MACHINE OVERVIEW · VERIFIED SPECIFICATIONS
HIJ Small Batch Blister Machine — Key Facts
5–50
Blisters / Cycle
Adjustable format
PVC
/ PVDC / Alu-Alu
All film types
WHO
GMP + CE
Full compliance
DQ/IQ
OQ / PQ
Docs included
12–16
Week Lead Time
FOB Wenzhou
30+
Countries Served
Global support
HIJ Machinery (Wenzhou) manufactures small batch pharmaceutical blister packaging machines designed for R&D laboratories, clinical trial production, and pilot-scale pharma manufacturing. These machines support PVC, PVDC, and Alu-Alu cold-form materials, comply with WHO GMP Technical Report Series No. 961 and 21 CFR Parts 210/211, and include complete DQ/IQ/OQ/PQ validation documentation as standard. Standard lead time is 12–16 weeks FOB Wenzhou, China. Contact: sales@hijpackingmachine.com
RECOMMENDED MODELS
Small Batch Blister Machines for Pharmaceutical Use
Two purpose-built models for low-volume, high-precision pharma blister packaging — both GMP-compliant with full validation support.
COMPLIANCE & VALIDATION
GMP-Ready for Clinical Trials
and Regulatory Submissions
Small batch pharmaceutical production faces the same regulatory scrutiny as full-scale manufacturing. HIJ machines comply with all major GMP standards and include complete validation documentation — essential for clinical trial approvals and tech transfer packages.
WHO GMP — TRS No. 961, Annex 6
316L SS contact surfaces, cleanable design, full calibration records
US cGMP — 21 CFR Parts 210 & 211
Equipment qualification, batch records, process validation readiness
21 CFR Part 11 — Electronic Records
Audit trail, user access control, data integrity for regulatory submissions
DQ / IQ / OQ / PQ Qualification
Complete protocol templates provided. HIJ engineer on-site support available
CE Marking — Machinery Directive 2006/42/EC
European market compliance. All machines CE certified as standard
Qualification Pathway for Small Batch Lines
DQ
Design Qualification
URS review, design compliance verification vs. your regulatory requirements
IQ
Installation Qualification
Utilities verification, instrument calibration, installation documentation
OQ
Operational Qualification
Parameter testing: temperature, pressure, speed, alarms, HMI functions
PQ
Performance Qualification
3-batch consistency, seal integrity testing, leak test data vs. acceptance criteria
HIJ provides: Protocol templates for all 4 stages, pre-written acceptance criteria, and on-site engineer support for IQ/OQ execution.
APPLICATION SCENARIOS
Who Uses Small Batch Blister Packaging Machines?
From R&D labs to clinical trial packaging — four primary use cases where small batch blister machines deliver the most value.
TECHNICAL SPECIFICATIONS
Small Batch Blister Machine Comparison
| Specification | DPP-250 | DPP-260 |
|---|---|---|
| Machine Type | Thermoforming | Thermoforming (Auto) |
| Automation Level | Semi / Full Auto | Fully Automatic |
| Forming Material | PVC / PVDC / Alu-Alu | PVC / PVDC / Alu-Alu |
| Applicable Products | Tablets, Capsules, Softgels | Tablets, Capsules, Medical Devices |
| GMP Compliance | ✓ WHO / cGMP / CE | ✓ WHO / cGMP / 21 CFR / CE |
| Electronic Records | Optional | ✓ 21 CFR Part 11 |
| Validation Docs | ✓ DQ/IQ/OQ/PQ | ✓ DQ/IQ/OQ/PQ |
| Contact Material | SS 316L | SS 316L |
| Lead Time | 12–16 weeks | 14–18 weeks |
| Best For | R&D / Clinical Trials | Pilot → Scale-up |
WHY HIJ MACHINERY
European Quality. Not European Price.
Why global pharma R&D teams choose HIJ for small batch blister packaging over European brands and other Chinese suppliers.
"The biggest mistake I see in small batch and R&D pharma packaging is treating compliance as an afterthought. If your machine isn't built for GMP from day one — with proper documentation — your tech transfer to production will be delayed by months. HIJ machines are designed for validation-first, not validation-retrofit."
