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โœฆ CE Certified   |   WHO GMP Compliant   |   cGMP Ready   |   20+ Years Pharmaceutical Machinery   |   100+ Factories Worldwide    โœฆ
Pharmaceutical Grade ยท GMP Certified

Thermoforming Blister
Packaging Machine
Manufacturer

HIJ Machinery designs and manufactures pharmaceutical-grade thermoforming blister packaging machines built to WHO GMP, cGMP, and CE standards โ€” at 30โ€“40% below comparable European brands.

20+
Years
Experience
100+
Pharma
Factories
CE
Certified
Equipment
GMP
WHO GMP
Compliant
24h
Quote
Response
HIJ DPP-250 thermoforming pharma blister packaging machine, WHO GMP and CE certified, manufactured in Wenzhou China
Featured Model
DPP-250
Thermoforming Series
โœ“ CE Certified โœ“ WHO GMP โœ“ cGMP
PVC/PVDC
Forming Film
12โ€“16 Wks
Lead Time
SS 316L
Contact Parts
CE Mark Certification GMP Compliant ISO 9001:2015 Certified Global Pharmaceutical Partner

What Is a Thermoforming Blister Packaging Machine?

A thermoforming blister packaging machine is a pharmaceutical packaging system that forms cavities in thermoplastic film โ€” typically PVC, PVDC, or PVC/PVDC composite โ€” using heat and pressure, fills those cavities with tablets, capsules, or softgels, then seals them with aluminum lidding foil.

Thermoforming is the standard blister packaging method for solid oral dosage forms in pharmaceutical manufacturing worldwide, and is required to meet WHO GMP, cGMP (21 CFR Parts 210/211), and EU GMP Annex 1 standards.

HIJ DPP-250 thermoforming pharma blister packaging machine โ€” CE and WHO GMP certified, manufactured in Wenzhou China

HIJ DPP-250 Thermoforming Pharma Blister Packaging Machine โ€” CE & WHO GMP Certified

Quick Reference

HIJ Thermoforming Blister Machine

Technology Thermoforming (heat + pressure forming)
Forming Material PVC / PVDC / PVC-PVDC / Aclar
Lidding Material Aluminum foil / Paper-Alu
Output Range 100 โ€“ 800 blisters/min
Key Model DPP-250
Compliance CE WHO GMP cGMP 21 CFR Part 11
Validation DQ / IQ / OQ / PQ included
Lead Time 12โ€“16 weeks
Origin Wenzhou, China
Contact sales@hijpackingmachine.com

How Thermoforming Blister Packaging Works: Step-by-Step

Understanding the thermoforming process helps pharmaceutical engineers specify the right machine parameters and validate the equipment correctly.

STEP 01

Film Unwinding & Pre-Heating

The forming web (PVC, PVDC, or composite film) unwinds from a roll and passes through a pre-heating station. Temperature is controlled within ยฑ1ยฐC to ensure uniform softening without degradation. Precise temperature control at this stage directly affects cavity depth consistency โ€” a critical parameter in blister GMP validation.

PVC PVDC film unwinding station on HIJ thermoforming blister packaging machine
Thermoforming cavity formation station with heating plate on HIJ blister machine
STEP 02

Thermoforming โ€” Cavity Formation

The pre-heated film enters the forming station, where a heated forming die presses the softened film into mold cavities using a combination of heat (typically 120โ€“180ยฐC depending on material) and compressed air or mechanical plug assist.

  • Stainless steel 316L forming dies
  • Independent temperature zones per forming row
  • Forming depth tolerance ยฑ0.1mm
  • Quick-change tooling system for format changeover
STEP 03

Product Feeding & Filling

Formed cavities move to the filling station, where tablets, capsules, or other solid dosage forms are deposited into each cavity. Filling accuracy and missing product detection are standard functions โ€” mandatory for WHO GMP and cGMP compliance.

  • Gravity feeding โ€” standard tablets & capsules
  • Brush feeding โ€” irregular shapes
  • Vibratory feeding โ€” fragile products
  • Vision inspection integration (optional)
Automated brush-type feeding station placing tablets into blister cavities on HIJ machine
Heat sealing station with aluminum lidding foil on HIJ pharma blister packaging machine
STEP 04

Sealing

The filled blister web passes through the sealing station, where aluminum lidding foil is heat-sealed under controlled temperature and pressure. Seal integrity directly determines product shelf life and moisture protection โ€” a primary focus of OQ and PQ validation.

