Pharmaceutical-Grade ยท GMP Validated ยท Global Supply
Softgel Blister
Packaging Machine
- All softgel shapes and sizes โ oval, oblong, round, custom
- PVC, PVDC, and Alu-Alu forming โ including moisture-sensitive formulations
- WHO GMP / cGMP / CE โ complete DQ/IQ/OQ/PQ documentation included
WHO GMP
CE
cGMP
DQ/IQ/OQ/PQ
Machine Overview
What Is a Softgel Blister Packaging Machine?
A softgel blister packaging machine is a pharmaceutical-grade thermoforming or cold-form system that encases soft gelatin capsules (softgels) individually in sealed blister cavities. Each cavity is formed from PVC, PVDC, or Alu-Alu laminate film, then heat-sealed with aluminum foil lidding to protect contents from moisture, oxygen, and light.
HIJ DPP-series softgel blister machines are manufactured in Wenzhou, China, and comply with WHO GMP Technical Report Series No. 961, cGMP 21 CFR Parts 210/211, and CE Machinery Directive 2006/42/EC. Full DQ/IQ/OQ/PQ validation documentation is included with every machine delivery.
Price range: USD 10,000 โ 45,000 (FOB Wenzhou, depending on speed, forming material, and compliance configuration). Quote within 24 hours.
HIJ Softgel Blister Machine โ Quick Facts
| Manufacturer | HIJ Machinery (Wenzhou), China |
| Application | Soft gelatin capsules (softgels), oval, oblong, round, custom shapes |
| Forming Material | PVC / PVDC / Alu-Alu cold form |
| Sealing Foil | Aluminum foil 20โ25ฮผm, paper-alu laminate |
| Speed Range | 100โ600 blisters per minute |
| Compliance | CE / WHO GMP / cGMP 21 CFR / EU GMP |
| Validation | DQ / IQ / OQ / PQ documentation included |
| Lead Time | 12โ16 weeks (FOB Wenzhou) |
| Price Range | USD 10,000 โ 45,000 |
| Contact | [email protected] |
Engineering Insight
Why Softgel Blister Packaging Requires Specific Machine Configuration
Softgels are the most mechanically delicate solid dosage form. Generic blister machines designed for tablets consistently fail on four critical parameters when applied to softgel production.
1
Cavity Shape Precision
Softgel cavities must precisely match the gelatin capsule's three-dimensional profile โ oval, oblong, or custom. Cavity mismatch of even 0.3mm causes softgel rocking inside the blister, leading to cosmetic defects, seal contamination, and failed leak integrity tests during QC or GMP inspection.
2
Temperature-Controlled Forming
Softgel shells begin to deform and stick at elevated temperatures. HIJ DPP-series machines use closed-loop PID temperature control with ยฑ1ยฐC accuracy at both the forming station and sealing station, preventing shell deformation during thermoforming and protecting encapsulated fill material integrity.
3
Gentle Product Handling
Softgels are susceptible to surface damage from aggressive mechanical feeding. HIJ softgel blister machines use adjustable brush-type and vibration feeding systems with validated gentle handling parameters, minimizing cosmetic defects and reducing product loss to under 0.1% in validated production environments.
4
High-Barrier Material Compatibility
Many softgel formulations โ fish oil, vitamin D, CBD, sensitive APIs โ require PVDC or Alu-Alu cold-form packaging for moisture and oxygen barrier performance. HIJ DPP-series supports all three forming materials on the same machine platform, with validated changeover procedures in the IQ/OQ documentation.
Have a specific softgel shape or API sensitivity requirement? HIJ engineers confirm machine configuration and forming tooling compatibility within 24 hours of receiving your softgel dimensional data sheet.
Application Coverage
Softgel Types & Formulations Supported
HIJ DPP-series softgel blister machines handle every standard and custom softgel format used in pharmaceutical, nutraceutical, and OTC production.
Standard Oval Softgels
The most common pharmaceutical softgel format. Supported across all HIJ DPP configurations with standard cavity tooling. Size 4 to size 20 oval.
PVC / PVDC / Alu-AluOblong Softgels
Elongated softgels for higher fill volumes (1,000mg omega-3, high-dose vitamin E). Requires orientation control feeding system โ included as standard on HIJ DPP-series.
