Production – Pharma Practices

In this article we are going to learn all aspect of tablet tooling. What is tablet tooling, purpose of it, different types of tooling and many terms related to it. What is Tablet Tooling? Tablet compression machine forms a tablet of specific shape, size and hardness. These criteria are met by a tablet press using compression force on granules. Tablet tooling refers to a special set of tool or equipment which is used to apply the compression force in order to turn granules into solid dosage form i.e. tablet. Basic Tablet tooling primarily consists of two main parts: Tablet Punches Dies Both of these parts are located on the turret section of a rotary tablet compression machine. The upper and lower punches come together within the die, compressing the material and shaping it into a solid tablet with the desired size, shape, and markings. Now, let's dive deeper. Tablet Punches: These are hardened steel tool with specific shape and sizes, designed to turn granules into desired shape, sizes and create markings on tablets. Tablet punches are manufactured in pairs; upper punch and lower punch. Upper Punches: Upper punches are positioned on the upper punch rail of the turret. They undergo compression force by the upper main roller. Upper punches create the upper part of the tablet. Upper part of the tablet usually consists of different identification mark, break line or logo. This is why the upper punches contains these marks to imprint on tablet surface. Lower Punches: These are installed on the lower punch rail in the turret. Lower punches are usually longer in shape as it takes most of the compression forces. It creates the overall shape of a tablet. The lower punch interacts with the die hole and upper punch to turn granules into solid form tablet. There are some special tablet punch designs modified for specific issues. Dies: Tablet die is like a mold with cavity in the middle. It shapes a specific product into desired shape usually round, oblong, caplet or oval shape. The upper punches and lower punches work in conjunction with the die. During the tablet compression process, granules are scraped into the die cavity. Later, the upper punch and lower punch come together by upper and lower roller, applying compression force to the granules and forms tablet. Types of Tablet Tooling: Tablet tooling varies depending on the punch and die size difference. There are different types of tablet tooling available in the market. However, types of tooling used varies depending on the geographical location. For example, most commonly used tooling are EU-B, BB, EU-D, DB, BBS, TSM-B, TSM-D, EU-441R4, TSM-441R4. What is TSM Standard? The TSM tooling specifications serve as the definitive point of reference for U.S. manufacturing standards concerning tablets and tablet tooling within the domain of engineering. These specifications, developed under the auspices of the American Pharmacists Association (APhA), represent the exclusive published standards governing the tablet compression industry. What is EU Standard? The Euro Standard (EU) is primarily utilized within the European region, yet its applicability extends globally. It is based on ISO 18084 standards. B Tooling and D Tooling Difference The major difference between B and D tooling lies in their OD(outer diameter) dimensions on the punch barrels and dies. For B tooling the OD is 19mm and 25.4mm for D tooling. The nominal Die size is 30.16mm for B tooling and 38.10mm for D tooling. It all comes down to the maximum size of tablet that a tooling can produce while between B and D tooling. The maximum nominal round shape tablet with 16mm size can be produced using B tooling, while for BB it comes down to 11mm. For D tooling the maximum capable nominal tablet size is 25mm, which is similar to the OD for D punches. Image courtesy: hvax B and D tooling are the most common sizes for both EU and TSM standard. They are also called TSM19 and TSM1. There some other factors that differentiates between all these tablet press tooling sizes: Die diameter Die length Working length Barrel length All these are compare in the table below. There are some difference among these tooling's punch head which is as mentioned in the picture and later described in the table: Let's look at a dimensional variation among these B, BB, D, TSM-B, TSM-D tooling: Tooling Standards/DimesionBBBBBSDTSM-BTSM-D ≥ R1 (mm)16161616-- ≥ R2 (mm)0.80.80.80.80.790.79 ≥ R3 (mm)----7.927.94 α (°)----24.0025.00 β (°)3030303037.0035.00 Ø Plateaue (mm)101012.1415.8012,7018.14 Upper punch length (mm)133.6133.6133.6133.6133.35133.35 Lower punch length (mm)133.6133.6133.6133.6133.35133.35 Ø Upper punch barrel (mm)19.019.019.025.3519.0025.35 Ø Lower punch barrel (mm)19.019.019.025.3519.0025.35 Max. Tablet Dia (mm)161311251625 Die outer Dia (mm)30.16242238.130.1638.1 How to Choose the Right Tablet Tooling Tablet tooling selection is considered very crucial in tablet manufacturing. There are few key things that need to be considered while selecting tablet tooling. While most manufacturers considered these points while offering the tooling set, yet it is equally crucial for a customer to understand this process.