INTERNATIONAL ISO

STANDARD 9187-1
First edition
1991-06-15

Injection equipment for medical use -

Part 1 :
Ampoules for injectables

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Ma t&iel d hjection 6 usage medical -
(standards.iteh.ai)
Partie 7 : Ampoules pour produits injectables

ISO 9187-1:1991
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8041f37c669c/iso-9187-1-1991

Reference number
ISO 9187-1 : 1991 (E)
ISO 91874 : 1991 (E)

Contents
Page

1 Scope . . . . . . . . . . . . . . . . . . . . .......................................... 1

2 Normative references . . =. . . . . .......................................... 1

3 Dimensions and designation . . .......................................... 2

4 Material ............................................................. 4

5 Requirements ........................................................ 4

6 Test for breaking forte ................................................ 4

7 Delivery
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............................................................. 4

8 Packaging
(standards.iteh.ai)
........................................................... 5

9 Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISO
. . . . .9187-1:1991
.............. 5
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0 ISO 1991
All rights reserved. No part of this publication may be reproduced or utilized in any form or by any
means, electronie or mechanical, including photocopying and microfilm, without Permission in
writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 e Switzerland
Printed in Switzerland

ii
 ISO 9187-1 : 1991 (E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of
national Standards bodies (ISO member bodies). The work of preparing International
Standards is normally carried out through ISO technical committees. Esch member
body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (1EC) on all
matters of electrotechnical standardization.

Draft International Standards adopted by the technical committees are circulated to

the member bodies for voting. Publication as an International Standard requires

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approval by at least 75 % of the member bodies casting a vote.

(standards.iteh.ai)
International
Transfusion,
Standard ISO 9187 was prepared by Technical Committee
infusion and injection equipment for medical use.
ISO/TC 76,

ISO 9187-1:1991
ISO 9187 will consist of the following Parts under the general title lnjection equipmen t
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for medical use:
8041f37c669c/iso-9187-1-1991
Part 7: Ampoules for injectables

- Part 2: OPC-ampoules
ISO 91874 : 1991 (EI

Introduction
Ampoules are suitable primary packaging materials for storing pharmaceutical
products until they are administered to the Patient. Owing to the direct contact
between injectables and the primary Container over extended storage periods, possible
interactions must be avoided in Order to guarantee Patient safety. Adequate means to
achieve this objective include proper selection of primary packaging materials, the
choice of suitable package design and the availability of specific requirements and
methods for testing individual Container Systems.

Four standardized forms of ampoules (forms A, B, C and D) have, in the past, been in
widespread use; however, form A is no longer necessary for the pharmaceutical
industry and, consequently, has not been included in this International Standard. To
avoid any likelihood of confusion between manufacturers and users, it was decided to
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retain the same designation letters (i.e. B, C and D) for the forms of ampoule in current
use and to disregard the letter A.
(standards.iteh.ai)
lt is known that different dimensions of ampoules exist at present in various countries
as Standard Versions. Many countries have already switched ISO over9187-1:1991
to the dimensions
laid down in this part of ISO 9187. All other countries whose ampoules do not yet
comply with the dimensions
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laid down in this part of ISO 9187 should switch over
within a period of three years after publication. 8041f37c669c/iso-9187-1-1991

IV
INTERNATIONAL STANDARD ISO 9187-1 : 1991 (E)

Injection equipment for medical use - Ampoules

for injectables

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(standards.iteh.ai)
1 Scope ISO 9187. At the time of publication, the editions indicated
ISO 9187-1:1991were valid. All Standards are subject to revision, and Parties to
This part of ISO 9187 specifies materials, dimensions and agreements based on this part of ISO 9187 are
https://standards.iteh.ai/catalog/standards/sist/d963ff2f-423c-4d86-8392- encouraged to
capacities, and performante and packaging requirements for investigate the possibility of applying the most recent editions
8041f37c669c/iso-9187-1-1991
three forms of glass ampoules (forms B, C and D) for injec- of the Standards listed below. Members of IEC and ISO main-
tables. tain registers of currently valid International Standards.

lt applies to ampoules with and without a colour break ring. ISO 720 : 1985, Glass - Hydrolytic resistance of glass grains at
121 OC - Me thod of test and classification.
If ampoules with colour break ring are requested by the User,
this should be agreed between manufacturer and User, in-
ISO 2859-1 : 1989, Sampling procedures for inspection by
cluding a decision on break ring colour.
a ttributes - Part 7: Sampling Plans indexed b y accep table
quality level (AQL) for lot-by-lot inspection.
Ampoules complying with this part of ISO 9187 are intended for
Single use only.
ISO 4802-1 : 1988, Glassware - Hydrolytic resistance of the in-
terior surfaces of glass Containers - Part 7: Determination by
2 Normative references titra tion me thod and classifica tion.

