Tooling In Compression

A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight. A tablet press can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, nutraceuticals, cleaning products, industrial pellets and cosmetics. To form a tablet, the granulated powder material must be metered into a cavity formed by two punches and a die, and then the punches must be pressed together with great force to fuse the material together.

1. TOOLINGS IN COMPRESSION Presented by- Prashik Humane Research Associate FTF Pharma

2. Contents Introduction Parts of Punch Parts of Dies Standards in Tooling Types of Tooling Multi-tip Tooling Procurement of Punches Inspection of Tooling Lubrication and Polishing Destruction of Tooling Conclusion

3. What is compression? Compression is a process by which powders or granules are compressed, with the help of a compression machine, to form a tablet. Shape, size and hardness of a tablets depend upon the die and punches used. What are tablets? Tablets are oral solid unit dosage form of medicament or medicaments with suitable excipients, prepared either by molding or by compression. What is tooling? Compression tooling or tablet tooling is a set which includes a lower punch which fits into a die from the bottom and an upper punch, having a head of the same shape and dimensions, which enters the die cavity from the top after tablet material fills the die cavity. Introduction

4. HEAD : which guides the punch through the cam track of the machine during rotation HEAD FLAT (DWELL FLAT ): area of the head that receives the compression force from roller (in upper punches) and determines the weight and ejection height (in lower punches). OUTSIDE HEAD ANGLE : gets in touch with the roller prior to head flat, while compression. INSIDE HEAD ANGLE : which pulls down the lower punches after ejection and lifts the upper punches after compression. NECK : The relieved area between the head and barrel, which provides clearance for the cams. Parts of punch

5. BARREL : This area guides the punch (while going up and down) with reference to turrets guides. TIP : This determines size, shape and profile of the tablet. TIP FACE : This area of punch is where the tablet is formed. Good surface finish is required here to make quality tablets. KEY ANGLE : the relationship of the punch key to the tablet shape. The keys position is influenced by the tablet shape, take off angle, and turret rotation .

6. DIE OUTER DIAMETER:  The outside diameter of the die, which is compatible with the die pockets in the press. DIE HEIGHT : The overall height of the die. DIE BORE : The cavity where the tablet is made. The cavity’s shape and size determine the same form of tablet. CHAMFER : Entry angle of the die bore. TAPER DIES : These are the dies with tapered bore on one or both sides. They are used for easy ejection of tablets. DIE GROOVE:  The groove around the periphery of the die, which allows the die to be fixed in the press. Parts of dies

7. Standards in Tooling TSM: Tableting Specification Manual ( used in U.S) EU: Euronorm ( used outside the U.S) Specification TSM EU Inside head angle for “B” 37 ⁰ 30⁰ Punch head configuration Angled head Domed head Overall length 133.35 mm 133.60 mm

8. Types of Tooling The tooling vary in punch barrel diameter, die outer diameter and die height. Type of Tooling Punch length (mm) Barrel diameter (mm) Die diameter (mm) Height of dies (mm) Max. Tab. Size (mm) Round/ Capsule B 133.60 19 30.15 22.22 16/19 D 133.60 25.4 38.1 23.82 25/25 BB 133.60 19 24.0 22.22 13/14 DB 133.60 25.4 30.15 23.22 19/19

9. Multi-tip tooling Advantages- Significantly increase tablet production: Number of tablets per turret rotation multiplied by number of tips Reduce press run time per output, reduction in press setup time per output of tablets Cut operating costs as fewer tools required for a given output, less maintenance required per batch of tablets

10. For the procurement of punch set, an approved drawing of the same, from the production department is sent to the supplier. The drawing contains critical information like: Type of tooling Punch length Number of set Upper and lower punch embossing Cup depth Land MOC The punch set is then cleaned using 70% IPA and then inspected for any damage or defect. PROCUREMENT OF PUNCHES

11. Inspection of Tooling Overall height and working length: The height of punches is measured with the help of dial gauge. The dial gauge is set at zero position with the help of master punch. The punches are kept inside the punch holder over the metal pad of the gauge and checked for any deviation from the zero position. When head angle is kept at the upright position, the measured height is called overall height. While, when tip is kept at the upright position, the height measured is working length. For multi-tip tooling, a marking is given near a tip which is considered as tip no. 1, and then remaining tips are measured in anticlockwise direction. The overall height should be within 133.60 ± 0.08 mm.

12. Tip diameter of punches: Tip diameter is checked with the help of a Vernier caliper. The readings should be within ± 0.1 mm if the standard dimension. The tolerance limit for tip diameter is ± 0.02 mm. Barrel diameter of punches: Body diameter is checked with the help of a Vernier caliper. The tolerance limit for barrel diameter is ± 0.02 mm. Difference in concentricity of punches: Concentricity of a punch is checked with the help of V block pad by placing the punch horizontally on it. Dial gauge is set at zero position over the punch body. The punch is rotated in clockwise direction and checked for any deviation from the zero position. The deflection should be within ± 0.05 mm of the standard dimension.

13. Punch head angle: “Go-No Go” punch head tester is used for checking punch head. Punch head is passed through “go” side of punch head tester and it should pass easily. Punch head is passed through “no go” side of punch head tester and it should not pass through it. Embossing of punches: Embossing of punches is checked using magnifying lens or embossing checking kit. Height of dies: Height of dies is measured using Vernier caliper. The tolerance limit for height of dies in -0.03mm. Outer diameter of dies: Outer diameter of dies is measured using Vernier calipers. The tolerance limit for outer diameter of dies is -0.02mm.

14. Frequency of Inspection: When a new punch set is received. After completion of 100 million tablets ± 5 million tablets. For tablets having batch size of more than 10 million tablets, inspection is done after completion of 10 batches. For multi-tip tooling, inspection frequency depends on number of tips in a single punch. e.g. if tips in multi-tip tooling is 5, then inspection is performed after completion of 500 million ± 25 million tablets (100 million tablets ± 5 million tablets * 5) If a tip in multi-tip tooling gets damaged, then the tip is replaced and inspection of the punch is performed. Whenever required, or due to variation in tablet physical parameters.

15. LUBRICATION AND POLISHING Lubrication: Lubrication of tooling is important for smooth and efficient running of tablet compression machine. Lubrication reduces wear during use and oil coating during storage prevents rust. Punch sets are lubricated using food grade oil (light liquid paraffin/ OKS 370) Polishing: Polishing of punch set is important to increase its shelf life. Polishing is performed: When there is blackening or roughness on punch tip When there is continuous sticking on punch tip Before every usage and as and when required Polishing is carried out using polishing machine which contains walnut shells and food grade paste.

16. DESTRUCTION OF TOOLING Punch set gets damaged during handling or cleaning. Multi-tip punch set gets damaged during handling and cleaning. The punch set should be destroyed if any major wear and tear is found in them. After completion of 500 million tablets. During inspection, if any abnormality is found. If punches, tip, dies, etc gets damaged during operation, it should be addressed through deviation. The punches are defaced before discard to prevent misuse of the same.

17. Conclusion Tooling are an integral part of compression machine. The size, shape and strength of tablets depend upon the type of tooling used. Selection of appropriate design for meeting specific tablet compression applications is critical. Inspection of punches at regular interval helps in identification of any damage present in the punch set. Proper maintenance of tooling is important to prevent any wear and tear of punch set and improve the shelf life of the tools.

18. Thank you