Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru

“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS 14233 (1995): Packaging - Pharmaceutical products -Child resistant tamper-proof packaging for solid dosageforms - Code of practice [TED 24: Transport Packages]

IS 14233 : 1995

Indian Standard

PACKAGING - PHARMACEUTICAL PRODUCTS - CHILD RESISTANT TAMPER-

PROOF PACKAGING FOR SOLID DOSAGE FORMS - CODE OF PRACTICE

UDC 621.798.12 : 006.76

0 BIS 1995

BUREAU OF INDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

March 1995 Price Group 2

Packaging Codes Sectional Committee, LM 26

FOREWORD

This Indian Standard was adopted by the Bureau of Indian Standards after the draft finalized by the Packaging Codes Sectional Committee had been approved by the Light Mechanical Engineering Division Council.

Child poisoning may occur due to the suspected ingestion of household chemicals and medicines by children. Accidents involving the suspcctcd ingestion of household chemicals and mcdicinc by children arc rarely fatal but are potentially slrcssful.

The rcwmmcndations in this standard may not be adcquatc in practice to prevent all children from gaining access lo the contents of the packages but the aim of lhc standard is to form a practical basis for the dcvclopmcnt of packages with acccplablc child-resistant features and to offer an advice to manufac- tures when selecting unit dose packaging with a view to child safely.

Data on the slrcngth characteristics of strip and blister packaging have lo bc gathered on a continuing basis and furlhcr research needs to be undertaken inlo the abililics of young children lo open such packaging.

In the preparation of this standard assisrancc has been dcrivcd form BS 7236 : 1989 ‘Coclc of praclicc for non-rcclosablc packaging for solid dose units of medical products’, issued by British Sti~nditrds lnslilulion (BSI).

IS 14233 : 1995

Indian Standard

PACKAGING - PHARMACEUTICAL PRODUCTS - CHILD RESISTANT TAMPER-

PROOF PACKAGING FOR SOLID DOSAGE FORMS - CODE OF PRACTICE

1 SCOPE

This Indian Standard gives recommendations fo,r properties of materials used for non-reclosable packaging and guidance about design feautres which are thought important for child resistance for packaging of pharmaceutical products.

2 REFERENCE

IS 1060 (Part 1) : 1966 ‘Methods of sampling and test for paper and allied products, Part 1 (revi~eti)’ is a necessary adjunct to this standard.

3 DEFINITIONS

For the purposes of this standard, the following definitions shall apply.

3.1 Child Resistant Packaging

Any packaging which is difficult for young children under the age of five to open (or gain access to the contents), but which is not difficult for adults.

3.2 Immediate Packaging

Any packaging that is in direct contact with the contents of the package.

3.3 Non-reclosable Packaging

Any immediate packaging that having once been opened is not capable of being reclosed and which is destroyed or partially destroyed in the opening procedure.

NOTE - Slrip and blister pa&agings are examples of non- reclosable packaging.

3.4 Strip Packaging

Immediate packaging in which unit doses of a medicinal product are enclosed in a continuous strip made by bonding two layers of flexible material together.

NOTE-Thelayels maybeofthesameordiffcrenc malerials.

3.5 IBlister Packaging

Immediate packaging in which unit doses of a medicinal product are enclosed between a preformed tray with individual pockets and a lid- ding material which may be flat or shaped.

NOTE - The tray and lid may be of the same or differenc materials.

3.6 Unit Dose

An indivisual dose in the form of a tablet, capsule, pill, lozenge, pastille, suppository or pessary.

3.7 Single Unit Package

A package in which unit doses of a medicinal product are not only individually protected but are also individually packaged.

NOTE - A sachet is an example of a single unit package.

3.8 Medicinal Product

A product manufactured under the Drugs and Cos- metics Act, 1940 and Rules thereunder, Narcotic Drugs and Psychotropic Drugs Act, 1985.

