending practices. have a unique pathway to their optimum state of uni- formity. Because under blending and over blending fall on either side of the opti- mization curve the symptoms are somewhat similar and include Content Uniformity problems Weight and Hard- ness variation. The most common blenders used for final blending are the V blender the double cone blender and the tote blender. Materials go from an unmixed state to a state of relative homogenous consistency. Achieving a homogenous blend is accomplished through a combination of time and mechanical energy. Given enough time components will pass from an unblended state to a relatively homogenous blend and back to an un- blended state. Blend studies determine the optimum endpoint. All blends All use low shear tumble blend- ing as the most effective way to achieve good mixing with a variety of powders and gran- ules. Page 6 F I N A L B L E N D P OW D E R FL OW B L EN D I N G U N I F O R M B L E N D I N G An individual powder or fin- ished blend may flow very well under one set of circum- stance and not flow well at all under another. Notice that under Powder Flow we see attributes of the powder itself while under Powder Process we see what may happen under different processing circumstances. The message here is for man- agement to be aware of these potential issues on the pro- duction floor. Powder Flow Flow rate Com- paction and flow Hysteresis and flow Wall Friction perfor- mance Vertical shear Tensile Strength Powder Processing Segrega- t i o n : A tt r i ti on O v er - p r o c e s s i n g P o s t - storage/transportation time. The final blend represents the result of the formulating granulating and lubrication effort. The reason we test blends is to optimize blend time demonstrate lack of segregation after blending is completed and confirm that specified blend conditions produce acceptable uniformi- ty during validation. “The main purpose of the final blend is to distribute the lubricant” Training Volume 15.0 Copyright © 201 5 Techceuticals

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The Manufacturing Process While an experienced opera- tor can take a marginal granu- lation and make a good quali- ty tablet an inexperienced operator not fully under- standing tablet press opera- tion will be unable to produce a quality tablet. Understanding the machine operation and being able to identify the difference be- tween a machine issue and a granulation issue is im- portant. Operators should be qualified tested and certified in the operation of a tablet press. While tablet presses are used for many applications the basis of formula development is the same for each applica- tion. The final granulation to be compressed must have three basic characteristics all of which are critical: Flow Compress and Eject. A tablet press can be fully automated to the point that it can be operated in a lights out operation. This puts all the emphasis on the cleaning and proper set up of the ma- chine. This is also true of a non automated machine. The emphasis is on cleaning and proper setup. With few exceptions rotary tablet presses operate the same basic way. Many ma- chines have very advanced features that may provide better compression and weight control at high speed. However understanding the basics of compression is the key to understanding all tab- let presses. The tablet press is the report card on all previ- ous unit operations the tablet press is only half responsible for the final tablet quality the formula and powder prepara- tion operation is the other half. A good press cannot improve a bad formula. The compression cycle on a rotary tablet press: Overfill the die die fill. Adjust the volume of fill weight adjustment. Compress the tablet remove the air. Eject push the tablet from the die. When setting up the tablet press Adjust Tablet Weight Adjust Thickness Balance weight thickness and ma- chine speed to get proper Hardness. Page 7 T A B L E T W E I G H T C O N T R O L T A B L E T COMP R ESSI O N C O M P R E S S I O N thickness will result in a given hardness. Though excipients play a large roll in the dissolu- tion rate of a tablet so does tablet hardness. A tablet press and tools will not improve a granulation. If used correctly though the press and tools can be used to maximize the granulation and maintain a consistently hard tablet with acceptable disintegration dissolution rates. The three most important variables of making a good tablet are weight control weight control and weight control. Having consistent flow of a granulation provides the needed avenues to control tablet weights. Consistent tablet weight will result in repeatable tablet hardness. Tablet hardness is a function of tablet thickness and tablet weight. A given volume of granulation compressed to a specific “During compression the air evacuation forces fine particles to the edge of the tablet since “fines” will not compress the result is Capping” Copyright © 201 5 Techceuticals

