GOST 34036-2016 PDF

Full title and description

GOST 34036-2016 — "Упаковка стеклянная из стекломассы для лекарственных средств. Общие технические условия" (English: Glass packaging for medicines. General specifications). The standard establishes general technical requirements for glass containers (bottles and jars) made from glass melt intended for packaging, storage and transportation of medicinal products.

Abstract

GOST 34036-2016 defines classification, technical quality requirements, permissible dimensional and capacity deviations, acceptance rules and control methods, marking and packaging requirements, storage and transport conditions, and instructions for use of glass packaging intended for medicines. It is an interstate (межгосударственный) standard adopted for use by the participating states of the Commonwealth/Customs area and introduced into the Russian national standards system.

General information

• Status: Active / In force (introduced for the first time; replaces earlier national documents).
• Publication date: Introduced into force 1 June 2018 (approved by Rosstandart order dated 7 September 2017). Original designation year: 2016.
• Publisher: Adopted as an interstate standard and introduced into the Russian Federation national system by the Federal Agency for Technical Regulation and Metrology (Rosstandart).
• ICS / categories: Packaging and distribution of goods — bottles, pots, cans (OKS/ICS classification: 55.100).
• Edition / version: GOST 34036-2016 (first edition introduced 2018).
• Number of pages: 16 pages (typical published text length).

Scope

This standard applies to glass-packaging items produced from glass melt — specifically bottles and jars — intended for filling, storage and transportation of pharmaceutical products and medicinal substances. It covers classification of container types, mandatory technical and dimensional requirements, permissible defects and deviations, testing and inspection methods, acceptance rules, marking, packing, transportation and storage conditions, and recommendations for exploitation. The document is intended for application across the states participating in the interstate standard.

Key topics and requirements

• Classification of glass containers (types, shapes, nominal capacities) and coding/marking conventions.
• Technical requirements for material and product quality (surface quality, absence of critical defects, chemical compatibility with medicines).
• Permissible deviations of main parameters and dimensional tolerances; capacity tolerances from nominal values.
• Rules of acceptance and sampling plans; methods of control and testing (visual, dimensional, mechanical, thermal resistance where applicable).
• Requirements for packaging, marking, labeling, transportation and storage conditions to preserve product integrity.
• Normative references to related GOST/ISO documents used for test methods and related requirements.

Typical use and users

Primary users include pharmaceutical manufacturers and contract fillers, glass packaging producers and converters, quality control and testing laboratories, regulatory and conformity assessment bodies, packaging engineers, and logistics/warehouse specialists responsible for storing and transporting medicinal products. The standard is used when specifying and procuring glass containers for medicine packaging and when performing incoming inspection and quality control.

Related standards

GOST 34036-2016 cites and is used alongside a number of national and international normative documents, including (examples of normative references listed in the standard): GOST 1341-97, GOST 13903-2016 (methods for thermal resistance testing of glass packaging), GOST 15150-69 (climatic categories for storage/transport), GOST ISO 8106-2014, and other GOSTs and ISO-derived standards relevant to packaging, marking and test methods. It also forms part of a family of glass-packaging standards (for example GOST 34035-2016, GOST 33811-2016).

Keywords

glass packaging; pharmaceutical packaging; bottles; jars; classification; marking; acceptance rules; test methods; storage; transportation; GOST 34036-2016.

FAQ

Q: What is this standard?

A: GOST 34036-2016 is an interstate technical standard titled "Упаковка стеклянная из стекломассы для лекарственных средств. Общие технические условия" (Glass packaging for medicines — General specifications) that sets general requirements for glass containers used with medicinal products.

Q: What does it cover?

A: It covers classification of bottles and jars, material and product quality requirements, permissible dimensional and capacity deviations, acceptance and sampling rules, test and inspection methods, requirements for marking, packaging, storage and transport, and related normative references.

Q: Who typically uses it?

A: Pharmaceutical manufacturers, packaging suppliers, QC/testing laboratories, regulatory authorities and logistics/warehouse personnel involved with medicinal product packaging, inspection and transport.

Q: Is it current or superseded?

A: It is current (in force). The standard was introduced into force on 1 June 2018 by Rosstandart (Order N 1032‑st dated 7 September 2017). With its introduction, the earlier national standard ГОСТ R 53416-2009 was cancelled effective 1 June 2018.

Q: Is it part of a series?

A: Yes — it belongs to a set of standards addressing glass packaging and related topics (other GOSTs in the series cover glass packaging for cosmetics and perfumes, recycled cullet for glass melting, and specific test methods). The document also references multiple GOST/ISO test-method standards used across packaging standards.

Q: What are the key keywords?

A: Key keywords include: glass packaging; bottles; jars; pharmaceutical packaging; marking; acceptance rules; test methods; storage; transportation; classification.