  • Sealing temperature range: 120โ€“200ยฐC
  • Sealing pressure: precisely adjustable
  • Sealing pattern: knurled or flat-knurled
  • Peel strength tested per ISO 15223
STEP 05

Embossing, Perforating & Cutting

After sealing, the blister web passes through embossing (batch number, expiry date), perforation (for patient convenience), and cutting stations to produce individual blister cards of your specified dimensions.

Rotary die-cutting station producing individual blister cards on HIJ pharmaceutical blister machine
Automated visual inspection and rejection system on HIJ GMP blister packaging machine
STEP 06

Rejection & Collection

Non-conforming blisters โ€” detected by missing product sensors, seal defect detection, or vision systems โ€” are automatically rejected before the output conveyor. Rejection events are logged in the audit trail (21 CFR Part 11 compliant).

HIJ DPP Series Thermoforming Blister Machines

HIJ's DPP series covers the full range of pharmaceutical production scales โ€” from R&D and small-batch production to high-speed commercial manufacturing lines.

DPP Series Model Comparison

Model Output Forming Area Compliance Best For
DPP-80 80 / min โ€” CE / WHO GMP R&D / Pilot
DPP-140 140 / min โ€” CE / WHO GMP Small Batch
โ˜… DPP-250 Contact Us โ€” CE / WHO GMP / cGMP Mid-Scale โ† Most Popular
DPP-400 400 / min โ€” CE / cGMP High Volume
DPP-600 600 / min โ€” CE / cGMP / 21 CFR Commercial
HIJ DPP-250 thermoforming pharma blister packaging machine CE WHO GMP cGMP certified

The DPP-250 is HIJ's most-specified model for mid-scale pharmaceutical manufacturers in India, Southeast Asia, and Africa โ€” balancing output capacity, GMP compliance, and total cost of ownership.

View DPP-250 Full Specifications โ†’

Thermoforming vs. Cold Form (Alu-Alu): Which Do You Need?

Choosing the right forming method depends on your drug product's sensitivity to moisture and light. Use the comparison below to identify the right platform for your production needs.

PVC PVDC vs Alu-Alu cold form blister packaging material comparison thermoforming
Factor Thermoforming (PVC / PVDC) Cold Form โ€” Alu-Alu
Forming method Heat + pressure Mechanical cold forming
Barrier properties Moderate โ€“ High (PVDC) Maximum (full aluminum)
Moisture protection Good โ€“ Very Good Excellent
Light protection Transparent Opaque (full protection)
Suitable for Standard oral solids Highly hygroscopic / light-sensitive drugs
Machine cost Lower Higher
Running cost Lower Higher (alu foil cost)
Typical use Majority of OSD products ARVs, hygroscopic APIs
Thermoforming blister machine forming station PVC PVDC film pharmaceutical
HIJ DPH-300 Alu-Alu cold form blister packaging machine forming station

Most pharmaceutical manufacturers begin with thermoforming. The DPP-250 supports both PVC/PVDC forming AND optional Alu-Alu cold form โ€” a single platform for your full product range.

HIJ Thermoforming Blister Machine Technical Specifications

All HIJ DPP-series machines are built to GMP standards. Exact parameters confirmed against your URS within 24 hours.

DPP-250 Key Specifications

Parameter Specification
Output Speed Contact us for exact output speed
Forming Web Width Contact us for exact forming width
Max Forming Area Contact us for max forming area
Max Forming Depth Contact us for forming depth range
Forming Temperature Contact us for temperature range
Sealing Temperature Contact us for sealing temperature range
Compressed Air Contact us for air requirements
Electrical Supply Contact us for electrical specifications
Machine Dimensions (Lร—Wร—H) Contact us for machine dimensions
Machine Weight Contact us for machine weight
Contact Material Stainless Steel 316L
Non-Contact Material Stainless Steel 304
Control System Siemens / Allen-Bradley PLC
HMI Interface Touchscreen display
Data Recording 21 CFR Part 11 Audit Trail
Forming Material PVC / PVDC / PVC-PVDC / Aclar
Lidding Material Alu Foil / Paper-Alu / HSL
Noise Level Contact us for noise specification
โœ“ CE Marked โœ“ WHO GMP Compliant โœ“ cGMP (21 CFR 210/211) โœ“ 21 CFR Part 11 โœ“ DQ / IQ / OQ / PQ Included
DPP-250 pharma thermoforming blister packaging machine specification sheet HIJ Machinery

DPP-250 Full Specification Sheet

Complete parameters, compliance data & configuration options โ€” sent to your inbox within 24 hours.

