aluminium and aluminium alloy part 2: foil for pharmaceutical … · 2018-11-06 · aluminium and...

DRAFT UGANDA STANDARD

DUS1663-2

First Edition 2018-01-19

Reference number DUS 1663-3: 2018

© UNBS 2018

Aluminium and Aluminium Alloy — Part 2: Foil for Pharmaceutical Packaging — Specification

DUS 1663-2: 2018

ii © UNBS 2017 – All rights reserved

Compliance with this standard does not, of itself confer immunity from legal obligations

A Uganda Standard does not purport to include all necessary provisions of a contract. Users are responsible for its correct application

© UNBS 2018

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from UNBS.

Requests for permission to reproduce this document should be addressed to

The Executive Director Uganda National Bureau of Standards P.O. Box 6329 Kampala Uganda Tel: 256 414 505 995 Fax: 256 414 286 123 E-mail: [email protected] Web: www.unbs.go.ug

mailto:[email protected]

DUS 1663-2:2018

© UNBS 2018 – All rights reserved iii

Contents Page

Foreword ............................................................................................................................................................ iv

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

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

3 Terms and definitions ........................................................................................................................... 1

4 Pinhole count ......................................................................................................................................... 2

5 Freedom from Defects .......................................................................................................................... 2

6 Material ................................................................................................................................................... 2

7 Supply of Material .................................................................................................................................. 3

8 Lubricants .............................................................................................................................................. 3

9 Preferred Thicknesses .......................................................................................................................... 3

10 Average Thickness of Bare Foil ........................................................................................................... 3

11 Coating/Lamination ............................................................................................................................... 4 11.1 Pharma laminate .................................................................................................................................... 4 11.2 Coated blister pack foil ......................................................................................................................... 4 11.3 Winding .................................................................................................................................................. 4

12 Dimensions and Tolerances ................................................................................................................. 4

13 Mechanical Properties .......................................................................................................................... 4 13.1 Bursting Strength .................................................................................................................................. 4 13.2 Peel strength (for Pharma laminate) .................................................................................................... 5 13.3 Sealing Strength (for Coated Blister Pack Foil and Pharma Laminate) ........................................... 5

14 Surface Condition .................................................................................................................................. 5

15 Sampling ................................................................................................................................................ 5

16 Ordering Information ............................................................................................................................. 6

17 Marking ................................................................................................................................................... 6

Bibliography ........................................................................................................................................................ 7

DUS 1663-2: 2018

iv © UNBS 2017 – All rights reserved

Foreword

Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade, Industry and Cooperatives established under Cap 327, of the Laws of Uganda, as amended. UNBS is mandated to co-ordinate the elaboration of standards and is

(a) a member of International Organisation for Standardisation (ISO) and

(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and

(c) the National Enquiry Point on TBT Agreement of the World Trade Organisation (WTO).

The work of preparing Uganda Standards is carried out through Technical Committees. A Technical Committee is established to deliberate on standards in a given field or area and consists of key stakeholders including government, academia, consumer groups, private sector and other interested parties.

Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the general public for comments. The committee reviews the comments before recommending the draft standards for approval and declaration as Uganda Standards by the National Standards Council.

The committee responsible for this document is Technical Committee UNBS/TC 19, [Packaging and Packaging products].

DRAFT UGANDA STANDARD DUS 1663-2: 2018

© UNBS 2018 – All rights reserved 1

Aluminium and Aluminium alloy — Part 2: Foil for pharmaceutical packaging — Specification

1 Scope

This standard covers the requirements of aluminium and aluminium alloy-bare/coated/laminated foil for pharmaceutical packaging applications. It is applicable for 0.020 mm (20 µm) to 0.040 mm (40 µm) foil thicknesses.

2 Normative references

The following referenced documents referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies

ISO 6361-1; Wrought aluminium and aluminium alloys — Sheets, strips and plates — Part 1: Technical conditions for inspection and delivery

3 Terms and definitions

For the purposes of this standard, the following terms and definitions apply

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp

3.1 Bare blister pack foil Bare foil (of thickness 20 µm-25 µm without any lamination or coating) used for blister pack application for pharmaceutical packaging usually after coating.

3.2 Coated blister pack foil Bare foil (of thickness 20 µm -25 µm) with one side coated with heat seal lacquer and the other side with primer or printed, used for blister pack application in pharmaceutical packaging.

