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Pharmaceutical Packaging Equipment

Capsule Blister Packaging Machine

Pharmaceutical-Grade · WHO GMP Certified · Complete Validation Support

20+ Years Experience
100+ Pharma Factories
WHO GMP / cGMP / CE
DQ/IQ/OQ/PQ Included
24hr Response

Capsule blister packaging demands precise cavity sizing, consistent sealing temperature, and verified leak integrity — requirements that standard blister machines often fail to meet without pharmaceutical-specific configuration.

HIJ Machinery designs and manufactures capsule blister packaging machines built specifically for pharmaceutical-grade production. Every machine ships with complete GMP documentation and validation support.

HIJ Capsule Blister Packaging Machine — WHO GMP Certified, Pharmaceutical Grade
CE Certified
WHO GMP
cGMP / 21 CFR
DQ/IQ/OQ/PQ
100+
Pharma Factories Served
30+
Countries
24hr
Quote Response
Compliance: WHO GMP cGMP 21 CFR CE EU GMP
Product Reference Data

Capsule Blister Packaging Machine: Key Facts

Manufacturer
HIJ Machinery (Wenzhou), China
Application
Hard capsules, soft gelatin capsules (softgels), enteric-coated capsules, HPMC capsules
Forming Material
PVC / PVDC / PVC-PVDC composite / Alu-Alu cold form
Sealing Material
Aluminum foil (20–25 μm), paper-aluminum laminate
Speed Range
100–600 blisters per minute
Compliance
CE WHO GMP TRS 961 cGMP 21 CFR 210-211
Validation
DQ IQ OQ PQ  documentation included
Data Recording
21 CFR Part 11 compliant audit trail (optional)
Lead Time
12–16 weeks (FOB Wenzhou, China)
HIJ Machinery (Wenzhou) ·  Wenzhou, China  ·  Pharmaceutical Packaging Machinery Manufacturer
Engineering Insight

Why Capsule Blister Packaging Requires
Specific Machine Configuration

Most pharmaceutical manufacturers who approach HIJ for capsule blister packaging have encountered one of three problems with generic machines: cavity mismatch causing capsule movement, inconsistent sealing temperature damaging capsule shells, or failed leak integrity tests during validation.

1

Cavity Geometry Precision

Capsule cavities must match capsule size (000 to 5) within ±0.1mm tolerance. Incorrect cavity sizing causes capsule rotation inside the blister, leading to cosmetic defects and potential seal failure during leak testing.

±0.1mm tolerance — HIJ standard
2

Sealing Temperature Sensitivity

Hard gelatin capsule shells begin to deform above 130°C. HIJ machines use closed-loop PID temperature control with ±1°C accuracy, preventing capsule shell damage during the heat-sealing process.

PID closed-loop ±1°C control
3

Forming Depth Control

Capsules require deeper cavity forming than tablets. HIJ machines provide adjustable forming depth with validated parameters documented in the IQ/OQ protocol — ensuring consistent cavity geometry across every production batch.

Depth parameters in IQ/OQ docs
4

Orientation Control

Oblong and elongated capsules require orientation control to ensure consistent cavity filling. HIJ DPP-series machines include adjustable feeding systems for all standard capsule sizes, including oblong formats.

All capsule sizes incl. oblong

Not sure which configuration fits your capsule?

Send your capsule specs —
Engineering reply in 24 hours.

Capsule Types Supported

HIJ capsule blister packaging machines handle all standard pharmaceutical capsule formats — from hard gelatin to moisture-sensitive cold-form applications. Every configuration is validated to WHO GMP and cGMP standards.

HIJ capsule blister packaging machine handling hard gelatin and HPMC capsules — WHO GMP certified
Capsule Type Size Range Forming Material Special Requirement
Hard Gelatin Capsules (HGC)
Size 000 – 5
PVC PVDC
Standard configuration
HPMC Vegetarian Capsules
Size 00 – 3
PVC PVDC
Sealing temperature ≤120°C
Soft Gelatin Capsules (Softgels)
Custom Dimensions
PVC PVDC
Oval / oblong cavity tooling
Enteric-Coated Capsules
Size 0 – 2
PVDC Alu-Alu
Cold form recommended
Moisture-Sensitive Capsules
All Sizes
Alu-Alu Cold Form
No heat forming applied
Controlled-Release Capsules
Size 0 – 2
PVDC Alu-Alu
High barrier required

Not sure which configuration suits your capsule?

