EN 28362-2:1993
(Main)Injection containers for injectables and accessories - Part 2: Closures for injection vials (ISO 8362-2:1988)
Injection containers for injectables and accessories - Part 2: Closures for injection vials (ISO 8362-2:1988)
Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:1988)
Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons injectables (ISO 8362-2:1988)
Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:1988)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Vsebniki za parenteralne farmacevtske oblike in dodatna oprema - 2. del: Zapirala za viale (ISO 8362-2:1988)Injektionsbehältnisse für Injektionspräparate und Zubehör - Teil 2: Stopfen für Injektionsflaschen (ISO 8362-2:1988)Récipients et accessoires pour produits injectables - Partie 2: Bouchons pour flacons injectables (ISO 8362-2:1988)Injection containers for injectables and accessories - Part 2: Closures for injection vials (ISO 8362-2:1988)11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:Ta slovenski standard je istoveten z:EN 28362-2:1993SIST EN 28362-2:2000en01-januar-2000SIST EN 28362-2:2000SLOVENSKI
STANDARD
SIST EN 28362-2:2000
SIST EN 28362-2:2000
SIST EN 28362-2:2000
SIST EN 28362-2:2000
SIST EN 28362-2:2000
SIST EN 28362-2:2000
SIST EN 28362-2:2000
IS0 8362-2 : 1988 (El Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each 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. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the IS0 Council. They are approved in accordance with IS0 procedures requiring at least 75 % approval by the member bodies voting. International Standard IS0 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical use. IS0 $362 consists of the following parts, under the general title Injection containers for injectables and accessories : - Part I: Injection vials made of glass tubing Part 2 : Closures for injection vials Part 3 : Aluminium caps for injection vials Part 4: Injection vials made of moulded glass Annexes A, B and C form an integral part of this part of IS0 8362. SIST EN 28362-2:2000
IS0 8362-2 : 1988 (E) Introduction The materials from which injection containers (including the elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. SIST EN 28362-2:2000
INTERNATIONAL STANDARD IS0 8362-2 : 1988 (E) Injection containers for injectables and accessories - Part 2 I: Closures for injection vials 1 Scope This part of IS0 8362 specifies the design, dimensions, material, performance, requirements and tests for closures for injection vials covered by IS0 8362-l and IS0 8362-4. Closures specified in this part of IS0 8362 are intended for single use only. The closure shall be made from the formulation originally tested and approved by the end-user. The closure manufacturer will certify identity of the closure as well as conformance of the closure to previously agreed functional parameters or compen- dium requirements. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 8362. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 8362 are encouraged to investigate the possibility of applying the most recent editions of the standards listed below. Members of IEC and IS0 main- tain registers of currently valid International Standards. IS0 48 : 1979, Vulcanized rubbers - Determination of hardness (Hardness between 30 and 85 IR HDI. IS0 2859 : 1974, Sampling procedures and tables for inspec- tion by attributes. IS0 3302 : 1976, Rubber - Dimensional tolerances of solid moulded and extruded products. IS0 3696 : 1987, Water for analytical laboratory use - Specification and test methods. IS0 7864 : 1984, Sterile hypodermic needles for single use. IS0 7886 : 1984, Sterile hypodermic syringes for single use. IS0 8362-l : 1988, Injection containers for injectables and accessories - Part 7: Injection vials made of glass tubing. IS0 8362-4 : 1988, Injection containers for injectables and accessories - Part 4: Injection vials made of moulded glass. IS0 8871 : 1988, Elastomeric parts for aqueous parenteral preparations - lden tifica tion, requirements, test methods. SIST EN 28362-2:2000
IS0 8362-2 : 1988 (E) 3 Dimensions and designation 3.1 Dimensions The dimensions of closures shall be as shown in figure 1 and as given in table 1. Figure 1 illustrates two types of closure, types A and B. Dimensions in millimetres c43 @@0,-t A -a d6 - E E I NOTE - @d w c Other dimensions are as indicated for type A closures. Figure 1 - Dimensions and configuration of types A and B closures SIST EN 28362-2:2000