The following Standards contain provisions which, through IS 0 7500- 1 : 1986, ll4e tallic ma terials - Verifica tion of s ta tic
reference in this text, constitute provisions of this part of uniaxial testing machines - Part 7 : Tensile testing machines.
ISO 9187-1 : 1991 (E)

3 Dimensions and designation

3.1 Dimensions

The dimensions of ampoules shall be as shown in figures 1, 2 and 3 (forms B, C and D respectively) and as given in table 1.

d6

Funnel-,

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(standards.iteh.ai)
ISO 9187-1:1991
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8041f37c669c/iso-9187-1-1991

NOTE - For other dimen- NOTE - For other dimen-

sions, see figure 1. sions, see figure 1 .

Figure 1 - Form B: Figure 2 - Form C: Figure 3 - Form D:

Stern, Stern, Stern,
tut ampoule open-funnel ampoule sealed ampoule
with constriction with constriction with constriction

3.2 Designation

3.2.1 Designation example of a form B ampoule without a colour break ring with a nominal volume of 10 ml, made of colourless
glass (cl) complying with the requirements of this part of ISO 9187:

Ampoule ISO 9187-1 - B - 10 - cl

3.2.2 Designation example of a form B ampoule with a colour break ring (cbr) with a nominal volume of 10 ml, made of colourless
glass (cl) complying with the requirements of this part of ISO 9187:

Ampoule ISO 9187-1 - B - 10 - cl - cbr

2
 iTeh STANDARD PREVIEW
Table 1 - Dimensions of ampoules
(standards.iteh.ai) Dimensions in millimetres

External diameter Overall height I Heig ht T Base T Wall thickness

T ISO 9187-1:1991 T
Centre Glass Circu- Volume
Height Height of Glass Glass
https://standards.iteh.ai/catalog/standards/sist/d963ff2f-423c-4d86-8392- thick- lar to
Nominal Constric- to Glass thick- thickness
to Body constric- Depth of ness run- centre
Body Bulb Stern Funnel Dome Form B
8041f37c669c/iso-9187-1-1991 Form C Form D Radius thickness ness of
volume tion constric- gauging height tion the base of out of
tion of body at constric-
Point to stem at toler- constric-
bulb base tion
gauging ante tion
d, 3’ d,” d3 4 d, 2’ de2’ hl h2 h3 ha h5 h, r e Sl s2 s3 s4 t4’ V
I
ml
ml toi. k 0,5 tol. + 1 3’ tol. tol. +2 min. max. tro,5 tol. toi. +0,05 min. toi. =

10,75 &0,15 6,5 1 8,5 1 +0,5 10 60 +0,5 67 +l 47 21 3,5 f0,03 0,37 0,3 0,6 1,5
4,5
2 10,75 f0,15 10 72 +0,5 79 +1 57 33 3,5 f0,03 0,37 Ot3 0,7 fO,l 0,6 23
1 *0,5
3 12,75 f0,15 10,5 75 +0,5 82 kl 62 35 5 3,5 +0,03 0,37 OP3 W3 3,5
lt5
5 14,75 f0,15 7 1 9 1 &0,5 12 83 f0,5 90 +1 68 41 5,5 3,55 +0,03 0,42 0,4 Ot7 +0,15 1 5,5
10 17,75 f0,20 13,5 102 f0,5 109 +1 87 55 6 2 1,25 f0,75 3,6 f0,04 0,47 0,4 03 +0,15 1 11,5

20 22,5 f0,25 13,5 113 +1 120 kl,5 100 65 3,7 f 0,04 0,55 0,5 12 23,5

25 z5 +0,25 13,5 128 kl 135 kl,5 115 80 6,5 2,5 lt5 kl It7 f 0,04 0,55 0,5 1 *0,2 12 28,5

30 Dt5 kO,25 13,5 143 If-1 150 +1,5 130 95 3,7 It 0,04 0,55 0,5 12 33,5

1) If there is any need to reduce the diameter of the constriction, e.g. due to reducing of particles, it shall be agreed between manufacturer and purchaser.

