ISO 8362-7:2006 PDF

Name: ISO 8362-7:2006 — Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
SKU: ISO 8362-7:2006
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Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part

Название (английский):

ISO 8362-7:2006

Injection containers and accessories — Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 4
Дата публикации:: 19 апреля 2006 г.
Издание:: ISO IS 8362 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 8362-7:2006 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 8362-7:2006 specifies design, dimensional and test requirements for injection caps made of aluminium‑plastics combinations where the plastics part does not overlap the diameter of the vial body. The restriction on the plastics element prevents handling and automation issues (e.g., labelling, turntable storage) with certain injection vials defined in ISO 8362-1 and ISO 8362-4. Note: injection caps covered by this part are not considered primary packaging in direct contact with the pharmaceutical product.

Key topics and technical requirements

Scope and classification

Covers aluminium‑plastic caps for injection vials where the plastics element does not extend beyond the vial diameter.
Two types: Type OB (central opening, non-overlapping plastics) and Type OD (complete tear-off tab, non-overlapping plastics).

Dimensions and tolerances

Nominal sizes are specified (common sizes include 13 and 20); detailed dimensions are given in the standard and tolerances conform to ISO 2768‑1 and ISO 2768‑2.

Mechanical performance

Force required to remove the plastics component and to tear off the tab is specified and tested on a class 1 traction/pressure machine per ISO 7500‑1.
Test conditions: traction speed 100 mm/min, measuring range 100 N.
Maximum forces (Table values): for nominal size 13 - remove plastics ≤ 25 N, tear off tab ≤ 30 N; for nominal size 20 - remove plastics ≤ 35 N, tear off tab ≤ 40 N.

Sterilization, packaging and marking

Caps must withstand sterilization per ISO 8872; packaging and marking also follow ISO 8872 requirements.

Designation

Example: Cap ISO 8362-7-OD-13 (type OD, nominal size 13).

Applications and users

Practical use:

Ensures compatibility of aluminium‑plastic caps with automatic filling, labelling and storage equipment.
Guides quality control and incoming inspection (mechanical removal forces, dimensional checks).

Who uses this standard:

Pharmaceutical vial and closure manufacturers
Packaging engineers and automation integrators
Quality control and testing laboratories
Regulatory and procurement teams specifying compliant components

Related standards

ISO 8362 series: Part 1 (glass tubing vials), Part 3 (aluminium caps), Part 4 (moulded glass vials), Part 6 (aluminium‑plastics caps)

ISO 2768‑1 / ISO 2768‑2 (tolerances)

ISO 7500‑1 (force testing equipment)

ISO 8872 (aluminium caps - requirements, sterilization, packaging, marking)

Keywords: ISO 8362-7:2006, injection caps, aluminium-plastics combinations, injection vials, pharmaceutical packaging, tear-off tab, dimensions and tolerances, force test.

ISO 8362-7:2006 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

SIST EN ISO 8362-1:2019

Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)

SIST EN ISO 8362-4:2011

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

SIST ISO 2768-1:1999

General tolerances -- Part 1: Tolerances for linear and angular dimensions without individual tolerance indic…

ISO 2768-2:1989

General tolerances — Part 2: Geometrical tolerances for features without individual tolerance indications

SIST EN ISO 7500-1:2018

Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compr…

SIST EN ISO 8872:2023

Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials - General requirements and…

SIST EN ISO 8362-7:2011

Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without…

SIST EN ISO 8362-2:2024

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)