Orientation ControlRound / Sphere Softgels
Commonly used for OTC dietary supplements and children's formulations. Circular cavity tooling with anti-roll feed channel prevents cavity displacement.
Standard ConfigMoisture-Sensitive Formulations
Fish oil omega-3, vitamin D3, CoQ10, and hygroscopic APIs require Alu-Alu cold-form packaging. Zero heat forming eliminates thermal exposure to the softgel shell and fill.
Alu-Alu RequiredEnteric-Coated Softgels
Enteric-coated softgels for acid-sensitive APIs (proton pump inhibitors, probiotics). PVDC or Alu-Alu forming recommended to maintain coating integrity during packaging.
High-BarrierCustom Shape Softgels
Proprietary or brand-differentiated softgel shapes for OTC market positioning. HIJ engineers design custom cavity tooling from your 3D dimensional drawings. 6โ8 week tooling lead time.
Custom Tooling
Softgel Format ร Forming Material Compatibility Matrix
| Softgel Type | PVC Forming | PVDC Forming | Alu-Alu Cold Form | Recommended For |
|---|---|---|---|---|
| Standard oval (all sizes) | โ Standard | โ Standard | โ Available | General pharma / OTC |
| Oblong / elongated | โ With orientation feed | โ With orientation feed | โ With orientation feed | High-dose omega-3, vitamin E |
| Round / sphere | โ Standard | โ Standard | โ Available | Supplements, children's |
| Moisture-sensitive fill | Limited barrier | โ Improved barrier | Recommended | Fish oil, vitamin D, CoQ10 |
| Enteric-coated softgel | Not recommended | โ Suitable | Recommended | PPI, probiotics, acid-sensitive |
| Light-sensitive formulation | Not recommended | โ PVDC opaque | Recommended | Photosensitive APIs, ICH Q1B |
| Custom shapes | โ Custom tooling | โ Custom tooling | โ Custom tooling | Brand differentiation, OTC |
HIJ DPP Series
Recommended Softgel Blister Packaging Machines
Three configurations to match your production volume, compliance level, and softgel formulation requirements.
โ
Most Requested
HIJ DPP-250 โ Standard Softgel Blister Machine
Best for mid-scale pharma ยท 50Mโ300M softgels/year
The DPP-250 is HIJ's most widely deployed configuration for softgel blister packaging in pharmaceutical and nutraceutical facilities. PID temperature control at ยฑ1ยฐC protects gelatin shell integrity during forming. Supports all standard oval, oblong, and round softgel sizes with quick-change cavity tooling.
Speed: Up to 250 blisters/min
Forming: PVC / PVDC
Compliance: CE / WHO GMP
Validation: DQ/IQ/OQ/PQ included
Price from: USD 10,000
- All standard oval/oblong sizes
- PID temp control ยฑ1ยฐC
- WHO GMP / CE certified
- DQ/IQ/OQ/PQ documentation
- Siemens / Mitsubishi PLC
- 12โ16 week delivery
High-Speed
HIJ DPP High-Speed โ For Large-Scale Softgel Production
300M+ softgels/year ยท cGMP / 21 CFR Part 11
For nutraceutical manufacturers and pharmaceutical companies producing above 300 million softgels annually, the HIJ high-speed DPP configuration delivers 300โ600 blisters per minute with servo-driven precision forming, integrated vision inspection, and full 21 CFR Part 11 electronic batch record capability.
Speed: 300โ600 blisters/min
Forming: PVC / PVDC
Compliance: CE / cGMP / 21 CFR
Data: 21 CFR Part 11 audit trail
Price from: USD 28,000
- Servo-driven forming & sealing
- Vision inspection system
- 21 CFR Part 11 audit trail
- cGMP 21 CFR 210/211 compliant
- Continuous production ready
- DQ/IQ/OQ/PQ full package
Alu-Alu Cold Form
HIJ DPP Alu-Alu โ For Moisture-Sensitive Softgels
Fish oil ยท Vitamin D ยท CoQ10 ยท Hygroscopic APIs
Cold-form Alu-Alu blister packaging for softgels containing moisture-sensitive, light-sensitive, or highly oxygen-sensitive fill materials. No heat is applied to the softgel during cavity forming, eliminating the leading cause of shell degradation in high-humidity production environments. Achieves WVTR below 0.005 g/mยฒยทday โ far exceeding PVC or PVDC performance.