4 PACKAGING

4.1 General

Good quality, well sealed packs are necessary for protection of the contents as and being child resis- tant. If a manufacturer follows the recommenda- tions given in 4.2 to 4.7 the unit dose packs produced should withstand normal hgndling stresses.

4.2 Materials ’

4.2.1’ General

The packaging materials to be used should provide the necessary level of child resistance throughout the lifetime of the product as well as providing for the chemical and physical stability of the product. The materials may be plastics, metal foil, cellular film, paper and combinations of these materials and may be coated or uncoated, but they should follow the requirements given in 4.2.2 to 4.2.4.

4.2.2 Obscuri@ of Dosage Units

The materials from which the immediate packaging is manufactured should be opaque or dark-tinted or otherwise coldured or surface marked in such a manner that the unit doses are effectively masked.

NOTE - Manufacturers should avoid using immediate packaging and/or artwork which might make the produet mote attractive to children.

1

IS 14233 : 1995

4.2.3 Bursting Strength should be no evidence that the seal has been pulled

When tested in accordan , with IS 1060 (Part 1) : apart.

1966, the bursting stren,th of each web of the 4.5 Freedom from Rattle material should be not less than that given in Th e Table 1.

size and shape of the pockets should be designed to minimize the audible movement

Table 1 Recommendations for Packaging (rattle) of the .unit doses.

Materials NOTE-Rattle is worse. if the pocket is too large for the unit dose it contains. Manufacturers of filling machines can pro-

( Clauses 4.2.3,4.2.4 and 4.3 ) videguidanceon theoptimumsizeratiowhichmaydifferwith

Parameter Slrip Blister the machine type, the material used and the shape of the unit

Packaging Packaging dose.

(1) (2) (3) 4.6 Resistance to Bending of Blister Packages

Bursting strength, kPa, Min Hard temper foil Soft temper foil and

other materials

130

110

130

110

When tested in accordance with Annex C, no rup- ture or delamination of the pockets should occur.

4.7 Opening Features Breaking load, N/15 mm, Min

Hard temper foil Soft temper foil and other

materials

Seal strength, N/mm, Min

1 kPa = 0.01 kg/cm2

45

35

0.2

45

35

0.2

4.7.1 .Strip Packaging

The packaging may be opened by tearing, cutting or peeling to extract a unit dose, or the unit dose may be pressed through one web.

4.7.2 Blister Packaging

4.2.4 Breaking Load The packaging may be opened by applying pressure

When tested in accordance with IS 1060 (Part 1) : to the bottom of a pocket so that the unit dose is

1966 the breaking load of each web of the material pushed through the lidding material. Where the

should be not less than that given in Table 1. contents are friable the packages may be designed for opening by peeling or tearing.

4.3 Seal Strength Packages may also combine the ‘peelab. and

When tested in accordance with Annex A, the seal ‘push-through’ principles.

strength, that is the strength of the bond between 4.7.3 Perforations the top and bottom layers of the package, should be not less than that given in Table 1.

Strip and blister packaging may be perforated be- twcen Dockets but this could have the disadvantage

4.4 Seal Integrity of the’units becoming more easily detached and having sharp cutting edges. However, perforations

When tested in accordance with Annex B, the unit do provide a means of reducing the chances of a unit dose pockets should be free from liquid and there dose being released due to mishandling.

2

IS 14233 : 1995

ANNEX A ( Clause 4.3 )

METHOD FOR DETERMINATION OF SEAL STRENGTII

A-l PRINCIPLE

The two web materials which form the package are heat sealed together under specified conditions and the force required to separate the two web materials is measured.

A-2 APPARATUS

a) Heat Sealing Machine b) Tensile Tester, complying with IS 1060

(Part 1) : 1966.

A-3 TEST PIECE PREPARATION

Cut strips of the materials to be tested about 100 mm to 180 mm long and 10 mm to 30 mm wide. Set the heat sealer to the temperature required for the materials under test and seal the materials together under the time and pressure conditions appropriate to the materials, leaving one end of the test piece unsealed for a distance of about 25 mm. Coal the test piece to ambient temperature.

