👁️ STERILE OPHTHALMIC PACKAGING SOLUTION
Eye Drops Blister Packaging Machine
Eye Drops Blister Packaging Machine
Sterile · Preservative-Free · 0.3-1ml
Class 100 cleanroom compatible single-dose ophthalmic packaging. Eliminates BAK preservatives causing 30% irritation. EU GMP Annex 1 compliant.
cGMP
Annex 1
ISO 5
WHO PQ
HIJ Eye Drops Blister Machine — Quick Facts
Sterile ophthalmic packaging specifications
HIJ eye drops blister packaging machines are sterile ophthalmic-grade unit-dose packaging systems manufactured in Wenzhou, China. Designed specifically for preservative-free eye drops, ophthalmic solutions, glaucoma medications, antibiotic eye drops, and post-surgical eye care products. Filling range 0.3ml to 1ml per cavity with ±1% accuracy at 300-400 units per minute. Compatible with Class 100 (ISO 5) cleanroom environments, isolator/RABS configurations, and full compliance with EU GMP Annex 1 (2022 revision), cGMP 21 CFR 210/211, USP <771> ophthalmic preparations, USP <1207> container closure integrity, and WHO TRS 961. Each unit-dose blister maintains 24-month sterility without preservatives, eliminating the BAK irritation suffered by 30% of multi-dose eye drops users.
Filling Range
0.3–1ml per cavity
Filling Accuracy
±1% (USP <905> compliant)
Production Speed
300–400 units/min
Cleanroom Class
Class 100 / ISO 5 compatible
Sterility
24-month maintained
Preservative-Free
Yes, with isolator
EU GMP Compliance
Annex 1 (2022) ready
Lead Time
16–22 weeks (FOB Wenzhou)
Multi-Dose Bottles vs Unit-Dose Eye Drop Blisters
Why ophthalmic regulators worldwide prefer unit-dose format
Multi-Dose Eye Drop Bottles
Traditional format with growing safety concerns
BAK Preservative Irritation
30% of users experience burning, redness, dry eye worsening
50-70% Product Waste
28-day post-opening limit forces patients to discard most bottle
Cross-Contamination Risk
Bottle tip touches eye/eyelid → introduces bacteria back into bottle
Inaccurate Dosing
Drop size varies 25-56μl depending on bottle squeeze technique
Not for Post-Surgical Use
FDA prohibits multi-dose for cataract/LASIK post-op care
Travel Storage Issues
Once opened, requires careful storage; airline restrictions apply
HIJ Unit-Dose Blister Eye Drops
Modern preservative-free standard of care
Zero Preservatives Possible
Sealed unit-dose eliminates need for BAK or any preservative
100% Product Used
Every blister = full sterile dose, no waste, full shelf life until opening
Sterile Per Application
Each dose sealed sterile until moment of use — zero contamination
Precise Dosing ±1%
0.3-1ml exact prescribed volume — no squeeze variability
Post-Surgical Approved
Standard of care for cataract, LASIK, glaucoma surgery recovery
Travel-Friendly
TSA-compliant individual doses, no liquid restrictions
Sterile Filling System for Ophthalmic Drugs
Class 100 (ISO 5) compatible aseptic processing technology
Isolator / RABS Configuration
Restricted Access Barrier System or full isolator with VHP decontamination provides Grade A air over open product per EU GMP Annex 1.
Class 100 / ISO 5HEPA Filtration System
Triple HEPA filtration (H14 grade, 99.995% efficiency at 0.3μm) maintains continuous Grade A environment during entire filling cycle.
H14 HEPA filters0.22μm Sterile Filtration
Ophthalmic solution sterile-filtered through 0.22μm membrane immediately before filling. Bubble point integrity testing per USP <788>.
0.22μm filtrationVHP Decontamination Cycle
Vaporized hydrogen peroxide decontamination achieves 6-log sporicidal reduction. Validated cycle ≤45 minutes for production turnaround.
