pharmweb291.html38"3`B@ւqOqUp (y.@3qTEXTMSWD@īyVPManchester Pharmacy - PEAT Modules
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PEAT Modules


PHARMACEUTICAL ENGINEERING ADVANCED TRAINING PROGRAMME

SUMMARY OF MODULE CONTENTS

The descriptions of modules are indicative of contents and structure and may change from time to time to reflect current concerns and technical developments.

The PEAT Programme is intended for engineers and scientists working in the pharmaceutical industry. It addresses the seven key tasks performed by pharmaceutical engineers:

1. Design and select processes and equipment.

2. Design buildings and services for manufacturing plants, laboratories and warehouses.

3. Construct facilities and install equipment.

4. Commission and validate buildings, equipment and processes.

5. Operate manufacturing facilities.

6. Maintain buildings, services and equipment.

7. Improve manufacturing operations.

The programme is based on 12 modules presented as distance learning texts which include teaching material, exercises and references. Each module will require approximately 60 hours of study time.

MODULE 1 SAFETY HEALTH AND ENVIRONMENT

Law, Health at Work

General Safety Management, Human Factors

Hazard and Risk, Environmental Protection

Systems, Auditing and Reviewing Performance

Working Environment

MODULE 2 INTRODUCTION TO PHARMACEUTICAL TECHNOLOGY AND MICROBIOLOGY

Overview of Pharmaceutical Industry, Product and Process Development Procedures

International Regulatory Affairs Overview, Bulk Drug Isolation and Purification

Biotechnology Process Development, Dosage Form Selection

Sterilisation and Disinfection, Sterility Testing and Monitoring

Lyophilisation, Packaging

Dosage Forms Tablets, Capsules, Inhalations, Liquids and Semi-solids, Controlled Release

Micro-organisms - Types, Sources, Spoilage, Preservation

Parenterals - Aseptic Manufacture, Terminal Sterilisation, Inspection

MODULE 3 QUALITY ASSURANCE AND REGULATORY ISSUES

Principles and Concepts, QA, QC and GMP

Personnel and Training, Documentation

Premises and Equipment, Plant Services

Validation / Qualification, Calibration, Statistical Process Control

Quality of design ISO 9000, Total Quality Management

Comparative Regulatory Aspects - EU and FDA

MODULE 4 BUILDINGS - FOUNDATIONS TO FINISHES

End Users, Project Team, Suppliers, Project Initiation

Design Co-ordination, The Internal Environment

Building Superstructure and Fabric, Mechanical Services Integration

Electrical Service Provision, Process Equipment

Warehousing and Materials Handling, Fire Engineering

Refurbishment Projects, External and Internal Facility Finishes

Facilities Management, Design for Maintenance

MODULE 5 : ENVIRONMENTAL SYSTEMS - HVAC. EFFLUENT AND CONTAINMENT

Introduction to Environmental Systems, The Built Environment

Fan Engineering and Air System Components, Air Conditioning Processes and Psychrometics

Filtration and Air Diffusion, Clean Rooms and Ventilation System Design

Controls and Monitoring Systems, Commissioning of Ventilation Systems

Environmental Monitoring, Containment Technology

Waste Treatment, Lighting and the Visual Environment

Noise and the Acoustic Environment, Dust and Fume Control

MODULE 6 SERVICES AND UTILITIES

Introduction / Relationship of Services, Water

Purified Water, Water for Injection

Softened Water, Sanitary Water

Cooling Water, Chilled Water

Clean Steam, Plant Steam / Condensate

Compressed Air, Process Gases

Vacuum

MODULE 7 LIQUIDS PARENTERALS STERILISATION

Review of Product Types, Service and Equipment Selection Criteria

Filtration - Air and Liquids, Air Zones

CIP and SIP, Sterilization

Filling of SVP's and LVP's, Blow-Fill-Seal

Inspection and Leak Testing, Freeze Drying

Pumps and Tanks, Bulk Liquids Semi-solids and Suspensions

Layout / Design Criteria, Isolator Technology

Design Studies

MODULE 8 SOLID ORAL DOSAGE FORMS

Powder Technology, Manufacturing Technology

Dispensing, Granulation

Drying, Milling, Lubricating, Blending

Tabletting, Coating

Spheronisation, Capsules

Regulatory Review, Layout / Design Criteria

Design Study

MODULE 9 PACKAGING - DESIGN, OPERATIONS AND EQUIPMENT

Functions of Packages, Role of Engineers

Formulation Types and Packages, Bulk Drugs and Intermediates Packaging

Packing Line - Front End Operations, Tablet and Capsule Filling

Liquid and Parenteral Product Filling, Creams Filling

Blister Packaging, Strip Packaging and Form-Fill-Seal Labelling

Cartoning, Variable Data

Inspection, Secondary Packaging and Palletisation

Project Management, Installation, Commissioning and Validation

Maintenance and Technical Support

MODULE 10 MANUFACTURING OPERATIONS

Manufacturing Strategy, Capital Investment Decisions

Organisation of Technical Functions, Capacity Planning

Control of the Manufacturing Process, Purchasing and Supply

Improvement Strategies -JIT,SPC,TQM,OPT, CIM., MRP II

Functional Analysis, Value Engineering

Maintenance of Facilities, Management of Change

Management of the Engineering Function

MODULE 11 PROCESS CONTROL, AUTOMATION AND DATA MANAGEMENT

Production Control Systems, Project Planning and Control

Definition of Requirements, Design Philosophies and Methodologies

Computer System Selection, Design Verification

Commissioning Strategies, Acceptance Criteria

Site Automation, Packaging and Warehouse Systems

Sterile Production Facilities, Pilot Plants

Laboratory Information Systems, Waste Management Systems

CIM Regulatory Concerns

MODULE 12 PLANT, PROCESS AND COMPUTER SYSTEMS VALIDATION

Introduction to Validation, Validation Master Plans

IQ and Associated Documents, GMP Reviews of Design

Critical Instruments and Validation, OQ and Commissioning Documentation

Validation Work on Products -Bulk, Solids and Sterile SOP's and Training

Cleaning Validation, Sterilizer Validation

Computer Systems Validation, Links to SOP's / Batch Records

Change Control Systems, Retrospective Validation

Regulatory Aspects - EU and FDA, Pre-approval Inspections

Analytical Method Validation, Organising for Validation


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PharmWeb - Copyright©1994-1998. All rights reserved 2ramme is based on 12 modules prepharmweb291.htmlltmltsirect)-syTEXTMSWDpyV@nd references. Each module will require approximately 60 hours of study time.

MODULE 1 SAFETY HEALTH AND ENVIRON   @ O5   @ O   @ O)  2\Q2styl ۔