Flip-Off Button: Diameter 13-20 mm, Height 3-8 mm

Component Specifications

Definition

A mechanical sealing component used in pharmaceutical vials that provides a tamper-evident closure system. It consists of a plastic or aluminum button that flips off when the vial is opened for the first time, indicating potential tampering and ensuring product integrity during storage and transport.

Working Principle

The flip-off button operates through a mechanical interlock with the vial's rubber stopper and aluminum cap. When the vial is sealed, the button is crimped in place. During opening, applying upward force breaks the tamper-evident band, allowing the button to flip off, which visually indicates the vial has been accessed.

Materials

Typically made from aluminum alloy (e.g., 1050, 1100 series) or medical-grade plastics (e.g., polypropylene, polyethylene). Materials must comply with USP <661> and USP <87>/<88> for biocompatibility.

Technical Parameters

Parameter	Typical range	Notes & selection driver
Color	Typically aluminum silver or colored for identification
Height	3-8 mm
Diameter	13-20 mm
Breaking Force	5-15 N
Sterilization Compatibility	Autoclave, gamma irradiation, ETO

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 8362-4, DIN 58366, USP <671>

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

Tampering not detected if improperly sealed
Material incompatibility with drug formulation
Sterility breach during manufacturing

FMEA Triads

Trigger: Improper crimping during sealing
Failure: Button detaches prematurely or fails to indicate tampering
Mitigation: Implement automated vision inspection systems and torque monitoring during crimping

Trigger: Material degradation from drug interaction
Failure: Leaching or corrosion compromising drug safety
Mitigation: Conduct compatibility testing per USP <661> and use approved materials

Trigger: Human error during manual assembly
Failure: Inconsistent sealing leading to sterility issues
Mitigation: Automate assembly processes and provide operator training

Industrial Ecosystem

Compatible With

Typical Suppliers & Equivalents

Compliance & Inspection

Tolerance

±0.1 mm for critical dimensions, breaking force within ±10% of specification

Test Method

Visual inspection, torque testing, seal integrity testing (e.g., dye ingress), sterility testing per ISO 11737

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 Flip-Off Button

Manufacturer profiles associated with Flip-Off Button.

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Compiled and source-reviewed by the CNFX editorial team. Each manufacturer above links to the page on that company's own website where the product is listed, with the date we checked it. How we source and review

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Frequently Asked Questions

What is the primary function of a flip-off button in pharmaceutical vials?

The primary function is to provide tamper-evident protection, visually indicating if a vial has been opened or compromised, ensuring drug safety and integrity.

Can flip-off buttons be reused after removal?

No, flip-off buttons are designed for single use. Once removed, they cannot be reattached securely, maintaining the tamper-evident feature.

What materials are commonly used for flip-off buttons?

Common materials include aluminum alloys and medical-grade plastics like polypropylene, chosen for sterility, durability, and compliance with pharmaceutical 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.

Flip-Off Button