IS0 8362-2 : 1988 (E) Table 1 - Dimensions of injection closures Dimensions in millimetres Type Nominal d, d2 d3 = d4 d5 d6 d7 hl h2 h3 h4 rl Injection vials size .frO,l max. min. max. f0,2 +0,2 *0,3 +0,25 +0,25 IS0 8362-l IS0 83624 13 715 5 3 4 12,5 - 7 2 2,5 1,75 + 0,25 1 2 R and 4 R - A 20 13,2 10 4,5 5,5 18,8 - 8,8 3,3 2,5 3,3 max. 1,5 min. 2 6Rto30R 5HtolOOH 13 714 5 3 4 12‘5 7,6 7 2 115 1,5min. 1 - 2lto10l B 20 13 10 4,5 5,5 18,8 13,3 8‘8 3,3 1,5 3,3 max. - 1,5 min. 2 5 H to 100 H L 3.2 Designation Closures are designated according to type: the two types A and B are illustrated in figure 1. The designation is expressed as the number of this part of IS0 6362 followed by the nominal size of the vial followed by the type letter. For example a type A closure for injection vials of nominal size 13 complying with the requirements laid down in this part of IS0 8362 is designated : Injection closure IS0 8362-2 - 13 - A 4 Material The type of elastomeric material used shall meet the require- ments specified in clause 5. 5 Requirements 5.1 General The requirements specified in 5.2 to 5.4 represent minimum requirements which refer to the condition of the elastomeric closures on receipt by the user. NOTE - The resistance to ageing depends on the actual circum- stances of storage and handling. The minimum shelf life of the closure should be agreed upon between closure manufacturer and user. The useful lifetime of the closure in contact with the pharmaceutical product is part of the compatibility tests to be carried out by the user. 5.2 Physical requirements and performance 5.2.1 Dimensions 5.2.1.1 If not otherwise specified, general dimensional tol- erances shall be in accordance with IS0 3302. 5.2.1.2 If spacers are located on top of the flange, they shall not interfere with the marks for the injection site within the area of diameter d5 (see figure 1). The height of the spacers shall not exceed 0,3 mm. NOTE - The spacers in figure 1 for types A and B closures are shown for illustrative purposes only and do not form part of the requirements of this part of IS0 8362. 5.2.1.3 If the flange of the closure has a slightly conical shape, it shall be 0,3 mm max. in relation to the diameter in order to facilitate production. The tolerances of the trimming edge of the flange shall comply with the tolerances specified in table 1 for the diameter of the flange de. 5.2.1.4 All edges of the closure may be rounded. 5.2.2 Hardness When tested by the method given in IS0 48 using test plates supplied by the manufacturer, the hardness shall not differ from the value stated by the manufacturer by more than +5 IRHD. 5.2.3 Fragmentation (coring) When tested for fragmentation in accordance with annex A, not more than 5 fragments per 100 piercings shall be observed. 5.2.4 Penetration When tested for penetration in accordance with annex B, the force needed to penetrate the closure shall not exceed 10 N for any of the ten closures tested. 5.2.5 Closure/container integrity When tested in accordance with annex C, no methylene blue solution shall leak into the interior of the vial. 5.2.6 Self-sealing If the closure has to be pierced more than once, but not more than three times, the requirements for self-sealing shall be met. When tested in accordance with annex C, no methylene blue solution shall leak into the interior of the vial. 5.3 Chemical requirements The material of the closure shall satisfy the limits specified in table 2. SIST EN 28362-2:2000
IS0 8362-2 : 1988 (El Table 2 - Chemical limits for injection closures Characteristics Limit Test method as described in IS0 8871 Reducing matter (oxidizables) <7,0 ml of c(KMn0,) = 2 mmol/l per 20 ml Annex C Heavy metals (calculated as Pb2+ 1 < 10 pg Pb2+/10 ml Annex D Ammonium (calculated as NH,+) ~20 vg NH:/10 ml Annex E Acidity/ alkalinity Residue on evaporation (total solids) < 1,0 ml of c(HCI) or c(NaOH) = 5 mmol/l per 20 ml < 4 mg/lOO ml Annex G Annex H Volatile sulfides (at 2: pH 2) Discoloration of lead acetate paper 450 pg Na2S/20 cm2 of rubber surface Annex I Zinc (calculated as Zn2+) Conductivity’ Turbidity Zn2+ 4 30 pg/lO ml <40 @cm Not exceeding 3 Annex K Annex L Annex M 5.4 Biological requirements The elastomeric closure shall not release any substances which may adversely affect the therapeutic effectiveness of the injec- table products, including those substances which may exhibit toxic, pyrogenic or haemolytic reactions. NOTE - Since biological tests are usually requested by most of the na- tional Pharmacopoeias or related regulations of health authorities, they are mandatory for producers and users in countries where they exist. If this is not the case, reference should be made to biological tests, e.g. as described in the United States Pharmacopoeia, European Phar- macopoeia or other Pharmacopo
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