Technical Reference Document
DPP-250 Pharma Blister Machine: Complete Technical Specifications
The engineer's reference page for DPP-250 configuration, compliance data, and validation requirements — everything you need to specify, qualify, and validate this machine for your facility.
CE Certified
WHO GMP Compliant
⚡
cGMP / 21 CFR Part 11
✓
DQ / IQ / OQ / PQ Included
20+ Years Pharma Experience
No obligation. Our engineers review URS submissions within 24 business hours.
Output Speed
250
blisters / min
CE + GMP
Certified
Lead Time
12–16
weeks
Quick Reference
DPP-250 At a Glance
The HIJ DPP-250 is a pharmaceutical-grade flat-plate thermoforming blister packaging machine manufactured by HIJ Machinery (Wenzhou), China. It is designed for mid-to-high volume tablet, capsule, and softgel blister packaging in WHO GMP, cGMP, and CE-compliant pharmaceutical environments.
250
Blisters / Min
26mm
Max Blister Depth
4
Materials Supported
12–16
Weeks Lead Time
Validation & Compliance Included
✓
DQ / IQ / OQ / PQ documentation
✓
FAT at HIJ Wenzhou factory
✓
SAT + on-site commissioning
✓
21 CFR Part 11 audit trail
✓
URS review within 24 hours
Section 1 — Forming System Specifications
The DPP-250 uses a flat-plate thermoforming mechanism — the industry standard for pharmaceutical blister production requiring high cavity definition, tight dimensional tolerance, and compatibility with validated forming parameters.
Forming System Detail
| Parameter | Specification | Notes |
|---|---|---|
| Forming method | Flat-plate thermoforming | Plug-assist optional |
| Forming station stroke | Adjustable | Servo-controlled |
| Max forming depth | 28mm (PVC) / 8mm (Alu-Alu) | Material dependent |
| Max forming area | 250mm × 120mm | Per stroke |
| Forming temperature | 120–160°C (PVC zone) | PID controlled ±1°C |
| Heating method | Ceramic infrared + electric | Upper + lower zones |
| Cooling system | Water-cooled forming die | Mold temperature: 10–20°C |
| Cavity registration accuracy | ±0.3mm | Servo indexing |
Forming Material Compatibility
| Material | Standard Thickness | Cold Form | Moisture Barrier | Common Application |
|---|---|---|---|---|
| PVC | 0.25mm – 0.50mm | ✗ | Low | Standard oral solids |
| PVDC-coated PVC | 0.25mm – 0.50mm | ✗ | Medium-High | Moisture-sensitive tablets |
| PVC/PVDC laminate | 0.30mm – 0.60mm | ✗ | High | Premium pharma packaging |
| Alu-Alu (cold form) | 0.045 / 0.060mm foil | ✓ | Maximum | Hygroscopic, light-sensitive drugs |
| PP (polypropylene) | 0.30mm – 0.50mm | ✗ | Medium | High-temp resistance needed |
HIJ Engineering Note: Alu-Alu cold forming on the DPP-250 requires the cold-form tooling module. Confirm your forming material requirement when submitting URS — our engineers will specify the correct die set and parameter range.
