e05 weikmann automated visual inspection (1)

8/12/2019 E05 Weikmann Automated Visual Inspection (1)

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ISPE Tampa Conference

22-25 February 2010

Tampa, Florida USA

1

Automated Visual Inspection of

Pre-filled Syringes

Wolfgang Weikmann

Vetter Pharma-Fertigung GmbH & Co. KG

24-25 February 2010, Tampa

Content1. Manual Visual Inspection (MVI)

Basic requirements

.

overview

3. Qualification Approach

1. PQ: Pre-tests / Considerations

2. PQ 1: Knapp test (Test kit)

2

.4. Operational Approach

5. Conclusion


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1. MVI Basic requirements

Enclosed dedicated room Incandescent Lamp

(light intensity: 2000-3750 LUX)

Black & white background

Reject bin / Eject bin for measurements

Defect evaluation list (SOP)

Temperature monitoring of room

One product per room at a given time!

Inspection speed

3

uncontrolled units, rejects and good pieces!

Scheduled Eye Breaks

2. AVI - Machine Overview

Glass Barrel Remover(De-Trayer)

Inspection MachineGlass Barrel Inserter

(Re-Trayer)

4

Ejection o f syringes

Good PiecesProduct for inspection


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2. AVI Machine Overview

Unit 2 (TV 2a/3a & 2b/3b)

Glass BarrelUnder- and Overfilling

Empty syringe

Dirt/Abrasion

Unit 3 (TV 4/5)

Closure PartMissing closure part

Bent Needle Shield

Fit of closure part/Total

Unit 4 (TV 6/7)

StopperForeign particles

Solution in rib

Dirt/abrasion

Unit 5 (TV 8/9)

& 7 (TV 12/13)

SolutionForeign particles

amage ev a on

Scratches/Cracks zone 1

Airline over total length

Closure PartDirt/Abrasion

Damage/ deviation

Broken bridge

Pierced Needle Shield

Stopper position

Upside-down (180)

Crooked stopper

Double stopper

Unit 6 (TV 10/11)

SolutionGlass splinters

Unit 11 (HV)

INFEEDOUTFEED

0

12

5

Unit 1 (TV 1)

Glass BarrelDamaged finger rest

Broken

StopperMissing stopper

Unit 9 (CA) and 10 (OD)

SolutionDiscoloration, Turbidity

Unit 8 (TV 14/15)

Glass BarrelScratches/Cracks zone 2

SolutionLeaking system

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2. AVI Machine overview

Eject 0

Glass Barrel

Damaged finger rest

Eject 1

Solution

Discoloration, Turbidity

Eject 3

Solution

Glass splinter

Eject 2

Solution

Foreign particle

INFEEDOUTFEED

0

12

Broken

Stopper

Missing stopper

n er- an over ng

Empty syringe

Leaked system

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

Stopper

Foreign particle

Solution in rib

Dirt/ abrasion

Damage/ deviation

Stopper position

Crooked stopper

Double Stopper

6

34

Broken bridge

Pierced Needle Shield

Missing closure part

Bent Needle Shield

Fit of the closure part/Total

length

Other defects

Wrong primary packaging

component

Eject 4After a machine failure or

power break down, all

remaining syringes in the

machine are ejected here.


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3. Qualification / Validation Approach

Design Qualification (DQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

PQ 1: Knapp test with Test kit

P 2: Kna test with 3 commercial lots

7

in this presentation, focus on PQ

3.1 PQ: Pre-tests / Considerations

Definition of Spinning speed

Definition of Ins ection area / windows

Air bubbles

Evaluation of different turbidity levels

Evaluation of different colors of the

roduct solution

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Detection level of foreign matter

depending on different filling levels


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Light intensity Regular checks

Definition of the max. holding time

Measures to be taken in case of

decrease of light intensity special

maintenance / definition of acceptance

criteria

9

Handling of exchange of lighting

Burn-in time of LED spare parts to reachacceptable stability


Heat-up of syringes during machine

stop Definition of max. break time

without removal of syringes

Definition of Defect categories(Assignment of minor, Major and Critical

Creation of Batch Report)

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Strategy for Manual Classification

