Packaging regulations can be daunting, especially in the highly regulated world of pharmaceuticals. Ensuring that pharmaceutical products are packaged safely, securely, and in compliance with all applicable standards is not only a legal requirement but also a critical aspect of safeguarding public health. In this blog post, we will delve into the vital considerations that pharmaceutical companies must keep in mind when it comes to packaging their products. From maintaining product integrity to adhering to stringent regulatory guidelines, we'll explore the key factors that contribute to successful pharmaceutical packaging.

When packaging pharmaceuticals, carefully consider the following guidelines.



Compatibility testing should be conducted to ensure the packaging material will not react with or compromise the quality of the product. Furthermore, you should monitor and assess how temperature and humidity can affect the packaging to ensure the product is stored properly and will not deteriorate.

In addition, does the process required to package the product affect the product itself? Some types of packaging will expose the products they are protecting to heat as part of the packaging process.  In some cases, this can have a detrimental impact on the effectiveness and shelf life of the pharmaceuticals.



You must conduct sterility testing to ensure that the packaging does not compromise the sterility of injectable products. Cleanliness and sterility are key when your products are ingestible. Sterility in pharmaceutical packaging is vital to ensure patient safety, regulatory compliance, product efficacy, quality assurance, brand reputation, and global distribution of pharmaceutical products.



Confirm that the expiration date for each drug is accurate and test to determine the shelf life of a product within chosen packaging prior to distribution. Further, stability in pharmaceutical packaging is essential to maintain medication efficacy, ensure patient safety, comply with regulations, uphold quality standards, extend shelf life, and support global distribution of pharmaceutical products.

It is important to employ rigorous testing and quality control measures throughout the packaging process to guarantee that pharmaceutical products remain potent and safe from production through to patient use.



All pharmaceuticals must feature accurate labels with information such as directions for use, active ingredients, and weight/measurements. These labels must meet FDA guidelines to ensure consumer safety.

Consider the following. Firstly, they provide essential information to healthcare professionals and patients, ensuring the correct identification and usage of medications, which is crucial for patient safety. Secondly, labels convey important regulatory and compliance information, helping pharmaceutical companies meet legal requirements and quality standards. Additionally, labels often include barcodes, aiding in inventory management and tracking throughout the supply chain. Finally, they can also carry branding and marketing information for the pharmaceutical company, facilitating product recognition and differentiation in the market. Overall, labels play a vital role in ensuring the safety, quality, and effectiveness of pharmaceutical products.



Many pharmaceuticals should be packaged in child-resistant containers to prevent accidental ingestion. When selecting packaging materials, pay special attention to child safety features, including tamper proof designs.

Why is child safety important in pharmaceutical packaging? Child-resistant packaging safeguards the well-being of children, adheres to legal and regulatory requirements, mitigates the risk of accidental poisonings, and upholds a company's ethical obligations.



Make sure you think about the environment in every packaging decision. Consider eco-friendly packaging materials and optimization of size or weight to reduce waste.

In many cases, pharmaceutical manufacturers are finding ways to use fiber-based packaging products (i.e. paper) in place of plastics. Sustainability also applies to the amount of energy required for the packaging process. While sometimes necessary, shrink film requires large heat tunnels which require a significant amount of energy to operate. This expensive and has a much larger environmental impact than some alternatives. For example, ultrasonic banding can often replace shrink film to unitize retail cartons for distribution purposes.


At Felins, we offer a number of solutions for pharmaceutical packaging. Our machines and equipment guarantee precise, repeatable, and efficient secondary packaging so you can meet regulatory requirements in pharmaceutical packaging in the most consistent way.




FDA’s Labeling Resources for Human Prescription Drugs | FDA

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