Forming: Alu-Alu cold form (no heat)
WVTR: <0.005 g/mยฒยทday
Compliance: CE / WHO GMP
ICH: Q1B photostability
Price from: USD 18,000
- Zero heat forming process
- Superior moisture & Oโ barrier
- ICH Q1B photostability compliant
- WHO GMP documentation included
- Ideal for tropical/humid markets
- DQ/IQ/OQ/PQ included
Regulatory Compliance
GMP Compliance for Softgel Blister Packaging
Every HIJ DPP-series softgel blister machine is designed and documented to satisfy pharmaceutical equipment qualification requirements across major regulatory frameworks.
WHO GMP
WHO Technical Report Series No. 961, Annex 6
Equipment qualification requirements including DQ, IQ, OQ, and PQ. HIJ provides pre-written IQ/OQ protocol templates aligned with WHO TRS 961 for softgel blister packaging lines.
cGMP
21 CFR Parts 210 & 211
US FDA current Good Manufacturing Practice. 21 CFR 211.68 requirements for automated pharmaceutical equipment calibration and documentation fully met in HIJ DPP-series.
21 CFR Part 11
Electronic Records & Signatures
HIJ high-speed DPP-series includes 21 CFR Part 11 compliant audit trail, user access management, and electronic signature capability for FDA-registered facilities.
EU GMP
EudraLex Volume 4, Annex 15
Qualification and validation requirements for pharmaceutical equipment in EU-regulated markets. HIJ provides Annex 15-aligned DQ documentation on request.
CE
Machinery Directive 2006/42/EC
All HIJ DPP-series machines carry CE marking confirming compliance with EU machinery safety requirements. CE Declaration of Conformity included with shipment.
ICH Q1B
Photostability Testing
For light-sensitive softgel formulations, HIJ Alu-Alu cold-form configuration meets ICH Q1B photostability requirements with opaque, light-blocking blister cavity construction.
WHO GMP Requirements for Softgel Blister Packaging Equipment
According to WHO Technical Report Series No. 961, Annex 6, pharmaceutical packaging equipment for softgel blister packaging must satisfy the following qualification criteria:
- Product contact surfaces: stainless steel 316L or FDA-compliant polymers
- Temperature control: calibrated sensors with documented accuracy records
- Sealing integrity: validated leak test procedures per IQ/OQ protocols
- Cleaning validation: CIP capability or documented manual cleaning procedures
- Calibration: all measuring instruments within validated calibration schedule
- Change control: documented procedures for all equipment modifications
- Environmental controls: equipment compatible with classified cleanroom requirements
- Documentation: complete equipment history file, batch records, deviation logs
DQ
Design Qualification Report
IQ
Installation Qualification Protocol & Report
OQ
Operational Qualification Protocol & Report
PQ
Performance Qualification Protocol Template
Need the full validation documentation package before placing an order?
Request Validation Package โ
Engineering Data
Softgel Blister Machine Technical Specifications
Full specification comparison across HIJ DPP-series configurations. Send your URS for exact parameter confirmation.
