Difference Between 8011 a 8079 Alloy in Pharma Packaging

Difference Between 8011 a 8079 Alloy in Pharma Packaging

Difference Between 8011 a 8079 Alloy in Pharma Packaging

In the field of pharmaceutical packaging, aluminum foil is not only a packaging material but also a key guarantee for the stability and safety of drugs. Especially in the blister packaging system, aluminum foil needs to meet multiple requirements such as barrier performance, mechanická pevnosť, forming consistency, heat seal stability, and regulatory compliance simultaneously.
Among numerous aluminum foil alloy systems, 8011 a 8079 alloys are currently the two most widely used grades in pharmaceutical aluminum foil. Avšak, in actual procurement and engineering selection, they are often simply regarded as “replaceable materials”, which can often lead to hidden dangers in high-risk preparation packaging.
Starting from the perspectives of alloy composition, organizational performance, processing adaptability, and pharmaceutical application logic, this article systematically analyzes the essential differences between 8011 a 8079 alloys in Pharma Packaging, providing professional technical support for pharmaceutical packaging engineering selection and material procurement.
Medicinal packaging aluminum foil-1
Medicinal packaging aluminum foil-1

I. Differences in Alloy Systems and Chemical Compositions

From a materials science perspective, both 8011 a 8079 belong to the Al–Fe–Si series aluminum alloys, but their composition control strategies are significantly different, and this difference directly determines the subsequent performance differentiation and application boundaries of the two.

1. 8011 Zliatina

  • The Fe content is relatively high, which is one of the core characteristics of its composition.
  • The Si content is controlled within a moderate range, forming a reasonable ratio with Fe.
  • There are many Fe-rich phases distributed in the microstructure, which affect the basic mechanical properties of the material.

2. 8079 Zliatina

  • The Fe content is significantly lower than that of 8011, and the composition control is more stringent.
  • The Si content is strictly controlled at a low level to reduce the interference of impurities on performance.
  • The microstructure is more refined and uniform, without obvious phase segregation.
Core Conclusion on Engineering Impact: The reduction of Fe content endows 8079 alloy with better ductility and pinhole resistance during thin-gauge rolling, which is the fundamental reason for its preferential adoption in high-end pharmaceutical packaging and the direct impact of the core composition difference between the two.

II. Differences in Mechanical Properties and Forming Behavior

In pharmaceutical blister packaging, aluminum foil is usually used in the O state (soft state). Its performance focus is not high strength, but ductility, crack resistance, and forming consistency adapted to the blister forming process—these three performances directly determine the packaging production efficiency and qualified product rate.

1. Elongation and Plasticity

  • 8011 Hliníková fólia: It has a relatively high elongation, suitable for blister forming of conventional thickness (≥20μm). The forming process is not prone to obvious uneven deformation, and the process stability is good. Avšak, in ultra-thin specifications (<20μm), the plasticity decreases significantly, and the forming risk increases sharply.
  • 8079 Hliníková fólia: It has higher elongation than 8011 and more uniform plasticity distribution. Its core advantage is concentrated in the field of ultra-thin pharmaceutical aluminum foil ≤20μm. Even in the cold forming or deep drawing process, it can effectively avoid defects such as cracking and creasing, and the forming consistency is better.

2. Pinhole Resistance

Pinholes are one of the most critical failure risks of pharmaceutical aluminum foil. Once pinholes appear, they will directly damage the barrier of aluminum foil, leading to the penetration of water vapor and oxygen, which in turn affects drug stability. The difference in pinhole resistance between the two alloys directly determines the applicable drug grade.
  • 8011 Hliníková fólia: It has stable pinhole resistance in the conventional thickness range of 20–25μm, which can meet the packaging needs of ordinary preparations. Avšak, when the thickness is reduced below 20μm, the pinhole rate will increase significantly, which cannot guarantee high protection requirements.
  • 8079 Hliníková fólia: Relying on its refined and uniform microstructure, it can still maintain an extremely low pinhole rate in 16–20μm or even thinner specifications. Its pinhole resistance is far superior to that of 8011, which can effectively meet high protection demand scenarios.
Záver: When drugs have extremely high requirements for moisture and oxygen resistance (such as highly hygroscopic and photosensitive preparations), or ultra-thin aluminum foil is needed to achieve packaging lightweight, 8079 alloy has an irreplaceable engineering advantage.
Medicinal packaging aluminum foil
Medicinal packaging aluminum foil

