WHO GMP · cGMP · CE Certified
Cold Form Blister Packing Machine Manufacturer
Aluminum-aluminum (Alu-Alu) cold forming technology for absolute moisture, oxygen, and light barrier protection — engineered in Wenzhou, China for global pharmaceutical manufacturers.
100–300/min
Cold Form Output
Pharmaceutical-Grade Cold Form Blister Packing — Engineered by HIJ Machinery
The HIJ DPH-300 cold form blister packing machine is a pharmaceutical-grade aluminum-aluminum (Alu-Alu) blister forming and sealing system manufactured in Wenzhou, China. The machine uses cold-forming technology — no heat applied during forming — to create absolute moisture, oxygen, and light barriers required for hygroscopic APIs, photosensitive drugs, and high-value pharmaceutical products.
All HIJ cold form blister machines comply with WHO GMP TRS 961 Annex 6, US cGMP 21 CFR Parts 210/211, CE Machinery Directive 2006/42/EC, and EU GMP EudraLex Volume 4. Complete DQ/IQ/OQ/PQ validation documentation is included with every machine delivery.
Technology Overview
What Is Cold Form Blister Packing?
Cold form blister packaging uses pressure (not heat) to form aluminum-laminate film into blister cavities — delivering near-zero moisture transmission unmatched by thermoformed PVC.
How Cold Forming Works
Cold form blister packing creates blister cavities by pressing a laminate film — typically OPA (oriented polyamide) / Aluminum / PVC — between matched male and female tooling at room temperature. Unlike thermoforming (which uses heat to soften PVC), cold forming relies on aluminum's malleability to permanently deform under high pressure.
The resulting blister pack provides a complete metal barrier against moisture (MVTR ≈ 0.01 g/m²/day), oxygen, and UV light — making it the only acceptable choice for the most demanding pharmaceutical applications.
1
Film Feeding
OPA/Al/PVC laminate film is unwound and indexed into cold-forming station.
2
Cold Forming
Matched tooling presses film into cavity shape at 6–8 tons of force — no heat.
3
Product Filling & Sealing
Tablets/capsules loaded; aluminum lidding heat-sealed; batch/lot codes embossed.
4
Cutting & Discharge
Individual blister cards die-cut and transferred to downstream cartoner.
When You Need Cold Form
Applications That Demand Cold Form Blister Packaging
If your product is hygroscopic, photosensitive, oxygen-sensitive, or destined for tropical markets — cold form is not optional. Here's where it's required.
Moisture-Sensitive
Hygroscopic Tablets & APIs
Drugs that absorb moisture from ambient air — losing potency, changing physical form, or failing stability tests.
- Effervescent tablets
- Hygroscopic salts (e.g. citrates)
- Moisture-sensitive vitamins
Tropical Markets
Tropical & High-Humidity Markets
India, Bangladesh, Southeast Asia, Sub-Saharan Africa, Middle East — climates where PVC blister stability fails ICH Zone IVB testing.
- ICH Zone IVB (30°C/75% RH)
- WHO stability protocols
- Long shelf-life requirements
Light-Sensitive
Photosensitive Drugs
APIs that degrade under UV/visible light. Cold form's 100% opaque aluminum barrier provides complete light exclusion.
- Nifedipine, methotrexate
- Certain vitamins (B12, folic acid)
- Biologics & peptides
Oxygen-Sensitive
Oxygen-Sensitive APIs
Compounds that oxidize on exposure to air. Aluminum's near-zero oxygen transmission rate makes cold form the standard.
- Antibiotics (cephalosporins)
- Probiotics & live cultures
- Oxidation-prone APIs
High-Value
Premium Nutraceuticals
Brand-positioning benefit: cold form alu-alu blister communicates premium, pharmaceutical-grade quality to consumers.
- Premium multivitamins
- Botanical extracts
- Sports nutrition (capsules)
Regulatory
Controlled & Sensitive Substances
Tamper-evidence and child-resistance requirements often pair with cold form to satisfy regulatory packaging mandates.