Section 2 — Sealing System Specifications
| Parameter | Specification |
|---|---|
| Sealing method | Heat-seal flat plate |
| Sealing temperature | 140–220°C (adjustable) |
| Temperature control | PID ±1°C precision |
| Sealing pressure | Adjustable (servo-controlled) |
| Sealing area | Matches forming area (250mm × 120mm max) |
| Sealing material width | Up to 320mm web width |
| Lid foil material | 20–25μm hard-temper aluminum foil |
| Print registration | ±0.5mm (with print registration system) |
| Seal integrity | Meets USP <1207> leak test requirements |
Temperature Precision
PID ±1°C
Max Sealing Area
250 × 120mm
Seal Integrity Standard
USP <1207>
Print Registration
±0.5mm
Section 3 — Drive & Control System
| Component | Specification |
|---|---|
| Main drive | AC servo motor system |
| Indexing | Servo-driven precise indexing |
| PLC | Siemens S7 series (or equivalent) |
| HMI | 10" color touchscreen |
| Language | English / Chinese (others on request) |
| Recipe storage | 100+ product recipes stored |
| Alarm system | Multi-level fault alarm with auto-stop |
| Remote diagnostics | Ethernet / industrial LAN ready |
| Data recording | Production batch records, audit trail |
| 21 CFR Part 11 | Electronic signatures, audit trail, access control |
21 CFR Part 11 Compliance Checklist
- ✓ Electronic batch records with timestamp
- ✓ Role-based user access control
- ✓ Non-editable audit trail
- ✓ Operator ID logged on every change
- ✓ Electronic signature capability
- ✓ Recipe version control
- ✓ Alarm event log
- ✓ Data backup & recovery protocol
- ✓ GAMP 5 Category 4 support
FDA 21 CFR Part 11 Ready
Key Component Brands
Section 4 — Feeding & Cutting System
Product Feeding
| Parameter | Specification |
|---|---|
| Feeding method | Hopper + vibratory feed (standard) |
| Optional feeding | Rotary drum feeder / counting feeder |
| Product detection | Missing tablet/capsule detection (vision optional) |
| Reject system | Automatic defect rejection |
Cutting & Output
| Parameter | Specification |
|---|---|
| Cutting method | Punch-die cutting (flat-plate) |
| Cutting accuracy | ±0.3mm |
| Output direction | Front discharge / side discharge (configurable) |
| Output conveyor | Integrated discharge conveyor |
| Blister counting | Optional inline counter |
Production Flow
Product Feeding
→
Film Forming
→
Cavity Filling
→
Heat Sealing
→
Die Cutting
→
Output
Section 5 — Utility & Installation Requirements
Electrical Supply
3-phase, 380V / 50Hz
220V/60Hz available on request
Power Consumption
5.7 kW running
Peak load ~8 kW
Compressed Air
0.6 MPa / 200 L/min
ISO 8573-1 Class 2 (clean, dry)
Cooling Water
10–20°C / 5 L/min
For forming die cooling
Ambient Temp
18–26°C
Per GMP guideline
Relative Humidity
≤ 45%
Non-condensing
Full Utility & Installation Data
| Utility / Parameter | Requirement | Notes |
|---|---|---|
| Electrical supply | 3-phase, 380V / 50Hz | 220V/60Hz available on request |
| Power consumption | 5.7 kW (running) | Peak ~8 kW |
| Compressed air | 0.6 MPa, min 200 L/min | ISO 8573-1 Class 2 (clean, dry) |
| Cooling water | 10–20°C, 5 L/min | For forming die cooling |
| Ambient temperature | 18–26°C | Per GMP guideline |
| Relative humidity | ≤ 45% (non-condensing) | — |
| Cleanroom class | ISO Class 7 / 8 compatible | — |
| Floor load capacity | Min 800 kg/m² | Machine weight: 1,500 kg |
| Machine footprint | 4,200mm × 650mm | Plus 1m clearance all sides |
| Machine height | 1,640mm | Verify door clearance for installation |
Machine Dimensions & Weight
Length
4,200 mm
×
Width
650 mm
×
Height
1,640 mm
|
Net Weight
1,500 kg
⚠️ Minimum floor clearance: 1m on all sides. Verify building door height (min 2.2m recommended) prior to delivery.
