PHARMA KING ACE

 The medical field has been playing an important role in everyone’s life not only in human life but also in the life of other living species. The most important part of the medical field is the “Medicine” and when it comes to medicine, the manufacturing process and the packaging play a very critical role. So, what is pharmaceutical packaging, how it’s been done, does it have different types, what are the materials used? Well, let’s reach out to all such questions and more. Whether it’s any other product or medicine, packaging plays an important part in all.  Packaging has often been referred to as the 5th P of the marketing mix. In the case of medicines, the packaging is not just part of the marketing mix but very critically related to the product features, application, and shelf life. The packaging of drugs is important to protect drugs from damage, germs, outer atmosphere, and bacteria and at the same time have to take care of child and old age safety concerns. Types of Phar...

Tablet tooling: Don’t let it corroded Corrosion can severely affect tablet compression tooling if it is not addressed effectively. It can delay production, reduce efficiency and cause contamination problems. Corrosion can be detected by the appearance of discoloration, etching or common red rust. The main cause of corrosion is acidic substances, which can include ingredients found within the formulation being compressed and even in the surrounding atmosphere. The iron particles in the metal tooling are exposed to oxygen and moisture in the form of humidity or vapor. When the steel is exposed to water, the iron particles are lost to the water’s acidic electrolytes. This means they oxidize the iron particles, which form corrosion on the punches and dies. There are several reasons why corrosion can occur, and although challenging, it can be resolved with a combination of the correct steel, coating or treatment selection and proper maintenance procedures. Atmospheric moisture One of the pr...

  What is Data Integrity? Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. Data integrity is a key approach in the pharmaceutical quality control system. ALCOA is (Attributable, Legible, Contemporaneous, Original, and Accurate) was introduced in the 1990s for ensuring the pharma industry as a framework for data integrity and Good documentation practice (GDP). Then further introduced ALCOA plus is (Complete, Consistent, Enduring and Available) Currently used by the FDA, WHO, PIC/S, and GAMP. So overtime periods, data integrity concepts expand from ALCOA to ALCOA plus for ensuring data security and integrity ( data protection) are observed and maintained. ALCOA+ ALCOA has five basic principles (Attributable, Legible, Contemporaneous, Original, and Accurate) to stop data integr...

 Following parameters checked during granulation process  1. Angle of repose-  Angle of repose of any solid in pulverized form represent an angle measured in theta,  Angle of repose = tan-¹(2h/d), unit is degree (°) Acceptance =  < 25° = Excellent  25°-30°= Good 30°-40°= Average  >40°= Bad  2. LOD ( Loss on Drying )  Test is designed to measure the amount of water and volatile matters in a sample when the sample is dried under specified conditions eg. 100° C for 5 minutes  Formula  LOD = Initial weight before drying - final weight after drying / initial weight before drying ×100 3. Compressibility index  Measure of the propensity of a powder to be Compressed also known as Carr's index  Formula  Carr's index = true density - bulk density / bulk density ×100 Acceptance  <15% = Good flow  >25% = Poor flow  15%- 25% = Smooth for compression  4. Bulk density and tap density  Bulk densit...

  MONTHLY CALIBRATION OF BALANCES  For monthly Calibration of Balances check following parameters- 1. Accuracy - verify the balance with minimum weight (least count × 100), 5%, 20%, 50%, 90% capacity of respective balance capacity. Tolerance - the variation if any should be ± least count of the balance or ± 0.2% of certified standard weight used whichever is higher    2. Reproducibility -  Check the reproducibility by using minimum standard weight of balance capacity. Place the weight in the middle of the weighing pan observe the displayed value  Then calculate the %RSD by following formula  RSD= SD×100 / X  Where,  X= mean of the individual value Acceptance = %RSD should not be more than 2.0% 3. Eccentricity  Eccentricity is the difference between the weight placed in centre and at peripheral points of the weighing pan 

Systematic Diagram of Purified Water System