III. Correlation Between Barrier Performance and Drug Stability

Theoretically, the aluminum foil itself has complete barrier properties to gases (kyslík, vodná para) a svetlo. Avšak, in practical applications, ten “effective barrier performance” of aluminum foil is not determined by the material itself alone, but depends on the comprehensive performance of “material integrity × forming consistency × defect control ability”—this is also the core difference between the two alloys in the application of barrier performance.

1. Barrier Performance of 8011 Hliníková fólia

It is suitable for ordinary oral solid preparations (such as ordinary tablets and capsules). Such drugs have moderate sensitivity to humidity and relatively short storage cycles. 8011 aluminum foil can meet basic barrier requirements under conventional thickness, and has more advantages in cost control, making it the most cost-effective choice in large-scale production.

2. Barrier Performance of 8079 Hliníková fólia

It is more suitable for highly hygroscopic and photosensitive drugs (such as biological preparations, long-acting preparations, and easily oxidizable preparations). Such drugs have strict requirements on the storage environment and need to maintain a low humidity and oxygen-free state for a long time. Relying on its excellent material integrity and forming consistency, 8079 aluminum foil can continuously and stably exert its barrier effect during long-term storage, reduce the risk of drug degradation, and is more suitable for the packaging of export-grade or high-regulatory market (such as EU and Japan) products.

IV. Coating Adaptability and Heat Seal Stability

Pharmaceutical aluminum foil usually needs to be matched with substrates such as PVC, Pvdc, and PP, or adopt an ALU-ALU composite structure. Preto, the adaptability of the aluminum foil surface to coatings (such as heat seal layers and protective layers), coating adhesion, and stability during heat sealing directly affect the packaging tightness and production efficiency, especially adapting to the needs of high-speed blister production lines.

1. 8011 Zliatina

It has stable surface energy and good compatibility with conventional heat seal coating systems (such as polyolefin-based coatings). It has a wide heat seal temperature range, adapts to the production rhythm of most high-speed blister lines, has a low risk of coating peeling, and can meet the stability requirements of large-scale production.

2. 8079 Zliatina

Its surface is more delicate and smooth, without obvious impurity protrusions, and the bonding area with the coating is more uniform. Preto, the coating adhesion consistency is higher, and the peel strength fluctuation is smaller during heat sealing, with more stable sealing effect. In high-standard GMP production lines, the batch stability of heat seal consistency of 8079 aluminum foil can effectively reduce the risk of poor packaging tightness, making it more suitable for the production requirements of high-end preparations.
hliníková fólia
hliníková fólia

V. Differences in Regulatory Compliance and Market Positioning

From the perspective of global pharmaceutical packaging regulations, both 8011 a 8079 alloys can meet the compliance requirements of mainstream markets, including FDA (21 CFR), EÚ 1935/2004, and China Pharmaceutical Packaging Material Standard (YBB Standard), and both can be used as packaging materials in direct contact with drugs. Avšak, in actual market applications, there is an obvious positioning stratification between the two, adapting to different product needs and market scenarios.

1. Market Positioning of 8011 Hliníková fólia

  • It is the most widely used globally, covering mass categories such as conventional generic drugs, OTC products, and ordinary oral preparations.
  • Its core advantage lies in the “balance between cost and performance”, which is suitable for pharmaceutical enterprises sensitive to packaging costs and pursuing large-scale production.
  • The market supply is sufficient, the procurement channels are wide, the selection threshold is low, and it is the “basic model” alloy aluminum foil in pharmaceutical packaging.

