API / Finished Dose Manufacturing Processes and Equipment


Finished Dose - Processes

Dosage Form Introduction

Lesson Code: PUF-301. Introduces the concept of dosage forms and the different dosage forms currently in use.

Solid Dosage

Lesson Code: PUF-302. Covers solid dose products manufactured by the Pharmaceutical Industry. It describes what ingredients are used and what manufacturing steps are required.

Semisolid Dosage

Lesson Code: PUF-303. Describes semisolid dose products manufactured by the Pharmaceutical Industry. It describes what ingredients are used and what manufacturing steps are required.

Liquid Dosage

Lesson Code: PUF-304. Introduces liquid dose products manufactured by the Pharmaceutical Industry. It describes what ingredients are used and what manufacturing steps are required.

Aerosol Inhalers

Lesson Code: PUF-305

Water Types & Testing

Lesson Code: PUA-550. The different grades of water required in an API plant and the tests that are used to determine the water’s purity.

Water Impurities & Treatment

Lesson Code: PUA-551. The most common types of contaminants found and the different treatment steps used to purify water before it can be used in a chemical process.

Process Flow Diagrams (PFDs)

Lesson Code: PUA-560. Symbols used to represent key process equipment, pipe-work and gauges and how to interpret basic PFDs.

Finished Dose - Equipment

Milling

Lesson Code: PEF-302. Introduction to milling. Different milling equipment and techniques are described along with equipment control parameters and safety precautions.

Blending

Lesson Code: PEF-303. Introduction to blending. Describes different blending equipment and techniques and outlines blending equipment control parameters and safety precautions.

Filtration for Finished Dose

Lesson Code: PEF-304. 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-305. Introduction to drying. The operation of a Tray Drier is described along with drying equipment control parameters and safety precautions.

Fluidized Beds

Lesson Code: PEF-306. The process of granulation and the function of a fluidized bed granulator. Also details the equipment’s operation, control parameters, and safety issues.

Tablet Press

Lesson Code: PEF-307. Introduction to the workings of a tablet press. It details control parameters, in-process checks and safety for this type of equipment.

Tablet Coater

Lesson Code: PEF-308. The theory of the coating process and the equipment needed. Critical process parameters are also included and explained.

Kettles

Lesson Code: PEF-309. The purpose and operation of kettles in finished dose pharmaceutical manufacturing, including control parameters and safety for operators of this type of equipment.

API Manufacturing - Processes

Chemical Reactions – Introduction

Lesson Code: PUA-500. Explains how to control a chemical reaction by monitoring the critical process variables.

Chemical Reactions – Properties

Lesson Code: PUA-501. The main physical and chemical properties needed to monitor and control a chemical reaction.

Distillation & Reflux

Lesson Code: PUA-510. The principles of distillation and reflux. The critical control parameters of each process are described and safety issues are highlighted.

Crystallization

Lesson Code: PUA-520. The principles of crystallization, why it is used in the API industry, and the key parameters that affect pharmaceutical crystal production.

Drying

Lesson Code: PUA-530. The importance of drying products in the API industry. The different types of drying equipment and the control parameters associated with each type of dryer.

Filtration

Lesson Code: PUA-540. The theory of filtration and the various types of equipment used. This lesson also includes the most important parameters that control the filtration process.

API Manufacturing - Equipment

Chemical Reactor Design

Lesson Code: PEA-700. How a chemical reactor works and the most important connections needed to carry out a chemical reaction.

Working with Reactors

Lesson Code: PEA-701. Explains the main tasks involved in operating a chemical reactor such as weighing, charging and taking samples.

Centrifuges

Lesson Code: PEA-710. The operating principles and parameters of Batch Filtering and Inverting Filter centrifuges are explained.

Reciprocating Pumps

Lesson Code: PEA-740. The operating principles of reciprocating pumps.

Rotary & Centrifugal Pumps

Lesson Code: PEA-741. The operating principles of rotary and centrifugal pumps.

Valves

Lesson Code: PEA-750. The different types of valves used in a pharmaceutical plant are explained.

Pharma Manufacturing Validation

Fundamentals of Process Validation

Lesson Code: PVF-830. Introduction to validation in regulated industries using case study of tablet manufacturing process. Includes validation masterplan, validation life cycle, specification, qualification and revalidation.