- Scheduled medications
- Hormonal therapies
- WHO-prequalified products
Material Comparison
Cold Form (Alu-Alu) vs PVC (Thermoform) Blister Packaging
Cold form delivers absolute barrier; thermoformed PVC is lower-cost but limited protection. Here's the side-by-side a procurement engineer needs.
| Feature | Cold Form (Alu-Alu) | PVC (Thermoform) | PVC/PVDC |
|---|---|---|---|
| Moisture barrier (MVTR) | ≈ 0.01 g/m²/day (absolute) | 3.0–5.0 g/m²/day | 0.2–0.5 g/m²/day |
| Oxygen barrier | |||
| Light barrier | |||
| Forming method | Cold pressure (no heat) | Thermoforming (heat) | Thermoforming (heat) |
| Best for | Hygroscopic, photosensitive, oxidation-prone APIs | Stable APIs, OTC products | Moderate moisture protection |
| Tropical climate (ICH Zone IVB) | |||
| Product visibility | Hidden (silver matte) | Fully visible | Fully visible |
| Material cost | 30–50% higher | Baseline (lowest) | +15–25% over PVC |
| Machine speed | 100–300 blisters/min | 300–600 blisters/min | 250–500 blisters/min |
| HIJ machine model | DPH-300 / DPP-320 | DPP-250 / DPP-260 | DPP-260 / DPP-320 |
Engineering Specs
HIJ DPH-300 Cold Form Blister Machine — Full Specifications
Built for compliance audits. Built for procurement engineers. Built for 24/7 production reliability.
| Model | DPH-300 (Cold Form Series) |
| Max forming area | 280 × 145 mm |
| Production capacity | 100–300 blisters/min |
| Cutting frequency | Up to 60 cuts/min |
| Forming depth | ≤ 12 mm (cold form) |
| Forming pressure | 6–8 tons | Forming film width | ≤ 300 mm |
| Lidding film width | ≤ 300 mm |
| Film thickness — forming | OPA/Al/PVC 60–145 μm |
| Film thickness — lidding | Al-foil 18–25 μm |
| Main motor power | 2.5 kW (servo) |
| Total power | 9.5 kW |
| Compressed air | 0.6–0.8 MPa, 0.3 m³/min |
| Machine dimensions | 3500 × 760 × 1670 mm |
| Net weight | 1850 kg |
| Compliance | WHO GMP · cGMP · CE · 21 CFR |
Servo Drive System
Schneider/Mitsubishi servo motors deliver ±0.1 mm forming registration, eliminating film waste and ensuring synchronization across all stations.
Touchscreen HMI
Siemens HMI with multi-language interface, recipe management (50+ formats), and 21 CFR Part 11 electronic records (optional module).
SS 316L Contact Surfaces
All product-contact surfaces are stainless steel 316L — WHO GMP TRS 961 Annex 6 compliant for pharmaceutical packaging equipment.
Rapid Tooling Changeover
Format change in <30 minutes with quick-release tooling. Standard tooling library includes tablet, capsule, and softgel formats.
In-Process Inspection
Optional vision system rejects defective blisters (missing tablet, broken seal, mis-print). Reject rate <0.1%.
Full Validation Package
DQ/IQ/OQ/PQ protocols, FAT documentation, and traceability records compliant with EU GMP Annex 15 and PIC/S requirements.
Regulatory Compliance
WHO GMP & cGMP Compliance for Cold Form Blister Equipment
Built to pass your next FDA audit, WHO prequalification inspection, or EU GMP review — with documentation to prove it.
WHO GMP Requirements for Cold Form Equipment
According to WHO Technical Report Series No. 961, Annex 6, pharmaceutical cold form blister equipment must meet:
WHO GMP
TRS 961 Annex 6 — Pharmaceutical packaging equipment qualification; SS 316L contact surfaces; validated cleaning procedures.
US cGMP
21 CFR Parts 210/211 — Equipment design, calibration, and change control for finished pharmaceutical production.
21 CFR Part 11
Electronic records and electronic signatures — audit trails, user authentication, data integrity (optional module).
EU GMP
EudraLex Volume 4, Annex 15 — Qualification & validation protocols (DQ/IQ/OQ/PQ).
CE Marking
Machinery Directive 2006/42/EC — Safety, electromagnetic compatibility, and EU market access.
PIC/S
Pharmaceutical Inspection Co-operation Scheme — recognized across 50+ regulatory authorities globally.
