Qualification of water treatment systems for pharmaceutical use

Qualification of water treatment systems for pharmaceutical use

Details

  • Start date: 24 November 2022
  • Start time: 09:30 (Kyiv)
  • Finish date: 25 November 2022
  • Finish time: 16:30 (Kyiv)
  • Duration: 2 days 5.5 hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    BASIC (1 participant) - 350 Euro

    GROUP (2-5 participants) - 670 Euro

    COMPANY (6-10 participants) - 1260 Euro

     

    For all participants:

    - Participation in the webinar

    - Nominal electronic certificate of the participant

    - Presentation and video recording

     

    Breaks:

    11:00 - 11:15

    12:45 - 13:45

    15:15 - 15:30

     

    Day 1

    Selection and design of systems for the preparation, storage and distribution of water for pharmaceutical use and clean steam

    1. Design philosophy

    • Requirements for water and steam

    • Basic principles

    • Water quality specifications

    • Critical process parameters

    • WPU Life Cycle

    • Project management

    • User Requirements Specification, Functional Specification, Detailed Specification

    2. Overview of the elements of the treatment system for purified water, water for injection and pure steam

    • Water treatment methods

    • Pretreatment of water

    • Final preparation PW, HPW

    • Production of purified water

    • Production of highly purified water

    • Production of water for injection

    • Clean steam production

    3. Design of water storage and distribution systems. Pure steam distribution

    • General provisions

    • Materials in contact with WPU systems, clean steam

    • Elements of the storage and distribution system

    • Clean steam distribution

    • System design concept

    4. Devices and control systems

    • Scope of use in systems

    • Basic principles

    • Choice of fixtures

    • Calibration

    • Control systems

    5. Practice

     

    Day 2

    Acceptance and qualification of systems for the preparation, storage and distribution of water for pharmaceutical use and clean steam

    1. Launch and acceptance of the system

    2. System qualification

    • GMP qualification requirements

    • Project Qualification (DQ)

    • Installation qualification (IQ)

    • Operational Qualification (OQ)

    • Performance Qualification (PQ)

    3. Management of microbial contamination of systems for the production, distribution and storage of purified water and water for injection. Validation

    • General requirements

    • Management of microbial contamination

    • Development and implementation of validation tests

    4. Monitoring and maintenance

    5. Review of systems

    6. System Inspection

    7. Practice