| Aluminium Foil Thickness |
Approximately 45–60 µm for many pharmaceutical cold-forming applications |
The aluminium layer is the primary barrier against moisture, oxygen, light, and many external contaminants. |
Use a thicker foil when the product has high moisture or oxygen sensitivity, the forming depth is demanding, or additional mechanical robustness is required. |
| Overall Laminate Thickness |
Often approximately 140–160 µm, depending on the forming and sealing layers |
Total thickness affects cavity strength, puncture resistance, forming behavior, package volume, and material consumption. |
Select the minimum validated thickness that provides adequate cavity formation, handling strength, and barrier performance without unnecessary material use. |
| Typical Laminate Construction |
Cold-forming layer / aluminium foil / heat-seal layer; common constructions may use polymer layers such as polyamide and PVC or PVC-free alternatives |
Each layer contributes to formability, barrier protection, printability, chemical resistance, and sealing performance. |
Choose the construction according to regulatory requirements, product compatibility, sealing temperature, recycling policy, and local market expectations. |
| Moisture Barrier |
Very high when the aluminium layer is continuous and pinhole-free; exact water-vapor transmission must be verified by test |
Helps protect hygroscopic powders, tablets, capsules, and moisture-sensitive active ingredients from degradation and changes in physical properties. |
Request water vapor transmission data for the finished structure and confirm performance after forming, sealing, transport, and aging. |
| Oxygen Barrier |
Very high for an intact aluminium barrier layer; performance depends strongly on pinholes, cracks, seals, and cavity geometry |
Limits oxidative degradation, potency loss, color change, odor change, and other oxygen-related stability problems. |
Evaluate oxygen transmission at the finished-pack level rather than relying only on flat-film data. |
| Light Protection |
Near-total light blocking when the aluminium layer remains continuous |
Protects light-sensitive formulations, including products affected by ultraviolet or visible-light exposure. |
Use alu alu packaging when light protection is a critical stability requirement; verify that printing, forming, and sealing do not expose weak areas. |
| Pinhole Control |
Must meet the agreed pharmaceutical packaging specification; acceptance limits vary by foil gauge, test method, and application |
Pinhole defects can create localized paths for moisture, oxygen, and light, reducing the effective barrier of the package. |
Specify a recognized pinhole inspection method and test the material after forming whenever cavity depth or geometry is demanding. |
| Forming Depth |
Common cavity depths are approximately 5–12 mm; deeper cavities require specific forming validation |
Cold forming creates stretching and bending stresses that may cause cracks, thinning, or loss of barrier integrity. |
Match foil gauge, forming-layer design, cavity shape, radius, and tooling to the required product dimensions. |
| Puncture and Tear Resistance |
Depends on aluminium gauge, polymer layers, laminate adhesion, cavity design, and testing direction |
Reduces the risk of package damage during production, cartoning, shipping, dispensing, and consumer handling. |
Use puncture, tear, and drop testing on the complete blister rather than evaluating the foil alone. |
| Heat-Seal Performance |
Validated through seal-strength testing across the selected temperature, pressure, and dwell-time window |
A strong, continuous seal prevents leakage and protects the product from environmental exposure through the blister perimeter. |
Confirm seal initiation temperature, operating window, seal strength, visual quality, and compatibility with the lidding foil. |
| Seal Integrity |
Should be evaluated using leak, dye-penetration, burst, or other applicable package-integrity methods |
Barrier performance is ineffective if the sealed package contains channels, wrinkles, contamination, or incomplete seals. |
Validate the complete packaging process, including line speed, sealing pressure, tooling condition, product contamination, and storage conditions. |
| Laminate Adhesion |
Specified by the converter and verified by peel or separation testing; no universal value applies to every structure |
Adequate interlayer adhesion helps prevent delamination during forming, sealing, transport, and long-term storage. |
Set acceptance criteria for initial adhesion and after accelerated aging, humidity exposure, and temperature cycling. |
| Chemical Compatibility |
Must be confirmed for the specific formulation, excipients, coating, ink, adhesive, and sealant system |
Certain products or volatile components can interact with polymer layers, coatings, adhesives, or sealants. |
Conduct compatibility, extractables, leachables, and stability assessments when the formulation is reactive, volatile, oily, or highly sensitive. |
| Temperature Resistance |
Use within the validated temperature range of the complete laminate and sealing process; polymer layers may limit performance |
Temperature affects forming, sealing, dimensional stability, adhesion, and product protection during storage and distribution. |
Validate both the packaging process temperature and the expected distribution range, including hot and cold transport conditions. |
| Surface Cleanliness |
Controlled for particles, oil, residue, and other contaminants according to the intended pharmaceutical packaging specification |
Contamination can interfere with sealing, increase particulate risk, and affect product quality or regulatory acceptance. |
Define cleanliness requirements, protective packaging, handling controls, and inspection procedures for the complete supply chain. |
| Regulatory and Compliance Documentation |
Typically includes material specifications, certificates of analysis, change-control procedures, and applicable food or pharmaceutical-contact declarations |
Documented control supports market authorization, supplier qualification, traceability, and consistent product quality across regions. |
Request documentation relevant to the destination market and confirm compliance with applicable packaging, chemical, and product-contact requirements. |
| Storage and Shelf-Life Stability |
Must be established through product-specific stability studies and package-integrity testing |
The selected structure must maintain its barrier and seal properties for the entire labeled shelf life. |
Assess real-time and accelerated stability using filled, sealed blisters exposed to the intended temperature and humidity conditions. |