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Once a good tablet is made we often need to add a coat- ing. The coating can serve many purposes it makes the tablet stronger and tougher improves taste adds color and makes the tablet easy to handle and package. The coating can be a thick sugar based coating or a very thin film. Most pharmaceuti- cal tablets are coated with a thin film coating. This coating is sprayed as a solution a mixture of solids in a liquid. For many years the liquid was a solvent such as alcohol or some other quick drying sol- vent. The use of solvents can present problems in handling operator safety solvent recov- ery and the odor of the tablet can smell like the solvent which is not a desirable attrib- ute. In general many manufactur- ers have moved to a water based solution instead of using a solvent. This presents a challenge in applying and quickly removing this water based solution so it does not disrupt the integrity of the tablet. Tablet film coating equipment has evolved to enhance this drying capability. Essentially a tablet coating system is much like a fancy clothes dryer. The water based solu- tion is sprayed in a very fine mist so as to dry almost im- mediately as it reaches the tablets. As the water dries it leaves the solids as a thin film on each tablet. The coating system continu- ously supplies hot air at the same time pulling air through small holes in the coating drum. The drum is commonly referred to as the coating pan with small holes called perfo- rations. This process can take as little a 30 minutes or it can take several hours. Tablets must be tough enough to tumble while the solution is added. The solu- tion is distributed from tablet to tablet during the tumbling and drying process. The spraying distribution and drying all takes place at the same time. Tablets are loaded into the coating pan creating a bed of tablets. There must be enough tablets to attain good mixing but not too many or the tablets will spill when the door is opened. Consistent batch sizes are important to attain consistent results. The tablet bed is tumbled slowly as the warm air is in- troduced the dust collector pulls the dust off the tablets and into a collection bin. When the tablet bed temperature reaches the proper temperature the spraying can begin. Once tablets have an initial base coat- ing the spray rate can be in- creased. The controls are monitored by the operator or computer record- ing data frequently. Tablet de- fects can occur if the tempera- ture spray rate and air volume are allowed to fluctuate. Page 8 C O A T I N G E Q U I P M E N T T A B L E T C OAT I N G THE C OA T I N G P R O C E S S The spraying system consists of spraying guns a solution pump tank mixer and air lines. The solution is pumped into the guns and the air com- bines with the solution for atomization into a very fine mist. The air handling unit AHU is basically a way of heating and filtering the air. Dehumidifica- tion and/or humidification maybe be needed depending on your location and applica- tion requirements. The Dust Collector collects the dust during the preheat and tumbling cycles and the Controls connect all of the components creating a com- plete coating system. Tablet coating equipment combines several technolo- gies and is commonly referred to as a coating system. This system consists of the coating pan spraying system air han- dling unit dust collector and controls. The coating pan is really a drum within a cabinet allow- ing for control of air flow air temperature and controlled solution application. Tablet Coating Art or Science Training Volume 15.0 Copyright © 201 5 Techceuticals

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The Manufacturing Process Commonly referred to as a capsule filler the encapsula- tion machine has the ability to fill many different products. Powders granulations liq- uids tablets and capsules can be filled into a two piece capsule. Encapsulation machinery technology varies a great deal from one manufacturing to the next. Not all machines can fill a wide variety of prod- ucts most are designed to handle free flowing powders much like powders that are prepared for a tablet press. The capsule filler must first position all of the incoming capsules into an upright posi- tion rectification separate the cap from the body top from bottom attain the prop- er fill volume capsule weight and then the product filled body is rejoined with the cap and ejected from the machine. Some capsule fill- ing machines have the ability to compress or tamp the pow- der for proper filling volume and weigh control. Encapsulators can be defined as 1 Hand operated 2 Semi Automatic 3 Automatic. The Hand Operated capsule filler requires the operator to or- ganize the capsules in the correct position separate the cap from the body and fill close the caps basically the hand filler is a holder for the capsule body. There are exceptions and some hand operated fillers assist the operator with sepa- ration and closing functions. The Semi automatic machine requires the operator to move rings capsule holder rings from the rectifier to the filling and closing stations allowing for production up to 25000 capsule per hour. Automatic machines with speeds up to 90000 per hour can be divided into two cate- gories: Continuous and Inter- mittent operation. The intermittent motion ma- chine is divided into seg- ments. Each segment index- es from each machine func- tion rectify fill tamp close and eject. The automatic machine is a continuous operation some- what comparable to a rotary tablet press in that the rota- tion is continuous and does not start and stop. using a jeweler’s glass to inspect the ink retaining screens is recommended before the roll is placed in use. Rolls received with in- complete or missing screens will not be able to hold ink in the impression cavities and the image cannot be trans- ferred to the rubber roll. If this occurs you will have unknow- ingly introduced defectively printed tablets into the batch. Most equipment manufactur- ers recommend using a 50- The principle of operation in printing is the successful transfer of the image from a surface to the object. In the case of tablets the transfer is made from the ink pot to the gravure or design roll roll to the rubber roll to the tablet. All offset printing regardless of equipment manufacturer is accomplished in this man- ner. Gravure rolls should be inspected for defects before they are used on the produc- tion floor. As an example 50 mix of n-butanol and isopro- pyl alcohol as both an ink thin- ning and cleaning agent. All ink manufacturers supply recom- mended specific gravity ranges for their inks. Controlling the ink viscosity is critical throughout the entire batch. Page 9 C A P S U L E C A R E E N C A P S U L AT I O N P R I N T I N G T E C H N O L O G Y defective capsules have on production rates. Even on the semi-automatic model 8 ma- chinery defective capsules can slow production rates significantly. Common Cap- sule defects include: Dented cracked split over size caps and empty capsules after the filling cycle. Gelatin capsules that are old and improperly stored can dry out and become brittle they have a rather high defect rate when compared say to fin- ished tablets. Even with all the quality check points many capsules are unusable by the time they reach the produc- tion floor. Just ask any pro- cess operator and they will tell you about the impact that “Capsules are sensitive to temperature and moisture variations” Copyright © 201 5 Techceuticals

