PTP BLASTURA DE ALUMINIO

PTP blister aluminum foil is the core barrier material for blister packaging of pharmaceuticals, suplementos para la salud, y algunos alimentos. Se nombra porque los consumidores pueden presionar directamente el papel de aluminio con los dedos para acceder al contenido. Su valor central se encuentra en “Protección de barrera alta + acceso conveniente,” haciéndolo el más crítico y ampliamente utilizado en el campo de envasado farmacéutico.

Press Through Packaging Aluminum Foil, often referred to in the industry as “Papel de aluminio PTP” o “blister aluminum foil.” It is a “safety barrier” for pharmaceutical packaging—directly contacting pharmaceuticals (tabletas, cápsulas, etcétera), it must simultaneously meet four core requirements: propiedades de barrera, resistencia a la corrosión, resistencia a los pinchazos, and printability. It must also comply with mandatory standards such as the “Regulations on the Management of Pharmaceutical Packaging Materials and Containers” issued by the National Medical Products Administration (NDWA).

Structural Composition (5-layer composite structure with clear functional layers)

PTP blister de aluminio is not a single aluminum foil, but a “functional multi-layer material” formed through coating and printing. The functions of each layer are as follows:

1. Outer Protective Layer (OP Layer)

– Cloruro de polivinilo (CLORURO DE POLIVINILO), polipropileno (PÁGINAS), or Acrylic Resin

– Protects the inner printing ink and prevents fading due to friction;

– Isolates external moisture and oil, preventing aluminum foil oxidation;

– Improves surface smoothness for easy traction in packaging machines.

– Thickness 3-5μm, transparent or translucent.

2. Outer Printing Layer

– Food/Pharmaceutical Grade Gravure Ink

– Prints drug information (trademark, batch number, expiration date, especificaciones);

– Some anti-counterfeiting features (such as dark patterns or fluorescent markings) can be printed.

– Thickness 1-2μm, mostly single or two-color (to prevent ink migration).

3. Aluminum Foil Base (AL Layer)

– 8011-H18 Aluminum Alloy (Pharmaceutical Grade)

– Core Barrier Layer: 100% blocks oxygen, vapor de agua, y ligero (especially UV rays), preventing drug oxidation, Diiquescencia, y degradación.

– Provides structural strength while ensuring “easy puncture” (can be pressed through with a finger without breaking).

– Espesor: 20-25micras (mainstream pharmaceutical grade specification; too thick is difficult to puncture, too thin is prone to damage).

4. Internal Printing Layer (Opcional)

– Pharmaceutical-grade transparent or light-colored ink

– Prints an internal traceability code (such as a QR code for drug traceability).

– Masks the natural color of the aluminum foil to prevent potential aluminum ion migration (although 8011 aluminum foil is highly stable, dual protection is still required).

– Espesor: 0.5-1micras, used only for high-end pharmaceutical packaging.

5. Heat Seal Adhesive Layer (VC Layer):

– Polyvinylidene Chloride (PVDC) or Ethylene Vinyl Acetate (EVA).

– Blister base (CLORURO DE POLIVINILO) Heat seals are required for rigid sheets, PVC/PVDC composite rigid sheets.

– Ensure heat seal strength (≥1.5N/15mm to prevent unsealing during transport) and meet temperature resistance standards (no delamination during sterilization).

– Espesor: 5-8micras, heat seal temperature: 120-150°C.

Key Technical Parameters (Pharmaceutical Grade Standards)

PTP aluminium blister foil parameters directly determine packaging safety and must strictly comply with industry standards. Core parameters are as follows:

1. Thickness Deviation

Base Thickness: ±3μm, Espesor total: ±5μm.

Excessive deviation can lead to unstable puncture force (too thick to remove medication, too thin to leak).

2. Resistencia al sello de calor:

≥1.5N/15mm (after heat sealing with Hoja rígida de PVC).

Substandard values can easily lead to “bubbling” during transportation and storage, potentially exposing medication to moisture.

3. Propiedades de barrera

Water Vapor Transmission Rate (WVTR): 0g/(m² ・ 24h)

Oxygen Transmission Rate (OTR): 0cm³/(m² ・ 24H ・ 0.1MPA)

The core value of the aluminum foil substrate; if it fails to meet the standards, the drug will easily deteriorate.

4. Puncture Force:

5-15N (easily penetrated by a finger, no sharp edges).

Undersized foils are prone to breakage; oversized foils can affect access (especially for elderly patients).

5. Hygienic Performance:

Heavy metals (lead, cadmium, mercury, arsenic) ≤ 10mg/kg;

Total residual solvents ≤ 5mg/m²;

No detectable microorganisms (p.ej., mi. coli, mold).

