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FDA 2025 Aluminum Bottles +33%

News

FDA 2025 Aluminum Bottles +33%

2025-06-17

The New FDA Regulations Trigger Industry Turbulence, and Merrynewon Takes the Lead in Breaking Through

In early 2025, the new regulations issued by the FDA put forward a number of strict requirements for medical packaging, including an oxygen/water vapor barrier rate ≥ 99.9%, a 12-month stability test in extreme environments, and full life cycle blockchain traceability. Facing this industry challenge, Merrynewon's seamless Aluminum Bottles, with an ultra-high barrier rate of 99.99% and excellent performance of no deterioration in extreme environments for 18 months, far exceed the new regulatory standards, becoming one of the first innovative products to meet the requirements.

FDA

Three Core Technologies, Creating Excellent Performance

(I) Patented Laser Cold Welding, Creating a Seamless Barrier

Using independently developed laser cold welding technology, the bottle body is formed in one piece. The weld strength reaches 600MPa, completely eliminating leakage hazards. It has obtained patent certifications from China, the United States, and the European Union

OEM Alu Bottle

(II) Aviation-grade Aluminum Material, Ensuring Long-term Stability

Selecting 7075-T6 aviation-grade aluminum alloy material, its corrosion resistance is 2.5 times higher than that of traditional aluminum materials. Moreover, it complies with the FDA food contact material safety standard (21 CFR 175.300), safeguarding drug quality from the source.

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((III) Blockchain Traceability, Achieving Transparent Supervision

Through blockchain technology, users can view the full-link data from bauxite mining to terminal sales by scanning the code, covering raw material batches, welding parameters, sterilization records, etc., meeting the strict requirements of the FDA for supply chain transparency.

Custom Aluminum Bottle

 

III. Widely Adopted by Global Pharmaceutical Enterprises, with Remarkable Market Achievements

Currently, Merrynewon's seamless aluminum bottles have been recognized by more than 20 well-known global pharmaceutical enterprises and are widely used in the packaging of important drugs such as vaccines and insulin. After a multinational vaccine manufacturer changed the packaging, the number of transportation batches in Southeast Asia decreased by 42%, and the warehousing cost dropped by 38%. For a European anti-cancer drug enterprise, the product recall rate dropped sharply from 0.7% to 0.03%, fully verifying its practical application value.

IV. Production Expansion Plan: Meeting Global Compliance Requirements

As the new FDA regulations trigger a chain reaction globally and many countries follow up with strict standards, Merrynewon plans to expand the production capacity of seamless aluminum bottles by 50% by the end of 2025 and simultaneously build a clean workshop that meets EU standards to satisfy the urgent demand of global pharmaceutical enterprises for high-quality and compliant packaging.

Conclusion :

From technological breakthroughs to industry leadership, Merrynewon's seamless aluminum bottles have broken the technical barriers of international medical packaging with strong strength. It not only provides compliant and efficient packaging solutions for global pharmaceutical enterprises but also redefines the quality standards of medical packaging. In the future, Merrynewon will continue to focus on innovation and promote the medical packaging industry to a higher level.