Penetration Zone: Diameter 13-20 mm, Thickness 1.5-3.0 mm

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

Parameter	Typical range	Notes & selection driver
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

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 8871, ISO 8362, USP <381>, EP 3.2.9, FDA 21 CFR Part 211

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.

View Product Details

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

Typical Suppliers & Equivalents

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)

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 Penetration Zone

Manufacturer profiles associated with Penetration Zone.

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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.

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.

Penetration Zone