STDQ D E F E C T E V A L U A T I O N L I S T

Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official

1 of 6

1. AQL CLASSES

Non conformities should be classified using a quality risk management approach.

The following list provides the rationale for each classification of nonconformance:
1. Critical (C): Non conformities that are likely to result in personal injury or potential hazard to the
patient. This classification is assigned to any non conformities that compromise the integrity of
container.
2. Major A (MA): Non conformities leading to serious container impairments, for example, a
malfunction making the packaging unusable.
3. Major B (MB): Non conformities leading to impairments of a lesser degree, for example, reduced
efficiency in production.
4. Minor (N): Non conformities that do not impact product quality or process capability.

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Page 1 / 6

Form 447/ 00

STDQ D E F E C T E V A L U A T I O N L I S T
Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official
2.

2 of 6

DEFECT LIST AND AQL (ref. to ISO 2859-1)

a. General

Class

Code

Defect

Area

Size / Characteristics

AQL

ppm
(where available)

082

Glass color not

conforming

n.a.

Not conforming to
specification

n.a.

098

Container/ packaging
mix-up

n.a.

n.a.

n.a.

b. Attributes

Class

Code

Defect

013

Loose Glass (trapped)

788

Contamination,
Biological

004

Area

AQL

> Collar diameter

0,4

Container

n.a.

0,1

Chip

Sealing
surface

lead to leakage

0,4

003
037

Crack, penetrating the

wall (overall); ringoff;
lensing

Overall/
Bottom

any size

0,25

011

Contamination, not
removable (internal)

Internal
surface

> 0,5 mm

0,25

013

Glass particle, not

removable, internal
(Washing test)

Internal
surface

0,3 to 0,5 mm

0,25

016

Glass thread, not

removable (internal)

Internal
surface

> 0,3 mm

0,4

049

Deformation

Collar

lead to leakage,
Reference samples

0,4

598

Air bubble, open

Collar

> 0,5 mm

0,4

183

Pressure mark, vertical

Neckshoulder
junction

> 1/2 neck height OR >

3/4 neck circumference
long

0,4

279

Open airline (internal)

Body

> 0,1 width mm

0,4

013

Glass particle, not

Internal

> 0,5 mm

0,4

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Container

Size / Characteristics

Page 2 / 6

Form 447/ 00

STDQ D E F E C T E V A L U A T I O N L I S T
Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official

removable, internal
(Washing test)

3 of 6

surface

045

Missing siliconization (if

requested)

Overall

> 30% of inner surface

missing; Reference
sample

0,1

020

Notches

Sealing
surface

> 50 % of radial surface

0,4

MA

773

Chip

Body

> 0,5 mm

0,4

MA

033

Dark spot, not

removable (internal)

Internal
surface

> 0,5 mm

0,4

MA

035

Inclusions (Knots,
stones)

Body

0,5 to 1,0 mm

0,4

MB

013

Glass particle,
removable, internal
(Washing test).

Internal
surface

> 0,5 mm

MB

030

Outer body diameter out

of tolerance

Body

OOS

0,4

MB

020

Notches

Sealing
surface

25 to 50 % of radial
surface

0,65

MB

103
085

Bump check, not

penetrating the wall; fire
check

Overall

> 0,7 or sum >1,0 mm

0,65

MB

347

Chip, external

Collar

25 to 50% of collar height

OR 2mm on the
circumference

0,65

MB

058

Folds, internal

Collar /
neck

Clearly visible without

turning, function impaired

MB

371

Wavy bottom

Bottom

Rocking vials (Reference

sample/picture)

0,65

MB

017

Contamination,
removable (internal,
washing test)

Internal
surface

> 0,5 mm

1,5

MB

024

Contamination,
removable (washing
test)

Sealing
Surface

> 1 mm

1,5

MB

052

Air bubble, closed

Collar

> 1 mm

0,65

MB

040

Base perpendicularity
out of tolerance

Bottom

> 2 degrees

MB

058

Folds, internal

Collar /
neck

Function not impaired

1,5

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Page 3 / 6

Form 447/ 00

STDQ D E F E C T E V A L U A T I O N L I S T
Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official

