GOST R 53416-2009 PDF

Full title and description

GOST R 53416-2009 — Тара стеклянная для лекарственных средств. Общие технические условия (Glass containers for medicines. General specifications). The standard establishes classification, technical requirements, dimensional tolerances, acceptance rules, test methods, marking, packaging, transportation and storage requirements for glass jars and bottles used for pharmaceutical products.

Abstract

GOST R 53416-2009 specifies general technical conditions for glass containers intended for packaging and storage of medicinal products. It covers types and designation of jars and flacons, permitted materials (medical glass grades), surface and dimensional requirements, inspection and sampling procedures, permitted defects, test methods (including thermal and water‑resistance checks), marking and labelling, and handling/packaging and storage rules applicable to pharmaceutical glassware.

General information

• Status: Active / in force (national standard of the Russian Federation).
• Publication date: Approved 20 October 2009; effective (date of introduction) 1 March 2010.
• Publisher: National standard of the Russian Federation — Federal Agency for Technical Regulation and Metrology (Rosstandart); developed by ООО "Эксперт‑Стандарт".
• ICS / categories: OKS/ICS 55.100 (packaging and containers for products; pharmaceutical packaging).
• Edition / version: Original adoption: 2009 (GOST R 53416-2009).
• Number of pages: 16 pages (standard text).

Scope

The standard applies to glass containers — primarily jars (банки) and flacons (флаконы) — used in the medical and pharmaceutical industries for packaging and storage of medicinal products. It establishes classification by neck type (examples: БВ — jars with screw neck; БТ — jars with triangular rim; ФВ — flacons with screw neck), principal dimensions and nominal/full capacities, allowable dimensional deviations, quality and appearance requirements, sampling and acceptance rules, test methods and requirements for packaging, marking, transportation and storage.

Key topics and requirements

• Classification and designation of containers (type codes, nominal/full capacity, neck diameter, glass grade and standard reference).
• Material requirements — medical glass grades referenced (e.g., ОС, ОС‑1, МТО) and water‑resistance per related GOSTs.
• Dimensional tolerances for key dimensions (height, body diameter, wall and base thickness, neck/internal diameter) and methods for measurement and control.
• Surface and defect limits — prohibited defects (cracks, through chips, foreign inclusions, etc.) and allowable minor imperfections.
• Acceptance rules and sampling plans (references to statistical sampling standard GOST R ISO 2859‑1 and related test methods).
• Specific test methods referenced (thermal resistance testing, water‑resistance, capacity measurement and other inspection procedures).
• Marking, labelling and conditional designation format for finished items; packaging, storage and transport requirements for pharmaceutical glassware.

Typical use and users

Primary users are pharmaceutical manufacturers, glass container producers and toolmakers, quality control and testing laboratories, regulatory and certification bodies, procurement and supply chain specialists, and engineering/design teams that specify packaging for sterile and non‑sterile medicinal products. The standard is used to ensure interchangeability, compliance with pharmaceutical safety and stability requirements, and to guide incoming inspection and acceptance of glass packaging.

Related standards

Normative references and related documents commonly cited within GOST R 53416-2009 include: GOST R ISO 2859‑1 (sampling procedures), GOST 19808 (medical glass — grades), GOST 19809 (medical glass — water‑resistance test), GOST 13903 (thermal resistance testing for glass containers), GOST 24980 (methods for control of glass packaging), and other packaging, marking and testing standards referenced in the normative references section of the standard.

Keywords

GOST R 53416-2009; glass containers; pharmaceutical packaging; jars; flacons; medical glass; dimensional tolerances; marking; sampling; testing; thermal resistance; water resistance.

FAQ

Q: What is this standard?

A: GOST R 53416-2009 is the Russian national standard titled "Glass containers for medicines. General specifications" that sets general technical requirements for glass jars and flacons used in pharmaceutical packaging.

Q: What does it cover?

A: It covers classification, key dimensions and tolerances, material (medical glass grades), prohibited surface defects, acceptance and sampling procedures, test methods (thermal and water‑resistance among others), marking, packaging, transportation and storage rules for pharmaceutical glass containers.

Q: Who typically uses it?

A: Pharmaceutical manufacturers, glassware producers, quality/control labs, certification bodies, and procurement or engineering teams specifying sterile and non‑sterile medicinal product packaging.

Q: Is it current or superseded?

A: As published, GOST R 53416-2009 was approved in 2009 and introduced 1 March 2010; available sources list it as the active (in‑force) national standard. Users should verify the current legal/status repository for any amendments or replacements before relying on the text in regulatory or certification contexts.

Q: Is it part of a series?

A: The standard is a general technical specification for a class of products and references multiple related GOST/GOST‑R and ISO‑based standards for sampling, glass grades and test methods; it complements more specific standards or technical documents that set detailed dimensions or requirements for particular container types.

Q: What are the key keywords?

A: Glass containers; pharmaceutical packaging; jars and flacons; medical glass; dimensional tolerances; testing; marking; GOST R 53416-2009.