Request Spec Sheet โ†’

Available Options & Customization

HIJ thermoforming blister machines can be configured to your URS requirements. Every option below is documented in the DQ package and validated through IQ/OQ/PQ protocols.

Missing product detection system for pharmaceutical blister machine

Missing Product Detection

Reject individual blisters with unfilled cavities. Mandatory for cGMP compliance.

Vision inspection system for blister packaging machine color shape print verification

Vision Inspection System

Color, shape, and print verification. Integrated rejection without line stoppage.

Nitrogen flushing option for oxidation-sensitive pharmaceutical blister packaging

Nitrogen Flushing

For oxidation-sensitive products. Inert gas flush before sealing reduces Oโ‚‚ to <1%.

Serialization track and trace integration for regulated pharmaceutical markets

Serialization / Track-and-Trace

Meets DSCSA (US), FMD (EU), and CDSCO serialization requirements for regulated markets.

SCADA integration MES ERP connected pharmaceutical manufacturing blister machine

SCADA Integration

For MES/ERP connected manufacturing. OPC-UA and Modbus protocols supported.

Cleanroom compatible blister machine design ISO Class 7 8 pharmaceutical GMP

Cleanroom-Compatible Design

Smooth surfaces, minimal horizontal ledges, and sealed enclosures for ISO Class 7/8 environments.

Dust extraction system for HPAPI handling pharmaceutical blister packaging machine

Dust Extraction

For HPAPI and potent compound handling. Integrated extraction at filling and cutting stations.

Batch coding embossing laser inkjet printer for pharmaceutical blister packaging machine

Batch Coding & Embossing

Laser or inkjet coding. Batch number, expiry date, and lot code embossed on lidding foil.

Have specific configuration requirements?

Send us your User Requirement Specification (URS) and HIJ's engineering team will confirm machine configuration, compliance scope, and lead time within 24 hours.

โœ“ URS Review Free of Charge โœ“ Response Within 24 Hours โœ“ No Obligation

GMP Compliance for Thermoforming Blister Packaging Machines

Every HIJ thermoforming blister machine is engineered to meet the regulatory requirements of your target market โ€” from WHO GMP to US FDA cGMP and EU standards.

Regulatory Standards โ€” What Your Blister Machine Must Meet

Pharmaceutical thermoforming blister machines must comply with the applicable regulatory framework for your target market

Regulatory Standard Scope HIJ DPP-250 Status
WHO GMP (TRS 961, Annex 6) Global / emerging markets Compliant
cGMP 21 CFR Parts 210/211 US FDA regulated Compliant
EU GMP EudraLex Vol. 4 European markets Compliant
CE Marking (2006/42/EC) EU machinery directive CE Marked
ICH Q10 Pharmaceutical quality system Supported
GAMP 5 Computerized system validation Supported
21 CFR Part 11 Electronic records & audit trail Compliant

Validation Documentation HIJ Provides

Every HIJ thermoforming blister machine is delivered with a complete validation documentation package

DQ

Design Qualification

Confirms the DPP-250 design meets your User Requirement Specification. HIJ provides a DQ report template aligned to your URS before manufacturing commences.

IQ

Installation Qualification

Verifies correct installation, utility connections, and equipment condition at your facility. HIJ engineers conduct IQ on-site.

OQ

Operational Qualification

Tests all machine functions โ€” forming temperature, sealing pressure, speed, alarms, reject system, HMI data recording โ€” within specified parameters.

PQ

Performance Qualification

Demonstrates consistent blister quality across production batches using your actual pharmaceutical product. Seal integrity, leak test, and cosmetic inspection data are documented.

Ready to start your validation process? Request the complete DQ/IQ/OQ/PQ documentation package.

