I. Definition and Classification
Pharmaceutical/Medical Blister Packaging refers to primary packaging for pharmaceuticals and medical devices manufactured from medical-grade thermoplastic sheets using vacuum/pressure thermoforming (blister) processes. It is divided into two main categories:
Pharmaceutical Blister Packaging (PTP): Used for solid dosage forms such as tablets and capsules (commonly known as "aluminum-plastic" blister packs).
Medical Sterile Blister Packaging: Used for sterile trays and blister boxes for medical devices (including implantable and aesthetic medical devices).
II. Core Compliance Standards
Pharmaceutical Packaging: Chinese Pharmacopoeia 2025 Edition – Guidelines for Plastic Materials and Containers for Pharmaceutical Packaging
Medical Device Blister Packaging: YY/T 0698.1—2011, BB/T 0059—2012
General Sterile Packaging: ISO 11607-1/-2, GB/T 19633.1
Biocompatibility: ISO 10993 series
III. Core Raw Materials
| Material | Application Scenarios | Key Characteristics | Public Source |
|---|---|---|---|
| Medical PVC | General solid preparation blister packs | Low cost, easy to form; moderate barrier properties | China Pharmaceutical Packaging Association, 2023 Pharmaceutical Packaging Industry Development Report |
| PETG | Medical device sterile blister trays | Sterilization resistant, non-whitening, good toughness | YY/T 0698.1—2011 |
| Medical PP | High-temperature sterilization blister packaging | Withstands 121°C/134°C sterilization | BB/T 0059—2012 |
| PVC/PVDC Composite | High-barrier solid preparations | Excellent oxygen and moisture barrier properties | Public Material Performance Manual |
IV. Standard Process Flow (Industry Standard, No Literature Disputes)
Raw Material Inspection: Verify biocompatibility, heavy metals, easy oxidizable substances, vinyl chloride monomer, and other indicators.
Sheet Feeding & Preheating: Remove moisture to prevent bubbles during forming.
Heating and Softening: Infrared or hot air heating to above the material's glass transition temperature.
Vacuum/Pressure Thermoforming: Negative or positive pressure is used to form the sheet against the mold.
Cooling and Setting: Air or water cooling to below the heat deflection temperature.
Cutting / Punching: Separating the formed products from the waste web.
Cleaning and Decontamination: Control initial bioburden.
Heat Sealing: Sealing with aluminum foil for pharmaceuticals or Tyvek/medical lidding for medical devices.
Sterilization (Medical Devices Only): EO, gamma, or moist heat sterilization.
Finished Product Inspection and Warehousing.
V. Key Process Parameters
Heating Temperature
PVC: 80–120°C
PETG: 100–130°C
PP: 90–110°C
Forming Vacuum: -0.06 to -0.1 MPa
Cooling Requirement: Cool to below 60°C to prevent deformation.
Heat Sealing Parameters: Temperature 120–180°C, Pressure 0.2–0.5 MPa, Time 0.5–2 s (adjusted according to material).
Cleanliness Requirements: Production workshop with Class 10,000 cleanliness, initial bioburden ≤10 CFU/unit.
VI. Quality Control Requirements
Physical Properties: Dimensional tolerance ±0.1 mm; wall thickness uniformity deviation ≤5%.
Sealing Performance: No leakage, no false seals, no channels; must pass the methylene blue dye test.
Chemical Properties: Easy oxidizable substances ≤1 mL; vinyl chloride monomer ≤1 μg/g.
Sterilization Residue: EO sterilization residual ≤1 ppm.
Biocompatibility: No cytotoxicity, no sensitization, no irritation.
