In recent years, the U.S. Food and Drug Administration (FDA) issued Circular No. 132, which emphasized that for biological products, partially acid or alkali-sensitive injections, and pH-sensitive formulations, the 121°C particle method should be used for water resistance of Grade 1, while internal surface water resistance should meet HC1 standards. The regulation also recommends using pharmaceutical-grade glass or other suitable packaging materials. This updated guideline is seen as a clear signal from regulators to tighten industry standards, reflecting a growing focus on product safety and quality.
According to market research, the global pharmaceutical packaging sector has surpassed $30 billion since 2010, with a compound annual growth rate (CAGR) of 6.3%. Among various packaging types, pharmaceutical bottles are experiencing the highest growth, driven by rising demand for safe and reliable drug delivery systems. Industry experts suggest that China’s pharmaceutical sector is at a crucial stage of transformation, with continuous improvement in standards and alignment with international benchmarks being essential for sustainable growth and market expansion.
Industry insiders note that the production of medical bottles involves rigorous requirements. For example, in China, over 10 billion medical plastic bottles are consumed annually. However, due to strict specifications such as lightweight design, high strength, shatter resistance, excellent sealing performance, moisture resistance, and hygiene standards, most domestic production equipment still relies on imports. Many processes, such as molding without subsequent cleaning or drying, must meet stringent criteria before being approved for use in medical applications.
The direct contact between medicine and its container can pose risks if the material is not stable or properly tested. Such issues may lead to chemical reactions, affecting drug quality and even causing serious health consequences. As a result, regulatory oversight has become increasingly strict, with authorities continuously enhancing monitoring and compliance measures.
To stay competitive, domestic pharmaceutical bottle manufacturers must constantly upgrade their production standards and expand their capabilities to meet diverse packaging needs. Ensuring the safety and reliability of their products is not just a requirement but a fundamental responsibility in the industry. By focusing on innovation and quality, these companies can better support the evolving demands of the pharmaceutical market.
Full Cassette Motorized Retractable Awning
Full Cassette Motorized Retractable Awning,Motorized Retractable Folding Arm Awnings,Full Cassette Retractable Motorized Awning,Full Cassette Retractable Motorised Awning
Hebei Charlotte Enterprise Co., Ltd. , https://www.hbcharlotteawning.com