Pharma approach

ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries. ICH guidelines are followed throughout the world for product quality. Following is the list of ICH guidelines: Q1A(R2) - Stability Testing of New Drug Substances and Products: This guidance is for analysis of the product for its stability in different environmental conditions. Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products: This is also for stability studies of pharmaceutical products to test the effect of light on the product. Q1C - Stability Testing for New Dosage Forms: Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products: This section of the guideline is for stability testing of product using Bracketing and Matrixing. Q1E - Evaluation for Stability Data: This section

Entry and Exit procedure Drain Point numbering, cleaning and sanitization Transfer of finished goods to FG Store Product Change Over Issuance of extra packing material SOP on procedure for blend division Preventive measure to be taken during power failure SOP on control contamination Handling of dispatched packing material Cleaning and operation of 2 D bar coding and scanning system Operation and cleaning of scrubber drier make roots scrub Control of contamination Operation and cleaning of electronic weighing balance Generation of shipper label/ pallet label for track and trace system using bar code technology as per SSCC code following GSI global standards Batch packing Return of excess primary and secondary packing material Inspection of sieves and screens Operation and cleaning of vibro sifter Operation and cleaning of comminuting mill Operation and cleaning of co-mill Operation and cleaning of Fluid Bed Dryer/ Processor Operation and cleaning of cage blender

OPTIMIZATION OF TELMISARTAN TABLET FORMULATION ABSTRACT: The objective of the present study is optimization of telmisartan tablet formulation employing βCD, Primojel, and Tween 80 by 23 factorial design to achieve NLT 85% dissolution in 10 min. Eight telmisartan tablet formulations were prepared using selected combinations of the three factors as per 23 factorial design. Telmisartan tablets were prepared by direct compression method and were evaluated. Telmisartan tablet formulations Fb and Fbc disintegrated rapidly in 20 and 40 seconds and gave very rapid dissolution of telmisartan, 96.1% and 95.8% in 10 min respectively. The increasing order of dissolution rate (K1) observed with various formulations was Fc< F1< Fac< Fa< Fabc< Fab< Fbc< Fb. The polynomial equation describing the relationship between the response,  percent drug dissolved in 10min (Y) and the levels of βCD (X1) , Primojel (X2)  and Tween 80 (X3) based on the observed results is  Y = 55.327 + 3.6

PROCUREMENT OF TOOLING While ordering any punch set (From Approved Supplier only), following things should be covered: 1.Drawing for upper/lower punch/die, by the manufacturer as per the specifications are given or as per sample punch set. 2.Following details should be given with the purchase order: • Total number of set required • Type of punch set eg. D/B/BB etc. • MOC to be used (HCHC/OHNS) HCHC: High Carbon High Chromium OHNS: Oil Hardened non-shrinking Steel • Engraving details; Sr. no., Mfr name, Date of Mfg., Punch size in mm. • Special requirements like: Concavity, embossing, chrome plating etc. Tablet Tooling There are following types of Tooling available: ‘B’   -Tooling ‘D’   - Tooling ‘BB’ -Tooling 'DB’ - Tooling Approval of drawing /sample punch set from department head and unit head. These are the different types of tooling, their dimensions and maximum possible tablet sizes. Tablet Tooling Terminology Following definitions for direct terminology

Product Description Rapid Mixer Granulator - High Shear Mixer Granulator (RMG – With LEFT & RIGHT Side Discharge Valve) SPECIAL FEATURES: Gross Capacity Model available from 60 Liters to 1250 Liters capacity The gross capacity & working capacity in liters and working capacity in Kgs. are mentioned below . Model Gross Capacity in Litres Working Capacity in Litres Working Capacity in Kgs.* RMG - 60 60 45 25 RMG - 100 100 80 40 RMG - 150 150 120 60 RMG - 250 250 200 100 RMG - 400 400 320 150 RMG - 600 600 480 240 RMG - 750 750 600 300 RMG - 1250 1250 1000 500 * At Bulk Density of Material 0.50 GMS/ CC SPECIAL FEATURES: Homogeneous binder distribution for mixing purpose. Air purge sealing system for main stirrer shaft and granulator shaft. Short batch time and cleaning time. Maximize CIP effectiveness. For precise control of process & automation PLC based operating panel. A high-speed granulator is inserted horizontally throu

RMG (RAPID MIXER GRANULATOR) PRINCIPLE AND WORKING BY Bhupesh solanki In Rapid mixer granulator Mixing ,Densification and Agglomeration is achieved using Shear mixing(Breaking inter-molecular forces) and Compaction forces exerted by Impeller on the powder mass . RMG consists of Mixing chamber , Impeller , Chopper ,Discharge port , Filter assembly , Purging air and Solution inlet port .                             Mixing chambers Mixing Chambers in Rapid mixer granulator is of 3 types Conical shaped , Domed shape , and Circular shaped  although the basic aim behind all the shapes is to eliminate the dead points and wall adhesion i.e.the powder may not adhere to wall from where it cannot detach leading to inefficient granulation as well as mixing . Filter assembly is on the top of port in this vent air filter is placed which allows the purging air to leave the Mixing chamber and retains the granules inside . Purging air air coming from gasket present below the impeller at an

Rapid mixer granulator is widely used equipment in pharmaceutical manufacturing. It is used to mix the pharmaceutical ingredients and make the granules before compression. Impellers and chopper are mainly responsible for wet granulation in the rapid mixer granulator. Impellers: Impellers are fixed at the bottom of the dome-shaped stainless steel bowl. It has two full length and two half-length blades. These impellers are designed in such a way that small blades lift the material and full-length  blades push the material to mix well. These impellers break up the wet mass into small pieces and granules. Chopper:  These are specially designed small blades located at the bottom of the dome. It rotates at high speed (1440/2880) RPM to give easy and uniform granulation. Chopper cuts the wet lumps of material into small sized parts those are mixed equally by the impellers and its speed is responsible for the size of the granules. Chopper doesn't have any significant effect on the