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Content
1. Manual Visual Inspection (MVI)
Basic requirements
2 Automated Visual Inspection (AVI) Machine
2.
overview
3. Qualification Approach
1. PQ: Pre-tests / Considerations
2. PQ 1: Knapp test (Test kit)
3 PQ 2: Knapp test (3 batches)
3.
4. Operational Approach
5. Conclusion
2
Inspection Machine
Good Pieces
Glass Barrel
Closure Part
Stopper
Foreign particles
Solution in rib
Dirt/abrasion
Damage/deviation
Stopper position
Upside-down (180)
Crooked stopper
Double stopper
Closure Part
Dirt/Abrasion
Damage/ deviation
Broken bridge
Pierced Needle Shield
Foreign particles
OUTFEED
INFEED
Solution
Glass splinters
1
2
Unit 11 (HV)
3
4
Solution
Unit 1 (TV 1)
Leaking system
Glass Barrel
Damaged finger rest
Broken
Glass Barrel
Solution
Stopper
Scratches/Cracks zone 2
Discoloration, Turbidity
Missing stopper
Eject 1
Eject 2
Eject 3
Glass Barrel
Damaged finger rest
B k
Broken
Solution
Discoloration, Turbidity
Solution
Foreign particle
Solution
Glass splinter
Under and overfilling
UnderEmpty syringe
Leaked system
Stopper
Foreign particle
Solution in rib
Dirt/ abrasion
Damage/ deviation
Stopper position
Crooked stopper
Double Stopper
Stopper
Missing stopper
OUTFEED
INFEED
1
2
3
4
Eject 4
After a machine failure or
power break down, all
remaining syringes in the
machine are ejected here.
Stopper
Upside-down (180)
Glass Barrel
Dirt/Abrasion
Damage/Deviation
Scratches/Cracks area 1
Scratches/Cracks area 2
Airline over total length
Closure Part
Dirt/Abrasion
Damage/Deviation
Broken bridge
Pierced Needle Shield
Missing closure part
Bent Needle Shield
Fit of the closure part/Total
length
Other defects
Wrong primary packaging
component
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
(DQ)
(IQ)
(OQ)
(PQ)
11
12
13
14
Evaluation
M2.1 + M3.1 = RR AVI
M3.1 + M4.1 = RR MVI
Comparison
RR MVI vs. RR AVI
17
18
4. Operational Approach
19
4. Operational Approach
2. Manual Visual
Classification
Eject 0
3. AQL
(Good Pieces of Eject 0-4)
Rejects
AQL V l
AQL-Values
according
di to
t MVI (ISO 2859)
Eject 1
Eject 2
Rejects
Eject 3
Eject 4
Rejects
j
n = 200 (L
(Lott size
i b
between
t
3
3.201
201 and
d 10
10.000)
000)
Rejects
20
10
4. Operational Approach
2. Manual Visual
Classification
Eject
j
0
Eject 1
Eject 2
Eject 3
Eject 4
3. AQL
4. Batch Evaluation
(Good Pieces of
Ejects 0-4)
Rejects
Good Pieces (FRR)
Rejects
Good Pieces (FRR)
Rejects
minor:
Major:
Critical:
Rejects
Good Pieces (FRR)
Rejects
Rejects (total)
21
5. Conclusion
Main topics to be considered upfront:
Product characteristics
Evaluation strategy / Assignment of
defects to Eject bins
Creation of the Test kit
Acceptable False Reject Rate
Re-Classification of Ejects
Performance of lighting
Preventive maintenance
Re-Qualification concept
22
11
Thank You!
Wolfgang Weikmann
Director Pharmaceutical Production / Engineering
g
g
Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87
D - 88212 Ravensburg, Germany
+49-(0)751-3700-2401
Wolfgang.Weikmann@vetter-pharma.com
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