Complete Validation Documentation Package
DQ · IQ · OQ · PQ protocols + FAT/SAT records — included with every machine.
Why HIJ Machinery
European Quality. Smart Pricing. Global Track Record.
01
30–40% Below European Pricing
Same engineering standards as Romaco, IMA, Uhlmann — without the European overhead. Direct manufacturer pricing, no trading-company markup.
02
Complete Turnkey Capability
From URS through DQ/IQ/OQ/PQ — HIJ delivers the full pharmaceutical packaging line: cold form blister + cartoner + case packer + serialization.
03
URS-Driven Engineering
Every machine is configured to your User Requirements Specification. No generic templates — your API, your output, your regulatory market.
04
Global On-Site Support
Field engineers based in or traveling to India, Bangladesh, Vietnam, Indonesia, Nigeria, Egypt, and beyond. FAT, SAT, and PQ support included.
05
12–16 Week Lead Time
Standard cold form blister machine delivered in 12–16 weeks ex-Wenzhou. Rush production (8–10 weeks) available on select models.
Forester Xiang
Founder & CEO · HIJ Machinery
"In humid markets — South Asia, Africa, the Middle East — cold form alu-alu blister is not optional for moisture-sensitive APIs. The difference between a compliant cold form machine and a substandard one isn't visible at purchase; it shows up in your stability studies and FDA audit six months later."
20+
Years
100+
Factories
30+
Countries
100+
Pharma Factories
30+
Countries Served
20+
Years Experience
24hr
Response Time
🇮🇳 INDIA · 2024
500K Tablets/Day Cold Form Line
WHO-prequalified manufacturer — full DPH-300 line with cartoner and case packer. DQ/IQ/OQ/PQ signed off in 4 weeks.
🇳🇬 NIGERIA · 2024
WHO GMP Turnkey Project
New facility setup including cold form blister for antimalarials. Forester led on-site URS workshop and PQ commissioning.
🇧🇩 BANGLADESH · 2023
Tropical Climate Stability Project
Switched from PVC to cold form alu-alu — stability tests passed ICH Zone IVB; shelf life extended from 18 to 36 months.
Investment Guide
Cold Form Blister Packing Machine Price 2026
Cold form blister machine prices depend on output speed, automation level, compliance documentation, and turnkey integration. Below is HIJ's standard pricing reference (FOB Wenzhou, China).
Cold form blister machine price ranges (FOB Wenzhou, China): Semi-automatic units start at USD 28,000. Fully automatic high-speed cold form machines with complete DQ/IQ/OQ/PQ documentation reach USD 180,000. Complete turnkey lines including cartoner and case packer: USD 150,000–280,000.
Entry / Pilot
Semi-automatic cold form
USD 28K – 45K
Lead time: 8–10 weeks
- Up to 60 blisters/min
- OPA/Al/PVC capable
- CE certified
- Basic IQ docs
Standard
Automatic cold form
USD 55K – 95K
Lead time: 12–14 weeks
- 100–200 blisters/min
- Servo drive system
- WHO GMP / cGMP
- Full DQ/IQ/OQ/PQ
High-Speed
Production cold form
USD 110K – 180K
Lead time: 14–16 weeks
- 200–300 blisters/min
- 21 CFR Part 11 ready
- Vision inspection
- FAT in Wenzhou
Turnkey Line
Complete integrated
USD 150K – 280K
Lead time: 18–22 weeks
- Blister + cartoner
- Case packer + serialization
- SAT + PQ on-site
- 2-year warranty
FAQ
Cold Form Blister Packing Machine — Common Questions
Answers from Forester's team. Built on 20+ years of pharmaceutical machinery deployments.
What is a cold form blister packing machine?
A cold form blister packing machine forms blister cavities from aluminum-laminate film (OPA/Al/PVC) using pressure instead of heat. The aluminum layer creates an absolute barrier to moisture, oxygen, and light — making cold form blister packaging the standard for hygroscopic, photosensitive, and oxidation-prone pharmaceutical products. HIJ's DPH-300 cold form blister machine operates at 100–300 blisters/min and complies with WHO GMP, cGMP, and CE standards.
How does cold form differ from thermoform blister packing?