Request Validation Documentation Package

21 CFR Part 11 on HIJ Thermoforming Blister Machines

For US FDA regulated manufacturing or manufacturers preparing for FDA inspection

HIJ DPP-250 blister machine PLC control system 21 CFR Part 11 compliant audit trail

HIJ's DPP series thermoforming blister machines are built to support full 21 CFR Part 11 compliance out of the box โ€” essential for any manufacturer supplying the US market or undergoing FDA inspection.

The control system architecture uses Siemens or Allen-Bradley PLC with dedicated software modules for electronic records, ensuring every batch event is captured, traceable, and tamper-evident.

Electronic Batch Records

Time-stamped audit trail for every production event

Role-Based Access Controls

User access controls with individual login credentials

Electronic Signatures

For batch release and critical parameter approval

Alarm History Recording

Complete alarm log retained for audit review

Tamper-Evident Data

Data cannot be altered without a traceable record

Backup & Restore

Full data backup and restore functionality included

Verified Compliance: GMP Compliant certification badge HIJ Machinery CE Mark Certification HIJ blister machine ISO 9001 2015 Certified HIJ Machinery Wenzhou Get Compliance Details

Thermoforming Blister Packaging Applications

HIJ thermoforming blister machines handle the full range of pharmaceutical dosage forms, industries, and global regulatory markets.

Pharmaceutical Dosage Forms

HIJ thermoforming blister machines handle the full range of solid oral dosage forms:

Round tablets thermoforming blister packaging - HIJ DPP series all models
Round Tablets All DPP Series

Standard gravity feed โ€” compatible with all HIJ DPP thermoforming models.

Oval oblong tablets blister packaging - HIJ DPP-250 DPP-400 brush feed
Oval / Oblong Tablets DPP-250, DPP-400+

Brush feed recommended for reliable cavity placement with irregular shapes.

Hard gelatin capsule blister packaging machine - HIJ DPP all series
Capsules (Hard Gelatin) All DPP Series

Standard gravity feed โ€” suitable for all standard and elongated capsule sizes.

Softgel blister packaging machine gentle handling - HIJ DPP-250 DPP-400
Softgels DPP-250, DPP-400+

Gentle handling feed system prevents deformation of soft gelatin capsules.

Chewable tablets blister packaging irregular shape custom tooling - HIJ DPP-250
Chewable Tablets DPP-250+

Irregular shape tooling available โ€” custom cavity design matched to your product.

Coated tablets blister packaging no-scratch tooling - HIJ DPP all series
Coated Tablets All DPP Series

No-scratch tooling option preserves coating integrity throughout the packaging process.

Lozenge blister packaging custom cavity design - HIJ DPP-250
Lozenges DPP-250+

Custom cavity design for lozenge geometry โ€” tooling supplied and validated by HIJ.

Industry Applications

Pharmaceutical manufacturer WHO GMP cGMP blister packaging compliance
Pharmaceutical Manufacturer
WHO GMP / cGMP compliance

DPP-250 full compliance package โ€” CE, WHO GMP, cGMP, 21 CFR Part 11, complete DQ/IQ/OQ/PQ.

Contract manufacturing organization CMO multi-product blister packaging quick-change tooling
Contract Manufacturer (CMO)
Multi-product flexibility

Quick-change tooling system enables rapid format changeover across multiple product lines.

Nutraceutical supplement blister packaging CE certified HIJ DPP series
Nutraceutical / Supplement
CE certification

DPP series standard CE marking โ€” covers vitamins, minerals, softgels, and botanical extracts.

Veterinary pharmaceutical blister packaging non-standard cavity custom tooling HIJ
Veterinary Pharmaceutical
Non-standard cavity sizes

Custom tooling available for large-format veterinary tablets and non-standard dosage shapes.

Medical device blister packaging ISO 15223 seal integrity validated system
Medical Device
ISO 15223 seal integrity

Validated sealing system with documented peel strength and seal integrity testing per ISO 15223.

