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1 contents Aseptic Processing Table of Contents Chapter 1: Introduction... 1 About the Training... 1 Importance of the Training... 2 About the Training Manual... 2 About the Interactive Program... 2 About Central Intravenous Additive Services CIVAS... 3 About Parenteral Nutrition PN... 3 About Cytotoxics CYTOS... 4 About Intrathecals... 4 Aseptic Process Flow Summary... 5 Chapter 2: Good Manufacturing Practice... 1 Definition of Quality... 1 Guidelines Summary... 2 Questions... 5 Chapter 3: Basic Microbiology... 1 What are Micro-organisms?... 1 Types of Micro-organism... 2 Sources of Contamination... 4 Controlling Micro-organisms... 6 Questions... 7 Chapter 4: Legislation and Standards... 1 Key References... 1 Licensed Units... 2 Unlicensed Units... 2 Audits... 3 Standard Operating Procedures (SOPs)... 4 Other General Legislation & Standards... 4 Questions... 8 Contents 1
2 Aseptic Processing Chapter 5: Clean Room Design... 1 Introduction... 2 What is a Clean Room?... 2 Clean Room Design... 2 Other Aspects of Design of the Clean Room... 4 Environmental Control... 7 Examples of Cleanroom Grade... 7 Alarm Systems... 8 Malfunctioning and Problems... 8 Air pressure... 8 Clean Room Suite Layout... 9 Questions Chapter 6: Work Zones... 1 What is a Work Zone?... 1 Laminar Air Flow Cabinets (LAFC)... 1 Isolators... 2 Isolator Air Flow and Pressure... 3 Isolator Transfer Hatches... 4 Isolator Gloves... 4 Changing of Isolator Gloves... 5 Contamination... 6 Working within LAFC or Isolators... 6 Questions Contents
3 contents Chapter 7: Personal Hygiene... 1 Human Contamination... 2 Skin... 2 Hands... 2 Hand Washing Technique... 2 Personnel Testing... 4 General Hygiene... 6 Clean Room Clothing... 6 Gloves... 9 Dropped Items... 9 Questions Chapter 8: Quality Systems for Operators... 1 Operator Technique... 2 Operator Validation Transfer Tests (Universal Broth Transfer Test)... 2 Process Validation (Media Fills)... 3 How Often Do We Monitor and Test Operators?... 3 Documentation... 4 SOPs (Standard Operating Procedures)... 5 Worksheets... 6 Labels... 6 In-Process Checks... 9 Post Assembly Checks... 9 Aseptics Services CCTV Checking System Error Monitoring Final Product Sterility Testing Defect Reporting Complaints Questions Contents 3
4 Aseptic Processing Chapter 9: Cleaning... 1 Definitions... 1 Why Do We Need Clean Rooms?... 2 Training... 2 Cleaning Schedule Premises... 2 Cleaning Agents... 4 Disinfection... 5 Cleaning Laminar Flow Cabinets and Isolators... 6 Equipment... 8 Monitoring... 8 Questions Chapter 10: Environmental Monitoring... 1 Why Do We Need to Monitor The Environment?... 1 What Is Environmental Monitoring?... 2 Types of Environmental Testing:... 2 What Methods and Equipment Do We Use to Test The Environment?... 4 Microbiological Testing... 4 Physical Testing... 6 Validation Tests... 8 Control of Air Flow: Cleanroom Monitoring... 9 Control of Airflow: Workstation Monitoring... 9 Environmental Monitoring Systems Questions Contents
5 contents Chapter 11: Assembly... 1 Assembly... 2 Appearance... 2 Components... 3 Visual Inspection... 3 Drug Name and Strength... 3 Diluent and Quantity... 4 Component Sizes, Gauges and Quantities... 4 Expiry Dates... 4 Labelling... 4 Worksheets... 6 Questions... 7 Chapter 12: Transfer Procedures... 1 The Transfer Process... 1 Sanitisation... 2 Spray and Wipe... 3 Gas Sanitisation... 4 Transferring Components... 4 Summary of the Transfer Process... 6 Transfer to Critical Zone... 6 Transfer Out of Critical Zone... 7 Workflow... 8 Activity... 9 Questions Contents 5
6 Aseptic Processing Chapter 13: Aseptic Technique... 1 What Can Go Wrong... 1 Contamination... 1 Equipment... 2 Filters... 4 Glass ampoules... 4 Infusion Bags and Bottles... 5 The No Touch Technique... 6 Other techniques... 6 Closed procedures... 8 Activity... 9 Questions Chapter 14: Waste Disposal... 1 Methods of Waste Disposal... 2 Paper Waste... 2 Sharps... 2 Product waste... 2 General Clean Room Waste... 3 Questions Contents
