How to Maintain Blister Packaging Compliance
When it comes to blister packaging materials for pharmaceuticals and food, error can cause harm to the end-user. That’s why manufacturers are required to adhere to FDA packaging compliance standards.
Let’s explore the material regulations used for blister packaging, including adhesives, ink, lidding materials, and rubbers.
What Are the FDA Regulations for Blister Packaging Materials?
Manufacturers are required to comply with FDA regulations for the following blister packaging materials:
Adhesives
A good blister pack adhesive must be strong enough to keep the package sealed and secure but also flexible enough to allow for easy opening and closing. Adhesives used on blister packs must also be appropriate for food and pharmaceutical contact applications and not leach any toxic or hazardous substances into the product or its environment. The adhesive must also be free from visible particles or other impurities that could contaminate the product.
Inks
Ink used on blister packaging must meet the requirements set out by the FDA’s current Good Manufacturing Practices (cGMP) to ensure patient safety. According to the guidelines, the ink shouldn’t contain any ingredients considered toxic or hazardous, such as heavy metals and solvents. The FDA also requires the use of non-migratory inks, which means that the ink should remain within the printed area and not leach into the medication or food. To guarantee that inks stay within their designated area, manufacturers must use a printing method that prevents ink migration, such as inkjet printing.
Rubbers
To ensure that rubbers used in blister packaging meet FDA standards, manufacturers must select food-grade rubbers, meaning they’re safe for human consumption. Rubbers used on blister packs also can’t contain any toxic substances, and they’re required to be non-allergenic and non-irritant. Like ink, rubbers must also be resistant to the migration of chemicals and meet the FDA’s requirements for seal strength.
Lidding Materials
The FDA has strict regulations when it comes to selecting lidding materials for blister packaging. To ensure the safety and efficacy of the product, the FDA requires that the selected material be compatible with the drug and any other materials used in the packaging process. Additionally, lidding materials must not react with the drug and should have a minimum thickness to provide adequate protection from moisture and other environmental contaminants.
FDA Tablet Packaging Compliance Requirements
When it comes to medications, the FDA has a number of regulatory requirements regarding pharmaceutical packaging. Design guidelines must be compatible with the dosage and must consist of materials safe for use with the required method of administration. The materials used in pharmaceutical packaging must also prevent any adverse effects on the quality of a dosage. When it comes to blister packs specifically, manufacturers are also required to provide evidence of tampering and promote the integrity of the protected medication. By adhering to these regulations, pharmaceutical companies can ensure their products are as safe and effective as possible.
Along with printing adhesives, there’s a wide range of child-resistant packaging requirements you must meet before your product can make it to market.
The Benefits of Blister Packaging
When it comes to product visibility, blister packaging stands out from other packaging options. By displaying products in clear packaging, customers can get an immediate visual representation of the product. Another great advantage of blister packaging is the tamper-evident seal. By sealing the product with a clear plastic blister, businesses can prevent customers from opening the package prior to purchase.
Key Takeaways
- Manufacturers are required to comply with FDA regulations for blister packaging materials.
- Adhesives must be free from visible particles or other impurities that could contaminate the product.
- Inks shouldn’t contain any ingredients considered toxic or hazardous, such as heavy metals and solvents.
- Rubbers must be resistant to the migration of chemicals and meet the FDA’s requirements for seal strength.
- Substrates should have a minimum thickness to provide adequate protection from moisture and other environmental contaminants.
Blister Packaging Machines Designed With Compliance in Mind
At Ascend, our blister packaging machines are specifically designed to ensure maximum safety and compliance with industry standards. Our equipment features advanced engineering and technology that allow for precision sealing and filling. When you partner with us, you can ensure your products are securely and safely sealed to meet FDA packaging compliance. Contact us today to learn more about our blister packaging machines.
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Ascend Packaging Systems LLC is focused on bottle filling and blister packaging for the pharmaceutical industry. With our mix of self-manufactured and distributed products, we can support our customers with all their packaging equipment needs.
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Ascend Packaging Systems LLC.
3885 Industrial Avenue
Rolling Meadows, IL 60008
