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 reserv ed 
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary provisio ns of a contract. Users are 
responsible for its correct application  
© UNBS 20 18  
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 pho tocopying 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 41 4 505 995  
Fax: 256 41 4 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  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 reserv ed 
 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 con tact 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 Techni cal 
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 committ ee 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 alumin ium alloy -bare/coated /laminated foil for 
pharmaceutical packaging applicati ons. 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 alum inium 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 follo wing 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 µ m) 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 µ m 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 a pplication for pharmaceutical packaging.  DUS 1663 -2: 2018 
2 © UNBS 2018 – All rights reser ved 
 4 Pinhole count  
Pinhole count shall be mutually agreed upon between the purchaser and the supplier. However, a guideline 
for pinhole count is gi ven 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 sp lits, 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 co nform 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, Mi n 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 p urchaser, 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 
© UNBS  2018 – All rights reserved  3 
 6.5 Unless otherwise specified by the purchaser, pharma lami nate 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 ap pearance 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 ma y 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 = 
1.27W  
Where  
W is the mass of the foil sampl e (100 mm × 100 mm), in g.  DUS 1663 -2: 2018 
4 © UNBS 2018 – All rights reser ved 
 11 Coating/Lamination  
11.1 Pharma laminate  
It shall ha ve 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 pri nting 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 Thicknes s 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 
© UNBS  2018 – All rights reserved  5 
 NOTE  Bursting stren gth 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 su bjected  to a uniform pressure distributed over a known surface area and the 
bursting p ressure 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 shal l 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 
6 © UNBS 2018 – All rights reser ved 
 15.2 In a consignment the foils of same width and thickness and of the same surface condition and 
manu factured 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 separat ely. 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 di mensional 
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 an d 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 su itably marked for identification with the name of 
manufacturer, grade, and condition of the material, batch number  and date of manufacture.  DUS 1663 -2: 2018 
© UNBS  2018 – All rights reserved  7 
 Bibliography  
[1] IS 16011 (2012)  Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging - Specification   
 DUS 1663 -2: 2018 
© UNBS 2018 – All rights reserved  9 
 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 Stand ards. 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.  
 
 DUS 1663 -2: 2018   
 
ICS 11.120.99  
Price ba sed on nn pages  
© UNBS 2018– All rights reserved