7 contents Chapter 15: Reconciliation, Inspection and Checks... 1 Safe Checking Systems... 2 Worksheet Validation... 3 Assembly and Production Checks... 3 In-process Checks... 4 Reconciliation Checks... 5 Visual Inspection of products... 5 Labelling... 6 Worksheets... 8 Product Release... 8 Expiry and storage... 9 Questions Chapter 16: Completing Product Processing... 1 What Do These Temperature Ranges Mean?... 2 The Cold Chain... 2 Shelf Life... 2 Stability... 2 Correct Refrigeration... 3 Effect of Light... 4 Transportation... 5 Correct Labelling... 5 Packaging... 6 Questions Contents 7
8 Aseptic Processing Chapter 17: Preparation of Centralised Intravenous Additives (CIVA)... 1 What Does CIVAS Mean?... 2 Why Do We Have A CIVA Service?... 2 The National Patient Safety Agency (NPSA) and Injectable Medicines... 2 Purpose of Aseptic Dispensing Services (CIVAS)... 3 How Do We Prepare CIVA Products... 3 Types of CIVA Products... 4 How to Prepare CIVA Products... 5 Risks Associated With The Preparation of CIVA Products Risks to Product Quality When Compounding Risks to Product Risks to Patients Risks to Operators Questions Activities Chapter 18: Preparation of Parenteral Nutrition... 1 By the end of the chapter you will be able to:... 1 Parenteral Nutrition and Why Is It Used... 1 Identifying The Patients Nutritional Requirements... 2 Administration of Parenteral Nutrition... 2 Ingredients used in Parenteral Nutrition... 2 Preparation of Parenteral Nutrition and Mixing Protocols... 4 Adult Parenteral Nutrition Bags... 4 Paediatric Parenteral Nutrition Bag Parenteral Nutrition Automated Compounder Device Risks to Product Quality During Compounding Risks for Patients From Parenteral Nutrition Administration Risks to Operators Questions Contents
9 contents Chapter 19: Preparation of Cytotoxics... 1 What Are Cytotoxics?... 2 Indications for Cytotoxics... 2 How are Cytotoxics Administered?... 3 How Do We Prepare Cytotoxics for Patients?... 3 Key Facts When Handling and Working With Cytotoxics... 4 Safe Handling Techniques for Aseptic Preparation of Cytotoxics... 8 Prevention and Control of Exposure to Cytotoxics... 9 Equipment Labelling and Packaging Transportation and Distribution Cytotoxic Spillage Example Methods for the Preparation of Cytotoxic Products Risks to Products Risks to Patients Risks to Operators Questions Contents 9
10 Aseptic Processing Chapter 20: Intrathecal Preparations... 1 What is an Intrathecal Injection and Why Is It So Special?... 2 What Are Intrathecal Chemotherapy Drugs?... 2 Indications for Intrathecal Preparations... 2 How Are Intrathecal Preparations Administered?... 2 How Do We Prepare Intrathecal Preparations?... 2 The Intrathecal Register... 3 Key Facts when Handling and Working with Intrathecal Cytotoxic Preparations...3 Prevention of Errors During Production... 5 Prevention of Errors Checklist Important Reading Intrathecal Methotrexate Syringes Risks Risks to Patients Risk to Products Risks to Operators Questions Chapter 21: CIVAS Calculations Practice Prescriptions... 1 Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Contents
11 contents Aseptic Processing Assessments... 1 Introduction...1 Candidate Evidence Record...1 Good Manufacturing Practice Questions...2 Primary Assembly Questions...11 Clean Room Questions...13 Operational Queries Questions...18 Candidate Evidence Record...25 Candidate Test (Secondary Level)...26 Competencies Aseptic Training...1 NVQ Level 2 Mapping Document... 2 NVQ Level 3 Mapping Document... 4 NHS KSF Dimensions-Aseptic Processing... 6 Appendix... 1 Appendix 1: Glossary of Terms... 1 Appendix 2: References... 9 Acknowledgements Contents 11
12 Aseptic Processing 12 Contents
Aseptic Processing Assessments
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