INDUSTRY COMPONENT

Penetration Zone

The designated area on a rubber stopper designed for needle penetration during pharmaceutical vial filling and administration.

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Component Specifications

Definition
A precisely engineered zone on pharmaceutical vial rubber stoppers that facilitates sterile needle penetration while maintaining container closure integrity. This area is specifically designed to allow repeated punctures without compromising the seal or generating particulate matter, ensuring safe drug delivery and storage.
Working Principle
The penetration zone operates by providing a controlled thickness and material composition that allows hypodermic needles to penetrate cleanly while the surrounding rubber material self-seals upon needle withdrawal. This maintains sterility and prevents contamination or leakage through elastic recovery and compression properties.
Materials
Typically made from pharmaceutical-grade elastomers: bromobutyl rubber (BIIR), chlorobutyl rubber (CIIR), or synthetic rubber blends. Must meet USP <381> and EP 3.2.9 standards for elastomeric closures.
Technical Parameters
  • Diameter 13-20 mm
  • Hardness 40-50 Shore A
  • Thickness 1.5-3.0 mm
  • Resealability ≥5 punctures
  • Penetration Force 5-15 N
  • Particulate Matter ≤600 particles ≥10μm per vial
Standards
ISO 8871, ISO 8362, USP <381>, EP 3.2.9, FDA 21 CFR Part 211

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Penetration Zone.

pharmaceutical rubber stopper vial penetration zone sterile closure needle penetration container closure integrity elastomeric closure drug delivery system Penetration Zone Penetration Zone in Chemical Manufacturing

Parent Products

This component is used in the following industrial products

Pharmaceutical Vial Rubber Stopper

Elastic closure for pharmaceutical vials providing sterile seal and needle penetration.

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Engineering Analysis

Risks & Mitigation
  • Coring and particulate generation
  • Incomplete resealing leading to contamination
  • Leakage due to material fatigue
  • Chemical interaction with drug formulation
FMEA Triads
Trigger: Improper needle geometry or insertion angle
Failure: Coring and particulate contamination
Mitigation: Use non-coring needles and standardized insertion protocols
Trigger: Material degradation from sterilization or drug interaction
Failure: Loss of resealing capability
Mitigation: Validate material compatibility and sterilization cycles

Industrial Ecosystem

Compatible With

Interchangeable Parts

Compliance & Inspection

Tolerance
±0.2 mm thickness, ±0.5 mm diameter
Test Method
USP <381> Elastomeric Closure Functionality, ISO 8871 Self-sealability test, Container Closure Integrity Testing (CCIT)

Buyer Feedback

★★★★☆ 4.5 / 5.0 (8 reviews)

"Great transparency on the Penetration Zone components. Essential for our Chemical Manufacturing supply chain."

"The Penetration Zone we sourced perfectly fits our Chemical Manufacturing production line requirements."

"Found 20+ suppliers for Penetration Zone on CNFX, but this spec remains the most cost-effective."

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Frequently Asked Questions

How many times can a penetration zone be punctured?

High-quality penetration zones are designed to withstand 5 or more punctures while maintaining seal integrity, though single-use is recommended for optimal sterility.

What causes coring in penetration zones?

Coring occurs when needle design, angle, or rubber hardness causes small fragments to be removed during penetration. Proper needle geometry and optimized rubber formulation minimize this risk.

Can I contact factories directly?

Yes, each factory profile provides direct contact information.

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