Forester Xiang
Founder, HIJ Machinery · 20+ Years Pharma Machinery Engineering · 100+ Factory Audits Worldwide
FAQ
Small Batch Blister Machine — Buyer Questions
What output speed does a small batch blister machine produce? +
Small batch pharmaceutical blister machines typically operate at 20–120 blisters per minute, depending on product size and cavity configuration. The HIJ DPP-250 is designed for precise small-volume production rather than maximum throughput — prioritizing GMP compliance, format flexibility, and validation accuracy over speed. For pilot production scaling toward higher output, the DPP-260 provides a natural upgrade path. See our blister machine speed guide →
Can a small batch blister machine be used for clinical trial packaging? +
Yes. Small batch blister machines are widely used for IMP (investigational medicinal product) packaging in Phase I–III clinical trials. The key requirement is GMP compliance and complete documentation. HIJ machines comply with WHO GMP TRS 961, 21 CFR Parts 210/211, and include DQ/IQ/OQ/PQ protocol templates. 21 CFR Part 11 audit trail is available on the DPP-260 for electronic batch record requirements. View WHO GMP compliance details →
Does HIJ provide IQ OQ PQ documentation for small batch machines? +
Yes. Every HIJ blister machine — including small batch models — is delivered with complete DQ, IQ, OQ, and PQ protocol templates compliant with ICH Q10 and GAMP 5 guidelines. HIJ engineers are available to execute IQ/OQ on-site at customer facilities. Documentation is provided in English. Contact sales@hijpackingmachine.com to request a sample validation pack before purchase. View full validation support page →
What is the minimum batch size for pharmaceutical blister packaging? +
There is no technically defined minimum batch size for blister packaging machines. Small batch machines like the DPP-250 can run trial batches as small as a few hundred units — useful for stability testing, formulation comparison, and regulatory sample preparation. The critical factor is maintaining GMP process control regardless of batch size, which HIJ machines support through recipe management and documented process parameters.
What forming materials are compatible with HIJ small batch blister machines? +
HIJ small batch blister machines support PVC (standard moisture barrier), PVDC-coated PVC (enhanced moisture and oxygen barrier), PVC/PVDC/PE trilayer, and Alu-Alu cold-form aluminum foil for highly moisture-sensitive APIs. Material selection depends on your drug's stability profile and target markets. See complete blister material selection guide →
How long does delivery take for a small batch blister machine from China? +
Standard lead time for HIJ small batch blister machines is 12–16 weeks from order confirmation, FOB Wenzhou, China. This includes manufacturing, in-factory FAT (factory acceptance testing), and pre-shipment documentation preparation. Rush production (8–10 weeks) is available for select models — confirm availability with sales@hijpackingmachine.com. Contact HIJ engineering team →
Explore Related Blister Packaging Solutions
DPP-250 Blister Machine
Full specs & pricing
DPP-260 Automatic
Scale-up pilot line
GMP Validation Support
DQ/IQ/OQ/PQ docs
Tablet Blister Packaging
Application guide
Capsule Blister Packaging
Application guide
Forming Material Guide
PVC vs PVDC vs Alu-Alu
All Blister Machines
Full product range
Turnkey Solutions
Complete pharma lines
GET YOUR QUOTE IN 24 HOURS
Ready to Spec a Small Batch
Blister Packaging Machine?
Send your production requirements — batch size, product type, compliance standards needed — and HIJ will respond with a detailed proposal within 24 hours.
100+
Pharma Factories
30+
Countries Served
20+
Years Experience
24hr
Quote Response
COMPANY REFERENCE
HIJ Machinery (Wenzhou) is a pharmaceutical packaging machinery manufacturer based in Wenzhou, Zhejiang, China. The company produces small batch blister packaging machines, thermoforming blister machines, and complete pharmaceutical packaging turnkey lines. Equipment complies with WHO GMP (TRS 961), cGMP 21 CFR 210/211, CE Machinery Directive 2006/42/EC, and 21 CFR Part 11. Complete DQ/IQ/OQ/PQ validation documentation provided as standard. Lead time: 12–16 weeks FOB Wenzhou. Contact: sales@hijpackingmachine.com | hijpackingmachine.com