“Single-time-point surface bioburden study at 96 hour dirty-hold time on amlodipine manufacturing equipment in ‘Class D’ facility (non-sterile)”   Background The objective of dirty equipment hold time study (DEHT) was to find the load of microorganism on the equipments used for manufacturing amlodipine tablets 5 mg in class D (non- sterile) manufacturing facility. Amlodipine tablets contains starch and microcrystalline cellulose as major excipients which may serve as excellent growth medium for growth as well as proliferation of microbes on dirty equipments. Method The dirty equipment hold time study was carried out for single product, amlodipine 5mg tablet and hold time of a 96 hours was selected for hold time study on dirty equipment. From 9 equipments, altogether 18 samples were sampled using sterile swab from 25cm 2 on single time point (96 hours) for study purpose. Details of criteria for sample site selection mentioned in Table 1. Result Microbial limit...

  Validation of Microbial Limit Test Method

  Breast Cancer: Facts Breast cancer happens when cells in the breast start growing out of control. These cells often form a lump, or tumor. It’s the most common cancer in women worldwide, but men can get it too. In 2022, doctors diagnosed more than 2.29 million new cases in USA. Most new cases about 71% and deaths about 79%—happen in people over 50 years old. Fig: Breast Cancer Classification: 1.Carcinomas make up 80–90% of all cases. They start in the lining of organs, like the breast, lungs, or prostate. 2.Sarcomas start in connective tissues—think bone, muscle, fat, cartilage, or blood vessels. 3. Leukemias are cancers of the blood-forming tissues, like bone marrow. They don’t usually make solid tumors. 4. Lymphomas and Myelomas begin in the cells of the immune system. Lymphomas attack the lymphatic system; myelomas start in plasma cells in the bone marrow. 5.Central Nervous System Cancers grow in the brain or spinal cord.   Signs and Symptoms of Br...