ISO 4802-2:2023 PDF

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification

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ISO 4802-2:2023

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 15
Дата публикации:: 4 декабря 2023 г.
Издание:: ISO IS 4802 edition 4 version 1
ICS:: 71.040.20

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ruen

Срок поставки:3 раб. дн. (перевод)

Цена:225 €

Описание (английский):

This document specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this document. The test method specified in this document might not be applicable to containers whose surfaces have been treated for functional modifications, e.g. silicone (e.g. containers that are ready for direct filling).

Технические детали

Технический комитет: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 4802-2:2023

Abstract

Overview

ISO 4802-2:2023 - Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification describes a standardized laboratory method to evaluate how the inner surfaces of glass containers resist hydrolytic attack by water. The test uses controlled heating (121 ± 1 °C for 60 ± 1 min) and quantifies released alkali/alkaline‑earth species (notably sodium) in the extraction solution by flame atomic emission or absorption spectrometry (flame spectrometry). The document also defines a classification system (HC 1, HC 2, HC 3, HC B, HC D) for container hydrolytic resistance.

Key technical topics and requirements

Test conditions: containers filled with specified water, loosely capped and heated at (121 ± 1) °C for (60 ± 1) min.
Analytical method: measurement of sodium and other alkali/alkaline‑earth oxides in the extract by flame atomic emission or absorption spectrometry.
Sample preparation: detailed procedures for cleaning, determination of filling volume (different rules for ampoules, syringes, flat‑ or round‑bottomed containers), and sample size.
Classification: assignment to hydrolytic classes (HC 1, HC 2, HC 3, HC B, HC D) based on measured ion release and container‑specific limit values. Briefly:
- HC 1 - neutral/borosilicate glass with very high hydrolytic resistance (suitable for most preparations including parenterals);
- HC 2 - soda‑lime glass with high resistance due to surface treatment;
- HC 3 - typical soda‑lime‑silica glass with moderate resistance (often for non‑aqueous or less demanding uses).
Scope limitations: may not be applicable to containers whose internal surfaces have been functionally modified (e.g., silicone‑coated containers ready for direct filling).
Harmonization: updated to align cleaning and autoclaving procedures with Ph. Eur.; includes containers down to 0.5 ml filling volume.

Practical applications

Pharmaceutical packaging qualification: verifying primary packaging (vials, ampoules, syringes, cartridges, bottles) for parenteral and other drug products.
Quality control and lot release: routine testing to ensure glass batches meet hydrolytic resistance requirements.
Material selection and supplier qualification: comparing glass types (borosilicate vs soda‑lime‑silica) and surface treatments.
Regulatory support: producing test reports and classification data required by regulators or pharmacopeial monographs.

Who should use ISO 4802-2:2023

Quality control laboratories in pharmaceutical and medical device companies
Packaging engineers and material scientists selecting container types
Regulatory affairs and compliance teams preparing submissions
Glass manufacturers and contract testing organizations

Related standards

ISO 4802-1 (titration method for hydrolytic resistance)
ISO 719, ISO 720 (hydrolytic resistance of glass grains)
Ph. Eur. and USP <660> (pharmacopoeial context for glass types and classifications)

Using ISO 4802-2:2023 helps ensure reproducible, comparable hydrolytic resistance data for glass containers and supports safe selection and qualification of primary packaging for pharmaceutical use.

Overview

Key technical topics and requirements

Test conditions: containers filled with specified water, loosely capped and heated at (121 ± 1) °C for (60 ± 1) min.
Analytical method: measurement of sodium and other alkali/alkaline‑earth oxides in the extract by flame atomic emission or absorption spectrometry.
Sample preparation: detailed procedures for cleaning, determination of filling volume (different rules for ampoules, syringes, flat‑ or round‑bottomed containers), and sample size.
Classification: assignment to hydrolytic classes (HC 1, HC 2, HC 3, HC B, HC D) based on measured ion release and container‑specific limit values. Briefly:
- HC 1 - neutral/borosilicate glass with very high hydrolytic resistance (suitable for most preparations including parenterals);
- HC 2 - soda‑lime glass with high resistance due to surface treatment;
- HC 3 - typical soda‑lime‑silica glass with moderate resistance (often for non‑aqueous or less demanding uses).
Scope limitations: may not be applicable to containers whose internal surfaces have been functionally modified (e.g., silicone‑coated containers ready for direct filling).
Harmonization: updated to align cleaning and autoclaving procedures with Ph. Eur.; includes containers down to 0.5 ml filling volume.

Practical applications

Pharmaceutical packaging qualification: verifying primary packaging (vials, ampoules, syringes, cartridges, bottles) for parenteral and other drug products.
Quality control and lot release: routine testing to ensure glass batches meet hydrolytic resistance requirements.
Material selection and supplier qualification: comparing glass types (borosilicate vs soda‑lime‑silica) and surface treatments.
Regulatory support: producing test reports and classification data required by regulators or pharmacopeial monographs.

Who should use ISO 4802-2:2023

Quality control laboratories in pharmaceutical and medical device companies
Packaging engineers and material scientists selecting container types
Regulatory affairs and compliance teams preparing submissions
Glass manufacturers and contract testing organizations

Related standards

ISO 4802-1 (titration method for hydrolytic resistance)
ISO 719, ISO 720 (hydrolytic resistance of glass grains)
Ph. Eur. and USP <660> (pharmacopoeial context for glass types and classifications)

ISO 4802-2:2023 PDF

Технические детали

Abstract

Overview

Key technical topics and requirements

Practical applications

Who should use ISO 4802-2:2023

Related standards

Похожие стандарты

Abstract

Overview

Key technical topics and requirements

Practical applications

Who should use ISO 4802-2:2023

Related standards

Похожие стандарты

Glass — Hydrolytic resistance of the interior surfaces of glass containers — Methods of test

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