Blister Lines for Vial Product

Yes. Our blister lines seamlessly integrate with cartoners, vision inspection systems, and palletizing robots for full automation.

We provide 24/7 remote technical support, on-site training, spare parts services, and preventive maintenance programs.

Ensuring hermetic seal integrity is non-negotiable for parenteral products. The HIGHNOW line integrates a multi-stage, in-process control system. It begins with a precision thermal control system for the lidding foil, maintaining temperature within ±1.5°C to prevent micro-fissures. This is followed by a double-sided vacuum leak testing station that subjects each blister cavity to a test sensitivity of up to 5x10⁻⁶ mbar·L/s. We can provide the validation protocols and SOP templates for this test, aligning with USP <1207> guidelines. For critical applications, we offer an optional High Voltage Leak Detection (HVLD) module to non-destructively detect seal flaws as small as 2 microns.

We protect your valuable product through gentle handling technology. The system uses soft-contact, servo-controlled grippers with adjustable force and travel curves to cradle vials during transfer. The blister forming and sealing stations employ closed-loop pressure control to apply consistent, calibrated force, eliminating stress points. Furthermore, the transport system uses custom-machined, V-shaped pucks that securely hold the vial by its neck and base, preventing any body contact and reducing breakage rates to less than 0.1% even with delicate Type I glass vials.

Yes, interoperability is a fundamental design principle. Our Vial Blister Packaging Lines are equipped with industry-standard PLC controls (Siemens/Rockwell) and communication protocols (OPC UA, Ethernet/IP). We conduct pre-delivery integration tests with your specified upstream (vial filler) and downstream (cartoner) equipment models to ensure seamless material handling, data exchange, and synchronized line control. This creates a unified, efficient packaging line, eliminating bottlenecks.

Our Global Support Program is designed for maximum uptime. The standard SLA includes:

• Remote Diagnostics: 24/7 remote access for troubleshooting via a secure VPN connection.

• Spare Parts Guarantee: A 98.5% availability guarantee for critical spare parts, with global shipping within 24-48 hours.

• On-site Engineer Response: A commitment to have a certified engineer on-site within 72 hours for issues that cannot be resolved remotely.

• Preventive Maintenance Kits: Curated spare part kits based on your machine's MTBF data to preemptively address wear and tear.

Contamination control is engineered into every aspect of our design. Key features include:

• Stainless Steel 304/316L Construction with polished, crevice-free surfaces.

• Integrated laminar airflow hoods (Class A air shower) over critical zones like the vial loading and sealing stations.

• Servo-driven pick-and-place systems that eliminate the particulate generation associated with pneumatic vibratory feeders.

• Easy-clean design with quick-release panels and IP55-rated electrical cabinets for effective washdown.

We support a seamless and compliant qualification process. Our approach includes:

• Documentation: We provide a pre-delivery Factory Acceptance Test (FAT) protocol and a comprehensive Documentation Package including User Requirements Specification (URS), Design Qualification (DQ), and Installation Qualification (IQ) templates.

• On-site Support: Our engineers will support your team during the Installation & Operational Qualification (IQ/OQ) on-site, assisting with the Performance Qualification (PQ) using your actual vials and blisters.

• Validation: The entire process is designed to meet GAMP 5 guidelines, ensuring a smooth audit by regulatory bodies. We ensure the line performs as specified in your production environment, not just in our factory.

Our systems are built with data integrity and traceability as a core feature. The integrated HIGHNOW Plant Monitoring System (PMS) offers Level 3-4 automation, automatically collecting and storing critical process parameters (CPPs) like sealing temperature, pressure, and dwell time. The system features role-based access control, comprehensive audit trails, and electronic signatures that are fully compliant with FDA 21 CFR Part 11 and EU GMP Annex 11. All data is exported in a structured format for easy integration into your QMS, providing complete batch genealogy from raw material to finished blister.

20+ years of experience with 16,000㎡ smart manufacturing base

Global clientele across 60+ countries (e.g., USA, Russia, Southeast Asia)

Full compliance with ISO, CE, GMP, and cGMP standards

End-to-end support from design to aftersales, including validation

All HIGHNOW equipment meets CE, GMP, and FDA requirements where applicable, ensuring safe and compliant operations.

Stability takes priority over output. If client requirements conflict with standard machine capabilities, we prioritize reliability and long-term performance, ensuring consistent operation under production conditions.

Our machines support PVC, PP, APET, aluminum foil, and composite films, with options for both thermoforming and cold forming processes.

Yes, we specialize in end-to-end customizations—from mold design and material compatibility to downstream integration—tailored to your product requirements.

Yes. Our engineering team designs and manufactures precision molds in-house for unique cavity shapes, multi-layer blisters, or product-specific requirements.