A-4 PROCEDURE

Clamp one flap of the unsealed end of the test piece to the lower jaw of the tensile tester. Raise the lower jaw to a preset upper limit and clamp the other flap in the upper jaw, taking care not to

damage the heat seal, so that the flaps are at ap- proximately 180” to each other. Set the tensile tester in mot’m with a jaw separation rate of 100 mm/min and record the force in newtons required to peel the test piece apart.

A-5 EXPRESSION OF RESULTS

Calculate the test result (seal strenth) from the following equation :

R = F/W

where

R is the result in (N/mm);

F is the peel force (in N); and

W is the test piece width (in mm).

A-6 TEST REPORT

The test report shall include the following:

a>

b)

C>

the test results (in N/mm) to two significant figures; the time, temperature and pressure condi- tions used for heat sealing; and any other items which may be of value in interpreting the results.

ANNEX B

( CZause 4.4 ) METHOD FOR DETERMINATION OF SEAL INTEGRITY

B-l PRINCIPLE

A filled package is immersed in coloured water and subjected to a specified vacuum for a specified time. The package is returned to normal atmospheric pressure and examined for signs of water in the pockets or failure of the seal.

NOTE7 This test is carried out on filled packages manufac-

tured on production equipment.

B-2 APPARATUS AND REAGENT

B-2.1 Vacuum Chamber

Thcvacuum chamber shall be of capable of sustain- ing a vacuum of at least 100 kPa (750 mm of mercury).

H-2.2 Container

The container shall be of sufficient depth to allow complete immersion of the test package.

B-2.3 Coloured Water

The coloured water shall be at a temperature of 15°C to 25°C. The dye solution should be freshly prepared or checked before use to ensure that the solution is at the expected concentration.

B-3 PROCEDURE

Immerse the test package in a container (B-2.2) containing coloured water (B-2.3) and place the container in the vacuum chamber (B-2.1). Apply the appropriate vacuum of 33 kPa (250 mm of mercury) for strip packages or 24 kPa (180 mm of mercury) for blister packages for 30 s. Restore at- mospheric pressure and remove the container from the vacuum chamber. Remove the test package from the container and blot off excess water. Ex- amine the package for ingress of water into the pockets.

3

IS 14233 : 1995

B-4 REPORTING AND ACTION entered the package. If the result is unsatisfactory the reason could be due to pinholes in the material

Report the result of the test as satisfactory if or channels or other faults in the seal. The defects no Water has entered or unsatisfactory if water has should be investigated and remdied.

ANNEX C

( Clause 4.6 ) METIIOD FOR DETERMINATION OF RESISTANCE TO

BENDING OF BLISTER PACKAGES

C-l PRINCIPLE

The test package is bent once along both the long and short axis through 18CPwith the pockets on the outside bend and once through 90 ’ with the pock- ets on the inside bend and the pockets examined for signs or rupture.

C-2 PROCEDURE

C-2.1 With the pockets on the outside, bend the test package through 180” along the long axis and repeat the test along the short axis.

C-2.2 With the pockets on the inside, bend the test package through 900 along the long axis and repeat the test along the short axis.

C-2.3 After each test examine the pockets for rup- ture of the lidding material or signs of ply separa- tion.

C-3 RESULTS

Report the number of pockets which ruptured or delaminated.

4

Bureau of Indian Standards

BIS is a statu.tory institution established under the Bureau of Indian Standards Act, 1986 to promote harmonious development of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any form without the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Users of Indiaxr Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of ‘BIS Handbook’ and ‘Standards Monthly Additions’.

This Indian Standard has been developed from Dot : No. LM 26 ( 0048 ).

Amendments Issued Since Publication

,Amend No. Date of Issue Text Affected

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