Direct contact with drugs and substandard hygiene can lead to drug contamination.

6. Corrosion Resistance

No corrosion or discoloration when immersed in a 5% acetic acid solution (60°C, 2 hours).

Prevents reactions with acidic drugs (such as aspirin) that could produce harmful substances.

Performance Characteristics

– Ultimate Barrier Properties:

The aluminum foil substrate is an “absolute barrier,” completely isolating oxygen, agua, ligero, and odors. This addresses the core pain point of pharmaceuticals, which suffer from oxidative deliquescence and photolytic ineffectiveness (por ejemplo, vitamin C, antibióticos, and other easily degradable drugs must be packaged in Papel de aluminio PTP).

– Precise and Easy Puncture:

The 8011-H18 alloy’s hardness (Vickers hardness HV 50-60) and thickness control enable “finger-penetration” without aluminum foil debris, ensuring both convenience and safety (preventing debris from contaminating the drug).

– Stable Heat Sealability:

The heat seal peel strength between the VC layer and the PVC / PVDC rigid sheet is stable, compatible with high-speed blister packaging machines (hasta 300-500 tablets/minute), and prevents delamination or leakage after sterilization (p.ej., moist heat sterilization at 121°C). Seguridad y cumplimiento:

All materials (tinta, adhesivo, and aluminum foil) are pharmaceutical grade, ensuring no components migrate into the drug. They comply with major global certifications (such as the US FDA and EU CE).

– Anti-Counterfeiting Compatibility:

A variety of anti-counterfeiting technologies (such as laser holographic patterns, invisible fluorescent inks, and microtext) can be integrated to address the issue of counterfeit and substandard drugs without compromising basic packaging performance.

Application Areas

1. Pharmaceuticals (Encima 80%)

Main Packaging Types: Embalaje de aluminio-plástico (Papel de aluminio PTP + PVC Sheet), Aluminum-Aluminum Blister Packaging (Papel de aluminio PTP + Aluminum Foil Base, for drugs requiring high barrier properties).

Applicable Drug Types:

Oral Solid Dosage Forms: Tablets (p.ej., cold tablets), cápsulas (p.ej., cephalosporin capsules), píldoras (p.ej., traditional Chinese medicine pills), and lozenges.

Specialty Medications: Medications that require protection from light (p.ej., nitroglycerin tablets), medications that require moisture protection (p.ej., effervescent tablets), and medications that require oxidation protection (p.ej., vitamin E capsules).

Medical Devices: Individual packaging for small medical consumables (p.ej., Band-Aids, disinfectant pads).

2. Food/Health Products

Applicable Products:

Health Products: Fish oil capsules, vitamin tablets, probiotic tablets (requires moisture protection).

Comida: Chocolate chips, mints, instant bird’s nest (individual small packaging for increased portability).

Production Process

The PTP aluminum blister foil production process is complex, with its core focus being “multi-layer composite precision control.” The main steps are as follows:

– Aluminum Foil Base Rolling:

8011 aluminum alloy cast coils are cold-rolled into 20-25μm thin aluminum foil. Recocido (H18 condition) is also performed to control hardness and elongation.

– Surface Pretreatment:

The aluminum foil undergoes degreasing and passivation to remove surface oil and oxide layers, improving adhesion to inks and adhesives.

– Impresión (Outer Layer + Inner Layer):

Printing is performed using a gravure printing press (precision 50-100 lines/cm) using pharmaceutical-grade inks, with a drying temperature controlled at 80-120°C (to prevent residual solvents).

– Revestimiento (Protective Layer + Adhesivo):

A comma blade coater is used to apply an OP layer to the outer layer of the aluminum foil and a VC layer to the inner layer. The coating thickness deviation is controlled within ±1μm. After drying, the foil is cooled and set.

– Slitting and Inspection:

The foil is slit into rolls (width 100-1700mm) according to customer requirements (such as blister machine width). Espesor, heat seal strength, and barrier properties are tested roll by roll, and unqualified products are directly rejected.

Industry Trends (High Barrier, Verde, and Intelligent)

– High Barrier Upgrade:

Traditional PTP aluminum foil (AL+PVC) is gradually being upgraded to “AL+PVC/PVDC” y “AL+EVOH” composite structures to further enhance oxygen and water vapor barrier properties, meeting the packaging requirements of biologics and high-end pharmaceuticals.

– Green and Environmentally Friendly:

Material: Developing recyclable PTP aluminum foil (p.ej., solvent-free adhesives and biodegradable OP layers) to reduce VOC (volatile organic compound) emissions. Process side: Use water-based ink instead of solvent-based ink to reduce environmental impact and improve safety.