Cold form uses pressure at room temperature to deform aluminum-laminate film into blister cavities. Thermoform uses heat to soften PVC film, then forms it into cavities. Cold form delivers near-zero moisture transmission (MVTR ≈ 0.01 g/m²/day) and 100% light barrier; PVC thermoform offers product visibility and faster speeds but limited barrier protection. See our full comparison table above.
How much does a cold form blister machine cost?
Cold form blister machine prices (FOB Wenzhou, China): Semi-automatic USD 28K–45K · Automatic standard USD 55K–95K · High-speed USD 110K–180K · Complete turnkey lines USD 150K–280K. Pricing depends on output speed, automation level, compliance documentation, and integration scope. Request exact pricing based on your URS.
Is HIJ cold form blister machine WHO GMP certified?
Yes. HIJ cold form blister machines comply with WHO GMP Technical Report Series No. 961, Annex 6, US cGMP 21 CFR Parts 210/211, EU GMP EudraLex Volume 4, and CE Machinery Directive 2006/42/EC. All product-contact surfaces are stainless steel 316L. Complete DQ/IQ/OQ/PQ validation documentation is included with every machine.
Does HIJ provide IQ OQ PQ validation for cold form blister machines?
Yes. Every HIJ cold form blister machine ships with a complete validation documentation package: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. FAT (Factory Acceptance Testing) is performed in Wenzhou and can be witnessed by your team or third-party auditors. SAT and on-site PQ support available globally.
What is the delivery lead time for cold form blister machines from China?
Standard lead time: 12–16 weeks from order confirmation (FOB Wenzhou). Semi-automatic models: 8–10 weeks. Complete turnkey lines: 18–22 weeks. Rush production available on select standard configurations (subject to factory schedule). Lead time includes manufacturing, FAT, and pre-shipment inspection.
What output speed can HIJ cold form blister machines achieve?
HIJ DPH-300 cold form blister machine: 100–300 blisters per minute, depending on blister format size, forming depth, and product complexity. Larger forming areas and deeper cavities reduce speed. Semi-automatic models: up to 60 blisters/min. Real-world output depends on product changeover frequency and OEE.
What materials can a cold form blister machine process?
HIJ cold form blister machines process OPA/Al/PVC, OPA/Al/PVDC, and OPA/Al/PE cold form laminates. Forming film thickness: 60–145 μm. Lidding: aluminum foil 18–25 μm. The machine is also compatible with child-resistant (CR) lidding configurations for regulated markets.
Can HIJ cold form blister machine handle both tablets and capsules?
Yes. With format-specific tooling and feeding systems, HIJ cold form machines pack tablets, capsules, softgels, suppositories, and medical devices. Format changeover takes <30 minutes using quick-release tooling. Standard tooling library covers most common pharmaceutical sizes; custom tooling available for proprietary product shapes.
Can the cold form blister machine comply with 21 CFR Part 11?
Yes. HIJ offers an optional 21 CFR Part 11 electronic records module: audit trails, user authentication, data integrity controls, and electronic signatures for the HMI. This is recommended for US-market exporters and FDA-regulated products. Specify in your URS for inclusion in the quote.
Is HIJ Machinery a manufacturer or a trading company?
HIJ Machinery is a direct manufacturer based in Wenzhou, China — not a trading company. Founder Forester Xiang leads engineering and quality oversight. Visitors are welcome to audit the factory before placing an order. Direct manufacturer status means no markup, full transparency on specs, and direct technical support.
Does HIJ install cold form blister machines globally?
Yes. HIJ provides global on-site installation, commissioning, and PQ support. Field engineers regularly travel to India, Bangladesh, Vietnam, Indonesia, Philippines, Nigeria, Kenya, Egypt, Saudi Arabia, UAE, Brazil, and beyond. Installation and commissioning costs are typically included in turnkey quotes; standalone machine purchases include remote commissioning support, with on-site visits quoted separately.
Get Your Cold Form Blister Quote in 24 Hours
Send your User Requirements Specification. HIJ engineers will return a detailed proposal — pricing, delivery timeline, validation documentation scope, and turnkey integration options.
WHO GMP / cGMP / CE compliant
DQ/IQ/OQ/PQ documentation included
12–16 weeks lead time
Direct manufacturer (no middleman)
Global on-site PQ support
L/C, T/T payment accepted
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