4 of 6

MB

460

Grooves and notches;

rough surface; rings,
toolmarks

Bottom

Reference samples

1,5

MB

118
251

Bull eye

Bottom

Reference samples

MB

107

Ridge

Sealing
Surface

Reference sample

MB

073

Lap (not leading to

leakage)

Finish

Reference sample

1,5

MB

349

Unfilled (not leading to

leakage)

Collar

Reference sample

1,5

018

Contamination, not
removable (external,
washing test)

Container

> 1 mm

1,5

087

Notch, external

Sealing
surface

Reference samples

1,5

400

Folds, external

Shoulder

Function not impaired,

Reference sample

1,5

053

Closed airline

Body

width > 0,1 mm

1,5

449

Scratches

Sealing
surface

lead not to leakage,

Reference sample

1,5

022
366

Shoulder malformation;
twisted neck

Shoulder/
neck

Reference sample

1,5

024

Contamination,
removable (external,
washing test)

Container

> 1 mm

6,5

176

Scratch, glass to glass;

scuff

Body

Thickness >0.2 mm OR
lenght >20 mm

6,5

300

Pressure marks,
horizontal

Neck

1/2 circumpherence long

2,5

188

Pressure mark, vertical

Neck

1/2 neck height OR 1/4 to

3/4 neck circumference
long

2,5

124
125

Frost on neck/collar;
Orange peel

Neck/ collar

Reference sample

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Page 4 / 6

Form 447/ 00

STDQ D E F E C T E V A L U A T I O N L I S T
Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official

5 of 6

c. Printing

Class

Code

Defect

Area

Size / Characteristics
Text not
understandable
(missing)

AQL

019

Missing printing

n.a.

0.065

180

Printing width out of

tolerance

n.a.

OOS

0,1

MB

078

Not adherent printing

(scotch tape test)

n.a.

Not adherent

0,4

092

Dirty/stained printing

n.a.

Not readable

060

Non -allineated printing

n.a.

N/A (still readable)

1
6,5

d. Variables

Class
MB

Code
010

Defect

Area
Stress

Size / Characteristics

AQL

Overall

25 nm

0,4

Finish/
thread/
neck

OOS

0,4

MB

External finish or thread

outside diameter out of
026-048specification; neck
315
external diameter over
maximum tolerance.

MB

027-193

Finish height out of

tolerance

Finish

OOS

0,4

MB

047

External thread base

out of tolerance

Thread

OOS

0,4

MB

256

Thread base height out

of tolerance

Thread

OOS

0,4

MB

038

Bottom thickness below

lower specification limit

Bottom

OOS

MB

006-452

Neck height, total height

out of tolerance

Neck

OOS

MB

005

Inner collar diameter

Collar

OOS

MB

293-029322-021

Neck out of axis

(circular run-out);
Eccentricity; Neck offset

Neck

OOS

0,4

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Page 5 / 6

Form 447/ 00

STDQ D E F E C T E V A L U A T I O N L I S T
Description:

Document code:

Edition:

STDQ Clear glass Vials

DEL_SG_STDQ_EN

00

Specification type:

Valid as of:

Page:

18 Dec. 2011

Official

6 of 6

MB

050

Body thickness out of

tolerance

Body

OOS

043

Bottom radius out of

tolerance

Bottom

OOS

039-137

Bottom concavity;
rocker

Bottom

OOS

NOTES

Notes no.

Description

Date

01

CHANGE LOG

Ed. numb

Request no.

Description

Date

00

First Issue

04.10.2011

Date

SIGNATURES

Name

Function

Reason of signature

A.Landi

QA Manager Glass

Issued

B.Schmid

QA Manager Corp.

Approval

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy

Page 6 / 6

Signature

Form 447/ 00