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9780853695738

Pharmaceutical Isolators

by ; ; ;
  • ISBN13:

    9780853695738

  • ISBN10:

    0853695733

  • Format: Paperback
  • Copyright: 2004-06-01
  • Publisher: Pharmaceutical Pr

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Supplemental Materials

What is included with this book?

Summary

Pharmaceutical Isolators is a new indispensable guide to the design, construction, commissioning, maintenance, use and monitoring of pharmaceutical isolators. The current validation protocols are explained and the book includes some useful technical appendices.

Table of Contents

Preface xv
Acknowledgement xviii
About the editors xix
Contributors xxii
How to use this guide xxiv
Abbreviations xxxi
Isolator applications
1(8)
Introduction
1(1)
Applications
1(4)
Non-pharmaceutical applications
2(1)
Pharmaceutical industry applications
3(2)
Hospital pharmacy applications
5(1)
Summary
5(4)
Design
9(28)
Scope
9(1)
Definitions and terminology
9(1)
Characterisation of a pharmaceutical isolator
9(2)
Design considerations
11(2)
Product protection
11(1)
Operator protection (containment)
11(1)
Operator protection (containment) and product protection
12(1)
Protection against process-generated contamination
12(1)
Radiopharmacy
12(1)
Construction
13(2)
General
13(1)
Main components
13(1)
Flexible film
14(1)
Stainless steel
14(1)
Coated mild steel
14(1)
Rigid plastics
14(1)
Windows in rigid isolators
15(1)
Pneumatic and other gas services
15(1)
Filtration
15(7)
General
15(1)
Filter manufacturers' standards
16(1)
Standards for the in situ leak testing of installed HEPA filters
17(1)
Specification of HEPA filters
18(1)
Incorporation of HEPA filters into isolator designs
19(2)
Carbon filters
21(1)
Pressure regimes
22(1)
Positive pressure isolators
22(1)
Negative pressure isolators
22(1)
Containment
22(1)
Pressure differentials
23(1)
Leakage and leaktightness
23(4)
Summary
23(1)
Leakage in positive pressure isolators
23(1)
Leakage in negative pressure isolators
24(1)
High pressure integrity/low hourly leak rate isolators
24(1)
Gloves, sleeves and half-suits
24(1)
Internal leakage
25(1)
Filter seals
25(1)
Clean air
25(1)
Induction leakage
25(2)
Edge effects
27(1)
Macro-leakage
27(1)
Measurement and detection of leaks
27(1)
Airflow (flow) regimes
27(2)
Turbulent airflow (non-unidirectional)
27(1)
Unidirectional airflow
28(1)
Zoned airflow
28(1)
Gassing
29(1)
Fan systems
29(2)
Controls, instrumentation, alarms and performance monitoring
31(1)
Controls
31(1)
Instrumentation
31(1)
Alarms
31(1)
Performance monitoring
32(1)
Ergonomics, lighting, noise, vibration and electrical safety
32(2)
Ergonomics
32(1)
Lighting
32(1)
Noise levels
33(1)
Vibration
33(1)
Electrical safety
33(1)
Design for decomtamination
34(1)
Design for validation
35(2)
Transfer devices
37(12)
Scope
37(1)
Function of different transfer devices
37(2)
Types of transfer device
39(10)
Type A1 transfer device
39(1)
Type A2 transfer device
40(1)
Type B1 transfer device
41(1)
Type B2 transfer device
41(1)
Type C1 transfer device
42(1)
Type C2 transfer devices
43(1)
Type D transfer devices
44(1)
Type E transfer devices
45(1)
Type F transfer devices
46(3)
Access devices
49(16)
Introduction
49(1)
Gloves
49(6)
General requirements
49(2)
Glove type
51(1)
Glove material
51(1)
Glove sizes
51(2)
Glove manufacture
53(1)
Variable thickness gloves
53(1)
Laminated and loaded gloves
53(1)
Glove properties
54(1)
CE marking and standards
55(1)
Sleeves
55(3)
General properties
55(1)
Accordion sleeves
56(1)
Cuff rings and glove changes
57(1)
Changing gloves
57(1)
Leak testing
58(1)
Shoulder rings
58(1)
Provision for gassing
58(1)
Gauntlets
58(1)
Half-suits
59(1)
Full suits
60(1)
Robotics
61(1)
Training and user maintainence
62(3)
Siting of isolators and clothing regimes
65(8)
Scope
65(1)
Construction
65(1)
Access
66(1)
Isolator room
66(1)
Support room
67(1)
Clothing
68(1)
Isolator exhaust
69(1)
Grade of environment
70(1)
Segregation
70(2)
Cytotoxics
70(1)
Radiopharmaceuticals
70(1)