(Re-inspection) of Ejects


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Handling / Risk assessment in case ofglass breakage at different locations

within the machine

Implementation of effective Line Cleaning

and Line Clearance

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3.2 PQ 1: Knapp test (Test kit) Creation of a product specific Test

kit (Rejects + Good pieces) 500 pieces in total comprising approx. 160

Rejects

Rejects selected from routine batches as

far as possible

O tional: Usa e of standardized articles

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for better reproducibility in case of

replacement due to destruction


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3.2 PQ 1: Knapp test (Test kit)

Performance of the Knapp test MVI: 20 Visual Inspectors inspect each the

test kit (500 pieces) / routine inspection

conditions

AVI: Test kit (approx. 160 Rejects) are run

21 times in the production mode of the

AVI machineAim: simulation of real

13

production conditions as listed in the

following:

3.2 PQ 1: Knapp test (Test kit) AVI Efficiency Test

1. Reject Rate (RR) Rejects

1. Aim: Test of each Inspection unit per defect

(10 runs per defect)

2. AC: for each of the single defect categories:

RR AVI RR MVI

2. False Reject Rate (FRR) Good pieces

14

. good pieces

2. AC: tbd. for each inspection unit


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3.2 PQ 1: Knapp test (Test kit)

AVI Laboratory Test Run1. Reject Rate Rejects

1. Testing each single Inspection unit

1. Aim: Test of each Inspection unit with

all related defects (10 runs per defect)

2. AC: RR AVI RR MVI

15

.

1. Aim: Test of all Inspection units with all

defects (1 run with all defects)

2. AC: RR AVI RR MVI

3.2 PQ 1: Knapp test (Test kit)3. False Reject Rate Good pieces

1. Aim: Test of all Inspection units with 2000

2. AC: tbd. for the whole machine

AVI Performance Run (Good pieces; atleast Placebo)

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of detection within 3 technical runs of the

same lot (10.000 syringes recommended)

AC: tbd. dependent on Process Capability


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3.3 PQ 2: Knapp test (3 batches)

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Evaluation

M2.1 + M3.1 = RR AVIM3.1 + M4.1 = RR MVI

Comparison

RR MVI vs. RR AVI

3.3 PQ 2: Knapp test (3 batches)

Acceptance criteria:

Different a roaches are ossible e. .:

#1: RR AVI RR MVI for all defect categories,

not dependent on criticality of the defect

#2: Split into minor, Major and Critical:

Number of defects with (RR AVI RR MVI) (RR

AVI < RR MVI) per Criticality Class

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4. Operational Approach

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4. Operational Approach2. Manual Visual

Classification

Rejects

3. AQL(Good Pieces of Eject 0-4)

- a ues accor ng o

Lot size = Sum of syringes of Ejects 0-4

Sampling randomized of the Good Pieces

(FRR) from Ejects 0-4:

n = 125 (Lot size less than 3.200)

Eject 1

Eject 2

Good Pieces (FRR)

Rejects

Good Pieces (FRR)

Rejects

Good Pieces (FRR)

Rejects

Critical, Major, minor

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n = o s ze e ween . an .

n = 315 (Lot size between 10.001 and 35.000)Eject 3

Eject 4 Good Pieces (FRR)

Good Pieces (FRR)

Rejects

Good Pieces (FRR)


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4. Operational Approach

E ect 0Rejects

2. Manual VisualClassification

4. Batch Evaluation3. AQL(Good Pieces ofEjects 0-4)

Eject 1

Eject 2

Good Pieces (FRR)

Rejects

Good Pieces (FRR)

Rejects

Good Pieces (FRR)

Evaluation according to AVI

Evaluation matrix

Critical: X limit Batch Release

X > limit Deviation/Measures

Major: X limit Batch Release


minor: X limit Batch Release


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Eject 3

Eject 4

Good Pieces (FRR)

Rejects

Good Pieces (FRR)

Rejects (total)

5. Conclusion

Main topics to be considered upfront:

Product characteristics

Evaluation strategy / Assignment ofdefects to Eject bins

Creation of the Test kit

Acceptable False Reject Rate

Re-Classification of Ejects

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Performance of lighting Preventive maintenance

Re-Qualification concept


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Thank You!

Wolfgang Weikmann

Director Pharmaceutical Production / En ineerin

Vetter Pharma-Fertigung GmbH & Co. KGSchuetzenstrasse 87

D - 88212 Ravensburg, Germany+49-(0)751-3700-2401

[email protected]

e05 weikmann automated visual inspection (1)

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