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The Manufacturing Process

The Manufacturing Process

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The Manufacturing Process is a comprehensive solid dose training course that has been in the making since 1977. Loaded with practical information on how tablets and capsules are made, it is designed for experts and novices alike, putting the entire manufacturing team on the same page. The participant will be able identify machinery, why it is used, and what it does. In other words, the participant will be able to go into any facility and understand the equipment and process at a glance. This training event is a hands-on, step by step program, covering why and how we manipulate powders to improve them for tablet and capsule production. We define each unit operation: weighing, milling, granulating, encapsulation. This is a team building course, one that can be delivered to small hands-on groups, or for the entire manufacturing team. We find that many companies send out scouts to participant in the hands-on session and then often request we deliver this course at their facility.


Who Should Attend:

Managers, Supervisors, Operators, Tech Services, R&D, Formulators, QA/QC, and Maintenance. This course is designed to provide powerful tools that the participant can put to work immediately. If you are involved in the tablet or capsule manufacturing environment this course is for you.

 


This Course Covers:

Unit operations for tablet and capsule manufacturing. Weighing, milling, granulating, blending, tableting, tablet coating, and encapsulation. Tablet & Capsule defects will be discussed in detail.

 


Topics & Schedule

Day 1 – 8:30 am – 4:30 pm

  • Unit Operations
  • Formulating
  • GMP’s
  • Milling
  • Granulating
  • Blending

Day 2 – 8:30 am – 4:30 pm

  • Tablet Operations
  • Defects & Solutions
  • Coating

Day 3 – 8:30am – noon

  • Encapsulation
  • Summary/Q&A

 


Course Fee and Information:

This course fee will include the 2.5 day course, a detailed course manual, personalized training certificate, along with continental breakfast, lunch, snacks, and beverages each day. Special diets can be accommodated, please be sure to discuss your needs with our registration team!

Fee Schedule:

  • Single: $1,995
  • 2-4 People: $1,795 each
  • 5 or more people: $1,595 each

Classroom doors open at 8 am. Dress: Casual

Additional Course Information:

The Manufacturing Process is a two and a half day comprehensive course covering the essentials needed to make quality tablets and capsules.

The Manufacturing Process is exactly what our industry is about today; delivering the methodology, documentation and mindset required to meet the needs of our changing industry.

We will focus on a step by step explanation of each unit operation within the manufacturing process, common terminology, and practical knowledge of each topic. Hands on breakout sessions will be part of this course!

The main topics are Formulation, Blending, Milling, Granulation, Drying, Final Blending, Tableting, Tablet Press Tooling, Coating, and Encapsulation.

The participant will be able to quickly look at a formula and determine the processes used to manufacture it. They will be able to go into any pharmaceutical or supplement company and understand the equipment and the manufacturing pathways.

This program will put different departments on the same page and is an excellent platform for in-house training.

Even the most experienced veteran will gain from this seminar. This will be the most enjoyable and educational seminar you have ever attended.

 

Tablet and Capsule Manufacturing

The Manufacturing Process was created for companies and individuals to gain a complete understanding of the basic requirements needed to make tablets and capsules.

The objective is that the reader will gain a quick, yet comprehensive 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 Formulation, Blending, Milling, Granulation, Drying, Final Blending, Tabletting, Tablet Press Tooling, Coating, and Encapsulation.

Common tablet & capsule defects and problem solving are also part of the objective.

Designed for new & experienced employee training, the expectation is that having this information will create a common denominator; thus producing an opportunity for better communication between 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 operation. They should understand how machines work and the usage of each piece of equipment and why one technology is preferred over another.

 

Unit Dose Operations

Every separate manufacturing step is called a “Unit Operation”. Weighing, Blending and Tabletting are individual unit operations. A “Batch” of powder or granulation is processed in each unit operation. The objective is Batch to Batch Reproducibility in each Unit Operation. Unit Operations 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 Direct Compression, Wet Granulating, and Dry Granulating. Which pathway is used depends 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 compared to granulated sugar. Bad flow can be compared to powdered sugar. Products must flow freely to achieve proper dosage. Tablet presses and encapsulation machinery 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 compression. 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 compressed.

 

Granule Formation in the Wet Granulating Process

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 technologies. There are however at least three theories which have been accepted by academics as applicable. These three mechanisms are:
(1) Nucleation
(2) Transition in the funicular and capillary stage
(3) Ball growth. In nucleation,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 tumbling 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 formation.

Theoretically, at the end of the transition stage there are a large number of small granules with a fairly wide size distribution.

 

Powder Flow & Blending

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 texture, cohesivity, surface coating, particle interaction, static electricity, recovery from compaction 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 situations begin to affect unwanted 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 imperative to attaining a good tablet. Understanding powder characteristics will contribute to accurate blending practices.

 

Tablet Compression

While an experienced operator can take a marginal granulation and make a good quality tablet, an inexperienced operator (not fully understanding tablet press operation) will be unable to produce a quality tablet.

Understanding the machineoperation and being able to identify the difference between a machine issue and a granulation issue is important. 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 application. 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 machine. This is also true of a non automated machine. The emphasis is on cleaning and proper setup.

With few exceptions, rotary tablet presses operate thesame basic way. Many machines 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 tablet presses. The tablet press is the report card on all previous unit operations; the tablet press is only half responsible for the final tablet quality, the formula and powder preparation operation is the other half. A good press cannot improve a bad formula.

 

Common Tablet Defects

Making tablets batch after batch without an occasional defect would be unusual. Some products start up withproblems and end with them. Tablet to tablet weight variations 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 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.

 

Capping and Laminating

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 & 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 & light particles 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 compressing. Too much compression force flattens out thegranules 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. Machining a taper into the die will help eliminate capping and lamination.

 

Capping and Laminating

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 & 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 & light particles 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 compressing. Too much compression force flattens out thegranules 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. Machining a taper into the die will help eliminate capping and lamination.