API / Finished Dose Manufacturing Processes and Equipment

Finished Dose - Processes

Solid Dosage

Lesson Code: PUF-1202. This e-Lesson is aimed at personnel who require an overview of solid dosage forms, their advantages and disadvantages, the ingredients they typically contain, and the steps involved in their manufacture.

 

Semisolid Dosage

Lesson Code: PUF-1203. This e-Lesson is aimed at personnel who require an overview of semisolid dosage forms manufactured by the pharmaceutical industry, including their advantages and disadvantages, ingredients used in their manufacture, and the manufacturing steps involved.

 

Water Types & Testing

Lesson Code: PUA-1250. This e-Lesson is targeted towards personnel who require an understanding of the different grades of water typically used in a pharmaceutical manufacturing facility and the tests used to determine water purity.

 

Water Impurities & Treatment

Lesson Code: PUA-1251. This e-Lesson is aimed at personnel who require an understanding of the most common types of contaminants in water and the different treatment processes that can be used to purify water before it is used in a pharmaceutical manufacturing process.

 

Process Flow Diagrams (PFDs)

Lesson Code: PUA-1260. Symbols used to represent key process equipment, pipe-work and gauges and how to interpret basic PFDs.

 

Dosage Form Introduction

Lesson Code: PUF-1201. This e-Lesson is aimed at personnel who require an overview of pharmaceutical dosage forms. The most common dosage forms are described including solids, liquids, semisolids, aerosol inhalers, and transdermal patches, along with the mode of entry of each form into the body.

 

Liquid Dosage

Lesson Code: PUF-1204. This e-Lesson is aimed at personnel who require an overview of liquid dosage forms including liquid doses and suspensions. The advantages and disadvantages of liquid dosage forms are outlined followed by a description of the ingredients and methods typically used in the production of liquid doses and suspensions.

 

Aerosol Inhalers

Lesson Code: PUF-1205 This e-Lesson is aimed at personnel who require an overview of aerosol inhalers, including their purpose, ingredients, advantages and disadvantages, typical components, and mode of operation.

 

Finished Dose - Equipment

Milling

Lesson Code: PEF-1202. This Lesson provides an overview of milling operations, including different types of milling equipment and techniques, equipment control parameters, and safety precautions.

 

Blending

Lesson Code: PEF-1203 Blending. This Lesson is aimed at personnel who require an overview of blending operations, including different types of blending equipment, equipment control parameters, and safety precautions.

 

Filtration for Finished Dose

Lesson Code: PEF-1204. The principle of filtration. Describes the operation of a Plate and Frame Filter Press and outlines equipment control parameters and safety precautions.

 

Dryers

Lesson Code: PEF-1205. Introduction to drying. The operation of a Tray Drier is described along with drying equipment control parameters and safety precautions.

 

Tablet Press

Lesson Code: PEF-1207. This Lesson provides an overview of how a tablet press functions, key process control parameters, required in-process checks, and associated safety considerations.

 

Tablet Coater

Lesson Code: PEF-1208. This e-Lesson is aimed at personnel who require an introduction to tablet coaters and their use in the process of tablet coating in the pharmaceutical industry. It describes the purpose of coating, the equipment and process steps involved, critical control parameters, and required safety precautions.

 

Fluidized Beds

Lesson Code: PEF-1206. This e-Lesson is aimed at personnel who require an introduction to fluidized bed granulators and their use in the process of granulation in the pharmaceutical industry. It describes the granulation process, operation of the fluidized bed equipment, relevant control parameters, and required safety precautions.

 

Kettles

Lesson Code: PEF-1209. This e-Lesson is aimed at personnel who require an overview of kettles and their use in the manufacture of semisolid pharmaceutical products. It includes the critical parameters required for controlling a mixing process and the safety precautions that must be taken when working with kettles.

 

API Manufacturing - Processes

Chemical Reactions – Overview

Lesson Code: PUA-1200. This e-Lesson is aimed at operations personnel in API manufacturing and provides an overview of how chemical reactions are carried out and the various process variables that must be controlled.

 

Chemical Reactions – Properties

Lesson Code: PUA-1201. This e-Lesson is aimed at operations personnel in API manufacturing and explains the main physical and chemical properties used to monitor and control a chemical reaction.

 

Distillation & Reflux

Lesson Code: PUA-1210. This e-Lesson is aimed at employees involved in API manufacturing who require an introduction to the principles of distillation and reflux, the critical parameters associated with each process, and the relevant safety precautions that must be taken..

 

Crystallization

Lesson Code: PUA-1220. This e-Lesson is aimed at employees involved in API manufacturing who require an introduction to the principles of crystallization, the stages and process variables involved in a crystallization process, and the actions that can be taken to resolve some typical process issues.

 

Drying

Lesson Code: PUA-1230. This e-Lesson is aimed at operations personnel in API manufacturing and it explains the importance of drying products in the API industry, different types of drying equipment, and the control parameters involved in a drying process.

 

Filtration

Lesson Code: PUA-1240. This e-Lesson is aimed at operations personnel in API manufacturing and provides an overview of the theory of filtration, the types of equipment used, and the key process parameters.

 

API Manufacturing - Equipment

Chemical Reactor Design

Lesson Code: PEA-1200. This e-Lesson is aimed at API manufacturing personnel who are involved in the operation of Chemical Reactors.

 

Working with Reactors

Lesson Code: PEA-1201. Explains the main tasks involved in operating a chemical reactor such as weighing, charging and taking samples.

 

Centrifuges

Lesson Code: PEA-1210. This e-Lesson is aimed at operations personnel in API manufacturing and provides an overview of the theory of centrifugation and the operating principles and parameters of Batch Filtering and Inverting Filter Centrifuges.

 

Reciprocating Pumps

Lesson Code: PEA-1240. This e-Lesson is aimed at personnel who require an overview of reciprocating pumps, their mode of operation, and how they can be used in chemical and pharmaceutical processing.

 

Rotary & Centrifugal Pumps

Lesson Code: PEA-1241. This e-Lesson is aimed at personnel who require an overview of rotary and centrifugal pumps, their modes of operation, and how they can be used in pharmaceutical processing.

 

Valves

Lesson Code: PEA-1250. The different types of valves used in a pharmaceutical plant are explained.

 

Pharma Manufacturing Validation

Fundamentals of Process Validation

Lesson Code: PVF-1130. Introduction to validation in regulated industries using case study of tablet manufacturing process. Includes validation masterplan, validation life cycle, specification, qualification and revalidation.