Nowadays, disposable blister packaging is very popular. However, there are regulations and standards that apply to thermoformed blister packaging. The specific regulations and standards may vary by country or region.

Let me introduce to you some commonly ones include:

ISO 11607

This is an international standard that specifies the requirements for materials, design, and testing of pre-formed sterile barrier systems, including thermoformed blister packaging, used in healthcare facilities. It covers aspects such as package integrity, microbial barrier properties, and performance testing.

FDA (Food and Drug Administration) Regulations:

In the United States, the FDA has regulations that govern packaging materials used for food, drugs, and medical devices. Manufacturers need to comply with specific requirements to ensure the safety and quality of thermoformed blister packaging for these industries. The FDA's Code of Federal Regulations (CFR) Title 21, specifically Part 820 (Quality System Regulation) and Part 211 (Good Manufacturing Practices for Finished Pharmaceuticals), contains relevant guidelines.

Pharmacopeial Standards:

Various pharmacopeial organizations, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.), provide standards and guidelines for packaging materials used in pharmaceutical products. These standards often include specific requirements for blister packaging related to materials, closure systems, and performance testing.



Child-Resistant Packaging:

Many countries have regulations requiring child-resistant packaging for certain products, such as medications and chemicals. These regulations typically define specific testing methods and criteria to ensure that the packaging effectively prevents access by young children.



Consumer Product Safety Commission (CPSC) Regulations

In the United States, the CPSC regulates packaging for consumer products to prevent hazards, such as choking, suffocation, or ingestion of small parts. The regulations focus on child-resistant packaging, warning labels, and other safety fea.