HIJ DPP-Series โ Full Specification Table
All specs subject to final URS confirmation
| Parameter | DPP-250 Standard | DPP High-Speed | DPP Alu-Alu |
|---|---|---|---|
| Output speed | Up to 250 blisters/min | 300โ600 blisters/min | 100โ250 blisters/min |
| Forming process | Thermoforming (heat) | Thermoforming (heat) | Cold forming (no heat) |
| Forming material | PVC 0.25โ0.5mm / PVDC | PVC 0.25โ0.5mm / PVDC | Alu-Alu laminate |
| Sealing foil | Al foil 20โ25ฮผm | Al foil 20โ25ฮผm | Al foil 20โ25ฮผm |
| Temperature control | PID ยฑ1ยฐC | PID ยฑ0.5ยฐC | N/A (cold forming) |
| Softgel size support | All standard oval/oblong/round | All sizes with tooling | All sizes with tooling |
| Custom shape tooling | Available (6โ8 wk) | Available (6โ8 wk) | Available (6โ8 wk) |
| PLC system | Siemens / Mitsubishi | Siemens | Siemens |
| HMI display | 10" touchscreen | 15" touchscreen | 10" touchscreen |
| Data recording | Basic batch record | 21 CFR Part 11 audit trail | 21 CFR Part 11 (optional) |
| Vision inspection | Optional add-on | Integrated standard | Optional add-on |
| Contact surfaces | SS 316L | SS 316L | SS 316L |
| Compliance | CE / WHO GMP | CE / cGMP / 21 CFR | CE / WHO GMP |
| Validation docs | DQ/IQ/OQ/PQ | DQ/IQ/OQ/PQ | DQ/IQ/OQ/PQ |
| Power supply | 5.5kW / 380V 50Hz | 11kW / 380V 50Hz | 6.5kW / 380V 50Hz |
| Lead time | 12โ16 weeks FOB | 16โ20 weeks FOB | 12โ16 weeks FOB |
| Price range | USD 10,000โ18,000 | USD 28,000โ45,000 | USD 18,000โ32,000 |
Have specific production parameters?
Send your URS โ engineering confirmation within 24 hours.
Proven Track Record
Trusted by Softgel Manufacturers Worldwide
100+
Pharma Factories Served
30+
Countries Worldwide
20+
Years Experience
24hr
Quote Response
Omega-3 Softgel Blister Line โ 300M Capsules/Year
A leading Indian nutraceutical manufacturer required a WHO GMP-certified softgel blister line for oblong omega-3 fish oil capsules destined for export to regulated markets. HIJ supplied a DPP-250 with PVDC forming, orientation control feeding, and complete DQ/IQ/OQ/PQ documentation. Line validated and production commenced on schedule.
Vitamin D3 Softgel Alu-Alu Line โ High-Humidity Market
A pharmaceutical manufacturer in the Gulf region needed Alu-Alu cold-form packaging for vitamin D3 softgels to maintain shelf stability in a high-humidity, high-temperature distribution environment. HIJ DPP Alu-Alu achieved WVTR below 0.005 g/mยฒยทday, meeting product stability requirements. WHO GMP validation completed on-site by HIJ engineers.
cGMP Softgel Blister Turnkey Line โ US Export Facility
A Vietnamese pharmaceutical company exporting to the US market required a cGMP-compliant softgel blister line with 21 CFR Part 11 electronic batch records. HIJ supplied a high-speed DPP configuration with integrated vision inspection, audit trail, and complete FDA-aligned validation documentation. FAT completed in Wenzhou before shipment.
Certifications & Compliance Standards
WHO GMP
cGMP
21 CFR
ICH Q1B
20+ Years ยท 100+ Factories
From the Founder
Designed by Engineers Who Understand Softgel Production
"Softgel blister packaging fails most often at two points: cavity tooling that wasn't matched to the exact dimensional tolerance of the softgel from that specific supplier, and sealing temperature that was set for tablets, not gelatin shells. Before we design any softgel blister machine, we ask for the capsule supplier's dimensional data sheet and the fill material's temperature sensitivity profile. That's not extra work โ that's how you avoid a failed OQ."
โ Forester Xiang, Founder, HIJ Machinery (Wenzhou)Forester Xiang has personally audited softgel and pharmaceutical packaging lines at 100+ manufacturing facilities across 30+ countries over 20 years. This direct production floor experience informs every HIJ softgel blister machine design โ from cavity geometry tolerances to temperature setpoint parameters documented in the OQ protocol.
Learn more about HIJ's pharmaceutical machinery expertise โ
FAQ
Frequently Asked Questions: Softgel Blister Packaging Machine
Yes. HIJ DPP-series softgel blister machines support all standard pharmaceutical softgel formats: oval (size 4โ20), oblong/elongated, round/sphere, and custom shapes. Custom cavity tooling is manufactured in-house with a 6โ8 week tooling lead time. Send your softgel dimensional drawings to [email protected] for tooling confirmation.