3.3 Bare pharma strip pack foil Bare foil (of thickness 30 µm -40 µm without any lamination or coating) used for strip pack application for pharmaceutical packaging

3.4 Pharma laminate Laminated foil (with foil thickness of 30 µm-40 µm) with one side laminated and other side coated with primer or printed used for strip pack application for pharmaceutical packaging.

DUS 1663-2: 2018

2 © UNBS 2018 – All rights reserved

4 Pinhole count

Pinhole count shall be mutually agreed upon between the purchaser and the supplier. However, a guideline for pinhole count is given in Table 1.

Table 1 — Pinhole Count

Nominal Thickness Pinhole Count

No./m2

Dimensions

in mm

Dimensions

in µm

Max

0.020

0.025

0.030

0.040

20

25

30

40

25

20

10

5

5 Freedom from Defects

The foil shall be well finished, uniform in quality, free from splits, slivers, wrinkles, ragged edges and oil staining. If supplied in coated/laminated condition the coating/lamination shall be uniform. There shall be no delaminated areas.

6 Material

6.1 The material used for aluminium and aluminium alloy foil shall conform to the chemical composition of the Grades indicated in the table below.

Table — Chemical composition of the grades

Designation Aluminium Copper Magnesium Silicon Iron Manganese Zinc Titanium Chromium

19000 99.0, Min 0.1 0.2 0.5 0.7 0.1 0.1 - -

19500 99.5, Min 0.05 - 0.1 0.4 0.05 0.05 - -

19600 99.6, Min 0.05 - 0.25 0.35 0.03 0.06 - -

31000 Remainder 0.1 0.1 0.6 0.7 0.8-1.5 0.2 0.2 0.2

40800 98.0, Min 0.2 0.1 0.6-0.95 0.6-0.95 0.1 0.2 0.2 -

6.2 Unless otherwise specified by the purchaser, bare blister pack foil shall be supplied in ‘as rolled’ condition without a final annealing treatment.

6.3 Unless otherwise specified by the purchaser, bare pharma strip pack foil shall be supplied in fully annealed condition.

6.4 Unless otherwise specified by the purchaser, coated blister pack foil shall be supplied with one side of as rolled foil (without a final anneal) coated with heat seal lacquer and the other side coated with shellac or printed.

DUS 1663-2: 2018


6.5 Unless otherwise specified by the purchaser, pharma laminate shall be supplied with one side of fully annealed foil laminated with 35 g/m2 LDPE and other side coated with shellac or printed.

7 Supply of Material

General requirements relating to the supply of aluminium and aluminium alloy foil shall conform to ISO 6361-1

8 Lubricants

As the foils are to be used in pharmaceutical applications they shall be produced with rolling oils/ lubricants which do not contain substances which are injurious to health or have any deleterious effect on the flavour, odour or appearance of pharmaceutical products

9 Preferred Thicknesses

Unless otherwise stated, the preferred thickness shall be as given in Table 2.

Table 2 — Preferred Thicknesses

Nominal Thickness Nominal Covering

Area

Dimensions

mm

Dimensions

µm

m2/kg

0.020

0.025

0.030

0.040

20

25

30

40

18.5

14.8

12.3

9.26

10 Average Thickness of Bare Foil

10.1 The determination of average thickness shall be carried out using a method giving accurate and repeatable results.

10.2 In case of dispute, the average thickness may be determined by the gravimetric method, based on weighing a sample of 100 mm × 100 mm area, shall be dried and weighed on a balance, accurate to at least 0.5 mg

Thickness of the foil, in mm = 1.27

W

Where

W is the mass of the foil sample (100 mm × 100 mm), in g.

DUS 1663-2: 2018


11 Coating/Lamination

11.1 Pharma laminate

It shall have one side laminated with 35 g/m2 LDPE. Non-laminated side shall have primer coating with Shellac or shall be printed as desired by the purchaser.

11.2 Coated blister pack foil

It shall have one side of the aluminium foil coated with heat sealant lacquer with a coating weight in the range of either 4-6 g/m2 or 6-8 g/m2 depending on mutual agreement between the purchaser and the supplier. Primer coating with Shellac or printing shall be done on the non-heat seal side.

11.3 Winding

Coated blister pack foil shall be so wound so that the primer-coated side is on the outside surface.

