Pharma approach

 Line Clearance Checklist point Production/packing Last Updated on: December 18, 2022 by Naresh Bhakar Before proceeding to pack any product, the Production officer and Q.A. officer shall verify the Area as per the given line clearance checklist point in BMR/BPR records. During Line clearance, all points shall be complied to ensure product quality and better prevention from product contamination, Mixup, and cross-contamination. Line clearance checklist Line Clearance Checklist point for Primary Area: Are cleaned labels affixed on equipment as per the status labeling procedure? Is the statue’s board updated? Is the Area cleaned as per the frequency and types of cleaning? Area temperature and Relative humidity are within limits? Is the Differential pressure of the Area under control limits? Are the personnel follows proper gowning procedure? Is the area waste bin empty out? Check if Area is free from previous product residues. Is the product waste container cleaned and devoid of previous

  Calculate the Maximum Capacity of the Coating Pan Max imum Capacity of the Coating Pan in (in Kg) = Brim Volume (in Ltrs) x Bulk Density of Tablets (mg/ml) Calculate the Maximum Capacity of the Coating Pan The minimum capacity of the coating pan is simply 60% of the maximum capacity as given above. Minimum Capacity of coating Pan (in Kg) = Brim Volume (in Ltrs) x Bulk Density of Tablets (mg/ml) x 60/100 Example to Calculate Capacity of Tablet Coating Machine For example: 48” coating machine pan generally has brim volume 160 ltrs Bulk Density of Tablets = 620 mg/ml Maximum Capacity  = Minimum Capacity  = OR The size and form (shape) of the tablets affect the coating machine’s maximum and minimum capacities because changes in tablet size and shape result in differences in bulk density. Large-size tablets have a lower bulk density than small tablets of the same composition

  today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or process of forming or crystallizing into grains. Granules typically have a size range between 0.2 to 4.0 mm, depending on their subsequent use. Synonym “ Agglomeration “: Agglomeration processes or, in a more general term, particle size enlargement technologies are great tools to modify product properties. Agglomeration of powders is widely used to improve physical properties like wettability, flowability, bulk density, and product appearance. Pharmaceutical industry:  In the pharmaceutical industry, granulation refers to the act or process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules. It is the process of collecting particles together by creating bonds between them. Bonds are formed by compression or by using a binding agent. The granulation technique is extensively used in the manufac