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CLEAN ROOM SYSTEM IN STERIL PHARMA

WHAT IS A CLEAN ROOM? It’s a closed environment where “clean” or “aseptic” work is carried out.It has a “regulated” atmosphere . It has low particle count with “predefined limits” . It is designed to generate less particles . It is designed to remove generated particles Why Clean Room? To protect the Product from contaminants Head space is a portion of the Clean Room environment. CONTAMINANTS: What contaminants should be kept out? Physical - dust, dirt, fibre, grit, glass, lint, Chemical -   organic, inorganic, vapours, fumes, smoke Biological - bacteria, fungi, virus, spores, pollen, endotoxins, human cells Energies -   heat, light, sound, static, magnetic, electricity, radiation Sources of contamination - All inputs to the “Clean Room” are sources of contamination Material - RM, PM, lubricants, cleaning agents disinfectant Machines - wear & tear of moving parts, rust, peel-off, emissions People - sweat, breath, saliva, hair, cells, Air - can brin...

Walk in Sun Pharma at dehradun (U.K.) for production and quality control for Paonta ( H.P. ) (OSD) and Guwahati , Sikkim ( Parentral ) on 6th Aug 2017

Walk in Sun Pharma at dehradun (U.K.) for production and quality control for Paonta ( H.P. ) (OSD) and Guwahati , Sikkim ( Parentral ) on 6th Aug 2017

POTENCY OF DRUG AFTER EXPIRY DATE

“The medicine will degrade with time and will loose its potency to show its Pharmacological effects ”   Expiry date is most overlooked matter in pharmaceuticals . Many people across the world looks into the matter weather we can use these medicines or not . It is suggested to rather take part in clinical trials instead of taking Expiry dated medicines as it will generate some wealth also . The medicines are tested extensively for expiry dating . Shelf life (Time after which the medicine starts degrading)  studies are done on medicines at different ranges of Relative humidity and temperatures to ensure that before the expiry date the Drug content remains intact and the Drug content is maintained according to label claim throughout the Expiry dating .After expiry date the Drug may degrade and converts into harmful substance no one knows as study have not been performed on drugs after expiry date . So ,to use them after expiry date is nothing but to harm the b...

PRINCIPLE AND WORKING OF RAPID MIXER GRANULATOR

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 th...