Manufacturing

Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing

Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing

The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB 1 to OEB 5-6 degree…

High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing

High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing

Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be considered by an institution to…

Coating Process in Pharmaceutical Industry

Coating Process in Pharmaceutical Industry

Although both sugar coating and film coating are utilized by a significant number of pharmaceutical companies worldwide, the film-coating process is the one most often preferred today. Film coating was formally introduced into the pharmaceutical industry in the middle of the last century. It should be noted that there has been a steady transition in…

Frequently Asked Questions and Answers on cGMP

Frequently Asked Questions and Answers on cGMP

Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment. But no similar requirement exists for retaining what are intended to be quick reference or temporary…

Compression Process in Tablet Manufacturing

Compression Process in Tablet Manufacturing

Compression or compaction is the pharmaceutical unit operation of applying pressure or force to the powder to densify it and generate the physical bonds between the powder particles. The critical parameters of this operation are (1) the material properties of the particles being compacted and (2) the equipment used for the compaction. The basic mechanical…

Blending Process in Pharmaceutical industry

Blending Process in Pharmaceutical industry

Blending or Mixing are the reorientation of particles relative to one another in order to achieve uniformity. Types of Blending Operating Principles of Blending Diffusion Blending (Tumble) Particles are reoriented in relation to one another when they are placed in random motion and inter particular friction is reduced as the result of bed expansion (usually…

Milling Process in Pharmaceutical Industry

Milling Process in Pharmaceutical Industry

Milling is a mechanical process of breaking particles into smaller pieces via one or more particle size reduction mechanisms. Types of Milling Milling Operation Principles Milling Equipment Classifications 1. Fluid Energy Mills Fluid energy mill subclasses have no moving parts and primarily are distinguished from one another by the configuration and/or shape of their chambers,…

Granulation Process in Pharmaceutical Tablet Manufacturing

Granulation Process in Pharmaceutical Tablet Manufacturing

Granulation is the process of creating granules. The powder morphology is modified through the use of either a liquid that causes particles to bind through capillary forces or dry compaction forces. Importance of Granulation in Pharmaceutical Industry The granulation process will result in one or more of the following powder properties: Types of Granulation in…

GMP in Pharmaceutical Industry

GMP in Pharmaceutical Industry

GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control testing procedures. GMP compliance is…