6-log SALContinuous Particle Monitoring
Integrated viable and non-viable particle counters per Annex 1 (2022). Real-time alarm for excursions. Full data integrity per 21 CFR Part 11.
Continuous monitoringAseptic Process Simulation
Media Fill protocols included per FDA Aseptic Processing Guide. Validates aseptic capability with ≤1 contaminated unit per 5,000-10,000 unit fill.
Media Fill readyOphthalmic Applications & Drug Categories
Validated formulations for sterile unit-dose ophthalmic packaging
ARTIFICIAL TEARS
Artificial Tears & Lubricants
DRY EYE · LUBRICATION · COMFORT
Carboxymethylcellulose (CMC), hyaluronic acid, hydroxypropyl methylcellulose (HPMC), polyethylene glycol artificial tears for dry eye syndrome.
Volume:0.4-0.6ml per dose
Production:350-400/min
Format:Strip of 30-60 doses
Shelf Life:24 months sterile
GLAUCOMA
Glaucoma Medications
PRESCRIPTION · LONG-TERM USE
Prostaglandin analogs (latanoprost, travoprost), beta-blockers (timolol), carbonic anhydrase inhibitors. Daily long-term use makes preservative-free critical.
Volume:0.3-0.4ml per dose
Production:300-380/min
Compliance:cGMP Rx grade
Format:Daily strip 30-90
ANTIBIOTIC
Antibiotic Eye Drops
ANTI-INFECTIVE · POST-SURGICAL
Moxifloxacin, ofloxacin, ciprofloxacin, tobramycin antibiotics for bacterial conjunctivitis, post-cataract surgery, post-LASIK infection prevention.
Volume:0.5-1ml per dose
Production:300-350/min
Compliance:cGMP + EU Annex 1
Use Period:7-14 days treatment
ALLERGY
Allergy Eye Drops
ANTIHISTAMINE · MAST CELL STABILIZERS
Olopatadine, ketotifen, cromolyn sodium, azelastine for seasonal allergic conjunctivitis. Preservative-free critical for sensitive allergic eyes.
Volume:0.4-0.5ml per dose
Production:350-400/min
Format:OTC strip / Rx pack
Seasonal:30-60 day supply
POST-SURGICAL
Post-Surgical Eye Care
CATARACT · LASIK · GLAUCOMA SURGERY
Steroidal anti-inflammatories (prednisolone, dexamethasone), NSAIDs (ketorolac, bromfenac), antibiotic combinations for post-operative care.
Volume:0.3-0.5ml per dose
Production:300-380/min
Compliance:FDA mandates unit-dose
Pack Size:14-30 day supply
PEDIATRIC
Pediatric Eye Drops
CHILDREN · INFANTS · NEONATES
Pediatric formulations for conjunctivitis, blocked tear ducts, allergies. Children's eyes especially vulnerable to BAK preservative damage.
Volume:0.3-0.4ml per dose
Production:350-400/min
Safety:Child-safe blister
Format:Single dose strips
Aseptic 8-Step Eye Drops Packaging Process
Validated under EU GMP Annex 1 (2022) and FDA Aseptic Processing Guide
01
VHP Decontamination
Vaporized hydrogen peroxide cycle achieves 6-log sporicidal reduction in isolator before production.
PRE-GRADE A02
Sterile Film Loading
Pre-sterilized PVC/Aclar/COC forming film loaded under Grade A air supply with material verification.
GRADE A03
Aseptic Cavity Forming
Validated thermoforming creates ophthalmic blister cavities under continuous Grade A protection.
GRADE A04
0.22μm Sterile Filtration
Eye drop solution sterile-filtered through 0.22μm membrane immediately before filling. Bubble point tested.
CCP-105
Precision Aseptic Filling
Servo micro-pumps fill 0.3-1ml at ±1% accuracy. Photoelectric verification per cavity. Continuous particle monitoring.