HIJ softgel blister machine prices range from USD 10,000 to USD 45,000 (FOB Wenzhou, China), depending on output speed, forming material (PVC/PVDC/Alu-Alu), compliance level, and automation degree. DPP-250 standard configurations start from USD 10,000. High-speed cGMP configurations with 21 CFR Part 11 are priced from USD 28,000. Contact [email protected] for exact pricing based on your production requirements.
The choice depends on your API's moisture and oxygen sensitivity. PVC is suitable for standard softgels in controlled distribution environments. PVDC provides improved moisture barrier โ recommended for markets with high humidity (Southeast Asia, Africa, Middle East). Alu-Alu cold form is required for hygroscopic fills (fish oil, vitamin D3, CoQ10) or light-sensitive formulations requiring ICH Q1B compliance. Share your product stability data or ICH conditions with HIJ engineers for a forming material recommendation within 24 hours.
Yes, included as standard. Every HIJ softgel blister machine ships with a complete DQ/IQ/OQ/PQ documentation package. IQ (Installation Qualification) and OQ (Operational Qualification) are executed by HIJ engineers during on-site installation and commissioning at your facility. PQ (Performance Qualification) protocol templates are provided for customer execution. All protocols are pre-written and aligned with WHO TRS 961 requirements.
Standard delivery is 12โ16 weeks from order confirmation (FOB Wenzhou, China). This includes manufacturing, Factory Acceptance Testing (FAT), and pre-shipment documentation preparation. High-speed configurations or machines with custom tooling may require 16โ20 weeks. Rush production for select DPP-250 configurations is available at 8โ10 weeks โ subject to slot availability. Confirm your required delivery date with HIJ at inquiry stage.
HIJ Machinery is a direct manufacturer based in Wenzhou, China. All DPP-series softgel blister machines are designed, engineered, and manufactured in-house. HIJ does not resell or source from third-party machine builders. This means direct engineering support, full documentation control, and pricing without intermediary markup โ typically 30โ40% below European-equivalent equipment.
Yes. HIJ high-speed DPP-series includes a 21 CFR Part 11 compliant data acquisition module with electronic audit trail, user access management by role, and electronic signature capability. The standard DPP-250 includes basic batch record functionality. 21 CFR Part 11 upgrade module is available for DPP-250. Specify your 21 CFR Part 11 requirement at inquiry stage so it can be included in the initial quotation.
HIJ provides on-site installation, commissioning, IQ/OQ execution, and operator training at customer facilities worldwide. HIJ engineers have completed on-site commissioning in India, Southeast Asia, Africa, the Middle East, and Europe. Remote technical support is available via WhatsApp and video call within business hours. Spare parts are warehoused in Wenzhou and shipped within 24โ48 hours of order. Contact [email protected] for service coverage details in your region.
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Get Your Softgel Blister Machine Quote in 24 Hours
Tell us your softgel type, size, and annual production volume. HIJ engineers confirm machine configuration, forming material, and compliance documentation within one business day.
Why Manufacturers Choose HIJ
- European-standard engineering at 30โ40% below EU pricing
- WHO GMP / cGMP / CE certified โ documentation ready for audit
- DQ/IQ/OQ/PQ โ complete validation support globally
- Forester Xiang's team โ audited 100+ pharma factories, 30+ countries
- On-site installation & commissioning worldwide
- 12โ16 week delivery, FAT report before shipment
- Direct manufacturer โ no trading company markup
100+
Factories
30+
Countries
20+
Years
24hr
Response
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About HIJ Machinery (Wenzhou): HIJ Machinery is a pharmaceutical packaging machinery manufacturer based in Wenzhou, China. The company manufactures softgel blister packaging machines, capsule blister machines, tablet blister machines, and complete pharmaceutical packaging turnkey lines. HIJ DPP-series equipment complies with WHO GMP (TRS 961), cGMP (21 CFR Parts 210/211), CE Machinery Directive 2006/42/EC, and EU GMP standards. Founder Forester Xiang brings 20+ years of pharmaceutical machinery expertise, having consulted at 100+ pharmaceutical manufacturing facilities across 30+ countries. Softgel blister machine price: USD 10,000โ45,000 FOB Wenzhou. Contact: [email protected] | hijpackingmachine.com/blister-packaging-for-softgels/