The drug packaging design process must consider environmental conditions, medication requirements, and applicable regulations. This requires careful planning and selection of materials. Learn more about the key considerations of designing safe and effective medicine packaging.
Level of Packaging
Pharmaceutical packaging falls into three main categories: primary, secondary, and tertiary. Each has to meet specific requirements.
Primary materials are those that come in direct contact with medications. Examples include blister packs, vials, and segmented dispensing trays. They must directly protect the enclosed drugs while maintaining sterility.
Secondary packaging materials hold groups of primary packages. Display cartons and case packs of bottles fall into this category. This secondary medicine packaging design should consider branding and labeling in addition to physical protection.
Tertiary packaging is used for bulk storage and transport. This type of pharma packaging design should focus primarily on physical protection and organization.
Physical Security of Drugs
All packaging should ensure that medications are secure during storage and transport. Designers use appropriate materials, packaging dimensions, and sealing techniques to achieve this.
Drug packaging must be made of durable materials that can withstand the anticipated conditions. Plastics are ideal for this because they offer a high strength-to-weight ratio.
Manufacturing Best Practices
The pharmaceutical industry requires strict manufacturing practices for all packaging materials. Current regulations consider certain types of packaging to be part of medical devices. In these cases, manufacturing is subjected to the same level of scrutiny as the drugs and delivery devices themselves.
Additionally, all drug packaging designs should adhere to Food and Drug Administration requirements and Consumer Product Safety Commission guidelines.
FDA Requirements for Pharmaceutical Packaging
The Food and Drug Administration establishes requirements for drug packaging, including suitable materials, closure types, and labeling. They also address sterility requirements. Many drug packaging and labeling requirements are found in Title 21 of the Code of Federal Regulations, Parts 210 and 211.
Materials
Material selection should focus on the safety and stability of packaged drugs. According to the FDA, packaging materials used for pharmaceuticals must be chemically inert and non-reactive with the enclosed substances. They cannot leach any potentially dangerous chemicals into drugs.
Many materials must meet United States Pharmacopeia requirements, such as USP <661> for plastics. USP <661.1> and <661.2> cover raw materials and primary and secondary packaging components. They focus on suitability and testing for:
- Absorbance
- Acidity or alkalinity
- Biological reactivity
- Metals
Some packaging applications may require additional testing or review. Examples include tests for label adhesion and needle penetration.
Labeling
The FDA has strict regulations for drug labeling, covering label materials, placement, and content. Following established best practices for medical packaging design ensures that drugs are easily identifiable, which helps reduce the risk of administering incorrect products. It also facilitates recalls of tainted drugs and returns on expired ones.
Physical Design
All drug packaging designs must provide sufficient protection for the enclosed medications. Federal regulations apply to prescription, over-the-counter, and single-dose and multiple-dose drugs.
Package closures are also important. Drug packaging design should exclude moisture, bacteria, and other contaminants that could compromise the integrity of medications. To confirm proper sealing, packaging may require vacuum and dye ingress testing. Tamper-evident packaging ensures that enclosed pharmaceuticals are safe and unaltered.
Childproof containers are required under the Poison Prevention Packaging Act of 1970 in some instances. This requires packaging design to be difficult to open for most children under 5 years old while remaining easy for adults to open. The U.S. Consumer Product Safety Commission administers 16 CFR Subchapter E (parts 1700 to 1702) that covers these requirements.
Best practices for drug transportation and storage dictate that packaging must provide adequate protection from physical threats. Accommodations for temperature fluctuations and light exposure may also be necessary.
Good Manufacturing Processes
Current good manufacturing practices prevent drug contamination and preserve quality. Title 21 CFR Parts 210 and 211 outline CGMP regulations. Components include material selection, facility conditions, and record keeping.
Quality control practices play a major role in CGMP regulations. Pharmaceutical companies must show adherence to these during drug approval procedures.
Benefits of Plastic Packaging Trays for Medical Packaging
Plastics are lightweight and durable, offering excellent protection for sensitive medical devices, pharmaceuticals, and drug delivery products. They also provide:
- Cost-effectiveness: Many plastics are more cost-effective than other packaging materials. Their lightweight composition also reduces shipping and other transportation costs.
- Organization: Individual pockets in custom plastic trays keep drugs sorted and easily identifiable. They are ideal for separating pills and securely holding medical devices.
- Sterility: With easy-to-clean surfaces and multiple sterilization options, plastic drug packaging helps ensure medications are stored and transported in sterile conditions. Special sealing processes can improve this feature.
- Versatility: Plastic is very versatile. We can shape it into various configurations designed specifically for medical products and medications. This makes it an ideal medium for drug packaging design.
Furthermore, plastic is a sustainable solution for pharmaceutical packaging. At Ready-Made Plastic Trays, we use many recycled materials for our packaging products. We also work with suppliers who prioritize sustainability efforts, including alternative power and scrap material recycling.
Frequently Asked Questions About Drug Packaging Design
What are the different types of drug packaging?
There are many different types of drug packaging broken down into primary, secondary, and tertiary categories based on physical contact with medications. Blister packs, trays, vials, and bottles are among the most common choices for pharmaceutical manufacturers.
What are common materials used for drug packaging?
Plastic is among the most common materials used in drug packaging design. We frequently use recycled HIPS, but we can also use HIPS, RPET, and RPET ESD for specific medical applications. Glass, paperboard, foil, and plastic wrapping are also widely used.
What conditions does the package need to withstand?
Drug packaging design must consider typical conditions, which can vary widely between drug manufacturers. For example, warehouse or freezer storage may dictate material choice, and materials for shipping containers must generally absorb higher impacts than those used in primary packaging.
Safe, Secure Pharmaceutical Packaging
At Ready-Made Plastic Trays, we work with pharmaceutical companies and related manufacturers to create packaging that meets design specifications, budget parameters, and regulatory requirements. Learn more about our comprehensive drug packaging design process and request a free medical packaging sample today.