Blood labelling
70(1)
Live vaccines
70(2)
CIVAS including antibiotics
72(1)
CIVAS/TPN
72(1)
Further information
72(1)
Cleaning, decontamination and disinfection
73(20)
Scope
73(1)
Cleaning
73(4)
General considerations
73(2)
Cleaning schedule or timing
75(1)
Cleaning methods
75(1)
Cleaning agents
76(1)
Disinfection
77(2)
General
77(1)
Disinfectants (liquid sanitising agents)
78(1)
General guidance
79(1)
Nebulisation or fogging
79(3)
Sporidical gassing processes or fumigation
82(5)
Formaldehyde
82(1)
Hydrogen peroxide vapour
83(2)
Peracetic acid vapour
85(1)
Chlorine dioxide gas
86(1)
Ozone gas
86(1)
Ultraviolet and white light
86(1)
Sterilisation
87(1)
Biological indicators (Bls)
87(1)
Chemical contamination
88(1)
Validation
89(3)
Cleaning validation
89(1)
Disinfection validation
89(1)
Gassing validation
90(2)
Training
92(1)
Safety
92(1)
Physical monitoring
93(8)
Scope
93(1)
Leak testing of installed HEPA filters
93(2)
Particle counts
95(1)
Airflow testing
95(1)
Flow visualisation and recovery testing
96(1)
Pressure testing
97(1)
Breach testing
98(1)
Recommendations for physical testing
98(3)
Leak testing
101(22)
Scope
101(1)
Introduction
101(1)
Leak detection methods
102(3)
Distributed leak test
102(1)
Soap solution
103(1)
Ammonia
103(1)
Helium
103(1)
DOP (dispersed oil particulates)
104(1)
Sonics
104(1)
Leak rate measurement methods
105(4)
Introduction
105(1)
Factors which affect leak rate measurement
105(2)
Oxygen method
107(1)
Pressure hold method
107(1)
Parjo test method
107(1)
Pressure decay method
108(1)
Discussion of pressure decay leak rate measurement
109(1)
Changes in atmospheric pressure
109(1)
Changes in internal temperature of the isolator
109(1)
Movement in flexible parts
109(1)
Guidelines for leak rate measurement by pressure decay
110(3)
Test method for isolators where a maximum leak rate of 1.0% per hour is specified
110(1)
Test method for isolators where a maximum leak rate of 0.25% or 0.05% per hour is specified
111(2)
Expression of pressure decay and pressure hold leak rate results
113(5)
Hourly leak rate
113(2)
Percentage volume change per hour
115(1)
Standard decay time
115(1)
Volumetric leak rate
116(1)
Single hole equivalent (SHE)
117(1)
Summary of expressions
118(1)
Determination of acceptable leak rates
118(1)
Tests for gloves, sleeves and half-suits
119(2)
Gloves
119(1)
Sleeves
120(1)
Half-suits
121(1)
Leak testing schedule
121(2)
Microbiological monitoring
123(12)
Scope
123(1)
General
123(5)
Media
123(1)
Fertility challenge, sterility and records
124(1)
Sampling
124(1)
Culture incubation and recording
125(2)
Reporting
127(1)
Recommended test protocols
128(3)
Active air sampling
128(1)
Settle plates
128(1)
Surface sampling of isolator surfaces
129(1)
Finger dabs
130(1)
Process validation
130(1)
Microbiological validation of the operator
131(1)
Hand washing facilities
131(1)
Hand washing
132(1)
Sterility testing
132(1)
Suggested target levels
133(1)
Transfer devices
133(1)
Recommended microbiological sampling frequencies
134(1)
Validation
135(18)
Scope
135(1)
Overview
135(1)
Documentation
136(1)
Document types
136(1)
Document structure
136(1)
Change control
137(1)
Summary of validation stages
137(3)
User requirement specification (URS)
137(1)
Validation master plan (VMP)
138(1)
Validation plan (VP)
138(1)
Functional design specification (FDS)
138(1)
Design qualification (DQ)
138(1)
Factory acceptance testing (FAT)
138(1)
Type qualification testing (TQT)
139(1)
Factory qualification testing (FQT)
139(1)
Installation qualification (IQ)
139(1)
Site acceptance testing (SAT)
139(1)
Operation qualification (OQ)
139(1)
Performance qualification (PQ)
140(1)
Commissioning and validation
140(1)
Requalification testing
140(1)
User requirement specification (URS)
140(2)
URS bespoke isolators
140(1)
URS standard isolators
141(1)
URS content
141(1)
Validation master plan
142(2)
VMP structure and content
143(1)
Design qualification (DQ)
144(1)
Installation qualification (IQ)
145(1)
Operational qualification (OQ)
146(2)
Performance qualification (PQ)