Send your capsule specifications to sales@hijpackingmachine.com — HIJ engineers confirm the correct machine configuration within 24 hours.

Send Capsule Specs WhatsApp +86 13868822120

Engineering response within 24 hours · No obligation

Technical Data

Capsule Blister Machine Technical Specifications

Compare HIJ DPP-series configurations. All models include DQ/IQ/OQ/PQ documentation and CE certification.

Scroll to compare all models
Parameter DPP-250 Standard Most Popular DPP High-Speed DPP Alu-Alu
Output Speed Up to 250 blisters/min 300–600 blisters/min 100–250 blisters/min
Max Forming Area [X]mm × [X]mm [X]mm × [X]mm [X]mm × [X]mm
Forming Material PVC / PVDC PVC / PVDC Alu-Alu cold form
Forming Thickness 0.25–0.5mm PVC 0.25–0.5mm Alu laminate
Sealing Foil 20–25μm Al foil 20–25μm Al foil 20–25μm Al foil
Temperature Control PID ±1°C PID ±0.5°C N/A (cold form)
Capsule Sizes 000–3 standard 000–5 with tooling 000–5 with tooling
PLC System Siemens / Mitsubishi Siemens Siemens
HMI Display 10" Touchscreen 15" Touchscreen 10" Touchscreen
Data Recording Basic batch record 21 CFR Part 11 21 CFR Part 11
Power Supply 5.5 kW 11 kW 6.5 kW
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
ℹ️

Specifications subject to final URS confirmation. Forming area, speed, and compliance configuration vary by product type and production requirements. Send your User Requirement Specification (URS) for exact engineering confirmation within 24 hours.

Have specific capsule production requirements?

Submit your URS — cavity dimensions, capsule size, output target, compliance standard. HIJ engineers confirm machine configuration and pricing within one business day.

Response in 24hrs · No obligation · Direct manufacturer
Regulatory Compliance

GMP Compliance for Capsule Blister Packaging

Pharmaceutical capsule blister packaging lines are subject to equipment qualification requirements under multiple regulatory frameworks. HIJ DPP-series machines are designed and documented to meet:

WHO GMP

Technical Report Series No. 961, Annex 6

Equipment qualification requirements including installation, operational, and performance qualification. HIJ provides pre-written IQ/OQ/PQ protocol templates aligned with WHO TRS 961.

US cGMP

21 CFR Parts 210 and 211

21 CFR 211.68 requires that automatic, mechanical, and electronic equipment used in manufacturing, processing, packing, or holding of drug products shall be routinely calibrated, inspected, or checked. HIJ machines include calibration records for all measuring instruments.

Electronic Records

21 CFR Part 11 — Electronic Records and Signatures

For pharmaceutical manufacturers requiring electronic batch records, HIJ high-speed DPP-series includes 21 CFR Part 11 compliant data acquisition with audit trail, user access control, and electronic signature capability.

EU GMP

EudraLex Volume 4, Annex 15

Qualification and validation requirements for pharmaceutical equipment. HIJ provides Annex 15-aligned DQ documentation upon request.

CE Marking

Machinery Directive 2006/42/EC

All HIJ DPP-series machines carry CE marking, confirming compliance with EU machinery safety requirements.

What HIJ Provides with Every Capsule Blister Machine

Design Qualification (DQ) report
Installation Qualification (IQ) protocol and executed report
Operational Qualification (OQ) protocol and executed report
Performance Qualification (PQ) protocol template
Calibration certificates for temperature sensors and pressure gauges
FAT (Factory Acceptance Test) report
SAT (Site Acceptance Test) on-site support

Ready to review our complete validation documentation package?

Request Complete Validation Documentation Package

Response within 24 hours · Confidential · No obligation

Global Supply Network

Capsule Blister Packaging Machines
Supplied to 30+ Countries

HIJ supplies pharmaceutical-grade capsule blister packaging machines to manufacturers across Asia-Pacific, Africa, the Middle East, Europe, and the Americas — with full GMP documentation for every market.

100+
Pharma Factories
30+
Countries Served
20+
Years Experience
24hr
Quote Response
Capsule blister packaging machine for Indian pharmaceutical manufacturers — WHO GMP and Schedule M compliant Asia-Pacific
🌏 India — Largest Market

India is HIJ's largest single market for capsule blister packaging machines. Indian pharmaceutical manufacturers face dual compliance requirements: CDSCO Schedule M (Revised) for domestic production and WHO GMP for export. HIJ DPP-250 meets both standards with full validation documentation included.