2) No Point of the funnel and the dome shall be outside of the body diameter.

3) The tolerantes are valid only with the following restriction : the actual dimensions of d, shall be bigger than the actual dimensions of d6 + t,

4) The run-out tolerante shall be measured at the sealing Point.

m
ISO 9187-1 : 1991 (E)

4 Material 6.2 Apparatus

Colourless (cl) or amber (br) glass of hydrolytic resistance grain Tensile testing machine in accordance with ISO 7500-1 and
class ISO 720 - HGA 1 shall be used. having the following characteristics :

A Change in the Chemical composition of the glass material - test Speed, v: 10 mm/min
should be notified by the tube manufacturer to the user at least
- measuring range for forte: 200 N
nine months in advance.
NOTE - Other test procedures, e.g. with a power increase of 20 N/s
are admissible.
5 Requirements
An example of the test set-up is illustrated in figure 4.

5.1 Hydrolytic resistance

6.3 Sampling
When tested in accordance with ISO 4802-1, the hydrolytic
resistance of the internal surface of ampoules shall comply with
the requirements specified for hydrolytic resistance Container 6.3.1 Number of samples
class ISO 4802 - HC 1.
Random sampling in accordance with ISO 2859-1 (inspection
level S-4) shall be carried out.
5.2 Annealing quality

Ampoules shall be annealed; the maximum residual stress of 6.3.2 Conditioning of samples
uncoloured ampoules after annealing shall not produce an
Optical retardation exceeding 50 nm per millimetre of glass The temperature of the samples shall be 20 OC I-t: 5 OC.
thickness.

6.4 Procedure
5.3 Breaking forte
iTeh STANDARD PREVIEW Set the distance between the metal bars, as shown in figure 4,
lt is presumed that the ampoules to be tested are provided with
a predetermined breaking Point such as a ceramic ring at the (standards.iteh.ai) so that the forte is imparted in the middle of the bars at an
angle of 90° to the axis of the ampoule.
constriction.
Apply the forte using the tensile testing
ISO 9187-1:1991 machine to rupture.
When tested in accordance with clause 6, the breaking forte
Record the breaking forte.
shall be as specified in table 2.
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6.5 Expression of results
Table 2 - Breaking forte
All Single test results shall comply with the relevant values
Nominal volume Length Breaking forte specified in table 2.
I(= l, + l*) Fmin F max
mm N N
6.6 Test report
1
The following information shall be specified in the test report:
2
36 ( = 18 + 18) 70
a) a description of the test set-up, including the tensile
3
testing machine;
5 75
_ 30 b) a description of the Sample;
10 90
c) the number of samples;
20 -
60(= 22 + 38)
d) the test results, including the arithmetic mean, x and
25 100
the Standard deviation, s, of the Sample;
30
e) the place and date of the tests;

f) the name and signature of the person who carried out

the tests.

6 Test for breaking forte

7 Delivery
6.1 Principle

The test is suitable for determining the forte required to 7.1 Ampoules shall be sorted according to their design and
separate the ampoule stem from the body and for assessing nominal volumes and shall be delivered in packaging units (see
whether a clean break is obtained. clause 8).

4
 ISO 9187-1 : 1991 (EI

Dimensions in millimetres

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(standards.iteh.ai)
ISO 9187-1:1991
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8041f37c669c/iso-9187-1-1991
Figure 4 - Example of test set-up for determining the breaking forte of ampoules

7.2 Secondary sorting of ampoules according to the stem 8.2 The immediate packaging of all ampoules shall, as far as
diameter, d,, in the measuring axis, if desired, shall be subject possible, be made from materials that do not shed particles.
to agreement between the manufacturer and user-.

9 Marking
8 Packaging
The following information shall be marked on the packaging:

8.1 The packaging unit shall have the following dimensions: - the manufacturer’s name and address;

- length (internal): 384 mm

- the designation in accordance with 3.2.
- width (internal): 143 mm
Further marking shall be subject to agreement between the
- height: height of the appropriate type of ampoule manufacturer and User.
-+- 2mm

NOTE - Packaging units with other dimensions as laid down in 8.1

should be agreed between manufacturer and User.