aql defectos en frascos incoloro

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

Description:

STDQ Clear glass Vials

Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

1 of 6

Stevanato Group Via Molinella 17 - 35017 Piombino Dese Italy / 6 Form 447/ 00

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.


Description:


Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

2 of 6


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

a. General

b. Attributes

Class Code Defect Area Size / Characteristics AQL ppm (where available)

C 082 Glass color not

conforming n.a.

Not conforming to specification

n.a. 0

C 098 Container/ packaging

mix-up n.a. n.a. n.a. 0

Class Code Defect Area Size / Characteristics AQL

C 013 Loose Glass (trapped) Container > Collar diameter 0,4

C 788 Contamination,

Biological Container n.a. 0,1

C 004 Chip Sealing surface

lead to leakage 0,4

C 003

-037

Crack, penetrating the wall (overall); ringoff;

lensing

Overall/ Bottom

any size 0,25

C 011 Contamination, not removable (internal)

Internal surface

> 0,5 mm 0,25

C 013 Glass particle, not removable, internal

(Washing test)

Internal surface

0,3 to 0,5 mm 0,25

C 016 Glass thread, not

removable (internal) Internal surface

> 0,3 mm 0,4

C 049 Deformation Collar lead to leakage,

Reference samples 0,4

C 598 Air bubble, open Collar > 0,5 mm 0,4

C 183 Pressure mark, vertical Neck-

shoulder junction

> 1/2 neck height OR > 3/4 neck circumference

long 0,4

C 279 Open airline (internal) Body > 0,1 width mm 0,4

C 013 Glass particle, not Internal > 0,5 mm 0,4


Description:


Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

3 of 6


removable, internal (Washing test)

surface

C 045 Missing siliconization (if

requested) Overall

> 30% of inner surface missing; Reference

sample 0,1

C 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 1

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

1

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 1

MB 058 Folds, internal Collar / neck

Function not impaired 1,5


Description:


Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

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 1

MB 107 Ridge Sealing Surface

Reference sample 1

MB 073 Lap (not leading to

leakage) Finish Reference sample 1,5

MB 349 Unfilled (not leading to

leakage) Collar Reference sample 1,5

N 018 Contamination, not

removable (external, washing test)

Container > 1 mm 1,5

N 087 Notch, external Sealing surface

Reference samples 1,5

N 400 Folds, external Shoulder Function not impaired,

Reference sample 1,5

N 053 Closed airline Body width > 0,1 mm 1,5

N 449 Scratches Sealing surface

lead not to leakage, Reference sample

1,5

N 022

-366

Shoulder malformation; twisted neck

Shoulder/ neck

Reference sample 1,5

N 024 Contamination,

removable (external, washing test)

Container > 1 mm 6,5

N 176 Scratch, glass to glass;

scuff Body

Thickness >0.2 mm OR lenght >20 mm

6,5

N 300 Pressure marks,

horizontal Neck 1/2 circumpherence long 2,5

N 188 Pressure mark, vertical Neck 1/2 neck height OR 1/4 to 3/4 neck circumference

long 2,5

N 124

-125

Frost on neck/collar; Orange peel

Neck/ collar Reference sample 4


Description:


Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

5 of 6


c. Printing

d. Variables


C 019 Missing printing n.a. Text not

understandable (missing)

0.065

C 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

N 092 Dirty/stained printing n.a. Not readable 1

N 060 Non -allineated printing n.a. N/A (still readable) 6,5


MB 010 Stress Overall 25 nm 0,4

MB 026-048-

315

External finish or thread outside diameter out of

specification; neck external diameter over maximum tolerance.

Finish/ thread/ neck

OOS 0,4

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 1

MB 006-452 Neck height, total height

out of tolerance Neck OOS 1

MB 005 Inner collar diameter Collar OOS 1

MB 293-029-322-021

Neck out of axis (circular run-out);

Eccentricity; Neck offset Neck OOS 0,4


Description:


Document code:

DEL_SG_STDQ_EN

Edition:

00

Specification type:

Official

Valid as of:

18 Dec. 2011 Page:

6 of 6


3 NOTES

Notes no. Description Date

01 - -

4 CHANGE LOG

Ed. numb Request no. Description Date

00 - First Issue 04.10.2011

5 SIGNATURES

Name Function Reason of signature Date Signature

A.Landi QA Manager Glass Issued

B.Schmid QA Manager Corp. Approval

MB 050 Body thickness out of

tolerance Body OOS 1

N 043 Bottom radius out of

tolerance Bottom OOS 1

N 039-137 Bottom concavity;

rocker Bottom OOS 1

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