12 Dimensions and Tolerances

12.1 Unless otherwise agreed, the thickness tolerance for bare laminated foil shall be ± 8 %.

12.2 Unless otherwise stated, the width tolerances shall be as given in Table 3.

Table 3 —— Width Tolerances

All dimensions in millimetres

Product Tolerance on Width for width

<1000 >1000

All ±0.5 ±1.0

13 Mechanical Properties

13.1 Bursting Strength

13.1.1 Bursting strength for bare strip pack foil and pharma laminate shall be as per Table 4.

Table 4 — Bursting Strength

Product Nominal Thickness Bursting Strength

Dimensions

in mm

Dimensions

in µm

(kg/cm2)

Min

For Bare foil: 0.020

0.025

0.030

0.040

20

25

30

40

1.4

1.7

2.0

2.6

For laminated 0.030

0.040

30

40

2.2

2.8

DUS 1663-2: 2018


NOTE Bursting strength is only applicable for bare strip pack foil or pharma laminate. It is not applicable for bare

blister pack foil or coated blister pack foil.

13.1.2 The material is subjected to a uniform pressure distributed over a known surface area and the bursting pressure is measured to give an indication of the suitability of the material.

13.2 Peel strength (for Pharma laminate)

Peel strength is only applicable for pharma laminate and shall be as per Table 5

Table 5 — Peel Strength

Product Nominal Thickness Peel

Strength

Dimensions

in mm

Dimensions

in µm

g/25mm

Min

For Bare foil 0.030

0.040

30

40

250

250

13.3 Sealing Strength (for Coated Blister Pack Foil and Pharma Laminate)

Sealing strength is only applicable for coated blister pack foil and pharma laminate and shall be as per Table 6.

Table 6 — Sealing Strength

Product Nominal Thickness Sealing

Strength

Dimensions

in mm

Dimensions

in µm

g/25mm)

Min

For Bare foil 0.020

0.025

0.030

0.040

20

25

30

40

500

500

500

500

14 Surface Condition

14.1 For coated blister pack foil one of the foil surfaces is bright and the other surface is matte.

14.2 For pharma laminate either one of the foil surfaces is bright and the other surface matte or both the surfaces may be bright depending on requirements of the purchaser.

15 Sampling

15.1 Unless otherwise agreed to between the purchaser and the manufacturer the following procedure and the criteria for conformity shall apply.

DUS 1663-2: 2018


15.2 In a consignment the foils of same width and thickness and of the same surface condition and manufactured by a single firm under essentially similar conditions of production shall be grouped together to constitute a lot.

15.2.1 Tests for determining the conformity of the lot to the requirement of this standard shall be carried out on each lot separately. The number of rolls of foils to be selected for this purpose at random over the whole lot shall be in accordance with Table 7.

Table 7 — Scale of Sampling and Permissible Number of Defectives

No. of RoIIs of

Foils in the Lot

No. of Rolls of Foils

to be Selected

Permissible No.

of Defective

Up to 15

16 t0 25

26 to 50

51 to 100

101 to 300

Above 300

5

8

13

20

32

50

0

1

1

2

3

3

15.2.2 All the rolls shall be individually examined for manufacturing defects, surface defects and dimensional tolerances. A sample failing to meet any one of these requirements shall be called defective. The lot shall be considered as conforming to the corresponding requirements of this standard if number of defectives satisfy the freedom from defects and dimensions in less than or equal to the permissible number given in Table 7.

16 Ordering Information

The order shall include the following information:

a) Quantity, in kg;

b) Nominal thickness;

c) Foil width;

d) Dimensions of rolls (outside diameter, in mm);

e) Type and inside diameter of the core in mm; length of core (if different from the width of the rolls);

f) Surface condition; and

g) Packing mode.

17 Marking

Each package of bare or converted aluminium foil shall be suitably marked for identification with the name of manufacturer, grade, and condition of the material, batch number and date of manufacture.

DUS 1663-2: 2018


Bibliography

[1] IS 16011 (2012) Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging - Specification

DUS 1663-2: 2018


Certification marking

Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards (UNBS) Certification Mark shown in the figure below.

The use of the UNBS Certification Mark is governed by the Standards Act, and the Regulations made thereunder. This mark can be used only by those licensed under the certification mark scheme operated by the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The presence of this mark on a product or in relation to a product is an assurance that the goods comply with the requirements of that standard under a system of supervision, control and testing in accordance with the certification mark scheme of the Uganda National Bureau of Standards. UNBS marked products are continually checked by UNBS for conformity to that standard.

Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda National Bureau of Standards.

aluminium and aluminium alloy part 2: foil for pharmaceutical … · 2018-11-06 · aluminium and...

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