Introduction
In the pharmaceutical industry, packaging not only affects drug preservation and user convenience but also directly relates to regulatory adherence, logistic stability, and patient safety. Blister packaging is the most widely used format globally for solid dosage forms, commonly applied to tablets, capsules, and oral films. For pharmaceutical procurement, choosing the correct blister format and material can extend shelf life, reduce return rates, improve production quality, and boost market trust. This article explores blister types, materials, and selection guidance to support sound decision-making.
What Are Pharmaceutical Blister Packs?
Pharmaceutical blister packs are a packaging format where a single-dose drug is sealed between a transparent cavity and a backing material. They feature single-dose management to reduce contamination and dosing errors , as well as excellent sealing to block moisture and oxygen. The easy-push, tear-open design adds user convenience , and their compact size makes transport and storage easier. They also allow for clear labeling for batch and traceability compliance. Blister packs are commonly used for tablets, capsules, chewables, lozenges, oral dissolving films, and mini-tablets.
Common Types of Pharmaceutical Blister Packs
The three most common types of blister packs are Alu-PVC, Alu-Alu, and Cold Form.
- Alu-PVC: Has a low cost, visible contents, and is easy to form, but has moderate moisture resistance. It is recommended for daily OTC tablets.
- Alu-Alu: Provides an excellent barrier against moisture and light, but is opaque and has a higher forming cost. It is preferred for moisture/light-sensitive drugs and high-value or export drugs.
- Cold Form: Does not require heat forming and has great barrier and mechanical strength. Its disadvantages are a higher material cost and slower production speed. It is also recommended for moisture- or light-sensitive drugs.
Key Materials Used in Blister Packaging
- PVC: A low-cost, transparent cavity layer that is stable for thermoforming but has a poor barrier.
- PVDC: A coating layer that enhances moisture resistance and extends shelf life, though it has a slightly higher cost.
- OPA (Nylon): A stretchable and strong support layer often used in cold-formed structures.
- PP: A cavity substitute with good heat resistance, used for sterilizable products.
- Aluminum Foil: An airtight and lightproof backing material ideal for pharmaceutical packaging.
For powdered drugs like herbal powders or vitamins, aluminum pouches or bottles are more suitable.
How to Choose the Right Blister Pack for Your Product
Several factors should be considered when choosing blister type and materials:
- Product Characteristics: Use Alu-Alu or Cold Form for moisture-sensitive products and opaque aluminum foil for light-sensitive ones.
- Shelf Life Requirements: High-barrier composite materials like PVDC or OPA should be used for products requiring a shelf life of over two years.
- Target Market Regulations: The EU and US require clear labeling and tamper integrity.
- Production Line and Equipment: Use Alu-PVC for heat-forming machines to lower costs, or Cold Form for non-heat-forming machines.
- Brand and Visual Appeal: A transparent cavity with printed foil is great for branding.
Blister Packs and Regulatory Compliance
Key regulatory requirements for blister packaging in global markets include:
- Traceability: Requires a batch number, production date, and barcode.
- Seal Integrity: The packaging must pass seal strength and leakage tests.
- Label Clarity: The printed drug name, dosage, and usage must be clear.
- Child Resistance: Certain drugs require tamper-evident packaging.
- Material Compliance: Materials must meet FDA/EMA compatibility standards.
Always confirm that materials meet PIC/S, GMP, FDA, or EMA standards to avoid issues during international audits.
Frequently Asked Questions (FAQ)
- Q1: Does PVC blister affect drug quality?
- A: PVC alone has limited barrier performance. For moisture-sensitive drugs, use a PVDC coating or switch to Alu-Alu to extend shelf life.
- Q2: Should export products use Alu-Alu packaging?
- A: Yes, especially for humid regions or strict regulatory markets. Alu-Alu or Cold Form offers better protection.
- Q3: Can powder drugs be blister packed?
- A: Generally no, as blisters are best for solid forms like tablets and capsules. Powders are more often packed in bottles or pouches.
Our Packaging Equipment Solutions
We offer the following machines for efficient powder and granule filling:
- AF2000 Powder Filler: For pouches, paper bags, or bottles.
- AF100 Micro Filler: For small-dose, high-value powders.
- SF1002 Semi-Automatic Granule Filler: For bottles or pouches with granular meds.
We currently do not offer blister forming machines.
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Contact us to find the best packaging solution for your pharmaceutical product type and dosage. We can help you analyze the most suitable filling method and corresponding packaging options.