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0 PURPOSE: To provide a written procedure for the Operation and Cleaning of Hardness Tester (Monsanto Type). 2.0 SCOPE: Applicable to Hardness Tester (Monsanto Type ) used for checking Tablet Hardness in production. 3.0 RESPONSIBILITY: Executive Manufacturing and Executive QA, Assistant Manager QA. 4.0 ACCOUNTABILITY: Manager Quality Assurance 5.0 HISTORY: The first tablet hardness tester was introduced around the mid-1930s. This was a purely mechanical device and is still manufactured today. Force was applied with a screw thread and spring until the tablet fractured and the hardness was read from a sliding scale graduated in kg increments. This was followed by the so-called Strong-Cobb tester, introduced around 1950. The testing force was generated by a manually operated air pump and the tablet breaking force was measured on a dial graduated in 30 arbitrary units which were designated as Strong-Cobbs. The results given by the Strong-Cobb tester were not consistent with those of the earlier tester.

Engineering Systems C53 Tablet Hardness & Compression Tester Electro-mechanical tablet hardness testing machines were later introduced and have evolved into electronic test instruments such as those produced by Engineering Systems, for example the C53, shown on the right. These contain a motor drive system to generate the force and electronics to automate the test procedure, automatically detecting tablet fracture and displaying the force in a variety of units. Measurements can be printed and / or downloaded to a computer. 6.0 PROCEDURE: 6.1 OPERATION: 6.1.1 Hold one tablet between the two faces provided by pushing forward the movable face inside by turning the plunger clockwise. Coincide

the `Zero' in the scale with the pointer. 6.1.2 Enclose front part where tablet is held in a sample polybag. 6.1.3 Start applying pressure on the tablet by gently rotating the plunger 6.1.4 When the tablet breaks, note the hardness (in kg/sqcm) directly from the scale. In case, if the pointer is in between the two divisions of scale, read the hardness as 0.5 kg / 6.1.5 Discard the broken tablets in water and sample polybag in waste bin.

6.1 CLEANING: 6.2.1 After use, clean the hardness Tester with clean lint free cloth and keep in its box. This procedure is to be followed during product change over and at the end of shift. 6.2.2 After batch is completed dismantle the hardness tester and clean with potable water followed by 0.1% SLS solution followed by potable water to remove the SLS solution and finally rinse with purified water, and clean with lint free cloth and keep in its box. 7.0 REFERENCES: Nil 8.0 ENCLOSURES: Nil 9.0 ABBREVIATIONS: 9.1 SLS : Sodium lauryl Sulphate (0.1%) 9.2 Kg / : Kilogram / Square Centimeter

Tambahnnya Worlds most handy Hardness Tester Model MHT-20 is designed to use in QC / QA / R & D / Tableting / Production In-process etc.for taking quick readings of Hardness Of Tablets. It measures Hardness in Kg per sq. cm.

It is made of brass parts heavily chromium plated and has a scale of 0-20 kg. Per sq. cm. with each division. Marked for 1 kg. Readability 0.5 kg. /sq. cm.

Strong Cobb Hardness tester

Purpose : Strong Cobb Hardness Tester Model SHT - 17 is used for finding the Hardness of Tablets in Kg.per Scope : To measure the Hardness of tablets in Pharmaceuticals Quality control, R & D , Production areas even near the Tablet Press Description of the Instrument Basically hand operated Hardness Tester model SHT - 17 works on Peneumatic Pressure developed by hand operated lever system. Indication of the measured value will be on pressure gauage dial ( 017 kg per ) with idle pointer. In dial Guage there are two pointers : a) Red Pointer b) Air Pressure Pointer ( Black )