Pharmaceutical package testing ensures the safety, efficacy, and usability of the medicinal products. Packaging not only protects the sensitive drug products like vaccines or prescriptions from environmental factors like light, moisture, and air, but testing also prevents contamination and damage during storage and transportation. A lot of vital data can be gathered from comprehensive pharmaceutical package testing, data that will not only help save manufacturers money, but ultimately save the lives of patients.
Pharmaceutical Package Testing: A Case Study
Let’s imagine we’re packaging engineers at a leading pharmaceutical company, and we’re developing packaging for a new oral drug product that is prescribed in small tablets. The packaging consists of a plastic container with a twist-off cap and an aluminum foil seal.
Based on industry regulations, there are a few packaging requirements we must consider. The container must be tight and secure to prevent moisture and air from entering or exiting, and the cap must be easy to open and close by the users. The foil seal must be intact and tamper-evident to ensure that the product has not been tampered with or contaminated. The packaging must also comply with the regulations of the Food and Drug Administration (FDA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
With this information in mind, we’ll design and engineer the packaging. The design and engineering phases include identifying the critical requirements and functional needs of the packaging, such as the container size, material, and closure mechanism, as we did above.
Next, we’ll develop a prototype. This prototype will have to go through pharmaceutical package testing to determine its suitability and performance. This may include tests on the container’s resistance to compression, leakage, and chemical compatibility with the drug product.
Then, we’ll validate the packaging. This phase evaluates the packaging’s suitability and performance under actual handling, storage, and transportation conditions. This involves subjecting the packaging to several test conditions, such as temperature and humidity variations, vibration, and impact. The packaging must also pass child-resistant and senior-friendly accessibility tests to ensure that the product is safe and easy to open for its intended users.
The testing results are documented and reviewed for compliance with the regulatory requirements and internal quality standards.
The packaging testing process requires close collaboration between the packaging manufacturer, pharmaceutical manufacturer, and regulatory agencies to ensure the safety, efficacy, and usability of the drug products. By working closely with these bodies and testing your packaging thoroughly, you should have a product that is safe, effective, and ready for market.
Why Is Pharmaceutical Package Testing Important?
Pharmaceutical package testing won’t only ensure patient safety and regulatory compliance. It also provides benefits for manufacturers as well, including cost savings and enhanced marketability.
- Safety: This is the most critical factor in pharmaceutical packaging testing. The packaging must be designed and tested to ensure that it can protect the product from contamination, damage, moisture, and other elements. If the packaging fails, it can result in harm to the user, and potentially lead to lawsuits against the manufacturer.
- Regulatory Compliance: Pharmaceutical products are strictly regulated by the government, and package testing helps ensure that the packaging meets the requirements of regulatory bodies such as the FDA. Any failure to comply with the regulations can result in delayed product approvals, fines, and recalls, all which can cost the manufacturer time and money.
- Shelf Life Validation: The pharmaceutical product must maintain its potency and quality for an extended period. Package testing determines the shelf life of the product by studying the effects of various environmental factors. Testing ensures that the packaging can protect the product from degradation and maintain its integrity.
- Marketability: Packaging is often the first thing consumers interact with, and a product with a poorly designed package or faulty packaging will put off potential buyers. Testing ensures that the package is not only aesthetically pleasing but also functional.
- Cost Savings: Finding defects during the packaging testing phase saves the cost of recalls and lost sales due to customer complaints
Protect Your Pharma Product
Pharmaceutical package testing is crucial for ensuring the safety, regulatory compliance, and market viability of medicinal products. Through rigorous testing, manufacturers can identify and mitigate potential risks, such as contamination, damage, and user accessibility issues, safeguarding the health of patients and meeting FDA standards.
For expert guidance in pharmaceutical package testing that meets the highest industry standards, reach out to Purple Diamond. With years of experience in the field, our package testing experts can help ensure your products are safe, compliant, and ready for market. Connect with us today to take the next step in protecting your pharmaceutical products and your customers.