Section 6 — Materials of Construction (GMP Critical)
| Component | Material | Standard |
|---|---|---|
| Product contact surfaces | SS 316L | ASTM A316L |
| Machine frame / housing | SS 304 | — |
| Forming die body | Hardened tool steel | — |
| Sealing die surface | Hard chrome plated tool steel | — |
| Product guide channels | SS 316L | ASTM A316L |
| Gaskets / seals | FDA-compliant silicone | 21 CFR §177 |
| Lubrication (internal) | Food-grade lubricant | NSF H1 certified |
GMP Surface Standards
SS 316L
All product-contact surfaces
Ra ≤ 0.8μm
Surface finish — polished, crevice-free
CIP / SIP
Cleaning validation compatible
✓
No dead legs or crevices in product path
✓
All contact parts removable for cleaning
✓
Material certificates (CoA) provided
✓
FDA 21 CFR §177 silicone gaskets
✓
NSF H1 food-grade internal lubrication
All product-contact surfaces are crevice-free, polished to Ra ≤ 0.8μm, and fully compatible with CIP/SIP cleaning validation protocols per GMP requirements.
Regulatory Compliance
DPP-250 Regulatory Compliance Overview
The DPP-250 is designed and manufactured to comply with international pharmaceutical equipment regulations. Below is the full compliance matrix applicable to this model.
DQ / IQ / OQ / PQ Validation Support
HIJ provides full validation lifecycle support for the DPP-250 as standard — not an optional extra.
STAGE 1
DQ
Design Qualification
Confirms DPP-250 design meets your URS before manufacturing begins.
📍 Conducted at: HIJ Factory
STAGE 2
IQ
Installation Qualification
Verifies correct installation per HIJ specs. Protocol + completed report provided.
📍 Conducted at: Customer Facility
STAGE 3
OQ
Operational Qualification
Tests all functions within specified parameters. Includes alarm, PLC, and temperature testing.
📍 Conducted at: Customer Facility
STAGE 4
PQ
Performance Qualification
Demonstrates consistent production with your actual pharmaceutical product.
📍 Conducted at: Customer Facility
📋
Request the DPP-250 Validation Documentation Package
Complete DQ/IQ/OQ/PQ protocol templates available on request prior to purchase.
Configure Your Machine
DPP-250 Optional Modules & Customization
The DPP-250 is available in standard configuration and can be specified with the following optional modules. All options must be confirmed at order stage — they affect DQ documentation and FAT test protocols.
Optional Modules
Cold-Form (Alu-Alu) Tooling
Enables aluminum cold-form blister production for maximum moisture and light barrier performance.
Recommended for
Hygroscopic / light-sensitive drugs
Vision Inspection System
Inline camera system detects missing, broken, or misaligned tablets/capsules and triggers automatic rejection.
Recommended for
High-value products, FDA market
Nitrogen Purging
Creates inert atmosphere inside blister cavity immediately before sealing to prevent oxidative degradation.
Recommended for
Oxidation-sensitive products
Serialization / Track & Trace
Unique blister-level code printing and verification. Supports 2D matrix, DataMatrix, and QR code formats.
Recommended for
EU FMD, DSCSA, India SUGAM
Print Registration System
Automatic foil print-to-blister cavity alignment with ±0.5mm tolerance for precise graphics positioning.
Recommended for
Branded / complex foil graphics
Online Leak Tester
100% inline blister seal integrity testing per USP <1207>. Automatic rejection of failed blisters without line stoppage.
Recommended for
Sterile / high-risk products
Automatic Product Feeder
Rotary drum or vibratory bowl feeder for continuous uninterrupted product supply to blister cavities.
Recommended for
High-speed continuous operation
Accumulation Conveyor
Buffer conveyor between blister machine and downstream cartoner to absorb speed differences and prevent stoppages.
Recommended for
Integrated line applications
IPC Sampling System
Automatic in-process control blister sample ejection at configurable intervals for QC testing without line interruption.
Recommended for
cGMP / validated lines
Customization Capabilities
HIJ engineers can modify the DPP-250 to meet your specific URS requirements. All customizations are documented in the DQ package and reflected in FAT test protocols.