148(1)
GAMP -- Good automated manufacturing practice
149(1)
Summary
150(3)
Standards and guidelines
153(22)
Introduction
153(1)
Designation and terminology
153(2)
Clean air and isolator standards
155(1)
Filter standards
155(1)
Biotechnology standards
156(1)
Other relevant standards
156(1)
GMP guidelines
156(3)
EC GMP 2002 and Orange Guide 2002
156(2)
Quality Assurance of Aseptic Preparation Services 2000
158(1)
A Code of Practice for Tissue Banks providing tissues of human origin for therapeutic purposes DoH 2001
158(1)
GAMP Guide for Validation of Automated Systems
158(1)
PIC/S Recommendation PI 014-1 24 June 2002: Isolators used for aseptic processing and sterility testing
158(1)
PDA Technical Report No. 34: Design and validation of isolator systems for the manufacturing and testing of health care products
159(1)
FDA Sterile drug products produced by aseptic processing (Draft)
159(1)
Biotechnology and safety guidelines: ACDP (Advisory Committee on Dangerous Pathogens) documents
159(1)
Categorisation of biological agents according to hazard and categories of containment (Fourth edition, 1995)
159(1)
Second supplement to: Categorisation of biological agents according to hazard and categories of containment (Fourth edition, 1995)
159(1)
The management, design and operation of microbiological containment laboratories
160(1)
Biological agents -- managing the risks
160(1)
Working with hazard group 4 agents
160(1)
COSSH
160(15)
EH40 Occupational exposure limits 2002
161(14)
Definition of terms
175(14)
Scope
175(1)
Definitions
175(14)
A1 `Handling cytotoxic drugs in isolators in NHS pharmacies.' HSE/MCA January 2003
189(14)
Introduction
189(2)
Routes of operator exposure
191(3)
Factors involved in employee exposure or product contamination
192(1)
Factors specific to employee exposure
193(1)
Factors specific to product contamination
194(1)
Combining risk to operator with risk to product
194(2)
Negative and positive pressure: Decision table
196(7)
References
201(1)
Further information
202(1)
A2 Training
203(6)
Introduction
203(1)
Performance objectives
203(3)
Principles of basic theory, design, and siting of isolators
203(1)
Procedures for the operation of isolators
204(1)
Procedures for materials transfer -- non-gassed isolators
204(1)
Procedures for loading and sanitisation of gassed isolators
204(1)
Procedures for aseptic processing
204(1)
Procedures for integrity testing
204(1)
Procedures for routine glove changing
205(1)
Procedures for decontamination
205(1)
Environmental monitoring
205(1)
Safety
206(1)
Documentation and change control
206(1)
Structure and assessment
206(1)
Under-pinning knowledge
206(1)
Performance
206(1)
Assessment
206(1)
Ongoing treatment and assessment
206(1)
Records
207(1)
Other training
207(1)
Practical note
207(2)
References
208(1)
A3 Stainless steel for isolators
209(6)
Steel alloys
209(1)
Corrosion resistance of stainless steel
210(1)
Stainless steel finishing
211(1)
Finishing methods
211(1)
Prefinished
211(1)
Hand finish and emery belt finish
211(1)
Electropolishing
211(1)
Terminology
212(1)
Grit size
212(1)
Roughness average (Ra)
212(1)
Application to pharmaceutical isolators
212(3)
Very high corrosion resistant alloys
212(1)
Cleaning
213(1)
Suggested reading
213(2)
A4 HEPA filtration mechanisms, MPPS and typical particle sizes
215(4)
Introduction
215(1)
Mechanisms
215(1)
Straining
215(1)
Impaction
216(1)
Interception
216(1)
Diffusion
216(1)
MPPS (most penetrating particle size)
216(2)
Typical particle sizes
217(1)
Common particle sizes
217(1)
Viruses
218(1)
A5 Calculations to estimate the size of a leak that can be detected using DOP
219(4)
Scope
219(1)
Calculation
219(2)
Conclusion
221(2)
A6 Activated carbon filters
223(6)
Introduction
223(1)
Use
223(1)
Manufacture
224(1)
Characteristics of carbon filters
225(4)
Surface area and pore size
225(1)
Filtration technology
226(1)
Physical adsorption
226(1)
Chemisorption
226(1)
Adsorptive efficiency
226(3)
A7 Useful tables
229(6)
Index 235

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