This course aims to provide participants with a foundational understanding of the types of water used in biopharmaceutical manufacturing, including the methods of purification and the applications of water and steam in the industry.
Aims and Objectives
The programme will cover key aspects of water systems, including:
- Definition and specifications of different water types
- The regulatory standards governing water quality
- The processes used in the removal and identification of water impurities
- The principles of water system design, with a focus on the Water for Injection (WFI) generation, storage and distribution.
Course Content
Definition and specification of the different grades of water used in pharmaceutical manufacturing operations.
Regulatory standards governing water quality in pharma manufacturing.
Types of impurities and contaminants, and contaminant removal process.
Water system design and design principles.
Different types of WFI generation processes, multiple effects, vapor compression and reverse osmosis.
Learning Outcomes
On completion of this programme the learner should be able to:
- Understand the importance of water in biopharmaceutical manufacturing and the regulatory expectations for water quality (USP, EP, FDA) governing the use and standards of water.
- Differentiate the grades of pharmaceutical water and the specifications / limits for each grade.
- Explain the fundamentals of water system component and system design principles including material selection, compatibility, design considerations for preventing microbial contamination, risk assessment and mitigation strategies.
- Identify the different methods for generating WFI including the features and benefits of the following methods - MultipleEffect Distillation (MED), Vapor Compression Distillation (VC), Reverse Osmosis (RO) and Distillation
- Identify key sources of microbial contamination and describe monitoring and testing methods,
- Explain Biofilm prevention / control, and cleaning, sanitization and contaminant removal processes.
- Describe the approaches for WFI generation, storage, and distribution, including cold systems and hot systems.
