Pharmaceutical Water Treatment System

OUR TALENT INSTRUCTORS:

DR/ AHMED FOUAD

- ABOUT Dr/ Ahmed :

CEO Of Civar Technology.
Head Manager Of Water Treatment In SIGMATEC Pharma.
25 Years Of Experience In The Water Treatment Field Consultant.
Trainer Of Water Treatment In Several Countries In The Middle East And Africa.

- Expert In :

Installation Of Water Units And Solving Water Stations Problems According To CGMP Standards.
Comprehensive Solutions Covering Design, Qualification And Validation For RO, WFI, And Other Systems.
GMP Consulting By tailored Guidance To Ensure Adherence To International Standards And Regulatory Compliance.

PROGRAM OVERVIEW:

This Training Program Provides A Comprehensive Understanding Of Pharmaceutical Water Treatment Systems, Which Are Critical Utilities In Pharmaceutical Manufacturing Facilities. The Program Covers The Principles Of Water Purification Technologies, System Design, GMP Requirements, And Validation Practices Used To Produce Pharmaceuticalgrade Water Such As Purified Water (PW) And Water For Injection (WFI). Participants Will Gain Practical Knowledge On Water Treatment Technologies, System Components, Design Considerations, And Operational Requirements, Ensuring Compliance With GMP And International Regulatory Standards.

TARGET AUDIENCE?

• This training is designed for:

Pharmaceutical utility engineers.

Process engineers.

Maintenance engineers.

Quality assurance and quality control staff.

Validation engineers.

Professionals involved in pharmaceutical facility design and operation.

PROGRAM OBJECTIVES:

1- UNDERSTAND DIFFERENT WATER RESOURCES AND PHARMACEUTICAL WATER DEFINITIONS.
2- IDENTIFY AND EXPLAIN VARIOUS WATER TREATMENT TECHNOLOGIES USED IN PHARMACEUTICAL PLANTS.
3- UNDERSTAND GMP REQUIREMENTS AND GOOD ENGINEERING PRACTICES (GEP) RELATED TO PHARMACEUTICAL WATER SYSTEMS.
4- RECOGNIZE THE DESIGN APPROACH OF WATER TREATMENT SYSTEMS, INCLUDING PRETREATMENT AND FINAL TREATMENT STAGES.
5- UNDERSTAND STORAGE AND DISTRIBUTION SYSTEMS USED IN PHARMACEUTICAL WATER LOOPS.
6- LEARN THE METHODS OF SANITIZATION AND STERILIZATION OF WATER SYSTEMS.
7- UNDERSTAND THE BASICS OF PICKLING, PASSIVATION, AND WELDING REQUIREMENTS FOR HYGIENIC PIPING SYSTEMS.
8- GAIN KNOWLEDGE ABOUT SYSTEM QUALIFICATION AND VALIDATION PROCEDURES.

OUTLINE TOPICS :

1. TYPES OF PHARMACEUTICAL WATER PURIFIED WATER (PW) WATER FOR INJECTION (WFI).
2. WATER SYSTEM COMPONENTS PRE-TREATMENT RO / EDI STORAGE TANKS DISTRIBUTION LOOPS.
3. GMP REQUIREMENTS MICROBIAL CONTROL BIOFILM PREVENTION.
4. VALIDATION & QUALIFICATION IQ / OQ / PQ SAMPLING PLANS.
5. TROUBLESHOOTING CONTAMINATION CASES SYSTEM FAILURES.

TRAINING METHODOLOGY:

• The training will include:

1- TECHNICAL PRESENTATIONS.
2- REAL INDUSTRIAL EXAMPLES.
3- ENGINEERING SYSTEM DIAGRAMS.
4- CASE STUDY DISCUSSIONS.
5- VIDEO DEMONSTRATIONS OF SYSTEM OPERATION AND MAINTENANCE.
6- INTERACTIVE DISCUSSIONS AND Q&A SESSIONS.

TRAINING MODULES:

SEC 1- WATER RESOURCES AND DEFINITIONS.

1- Sources of water used in pharmaceutical industries.

2- Types of pharmaceutical water.

3- Regulatory definitions (USP, EP, WHO).

SEC 2- GENERAL METHODS OF WATER TREATMENT.

Overview Of Common Water Purification Technologies:

1- MF, NF, CNF, UF.

2- Ion Exchange.

3- RO, EDI, Distillation Systems.

SEC 3- DESIGN PRINCIPLES FOR WATER TREATMENT.

1- GMP Fundamentals For Utility Systems.

2- Pharma Water Applications In Manufacturing.

3- Quality Monitoring And Testing.

4- Good Engineering Practices (GEP).

SEC 4- WATER SYSTEM DESIGN APPROACH.

1- Pretreatment & Final treatment (RO+EDI).

2- WFI generation.

3- Pharmaceutical clean steam.

4- Storage tanks and distribution loops.

SEC 5- SYSTEM SANITIZATION AND STERILIZATION.

1- Thermal & Chemical Sanitization.

2- Ozone Systems.

3- Preventing Biofilm Formation.

SEC 6- MECHANICAL INSTALLATION REQUIREMENTS.

1- Pickling And Passivation.

2- Hygienic Piping Systems.

3- Orbital Welding.

4- Surface Finish Requirements.

SEC 7- QUALIFICATION AND VALIDATION.

1- DQ, IQ, OQ, PQ.

2- Practical Discussions: Problem-Solving & Case Studies.

3- Video Instructions For System Operation.

EXPECTED OUTCOMES:

PARTICIPANTS WILL GAIN A PRACTICAL UNDERSTANDING OF PHARMACEUTICAL WATER TREATMENT SYSTEM DESIGN, OPERATION, MAINTENANCE, AND VALIDATION, ENABLING THEM TO SUPPORT GMP COMPLIANCE, SYSTEM RELIABILITY, AND PRODUCT QUALITY IN PHARMACEUTICAL MANUFACTURING ENVIRONMENTS.

TRAINING DELIVERABLES:

PARTICIPANTS WILL RECEIVE:

TRAINING PRESENTATION MATERIALS (PDF).
ENGINEERING DIAGRAMS OF WATER SYSTEMS.
REFERENCE GUIDELINES FOR PHARMACEUTICAL UTILITIES.
CASE STUDY EXAMPLES.

TRAINING CERTIFICATION:

PARTICIPANTS WILL RECEIVE A CERTIFICATE OF COMPLETION AFTER ATTENDING THE TRAINING PROGRAM.

TOTAL DURATION:

2 Days

Speak to a training specialist

PHARMACEUTICAL Water Treatment System.

MODULE 2