Overview - ISO 13926-1:2018 (Pen systems: Glass cylinders for pen-injectors)
ISO 13926-1:2018 specifies design, materials, performance and test methods, and gives recommended dimensions for glass cylinders used in pen‑injectors for medical use. It applies to primary containers in direct contact with drug products and is the Part 1 standard in the ISO 13926 pen systems series. The document ensures glass barrels meet packaging, compatibility and quality requirements needed for safe, stable drug delivery in pen-based injection systems.
Key topics and technical requirements
- Materials: Colourless (cl) or amber (br) glass of hydrolytic resistance grain glass in accordance with ISO 720 - corresponding to pharmacopoeial glass type 1. Glass must be free of seeds/bubbles that interfere with visual inspection.
- Dimensions and geometry: Nominal dimensions and tolerances for bore, outer diameter and flange are specified (see Table 1 and Figure 1). The cylinder opening should be cylindrical for the specified depth; a slightly conical (truncated cone) opening is allowed only if the larger diameter does not exceed the smaller by more than 0.3 mm.
- Sealing surface: Sealing surface must be flat, free from ripples or undulations to ensure closure integrity with plunger stoppers and seals.
- Hydrolytic resistance: Internal surface must meet HC 1 container class when tested per ISO 4802‑1 or ISO 4802‑2 (and linked to ISO 720 for classification). Bottom end is sealed prior to testing.
- Annealing quality: Residual stress limits are expressed as optical retardation not exceeding 40 nm per mm of glass thickness when viewed in a strain viewer; test method to be agreed between manufacturer and customer.
- Change control: Chemical composition changes to glass require at least nine months’ notice to users.
- Designation & marking: Product designation format (e.g., Cylinder ISO 13926-1-cl-11,6) and package marking requirements (designation, lot, quantity, manufacturer) are specified.
- Compatibility and validation: Dimensional selection and system validation (glass cylinder + plunger stopper + seal) must follow ISO 11608‑3. Related parts: ISO 13926‑2 (plunger stoppers) and ISO 13926‑3 (seals).
Applications and users
This standard is used by:
- Medical device and pen‑injector manufacturers designing or qualifying cartridge/barrel components.
- Glass tubing and primary packaging suppliers producing pharmaceutical glass cylinders.
- Pharmaceutical formulation and packaging engineers validating container–closure systems for drug products.
- Quality assurance, regulatory affairs, and testing laboratories performing hydrolytic resistance, dimensional, and stress tests.
Practical applications include selection and procurement of pen‑injector barrels, design verification, incoming inspection criteria, and validation of container–closure compatibility for injectable drugs.
Related standards
- ISO 720 - Hydrolytic resistance of glass grains
- ISO 4802‑1 / ISO 4802‑2 - Hydrolytic resistance of interior surfaces of glass containers
- ISO 11608‑3 - Needle-based injection systems: finished containers (validation)
- ISO 13926‑2 - Plunger stoppers for pen‑injectors
- ISO 13926‑3 - Seals for pen‑injectors
Keywords: ISO 13926-1:2018, pen systems, glass cylinders, pen‑injectors, hydrolytic resistance, HC1, sealing surface, annealing quality, primary container, ISO 11608-3.
