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Vial Body Component – Chemical Manufacturing

Component Specifications

Definition

The vial body is the main cylindrical container in pharmaceutical vial assemblies, designed to maintain sterility, prevent contamination, and ensure drug stability through precise dimensional tolerances, material compatibility, and sealing integrity. It serves as the primary barrier between the pharmaceutical product and external environments.

Working Principle

Functions as a hermetic containment vessel using glass or polymer materials that provide chemical inertness and barrier properties. Works with closures (stoppers/caps) to create sealed systems that prevent microbial ingress, maintain vacuum or inert gas atmospheres, and allow sterile withdrawal of contents via syringe puncture.

Materials

Type I borosilicate glass (ISO 719), cyclic olefin copolymer (COC), cyclic olefin polymer (COP), or polyethylene terephthalate (PET). Glass vials typically have 3.3 expansion coefficient; polymer vials meet USP <661> and <381> standards.

Technical Parameters

Height 35mm to 100mm
Capacity 1mL to 100mL
Diameter 13mm to 28mm (nominal)
Neck Finish 13mm, 20mm (ISO 8362-1)
Wall Thickness 0.8mm to 1.5mm
Bottom Thickness 1.2mm to 2.5mm
Surface Treatment Siliconization for glass vials

Standards

ISO 8362-1, ISO 11040-4, USP <660>, USP <381>, EP 3.2.1, DIN 58368

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Vial Body.

Parent Products

This component is used in the following industrial products

Pharmaceutical Vials

Sterile glass or plastic containers designed for storing and dispensing pharmaceutical products, vaccines, and injectable medications.

View Product Details

Engineering Analysis

Risks & Mitigation

Glass breakage during handling
Delamination of inner surfaces
Particulate contamination
Inadequate sealing with closures
Chemical interaction with drug formulation

FMEA Triads

Trigger: Thermal shock during sterilization
Failure: Glass cracking or breakage
Mitigation: Controlled heating/cooling rates during depyrogenation; use of annealed glass

Trigger: Incompatible material-drug interaction
Failure: Drug degradation or precipitation
Mitigation: Material compatibility testing per USP <1660>; use of certified materials

Trigger: Dimensional variation in neck finish
Failure: Leakage or stopper pop-up
Mitigation: Statistical process control of molding; 100% dimensional inspection

Industrial Ecosystem

Compatible With

Interchangeable Parts

Compliance & Inspection

Tolerance

±0.2mm diameter, ±0.3mm height, ±0.1mm wall thickness per ISO 8362-1

Test Method

Dimensional verification (CMM), visual inspection (USP <790>), particulate testing (USP <788>), extractables testing (USP <1663>)

Procurement Evaluation Criteria

Not customer reviews or live demand data. These dimensions support RFQ preparation and supplier evaluation.

Technical documentation

4/5

Manufacturing capability

4/5

Inspection readiness

5/5

Supplier transparency

3/5

These scores are example evaluation dimensions, not real customer ratings, country-specific buyer feedback, or live inquiry activity.

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Frequently Asked Questions

What are the main differences between glass and polymer vial bodies?

Glass vials (Type I borosilicate) offer superior chemical resistance and clarity but are brittle. Polymer vials (COC/COP) provide better break resistance, lighter weight, and reduced delamination risk but may have different barrier properties.

How are vial bodies tested for integrity?

Through helium leak testing, vacuum decay testing, high-voltage leak detection (HVLD), and visual inspection for defects per USP <1207> and ISO 8362 standards.

Can I contact factories directly?

Yes, each factory profile provides direct contact information.

Data Basis

CNFX manufacturer profiles, technical classification, publicly available product information, and ongoing plausibility checks.

Preliminary Technical Classification

This page supports structured research, RFQ preparation, and supplier evaluation. It does not replace buyer-led supplier qualification, standards review, or technical approval.

Vial Body