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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 varia- tions create tablet defects. Consistent tablet weight is essential to making a good tablet. Without good and consistent weight control solving other defects will be difficult if not impossible because of how a tablet press operates. Some of the most common tablet defects are:  Weight variation  Friability variation  Picking Sticking  Capping  Laminating  Chipping  Mottled  Double pressing Often problems with compres- sion 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 surfac- es. The reason a lubricant is in the product is to prevent granules from sticking. Many companies are very accus- tomed to a double start up. The first one distributes pow- ders 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 lub- ricant. granules break open and the wet product sticks to the punch faces. If this occurs the drying process must be improved. To overcome stick- ing on the press increase hardness by making the tab- let thinner and increase dwell time to make the wet gran- ules adhere to other granules rather than the punch face. Also if a blend is incomplete this could mean that the lubri- cant in the formula is not Picking Sticking occurs when granules stick to the punch faces during compres- sion. Sometimes the punch face design and debossing can be modified to eliminate the problem. Other times granules are not dried proper- ly. They become case hard- ened during the drying pro- cess which means that the granules are wet on the in- side. During compression these protecting the granule from sticking to the punch cup sur- face. If all else fails polish the punch cup surface. Page 10 W E I G H T F R I A B I L I T Y C O M M O N T A BL ET D EFEC TS P I C K I N G AND S T I C K I N G 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 de- fects. Friability testing is done by tumbling tablets to see how well they will withstand the tumbling action which repli- cates typical handling situa- tions. This test is done to make certain that the tablet does not fracture of break apart. Too much friability means that the tablet chips or fractures break away from the rest of the tablet. Tablet weight is the key to controlling hardness and fria- bility. 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 density proper tablet Good tablet weight control must be attained before trouble shooting other tablet defects. Training Volume 15.0 Tablet Defects Sticking occurs when particles adhere to the punch face Copyright © 201 5 Techceuticals

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Punch tip edges are easily damaged usually from poor han- dling practices rarely from opera- tion. Extreme chipping and breakage The Manufacturing Process 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 com- pression process the top of the tablet the tablet cap wants to come off. The tool- ing punches dies are de- signed 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 entrap- ment. During compression air evacuation pushes the very fine dry granules out with the air. It is these dry light par- ticles that do not want to lock together resulting in tablet “caps” wanting to come off the tablet. Lamination is when the tablet splits apart anywhere except at the upper cap. Lamination is often blamed on over com- pressing. Too much compres- sion 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 com- press well. Reducing thick- ness 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. Machining a taper into the die will help eliminate capping and lamination. punch retainers are clean and not worn. They do need to be replaced often. When a ma- chine starts up it is cold. As it warms up lower punch retain- ers 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. Double Impressions will hap- pen 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 compres- sion. Make certain the lower Page 11 C H I P P I N G C A PP IN G AN D LAM I NATI N G D O U B L E I M P R E S S I O N S proper ejection off the ma- chine. If the blade is too high it will allow the tablet to wedge under the blade caus- ing 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 met- al 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. Many tablets are sensitive to chipping after compression. First make certain that the punch tip edges are not dam- aged. Some punch tip de- signs are more sensitive to damage from handling than others. Once confirmed that the chips are not being creat- ed by damaged punches then make certain that the “take off blade” is set correctly for The tablet press punches are designed to allow air to escape during compression along the upper punch tip. Capping Double Impressions are caused by punches twisting and jumping during compression Copyright © 201 5 Techceuticals

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Techceuticals PO Box 605100 Cleveland OH USA 44105 Phone: 216-658-8038 Fax: 216-916-4383 Email: types of applications will be covered in detail. We will focus on Bottles plastic glass Caps Cotton La- bels Coding Shrink wraps Inserts Outserts and bun- dlers. We will discuss line speed machine flow and process and the roll of the operator. Supervisor func- tion and line management Solid Dose Packaging Training covers each compo- nent of the packaging line setup operation cleaning changeover covering a wide variety of applications. Each packaging line compo- nent item is discussed sepa- rately: Unscrambler Bottle Cleaner Counter/Fillers Cottoner Capper Induction Sealer Retorquer Body/ Neck Bander Labeler Over-wrapper Cartoning and Conveyors. We will also discuss line integration inspections stations and trou- bleshooting. Many different will be main topics. This is a multiple shift training session we will pro- vide the program based on your shift requirements. Often we present this pro- gram to 2 nd shift from 3pm until 10 pm and then pre- sent the same information to 1 st shift from 8am to 3pm on the following day. This is a classroom lecture series presented to managers su- pervisors tech services quali- ty control leads mainte- nance and operators. P AC KAG ING T RA I N ING I have been involved in the pharmaceutical industry since 1973 and have provided training to phar- maceutical and nutritional companies throughout the world. Everyone within the manufacturing facility from management to the operator including RD QA Tech Services Maintenance Supervisors and Leads will benefit from our training programs. The goal is to have everyone exposed to the same information to create a common denominator and to open communication between departments. Companies that participate in our programs are encouraged to use our training materials to improve their own in-house training programs. If you would like to discuss this information with me in person please contact me. Sincerely Michael D Tousey Technical Director/Owner Techceuticals Mike Tousey Copyright © 201 5 Techceuticals

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