INDUSTRY COMPONENT

Vial Body

Primary container component for pharmaceutical vials that holds sterile injectable drugs, vaccines, or biological products.

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
ParameterTypical rangeNotes & selection driver
Height35mm to 100mm
Capacity1mL to 100mL
Diameter13mm to 28mm (nominal)
Neck Finish13mm, 20mm (ISO 8362-1)
Wall Thickness0.8mm to 1.5mm
Bottom Thickness1.2mm to 2.5mm
Surface TreatmentSiliconization for glass vials

Ranges are indicative industry figures for RFQ preparation, not a supplier commitment. Confirm every value and standard with the legal manufacturer before ordering.

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

Parent Products

This component is used in the following industrial products

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

Typical Suppliers & Equivalents

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

A practical evidence checklist for RFQ preparation and supplier evaluation.

Technical documentation
Request current drawings, revision history, and a signed specification sheet.
Manufacturing capability
Verify equipment lists, process limits, capacity, and representative production evidence.
Inspection readiness
Confirm test methods, calibrated equipment, sampling plans, and traceable reports.
Supplier transparency
Check the legal entity, factory address, ownership, certifications, and direct contacts.

CNFX does not score or rank suppliers. Buyers must verify all claims and documents with the legal manufacturer before ordering.

Manufacturers of Vial Body

Manufacturer profiles associated with Vial Body.

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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.

Data Basis

Editorial classification, named public sources where available, and source-reviewed manufacturer records. See the editorial policy.

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.

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