PDA-TR49-生物清洁验证-中英文翻译
Page 1 of 95
Points to Consider
for
Biotechnology
Cleaning
V
alidation
Technical Report No.
49
ISBN: 978-0-939459-30-8
©
2010 Parenteral Drug Association,
Inc.
All rights
reserved.
Page 2 of 95
Table of Contents
1.0
I
NTR
odu
CTI
o
N
..................................................3
1.1
Purpose/Scope
...............................................
3
2.0
Gl
ossa
R
y
oF
Te
R
ms
........................................5
3.0
CleaNING PRoCess
desIGN
aNd
deVeloPmeNT
..........................................6
3.1
Introduction ....................................................
6
3.2
Cleaning Process Controls
(Inputs)
and Measurements (Outputs)
.........................
6
3.2.1
Cleaning Cycle Design ........................
6
3.2.2
Physical-Chemical Aspects ................
7
3.3
Measurements Used to
Determine
Cleaning
Effectiveness....................................
8
3.4
Equipment and Plant
Design Considerations
....................................
8
3.4.1
Piping..................................................
8
3.4.2
Automated vs. Manual Systems.........
9
3.4.3
Centralized CIP vs.
Discrete
Cleaning of Isolated Equipment...........
9
3.4.4
Clean Out of Place (COP)
....................
9
3.5
Soil Evaluation and
Categorization
..................
9
3.5.1
Soil Categories....................................
9
3.5.2
Soil
R
emoval
.....................................
10
3.5.3
Cleaning
Comparability
Based on Soil and
Surface
................
11
3.5.4
Soil Selection
for
Laboratory Evaluations .....................
12
3.6
Performing Cleaning
Development Experiments
............................
12
3.6.1
Parameter Selection..........................
13
3.6.2
Parameter Interactions......................
13
3.7
Cleaning Process Scale-Up
...........................
13
3.7.1
Setting Process Controls...................
14
3.7.2
Introduction of New
Soils
to a Validated Cleaning System ........
14
3.8
Applying the “Design
Space”
Concept to Cleaning Processes ....................
15
4.
0
aCC
e
PT
a
NC
e
lI
m
IT
s
.......................................17
4.1
Key Issues in Limits for
Actives
....................
17
4.1.1
Establishing Limits for Actives
in
Formulation and Final Fill
..................
18
4.1.2
Establishing Limits
for
Actives in Bulk Manufacture.............
18
4.1.3
Limits Based on Toxicity Data...........
19
4.2
Limits for Cleaning
Agents............................
20
4.2.1
Limits for Commodity
Chemicals
......
20
4.2.2
Limits for
Formulated
Cleaning
Agents................................
20
Page 3 of 95
4.3
Bioburden Limits...........................................
21
4.4
Endotoxin
Limits
...........................................
21
4.5
Visual Clean
Criterion....................................
21
4.6
Modifying
Limits
...........................................
22
5.0
s
am
P
l
ING
m
e
T
hods
......................................23
5.1
Sampling Method Selection..........................
23
5.1.1
Direct Sampling Methods .................
23
5.1.2
Rinse
Sampling
.................................
23
5.1.3
Swab Sampling.................................
24
5.1.4
Comparison of
Swab
and Rinse
Sampling
..........................
25
5.2
Placebo
Sampling
.........................................
26
5.3
Sampling for
Microbial
and Endotoxin Analysis.................................
26
5.4
Sampling Recovery Studies
..........................
26
5.4.1
General
Considerations
.....................
26
5.4.2
Swab Recovery.................................
27
5.4.3
Rinse Recovery ................................
27
5.4.4
“R
ecovery
”
in Visual Inspection........
28
5.4.5
Recovery for
Bioburden
and Endotoxin Sampling ...................
28
5.5
Training and Qualification of Samplers
..........
29
5.5.1
Key Issues for
T
raining
for Swab Sampling ...........................
29
5.5.2
Key Issues for
T
raining
for Rinse Sampling............................
30
5.5.3
Training for Visual Inspection
............
30
6.0 aN
al
y
TIC
al
m
e
T
hods
...................................31
6.1
Specific Analytical Methods
.........................
31
6.2
Impact of
Inactivation/Degradation
of the
Active
.................................................
31
6.3
Nonspecific Analytical Methods
...................
32
6.3.1
Total Organic Carbon (TOC)...............
32
6.3.2
Total
P
rotein
......................................
33
6.3.3
Conductivity......................................
33
6.3.4
Visual Inspection...............................
34
6.4
Microbial Test
Methods
................................
35
6.4.1
Endotoxin..........................................
35
6.4.2
Bioburden .........................................
35
6.5
Analytical Method Validation ........................
35
6.5.1
General
P
rinciples
.............................
36
6.5.2
Compendia
Methods.........................
37
6.5.3
Visual Inspection...............................
37
6.5.4
Bioburden Methods ..........................
37
6.5.5
Use of a Contract Laboratory
............
37
7.0
CleaNING
V
al
Id
a
TI
o
N
PRoToCols
..............39
7.1
Cleaning Verification Protocols......................
39
摘要：
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Page1of95PointstoConsiderforBiotechnologyCleaningValidationTechnicalReportNo.49ISBN:978-0-939459-30-8©2010ParenteralDrugAssociation,Inc.Allrightsreserved.Page2of95TableofContents1.0INTRoduCTIoN..................................................31.1Purpose/Scope...........................................
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