Global Market Requirements

Market Key Regulatory Requirement HIJ Support
๐Ÿ‡ฎ๐Ÿ‡ณ India WHO GMP / Schedule M (Revised) Full DQ/IQ/OQ/PQ, Schedule M compatible
๐ŸŒ Southeast Asia WHO GMP / ASEAN GMP WHO GMP documentation package
๐ŸŒ Africa WHO GMP (PIC/S) WHO GMP certified, local install support
๐ŸŒ Middle East GCC GMP / WHO GMP Full compliance documentation
๐Ÿ‡บ๐Ÿ‡ธ USA 21 CFR / cGMP 21 CFR Part 11, full cGMP package
๐Ÿ‡ช๐Ÿ‡บ Europe EU GMP / CE CE marked, EU GMP documentation
Serving pharmaceutical manufacturers across India and Southeast Asia
WHO GMP certified ยท Schedule M compatible ยท Full validation support ยท Local installation
View India Market Page โ†’

Why Pharmaceutical Manufacturers Choose HIJ
for Thermoforming Blister Machines

European engineering standards. Field-validated expertise. Full turnkey support โ€” from URS to PQ sign-off.

Quality Promise

European Quality, Smart Pricing โ€”
What This Actually Means

HIJ thermoforming blister machines use the same class of components specified in European pharmaceutical machinery โ€” engineered and assembled in Wenzhou, China.

Siemens PLC
Siemens / AB PLC
Control System
SMC Festo Pneumatics
SMC / Festo
Pneumatics
Allen Bradley
SS 316L Surfaces
Product Contact
Festo
NSK / SKF
Bearings

The result: machines that pass WHO GMP audits, FDA inspections, and EU GMP assessments โ€” priced 30โ€“40% below comparable European brands.

This is not a compromise. This is the reason 100+ pharmaceutical factories in 30+ countries have chosen HIJ.

Forester Xiang HIJ Machinery founder pharmaceutical engineering team
Founder & CEO

Forester Xiang

20 Years ยท 100+ Factories ยท 30+ Countries

Forester Xiang has spent 20+ years engineering pharmaceutical packaging solutions across 30+ countries. Having personally audited 100+ pharmaceutical manufacturing facilities โ€” from WHO GMP plants in India to FDA-regulated facilities in the US โ€” Forester brings field-validated expertise to every machine HIJ designs.

The DPP series thermoforming blister machines were designed based on direct observations of what pharmaceutical production lines actually need: reliable forming temperature control, fast format changeover, validation-ready documentation, and service support that doesn't stop at shipment.

20+
Years
100+
Factories
30+
Countries
HIJ complete turnkey pharmaceutical packaging line blister to case packing
Turnkey Capability

From URS to PQ Sign-Off

HIJ doesn't just ship machines. We support the complete project lifecycle for manufacturers setting up new lines or upgrading existing packaging operations.

1
URS Review โ€” HIJ engineers confirm machine configuration
2
DQ Documentation โ€” Design qualification aligned to your URS
3
FAT โ€” Full functional test at HIJ Wenzhou facility
4
Shipping & Logistics โ€” Sea or air freight, full insurance
5
Site Installation โ€” HIJ engineer on-site at your facility
6
IQ/OQ Execution โ€” Conducted at your facility
7
Operator Training โ€” Machine operation and routine maintenance
8
PQ Support โ€” Engineering support through performance qualification
9
After-Sales โ€” Global spare parts, remote diagnostics, on-site service
View Turnkey Pharmaceutical Solutions โ†’
HIJ engineer on-site after-sales service pharmaceutical client training
Global After-Sales

Global After-Sales Network

Service support that doesn't stop at shipment. HIJ's global network ensures your production line stays running.

HIJ spare parts warehouse
48-Hour Spare Parts Dispatch
Standard components shipped within 48 hours globally. Stocked warehouse in Wenzhou.
HIJ remote diagnostics PLC control
Remote Diagnostics via VPN
Secure remote access to your machine's PLC for rapid fault diagnosis โ€” no waiting for on-site visits.
HIJ global service map
On-Site Engineers Available
Field service engineers available in India, Southeast Asia, and Africa for installation and maintenance.
HIJ technical support team
24-Hour Response Guarantee
All service inquiries responded to within 24 hours. Dedicated WhatsApp support line always available.
20+
Years Experience
100+
Pharma Factories
CE Mark GMP Compliant
CE ยท WHO GMP ยท cGMP
30+
Countries Served
24hr
Response Guarantee

Trusted by Pharmaceutical Manufacturers Worldwide

20 years. 30+ countries. 100+ pharmaceutical factories served.

