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 testing of Grade 1 materials, with internal surface water resistance classified as HC1. This regulation highlights the importance of selecting appropriate pharmaceutical packaging materials, such as high-grade glass or other suitable alternatives. These provisions are seen by industry professionals as a clear signal that regulatory bodies are tightening standards across the sector.
According to industry data, the global pharmaceutical packaging market has grown significantly, surpassing $30 billion by 2010, and continues to expand at a compound annual growth rate (CAGR) of 6.3%. Among all packaging types, pharmaceutical bottle packaging is experiencing the fastest growth. Experts suggest that the domestic pharmaceutical industry is currently undergoing a crucial phase of transformation and upgrading. Raising industry standards and aligning with international benchmarks have become essential goals for sustainable growth and market expansion.
Industry insiders note that the production of medical bottles is highly regulated. For instance, in the case of plastic bottles, China consumes over 10 billion medicinal plastic bottles annually. However, due to stringent requirements—such as lightweight design, high strength, unbreakability, excellent sealing performance, moisture resistance, hygiene, and the ability to be used directly after molding without cleaning or drying—domestic manufacturers still rely heavily on imported equipment for production.
The direct contact between medicine bottles and the drugs they contain makes material stability critical. Any instability can lead to chemical reactions, potentially compromising drug quality and even posing serious health risks. As a result, regulatory oversight in this area has been increasing steadily.
To remain competitive, domestic pharmaceutical bottle manufacturers must continuously improve their production standards and adapt to evolving packaging demands for a wider range of drug forms and dosages. Ensuring product safety remains a top priority, not just for compliance, but for maintaining consumer trust and long-term industry sustainability.
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