Differences between Ordinary Coloured Aluminium And Pharmaceutical-grade Coloured Aluminium

Differences in the manufacturing processes of ordinary coloured aluminium and pharmaceutical-grade coloured aluminium

Material pre-treatment process

Ordinary coloured aluminium:

Only requires conventional cleaning (removal of oil stains and oxide layers), with a focus on surface flatness to ensure coating adhesion, and low requirements for residual impurities.

Pharmaceutical-grade coloured aluminium:

Requires ultra-clean pre-treatment, including multiple precision cleaning steps (e.g., electrolytic degreasing, pure water rinsing) to remove trace heavy metals, microorganisms, and particles. Some processes may require high-temperature annealing to eliminate residual processing stresses, ensuring no risk of contaminant migration from the substrate.

Production environment control

Standard coloured aluminium:

Produced in conventional industrial workshops with no special requirements for air cleanliness, temperature, or humidity.

Pharmaceutical-grade coloured aluminium:

Produced in GMP-certified cleanrooms (e.g., Class 100,000 or higher cleanliness level), where air is filtered, and personnel wear sterile clothing to prevent the introduction of impurities or microorganisms during production, ensuring the product meets pharmaceutical hygiene standards.

Quality inspection items

Ordinary coloured aluminium:

Mainly tests coating adhesion, corrosion resistance, colour difference, and other appearance and mechanical properties.

Pharmaceutical-grade coloured aluminium:

In addition to routine testing, additional hygiene and safety tests are required, such as heavy metal content (lead ≤ 0.1 mg/kg), microbial limits (total bacterial count ≤ 10 CFU/g), and solvent residue (≤ 5 mg/m²), and must comply with national pharmaceutical packaging material standards (e.g., YBB standards).

Differences between ordinary coloured aluminium and pharmaceutical-grade coloured aluminium coatings

Coating material safety

Ordinary coloured aluminium:

Uses industrial-grade coatings (such as polyester or fluorocarbon-based coatings), which may contain trace amounts of volatile organic compounds (VOCs), heavy metal impurities, or additives. These coatings do not need to comply with food/pharmaceutical contact safety standards and only need to meet basic performance requirements such as weather resistance and adhesion.

Pharmaceutical-grade coloured aluminium:

Must use food and pharmaceutical-grade specialised coatings (e.g., water-based environmentally friendly resins, pharmaceutical-grade inks), strictly prohibiting harmful substances such as lead, cadmium, and phthalates. All components must pass migration testing (simulating pharmaceutical storage environments to ensure no component leaching contaminates pharmaceuticals).

Coating functionality focus

Ordinary coloured aluminium:

Focuses on weather resistance and aesthetics (e.g., UV resistance, acid-alkali corrosion resistance, colour stability), used in construction, home appliances, and other scenarios, without considering compatibility with pharmaceuticals.

Pharmaceutical-grade coloured aluminium:

Emphasises chemical inertness and protective properties. The coating must be compatible with pharmaceuticals (e.g., tablets, capsules) and the packaging environment (e.g., humidity, temperature) without causing chemical reactions. It must also have sufficient barrier properties to prevent external moisture and oxygen from infiltrating and affecting pharmaceutical stability.