QUALIFICATION: Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended. All manufacturing equipment, laboratory instrument and supporting utilities shall be considered for qualification. After successful completion of qualification exercise, the Equipment / instrument / Utilities … Read more
The premises used for warehousing, manufacturing, processing, storage, packaging labeling and testing purposes shall be; WAREHOUSING AREA: PRODUCTION AREA: ANCILLARY AREAS: QUALITY CONTROL AREA: REFERENCE: 1. Schedule M 2. 21 CFR art 210 & 211 3. WHO Technical Report Series 908
UNDERSTANDING COATING: Coating can be defined as a physical deposition of a layer on Tablet surface for the purpose of masking the Taste, odour, appearance, physical / chemical protection or to control the drug release. Coating process is the application of coating composition to a moving bed of Tablets in a coating pan by concurrent … Read more
TABLET COMPRESSION: Reducing the bulk volume of a powder by applying mechanical force so as to form a defined shape of desired weight and strength is called ‘Compression’. Tablet compression is the process of squeezing powders together and driving out the air between the particles, resulting in a compressed Tablet. WHY COMPRESSION? TABLET PRESS OR … Read more
BLENDING PROCESS: Blending of solid particles refers to mixing of solids with the aim of attaining a uniform composition throughout the mix. In powder blending two or more dissimilar particulate solids are blended to give a random mix. Objective of blending is to form a homogeneous final product from two or more dissimilar raw materials. … Read more
MILLING PROCESS: Milling process is also called as ‘screening’ and ‘sizing’ process. Milling is employed between RMG and Blending to crush the larger particles from granulation into uniform small particles which meets the process requirement. Milling isperformed to remove lumps, improve flow, reduce segregation and to control the particle size. Milling is performed by using … Read more
Granulation is required to improve the flow of powder mixtures and mechanical properties of Tablet. Granulation is 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 … Read more
Sifting is a screening process to exclude foreign matter / particles (if any) and particles beyond the required size. Sifting is carried out by allowing particles to pass through specified mesh under the influence of vibration and gyration. The mesh (sieve) size is specified as the number of pores on 1 inch. Example 100 mesh … Read more
Unit Operations: The manufacture of Tablets is a complex multi-stage process under which the starting materials change their physical characteristics a number of times before the final dosage form is produced. Numerous unit operations are involved in making Tablets including sifting, mixing, granulation, drying, sizing, blending, lubrication, compression and coating. DISPENSING OF RAW MATERIALS (API … Read more
Formulation of Capsules includes active ingredient and excipients (Fillers, Disintegrant and Glidant / Lubricant). Particle size distribution (PSD) and bulk density (BD/TD) of API/Excipients is important parameter in the selection of capsule size. Determination of appropriate capsule size for formulation: Blend with BD 0.4 g/cc and fill weight 200 mg to filled D= M/V 0.4 … Read more
