EN 12377:2022

Overview

EN 12377:2022 is a European standard developed by CEN that specifies a test method for determining the airtightness of closures on flexible tubes. These flexible tubes are widely used in packaging for pharmaceutical, cosmetic, hygiene, food, and various industrial products. This standard ensures product integrity by testing the closure system's ability to maintain an airtight seal, preventing contamination and preserving the contents.

The test method described in EN 12377:2022 is applicable exclusively to flexible tubes with fixed closure systems integrated during production, excluding tubes with consumer-added external applicators or pumps. The standard supersedes EN 12377:2014, with an expanded scope to cover a broader range of flexible tubes.

Key Topics

• Scope: The test method applies to closures on flexible tubes for multiple sectors including pharmaceuticals, cosmetics, hygiene, and food industries.
• Test Principle: Detects air leakage by submerging the tube’s shoulder and closure under water while subjecting it to an internal air pressure of 0.25 bar. Escaping air bubbles indicate an airtightness failure.
• Testing Apparatus:
  • Air compressor capable of maintaining 0.25 ± 0.01 bar.
  • Precise manometer for pressure measurement.
  • Conical connector tailored to tube diameter for leak-free attachment.
  • Transparent water container large enough for immersion of tube closure.
• Testing Procedure:
  • Conduct tests at a stable temperature between 10 °C and 25 °C.
  • The open end of the tube is connected to the pressurized air source.
  • The closure and tube shoulder are immersed in water for at least 3 seconds.
  • Air bubbles appearing after the initial 3 seconds constitute a failure.
• Test Reporting: Detailed reporting includes batch identification, test results, number of defects, acceptance criteria, testing conditions, and tester information to support traceability and quality assurance.

Applications

• Pharmaceutical Packaging: Ensures sterile and contamination-free packaging for medicinal creams, gels, and ointments.
• Cosmetics: Protects sensitive cosmetic products such as lotions and creams from air exposure that could degrade active ingredients.
• Food Industry: Maintains freshness and hygiene of food pastes, sauces, and condiments sealed in flexible tubes.
• Hygiene Products: Assures airtight sealing for products like toothpaste and topical creams.
• Industrial Products: Applicable to flexible tubes used to package adhesives, lubricants, and other substances requiring airtight conditions.

Implementing the EN 12377:2022 test method promotes high-quality packaging with verified closure performance, reducing product recalls and improving consumer confidence.

Related Standards

• EN 12374: Packaging - Flexible tubes - Terminology
  Defines terms relevant to flexible tube packaging, supporting consistent interpretation of EN 12377.
• Other packaging and testing standards developed by CEN/TC 261 that complement quality assurance in flexible packaging solutions.

By adhering to EN 12377:2022, manufacturers and quality controllers can ensure compliance with European regulations for packaging performance, facilitating market access and enhancing product safety.

Keywords: EN 12377, flexible tubes, airtightness test, closure system, packaging standards, pharmaceutical packaging, cosmetic tubes, hygiene product packaging, food packaging, flexible tube closures, CEN standard, test method, airtight seal, packaging quality control.