CCP-2 — SAL06
Heat Sealing
Aluminum foil lidding heat-sealed at validated temp/pressure. CCI integrity verified per USP <1207>.
CCP-3 — CCI07
Serialization & Coding
Lot number, expiry date, unique ID printed for full Track & Trace per DSCSA / EU FMD.
SERIALIZATION08
100% Vision Inspection
Automated AI inspection rejects any non-conforming blisters. 21 CFR Part 11 audit trail per reject.
QC RELEASEHIJ Eye Drops Blister Machine — Specifications
Sterile ophthalmic-grade engineering parameters
| Parameter | Specification | Standard / Notes |
|---|---|---|
| ⚙️ Production Performance | ||
| Production Speed | 300-400 units/min | Sterile validated operation |
| High-Speed Option | Up to 600 units/min | Multi-cavity tooling |
| Daily Output (8h) | 144,000-192,000 doses | Sterile aseptic batch |
| Filling Volume | 0.3-1ml per cavity | Custom range possible |
| Filling Accuracy | ±1% | Exceeds USP <905> |
| Repeatability RSD | ≤ 0.5% | Per ICH Q2(R1) |
| 🔬 Sterile Filling System | ||
| Cleanroom Class | Class 100 / ISO 5 | EU GMP Grade A |
| Barrier Configuration | RABS / Isolator | Customer choice |
| HEPA Filtration | H14 (99.995% @ 0.3μm) | Triple stage |
| VHP Decontamination | ≤45 min cycle | 6-log sporicidal |
| Sterile Filtration | 0.22μm membrane | Bubble point tested |
| Particle Monitoring | Continuous viable + non-viable | Per Annex 1 (2022) |
| Aseptic Process Sim | Media Fill compatible | FDA APG ready |
| 🌡️ Liquid Handling System | ||
| Drug Solution Tank | SS 316L jacketed | Electropolished Ra ≤ 0.4μm |
| Tank Capacity | 10L / 20L / 50L | Customer specified |
| Temperature Control | 2-30°C ±0.5°C | Cold chain compatible |
| Filling Method | Servo micro-volumetric | Peristaltic for biologics |
| pH Compatibility | 3-9 | Most ophthalmic formulations |
| CIP/SIP | Standard (recommended) | FDA cleaning validation |
| 📐 Forming & Sealing | ||
| Max Forming Area | 120 × 80 mm | Larger area optional |
| Forming Depth | 5-15mm | Per cavity volume |
| Forming Material | PVC, Aclar, COC, COP | Pharma-grade certified |
| Lidding Foil | Aluminum 20-30μm | Easy peel-off design |
| Sealing Technology | Heat seal validated | ±2°C precision |
| CCI Compatibility | Yes | USP <1207> methods |
| 💻 Control & Compliance | ||
| PLC System | Siemens S7-1500F | Failsafe certified |
| HMI Touchscreen | 15" Siemens TP1500 | Multi-language |
| 21 CFR Part 11 | Full compliance | e-records, e-sigs, audit trail |
| EU GMP Annex 11 | Compliant | Computerized systems |
| Data Integrity | ALCOA+ principles | FDA inspection ready |
| OPC-UA / MES Integration | Standard | ERP ready |
| 🔌 Power & Installation | ||
| Power Supply | 380V / 50Hz / 3-phase | 110V/220V custom |
| Total Power | 8.5 kW | With isolator |
| Compressed Air | 0.6-0.8 MPa pharma-grade | Oil-free, dry, sterile |
| Machine Dimensions | 3000×1200×2200 mm | L×W×H w/ isolator |
| Net Weight | 2,200 kg | SS 304/316L frame |
| ✅ Validation & Documentation | ||
| DQ/IQ/OQ/PQ | Complete package included | Pre-approval inspection ready |
| Aseptic Process Sim | Media Fill protocols | ≤1/5,000-10,000 units |
| CCI Testing | USP <1207> methods | Helium leak / dye ingress |
| Sterility Testing | USP <71> protocols | 14-day incubation |
| Particulate Matter | USP <788> protocols | Light obscuration |
| FAT/SAT Reports | Witnessed available | Customer present |
Need Annex 1 Validation Package?