WHO GMP Schedule M CDSCO DQ/IQ/OQ/PQ
Capsule blister machine for Indian pharma manufacturers
WHO GMP certified capsule blister packaging machine for Southeast Asia — Vietnam, Indonesia, Philippines, Thailand, Bangladesh Southeast Asia
🌐 Southeast Asia

Pharmaceutical manufacturers in Vietnam, Indonesia, Philippines, Thailand, and Bangladesh increasingly require WHO GMP certified equipment for export market access. HIJ provides complete validation support for regional regulatory submissions, reducing time-to-compliance for export-oriented manufacturers.

WHO GMP CE Certified Validation Support Export Compliance
View capsule blister machine specifications
WHO GMP capsule blister packaging machine for Africa and Middle East — UNICEF Global Fund procurement compliant Africa & Middle East
🌍 Africa & Middle East

WHO GMP certification is mandatory for pharmaceutical manufacturers supplying to public health procurement channels including UNICEF and Global Fund. HIJ DPP-series capsule blister machines include WHO GMP documentation packages specifically structured for African and Middle Eastern regulatory submissions.

WHO GMP UNICEF Supply Global Fund Full Doc Package
DPP-250 WHO GMP documentation details
cGMP and 21 CFR Part 11 compliant capsule blister packaging machine for Europe and Americas Europe & Americas
🌎 Europe & Americas

For manufacturers supplying to EU or US markets, HIJ provides cGMP and 21 CFR Part 11 compliant capsule blister machine configurations with complete validation documentation. CE marked per Machinery Directive 2006/42/EC. Electronic audit trail and 21 CFR Part 11 data recording available on all high-speed DPP models.

cGMP 21 CFR Part 11 CE Marked EU GMP
21 CFR Part 11 compliance details

Supplying to a Regulated Market?
Get a GMP-Ready Capsule Machine Quote

Tell us your target market and regulatory requirement — WHO GMP, cGMP, 21 CFR, or EU GMP. HIJ engineers confirm the correct machine configuration and documentation package within 24 hours.

Forester Xiang – HIJ Machinery Founder, 20 Years Pharmaceutical Machinery Expert
Forester Xiang
Founder & CEO · HIJ Machinery (Wenzhou)
20+ YEARS EXP.
Engineering Expertise

Designed by Engineers Who Have
Walked Your Factory Floor

HIJ Machinery founder Forester Xiang has personally audited capsule packaging lines at 100+ pharmaceutical facilities across 30+ countries over 20 years. That field experience is built into every machine HIJ designs.

"

The most common capsule blister packaging failure I see is not the machine itself — it's a mismatch between cavity dimensions and capsule size tolerances from the capsule supplier. Before specifying your blister machine, always get dimensional data sheets from your capsule supplier and confirm with your machine manufacturer. We do this confirmation as standard practice for every HIJ project.

Forester Xiang, Founder — HIJ Machinery (Wenzhou)
100+
Pharma Factories
30+
Countries
20+
Years Exp.

This direct production experience informs every HIJ capsule blister machine design, from cavity tooling tolerances to validation documentation structure.

Global Track Record

Trusted by Pharmaceutical Manufacturers Worldwide

100+
Factories
Served
30+
Countries
Covered
20+
Years
Experience
24hr
Quote
Response
Selected Capsule Packaging Projects
Hard gelatin capsule blister line — 200M capsules/year
India · 2024 · DQ/IQ/OQ/PQ completed
WHO GMP
HPMC vegetarian capsule packaging line
Southeast Asia · 2024 · 21 CFR Part 11 compliant
cGMP
Moisture-sensitive capsule Alu-Alu blister line
Middle East · 2023 · Cold-form configuration
WHO GMP
Softgel blister packaging line — Turnkey
Africa · 2023 · Complete validation support
WHO GMP

Ready to join 100+ pharma factories worldwide?

Get your custom capsule blister machine quote within 24 hours.

FAQ

Frequently Asked Questions
Capsule Blister Packaging Machine

Technical and procurement questions answered by HIJ Machinery's engineering team.

