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
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... 11 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... 9 2 Contents
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... 11 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... 11 Error Monitoring... 12 Final Product Sterility Testing... 13 Defect Reporting... 13 Complaints... 13 Questions... 15 Contents 3
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... 10 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... 10 Questions... 12 4 Contents
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... 10 Contents 5
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... 10 Chapter 14: Waste Disposal... 1 Methods of Waste Disposal... 2 Paper Waste... 2 Sharps... 2 Product waste... 2 General Clean Room Waste... 3 Questions... 4 6 Contents
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... 12 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... 10 Contents 7
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... 12 Risks to Product Quality When Compounding... 13 Risks to Product... 14 Risks to Patients... 15 Risks to Operators... 16 Questions... 17 Activities... 18 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... 10 Parenteral Nutrition Automated Compounder Device... 16 Risks to Product Quality During Compounding... 17 Risks for Patients From Parenteral Nutrition Administration... 19 Risks to Operators... 20 Questions... 21 8 Contents
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... 10 Labelling and Packaging... 11 Transportation and Distribution... 12 Cytotoxic Spillage... 12 Example Methods for the Preparation of Cytotoxic Products... 15 Risks to Products... 24 Risks to Patients... 25 Risks to Operators... 27 Questions... 30 Contents 9
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... 10 Important Reading... 11 Intrathecal Methotrexate Syringes... 12 Risks... 13 Risks to Patients... 13 Risk to Products... 14 Risks to Operators... 15 Questions... 17 Chapter 21: CIVAS Calculations Practice Prescriptions... 1 Prescription 1... 1 Prescription 2... 2 Prescription 3... 3 Prescription 4... 4 Prescription 5... 5 Prescription 6... 6 Prescription 7... 7 Prescription 8... 8 Prescription 9... 9 Prescription 10... 10 Prescription 11... 11 10 Contents
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... 11 Contents 11
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