-
Non-standard forming dimensions — custom cavity size & shape to your product geometry
-
Non-standard electrical supply — 220V/60Hz, 415V/50Hz, or other specifications
-
Non-standard language HMI — Spanish, French, Arabic, Portuguese, and more
-
ATEX / explosion-proof — for hazardous location and solvent-based product requirements
-
Full SS 316L housing upgrade — custom material of construction for enhanced corrosion resistance
-
Cleanroom Class 5/6 upgrade — modified sealing, no exposed fasteners, reduced particle generation
Submit Your URS
Our engineering team reviews every User Requirement Specification and responds with a feasibility confirmation within 24 hours. No obligation.
Feasibility confirmed in 24 hours
All customizations reflected in DQ documentation
No generic quotes — every proposal is URS-specific
Important: All optional modules and customizations must be confirmed at order stage. They affect DQ documentation scope, FAT test protocols, and lead time. Late-stage additions cannot be accommodated after production begins.
DPP Series Comparison
How DPP-250 Fits in the HIJ DPP Series
Choose the right model for your production volume and compliance requirements.
| Model | Output | Best For | Compliance Level | Key Difference vs DPP-250 |
|---|---|---|---|---|
| DPP-160 | Up to 160/min | Small-batch, R&D, pilot | CE WHO GMP | Lower output, smaller footprint |
|
DPP-250
← You Are Here |
Up to 250/min | Mid-volume pharma | CE WHO GMP cGMP | Balanced speed + compliance |
| DPP-350 | Up to 350/min | High-volume, export focus | CE cGMP 21 CFR | Higher speed, expanded I/O |
| DPP-500 | Up to 500/min | Large-scale production | Full cGMP 21 CFR | Servo-driven, full automation |
💡
Not sure which model fits your production volume?
Use the rule of thumb: Required daily output ÷ operating hours ÷ 60 = minimum blisters/min needed.
Or send us your production data — we'll specify the correct model within 24 hours.
Application Fit Guide
Is DPP-250 Right for Your Application?
Check your product type and production scale against the DPP-250's verified capabilities before you enquire — or send us your URS and we'll confirm fit in 24 hours.
Product Type Compatibility
| Product Type | DPP-250 Compatible | Notes |
|---|---|---|
| Round tablets (4–12 mm) | Yes | Standard tooling — no modification needed |
| Oval / oblong tablets | Yes | Custom cavity tooling required — specify dimensions at order |
| Capsules (size 000–4) | Yes | Capsule-specific tooling supplied; all standard sizes supported |
| Softgel capsules | Yes | Softgel tooling module required — confirm size & shore hardness |
| Medical devices (small) | Yes | Custom cavity + adjusted sealing temperature — URS review required |
| Suppositories | Yes | Cooling modification to forming station needed |
| Nutraceutical tablets | Yes | Standard configuration — no modifications needed |
| Effervescent tablets | Yes | Alu-Alu cold-form module + N₂ purging option strongly recommended |
| HPAPI products | Consult HIJ | Containment modifications required — submit OEB level with URS |
| Injectables (vials / ampoules) | Not Applicable | Liquid vial filling requires a dedicated filling-sealing machine |
Production Scale Match
| Annual Volume | Daily Output Needed | DPP-250 Fit |
|---|---|---|
| < 50 M units / yr | < 200 K units / day | Good fit |
| 50 – 150 M units / yr | 200 K – 600 K units / day | Primary fit — ideal range |
| 150 – 300 M units / yr | 600 K – 1.2 M units / day | Consider DPP-350 / DPP-500 |
| > 300 M units / yr | > 1.2 M units / day | DPP-500 or multi-machine line |
💡 Quick calculation:
Required daily output ÷ operating hours ÷ 60 = minimum blisters/min needed.
Not sure which model fits your line? Send us your production data — we'll specify the correct model within 24 hours.
Not 100% sure the DPP-250 fits your line?
Submit your URS or production requirements — HIJ engineers confirm compatibility and propose the right configuration within 24 hours. No obligation.
FAQ
Frequently Asked Questions
DPP-250 Pharma Blister Packaging Machine — Specifications & Compliance
Still Have Questions?
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20+ years pharma machinery experience
URS review within 24 hours
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21 CFR Pt.11
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