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Parenteral Products - 1st Edition - ISBN: 9780433126409, 9781483141756

Parenteral Products

1st Edition

The Preparation and Quality Control of Products for Injection

Author: M. J. Groves
eBook ISBN: 9781483141756
Imprint: Butterworth-Heinemann
Published Date: 1st January 1969
Page Count: 324
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Parenteral Products: The Preparation and Quality Control of Products for Injection deals with modern pharmaceutical practice in the preparation, quality control, and storage of injectable drug solutions. The book gives a basic background of parenteral solutions, the routes of administration, the effects of the different administrations of injection solutions, and the formulation of these products.
The text discusses the theories of filtration, the different methods used, such as screen filters, depth filters, and the possible choices of filtration to capture any preselected unwanted particle size. Developments on sterilization of the product are given attention, citing techniques and equipment. The working and preparation conditions are discussed, since the sterile intravenous solutions, whether in large or small quantities, are done in quite the same procedures, with the similar equipment, and same organization. Equally important in the discussion are the monitoring and control of contamination by particulates through the application of standards known as the Coulter principle and the light-blockage method. The pharmaceutical problems encountered during the administration of large volume drip solutions are analyzed.
This book is helpful for pharmacists, pharmaceutical students and professors, and those working in the pharmaceutical industry and hospital/health sector.

Table of Contents


Chapter 1 Perspective on the Use of Parenteral Solutions


Routes of Administration

The Effect of Route on the Duration of Drug Activity

The Origins of the Intravenous Therapy

The Development of Hypodermic Medication

The Sterilization of Injection Solutions

The United States Pharmacopoeial Clarity Test


Chapter 2 The Formulation of Parenteral Products


The Tonicity of Injection Solutions

The Choice of Solvent

Oily Solvents

Colloidal Dispersions

The Formulation of Parenteral Emulsions

Amino Acids and Other Parenteral Nutrients

The 'Browning' Reaction of D-Glucose on Autoclaving


Chapters 3 Filtration


Classification of Filtration Operations

Theories of Filtration

The Relative Advantages and Disadvantages of Screen and Depth Filters


The Criteria of an Ideal Filter

The Choice of Filtration Media

Discussion: The Choice of A Filtration System For Parenteral Products


Chapter 4 Sterilization


The Meaning of Sterilization

Methods of Sterilization

The Kinetics of Microbial Death

Factors Affecting the Survival of Micro-Organisms

The Control of Sterilization Processes

The Steam Autoclave

Continuous Autoclaves


Chapter 5 The Working Environment


The Manufacturing Process

Codes of Good Manufacturing Practice

Clean Water

Clean Containers

Clean Air

Laminar Flow Cabinets

Clean Rooms


Chapter 6 The Monitoring and Control of Particulate Contamination



The Particle Size of Particulate Contamination

Visual Methods of Inspection

Projection Methods for the Inspection of Ampoules

Machine Methods Used for the Inspection of Ampoules Made on the Large Scale

Automatic or Semi-Automatic Inspection Methods for The Inspection of Ampoules Made on A Large Scale

Filtration Methods and the Identification of Contamination

Electrical Sensing Zone Methods of Analysis

Turbidimeters and Nephelometers

Other Instruments Using Light Scattering Principles of Detection

Detection of Particles by the Light-Blockage Principle

Detection of Particulate Contamination By Means of A Screen Filtration Pressure Method



Appendix 1 Publications Using Electrical Zone Sensing Methods To Determine Parenteral Fluid Contamination

Chapter 7 The Size Distribution of Particulate Contamination and Standards of Cleanliness


The Size Distribution of Powders and Powdered Materials

The Experimental Evidence for The Size Distribution of Contamination In Parenteral Solutions

The Ephemeral Nature of Particulate Contamination

Suggested Standards of Cleanliness

Applications of Standards and the Log-Log Size Distribution

Progress Towards An Objective Standard of Cleanliness

Discussion: The Problems of Applying Standards for Cleanliness


Chapter 8 The Nature, Origin and Hazards of Particulate Contamination


Nature and Origin of Particulate Contamination

The Size and Number of Contaminating Particles

The Hazard Due To Injected Particulate Contamination



Chapter 9 Pharmaceutical Problems Associated With the Administration of Large Volume Parenteral Fluids

Introduction: The Setting-Up of a Large Volume Drip Solution

Pharmaceutical Incompatibilities of Drugs Added To Intravenous Solutions

The Loss of Therapeutic Effectiveness of Drugs During Administration

Microbiological Hazards Associated With Intravenous Fluid Therapy

The Inspection of Containers and Giving Sets Prior To Administration

The Use of Terminal Filters

The Effectiveness of Terminal Filters

Discussion: The Implications of Pharmaceutical Incompatibilities For The Hospital Pharmaceutical Service




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© Butterworth-Heinemann 1973
1st January 1969
eBook ISBN:

About the Author

M. J. Groves

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