Yes. HIJ DPP-series machines handle hard gelatin capsules (size 000 to 5) and HPMC vegetarian capsules with the same tooling, provided sealing temperature is adjusted to ≤120°C for HPMC shells. HIJ engineers confirm temperature parameters during OQ execution.

The DPP-250 standard configuration supports capsule sizes 000 through size 3. Size 4 and size 5 tooling is available as an option. Send your capsule dimensions to sales@hijpackingmachine.com for cavity tooling confirmation.

Yes. HIJ manufactures cold-form Alu-Alu blister packaging machines for moisture-sensitive and light-sensitive capsule formulations. Cold-form packaging provides significantly higher moisture barrier than PVC or PVDC forming. Contact HIJ to confirm WVTR requirements for your formulation.

Yes. Every HIJ capsule blister machine ships with a complete DQ/IQ/OQ/PQ documentation package. IQ and OQ are executed by HIJ engineers during installation and commissioning at your facility. PQ protocol templates are provided for customer execution.

Standard delivery is 12–16 weeks from order confirmation (FOB Wenzhou, China). This includes manufacturing, Factory Acceptance Testing (FAT), and pre-shipment documentation. Rush production for select configurations available at 8–10 weeks — confirm availability with HIJ.

Capsule blister machine pricing depends on output speed, compliance level, and forming material configuration. Contact sales@hijpackingmachine.com with your production requirements for exact pricing within 24 hours.

Yes. HIJ high-speed DPP-series includes 21 CFR Part 11 compliant data acquisition with electronic audit trail, user access management, and electronic signature capability. Standard DPP-250 includes basic batch record functionality; 21 CFR Part 11 module is available as an upgrade.

Yes. HIJ provides on-site installation, commissioning, operator training, and IQ/OQ execution at customer facilities worldwide. HIJ engineers have conducted on-site commissioning in India, Southeast Asia, Africa, the Middle East, and Europe.

PVC (polyvinyl chloride) provides basic moisture barrier suitable for most standard capsule formulations. PVDC (polyvinylidene chloride) coating over PVC provides significantly higher moisture and oxygen barrier, suitable for hygroscopic APIs or products with strict shelf-life requirements in humid climates. For the highest barrier, Alu-Alu cold-form is recommended. HIJ machines support all three options.

HIJ Machinery is a direct manufacturer based in Wenzhou, China. All DPP-series blister machines are designed, manufactured, and validated in-house. HIJ does not resell third-party equipment. This means direct engineering support, full documentation control, and competitive pricing without intermediary markup.

Still Have Questions?

Get Your Capsule Blister Machine
Quote in 24 Hours

Send your capsule type, size, and annual production volume. HIJ engineers confirm machine configuration, compliance documentation, and pricing within one business day.

Response in 24 hours
WHO GMP & CE certified
DQ/IQ/OQ/PQ included
Direct manufacturer

Get Your Capsule Blister Machine Quote in 24 Hours

Tell us your capsule type, size, and production volume. HIJ engineers will confirm machine configuration, compliance documentation, and pricing within one business day.

Why Pharmaceutical Manufacturers Choose HIJ

  • European-standard engineering at 30–40% below EU pricing
  • WHO GMP / cGMP / CE certified — documentation ready for audit
  • DQ/IQ/OQ/PQ — complete validation support, globally
  • Forester Xiang's team has audited 100+ pharma factories across 30+ countries
  • On-site installation and commissioning worldwide
  • 12–16 week delivery, FAT report before shipment
  • Direct manufacturer — no trading company markup
100+ Factories Served
30+ Countries
20+ Years Experience
24hr Quote Response

Ready to Get Your Quote?

Click below to submit your capsule specifications — our engineering team responds within 24 hours with configuration, pricing, and compliance details.

or contact directly
Confidential  ·  Response within 24 hours  ·  No spam

About HIJ Machinery (Wenzhou): HIJ Machinery is a pharmaceutical packaging machinery manufacturer based in Wenzhou, China. The company manufactures blister packaging machines, capsule filling machines, tablet press machines, and complete pharmaceutical packaging turnkey lines. HIJ equipment complies with WHO GMP (TRS 961), cGMP (21 CFR Parts 210/211), CE Machinery Directive, and EU GMP standards. Founder Forester Xiang brings 20+ years of pharmaceutical machinery expertise, having consulted at 100+ pharmaceutical manufacturing facilities across 30+ countries. Contact: sales@hijpackingmachine.com | hijpackingmachine.com

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