2. Market Positioning of 8079 Hliníková fólia

  • It is mainly used in high-value-added preparations, such as biological preparations, innovative drugs, long-acting sustained-release preparations, and high-end generic drugs.
  • It has higher acceptance in high-standard regulatory markets such as the EU and Japan, and is more suitable for the product packaging needs of export-oriented pharmaceutical enterprises.
  • It is the preferred choice of high-end pharmaceutical customers, and its core value lies in “extreme protection and risk control” rather than cost advantage.

VI. 8011 vs 8079: Summary of Application Scenario Decision Logic

Dimension
8011 Hliníková fólia
8079 Hliníková fólia
Alloy Stability
Dobre, stable performance in conventional specifications
Better, maintaining excellent stability in thin specifications
Ultra-thin Specification Capability
generál, only suitable for conventional thickness ≥20μm
Vynikajúci, suitable for 16–20μm and thinner specifications
Pinhole Resistance
Stredná až vysoká, stable performance in conventional thickness
Vysoký, maintaining low pinhole rate in thin specifications
Forming Consistency
Stable, suitable for conventional forming processes
More stable, suitable for cold forming and deep drawing processes
Cost Control
Better, outstanding cost performance
Vyšší, focusing on high-end demand scenarios
Applicable Drugs
Conventional preparations, generic drugs, OTC products
Highly sensitive preparations, innovative drugs, export-grade products
Aluminum foil strip
Aluminum foil strip

Záver: There Is No “Better”, Only “More Suitable”

In Pharma Packaging, 8011 a 8079 are not competitive relations, but two core material systems with precise division of labor based on different application needs. The core of their selection logic is “matching drug characteristics, production processes and risk control needs”, rather than simply comparing the advantages and disadvantages of alloy grades.
If your goal is large-scale production and controllable cost, and the drug has moderate requirements for packaging protection (such as ordinary oral solid preparations), 8011 is a rational and cost-effective choice; if your focus is on ultra-thin packaging structure, extreme barrier performance, long-term storage stability, or adapting to high-standard regulatory markets, 8079 can reflect long-term value and effectively reduce the risk of packaging failure.
A truly professional pharmaceutical packaging selection never focuses on the alloy grade itself, but returns to the overall logic of drug stability, production processes and risk control to achieve precise matching of materials, processes and product needs.

QA: Common Selection Questions and Professional Answers

  • Q1: Can 8011 a 8079 aluminum foils be directly replaced without adjusting the packaging process? A1: Direct replacement is not recommended. The performance differences between the two will affect production stability and packaging safety. Small-batch trial production verification should be carried out in combination with thickness and process parameters before replacement.
  • Q2: What is the approximate cost difference between the two alloy aluminum foils, and how to balance cost and packaging risk? A2: Under the same thickness, the cost of 8079 je 10%-15% higher than that of 8011. For conventional preparations, 8011 is preferred to control costs; for highly sensitive and export-grade preparations, 8079 is preferred to control risks.
  • Q3: The Fe content of 8079 aluminum foil is lower, will it affect its stability in long-term use? A3: Nie. 8079 makes up for the lack of Fe content by strictly controlling Si content and refining the structure, with better long-term stability, suitable for preparations with long storage cycles.
  • Q4: Is there any difference in compliance between the two aluminum foils, and what should be paid special attention to when exporting to the EU and Japan markets? A4: There is no essential difference in compliance, and both meet mainstream standards. For exporting high-end preparations, 8079 is preferred, and component testing and impurity control certificates should be provided.
  • Q5: For the selection of ultra-thin specification (<20μm) hliníková fólia, besides 8079, is there any optimization space for 8011? A5: The optimization space is limited. The pinhole rate of 8011 ultra-thin specifications is prone to increase. If selected, it is recommended to control the thickness at 18-20μm and strengthen quality inspection.