100+
Pharma Factories
Served Worldwide
30+
Countries
Served
20+
Years
Industry Experience

Recent Project References

โœ“
Mid-scale tablet blister line, WHO GMP โ€” India (2024)
โœ“
cGMP thermoforming line upgrade โ€” Vietnam (2024)
โœ“
Turnkey blister + cartoning line โ€” Nigeria (2023)
โœ“
DPP-250 ร— 3 units, Schedule M compliance โ€” India (2023)
โœ“
Thermoforming line, 21 CFR Part 11 โ€” Bangladesh (2024)
HIJ DPP-250 thermoforming pharma blister packaging machine installed at pharmaceutical factory
CE Mark Certification
CE Certified
WHO GMP Compliant
WHO GMP
ISO 9001:2015 Certified
ISO 9001

Customers Include

Indian Pharmaceutical Company
European Nutraceutical Company
Global Pharmaceutical Partner
Global Pharma Co

Frequently Asked Questions

Thermoforming Blister Packaging Machine

What is the difference between thermoforming and cold form (Alu-Alu) blister packaging? +

Thermoforming uses heat and pressure to form cavities in thermoplastic film (PVC, PVDC), while cold form uses mechanical pressure to form cavities in aluminum-based laminate without heat.

Thermoforming is lower cost and suitable for the majority of oral solid dosage forms. Cold form (Alu-Alu) provides maximum moisture and light barrier for highly sensitive products.

HIJ's DPP-250 pharma blister packaging machine supports both forming methods on a single platform.

What forming materials does a thermoforming blister machine use? +

Standard thermoforming materials include PVC (polyvinyl chloride), PVDC-coated PVC, PVC/PVDC composite, Aclar (PCTFE), and PVC/PE laminates.

Material selection depends on the moisture vapor transmission rate (MVTR) required for your drug product. HIJ engineers can advise on material selection based on your product stability data.

See also: Alu-Alu blister packing machine for maximum-barrier cold form applications.

How long does it take to validate a thermoforming blister machine? +

A typical DQ/IQ/OQ/PQ validation for a thermoforming blister machine takes 4โ€“8 weeks depending on facility readiness, protocol approval timelines, and product availability for PQ runs.

HIJ provides all protocol templates and supports customers through each validation stage โ€” from Design Qualification (DQ) aligned to your URS, through to Performance Qualification (PQ) sign-off at your facility.

Can a thermoforming blister machine handle both tablets and capsules? +

Yes. HIJ DPP series thermoforming blister machines handle tablets (round, oval, oblong, coated), hard gelatin capsules, softgels, and other solid dosage forms.

Different product forms require corresponding cavity tooling, which HIJ supplies and validates as part of the machine delivery package.

What is the minimum order for HIJ thermoforming blister machines? +

HIJ supplies single machines (MOQ = 1 unit). Full turnkey line projects and multi-unit orders are also accepted.

Contact sales@hijpackingmachine.com to discuss your project requirements, or submit an inquiry and our team will respond within 24 hours.

How does HIJ support 21 CFR Part 11 compliance on thermoforming blister machines? +

HIJ DPP series machines feature Siemens or Allen-Bradley PLC control systems built for full 21 CFR Part 11 compliance:

  • Electronic batch records with time-stamped audit trail
  • Role-based user access controls
  • Electronic signatures for batch release
  • Alarm history recording
  • Data integrity โ€” records cannot be altered without trace
  • Backup and restore functionality

CSV (Computer System Validation) documentation is available on request. Contact HIJ for your compliance documentation package.

Have a question not covered here?

Send us your URS or technical requirements โ€” our engineers respond within 24 hours.

Get Your Thermoforming Blister Machine Quote in 24 Hours

European Quality ยท Smart Pricing ยท WHO GMP Certified ยท Full Validation Support

โœ“ European Quality Components
โœ“ WHO GMP / cGMP Certified
โœ“ 30โ€“40% Below European Pricing
โœ“ Full DQ / IQ / OQ / PQ Support
โœ“ Turnkey Installation
โœ“ Global After-Sales Network

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