Selecting a blister packaging machine is a complex process that requires considering multiple dimensions, including product characteristics, production requirements, regulatory standards, and investment budget. Improper selection can lead to low production efficiency, substandard packaging quality, or cost overruns. The following are key considerations during the selection process, summarized as a "four-step method":
Step 1: Define Core Needs and Constraints
Product Characteristics (determining basic equipment configuration)
- Shape and Size: Is the product tablets, capsules, irregularly shaped objects, liquid ampoules, or electronic components? Precise dimensions (length, width, height) determine the size and depth of the forming mold cavities.
- Physical Properties: Is the product fragile, hygroscopic, or light-sensitive? This relates to the barrier properties required of the packaging material.
- Chemical Properties: Does the product react with certain packaging materials (such as PVC)? Compatibility testing is necessary.
- Arrangement: How many units need to be packaged per blister pack? Is it a single row, double row, or a complex arrangement?
Capacity and Speed Requirements
- Production Rate: Clearly define the target production volume for the current and next 3-5 years (e.g., how many blister packs per month, or how many units per minute).
- Operating Time: Does the equipment need to operate continuously for 24 hours? This relates to the required durability and stability of the equipment.
Packaging Materials (determining forming and sealing methods)
- Blister Material: Commonly used materials include PVC, PVC/PVDC, PET, PP, ALU/PVC, etc. Different materials have significant differences in thermoforming temperature, barrier properties, and cost.
- Lidding Film Material: Primarily aluminum foil (such as tropical aluminum), with single or double-sided coatings. Selection depends on sealing strength and ease of tearing.
- Pre-printed or not: Is the material pre-printed on the roll, or does the equipment need to perform online printing?
Regulations and Standards
- Industry Standards: The pharmaceutical industry must comply with regulations such as cGMP and FDA 21 CFR Part 211. Equipment materials (e.g., 316L stainless steel for contact parts), cleaning, and validation documentation requirements are stringent.
- Regional Standards: Exported products must meet the certification requirements of the target market (e.g., EU, US, China NMPA).
- Special Requirements: Are child-resistant (CR), elderly-friendly, or Braille labeling features required?
Step 2: Evaluate Key Technologies and Equipment Configuration
Forming Method
- Roller Forming: High-speed, continuous, suitable for large-volume, standard-depth tablet and capsule packaging; the mainstream choice.
- Flat Plate Forming: Deep forming depth, uniform stretching, suitable for large-volume, irregularly shaped, or deep-drawn products (such as medical devices, large capsules), but relatively slower.
Sealing Method
- Heat Sealing: Most common, fusing the aluminum foil coating with the blister base material through heating. Requires precise control of temperature, pressure, and time.
- Cold Press Sealing: Suitable for heat-sensitive products or materials (such as certain biological products), or situations where high sealing strength is not required.
Automation and Inspection Level
- Feeding System: Vibratory feeder, counting screw, robotic vision grasping? For fragile or irregularly shaped products, a gentle and precise feeding method is necessary.
- Inspection System: This is crucial for quality assurance. Must include "online missing tablet detection" (photoelectric or vision). High-end models can be equipped with visual inspection (identifying foreign objects, fragments, characters), seal integrity testing (leak detection), and metal detection.
- Control System: PLC brand (such as Siemens, Mitsubishi) and HMI (Human-Machine Interface) user-friendliness, data recording and tracking capabilities (to meet audit trail requirements).
Mold System
- Ease of Replacement: Is mold replacement convenient and quick? This directly affects product changeover time and is crucial for multi-product production.
- Material and Precision: Molds are usually made of aluminum or copper alloy, precision ground to ensure consistent forming and blister appearance.
Step 3: Evaluate the Supplier and the Equipment Itself
Supplier Qualifications and Experience
- Industry Reputation: Does the supplier have successful cases in the target industry (such as pharmaceuticals, food)?
- Technical Support: Can they provide installation, commissioning, validation (IQ/OQ/PQ) support, and long-term spare parts supply?
- Customization Capabilities: Can they perform non-standard design and modification based on specific needs?
Equipment Performance and Parameters
- Actual Operating Speed: Require the supplier to conduct on-site or video testing with your products and materials to verify the operating stability and yield rate at their claimed speed.
- Material Utilization Rate and Waste Rate: Optimized layout design can save packaging material costs.
- Footprint: Does it fit the workshop layout? Ensure sufficient space for operation and maintenance. Noise and Energy Consumption: Meets factory environmental protection and energy saving requirements.
Step 4: Calculate Comprehensive Costs and Long-Term Benefits
- Initial Investment: Equipment price, mold costs, transportation and installation costs.
- Operating Costs: Packaging material costs (saved through layout optimization), energy consumption, labor costs (the higher the degree of automation, the lower the labor costs), and losses due to defective products (high-quality inspection systems can reduce waste).
- Maintenance Costs: Spare parts prices, convenience and cost of regular maintenance.
- Flexibility Value: The equipment's ability to adapt to future new products and materials is key to long-term return on investment.
(Machine testing in factory)