Get DQ/IQ/OQ/PQ + Aseptic Process Simulation + CCI testing protocols
Request Annex 1 DocumentsWhy Ophthalmic Manufacturers Choose HIJ
Specialized expertise in sterile unit-dose eye drops packaging
Sterile Engineering DNA
Designed for aseptic processing from day one. Class 100 ISO 5 architecture, not retrofit. Annex 1 (2022) compliant out of the box.
Annex 1 NativePreservative-Free Specialist
Validated for BAK-free, EDTA-free formulations. Each unit-dose maintains 24-month sterility without any preservatives.
PF ValidatedAseptic Process Simulation
Media Fill protocols included. Validated to ≤1 contaminated unit per 5,000-10,000 unit fill per FDA Aseptic Processing Guide.
FDA APG ReadyUSP Standards Coverage
USP <771> ophthalmic preparations, USP <1207> CCI testing, USP <788> particulates, USP <71> sterility — all protocol-ready.
Full USP SuiteForester's Pharma Expertise
20+ years pharmaceutical machinery. Has commissioned ophthalmic lines in India, Egypt, Brazil, Vietnam, Bangladesh, and EU.
100+ pharma factoriesSmart Pricing for Sterile
European-grade isolator engineering at 30-40% below European pricing. Same Siemens/Schneider components, better value.
30-40% saving📜 Regulatory Standards for Ophthalmic Blister Packaging Equipment
Sterile ophthalmic blister packaging equipment must comply with the most stringent pharmaceutical regulations due to the eye being a sensitive sterile route of administration. HIJ Machinery's eye drops blister packaging machines are engineered to meet all major international ophthalmic standards:
EU GMP Annex 1 (2022)
Manufacture of sterile medicinal products — current revision with CCS requirement
FDA 21 CFR Parts 210 & 211
U.S. Current Good Manufacturing Practice for finished pharmaceuticals
FDA 21 CFR Part 11
Electronic records and electronic signatures regulation
USP <771> Ophthalmic Preparations
U.S. Pharmacopoeia ophthalmic dosage form standards
USP <1207> CCI Testing
Container closure integrity for sterile pharmaceutical products
USP <788> Particulate Matter
Light obscuration testing for ophthalmic injections/solutions
USP <71> Sterility Testing
Direct inoculation and membrane filtration sterility methods
USP <905> Uniformity
Uniformity of dosage units for unit-dose ophthalmic products
WHO TRS 961 + 986
WHO good manufacturing practices and validation guidelines
FDA Aseptic Processing Guide
Sterile drug products produced by aseptic processing (2004)
ICH Q7, Q8, Q9, Q10
International harmonized GMP and quality risk management
EP 5.1.1 Sterility Methods
European Pharmacopoeia methods of preparation of sterile products
Sterile ophthalmic blister packaging requires a Class 100 (ISO 5) Grade A environment per EU GMP Annex 1, with continuous viable and non-viable particle monitoring, integrated barrier systems (RABS or isolator), HEPA filtration (H14 minimum, 99.995% efficiency at 0.3μm), and Aseptic Process Simulation (Media Fill) qualification. HIJ machines are designed to meet all these requirements out of the box, with full validation documentation package (DQ/IQ/OQ/PQ + Aseptic Process Simulation + CCI testing) included with every machine.
Source Information
HIJ Machinery (Wenzhou) — Sterile pharmaceutical packaging machinery manufacturer
Specialization: Eye drops blister packaging, 0.3-1ml unit doses, Class 100 ISO 5 compatible
Compliance: EU GMP Annex 1 (2022), cGMP 21 CFR 210/211, USP <771>, USP <1207>
Founder: Forester Xiang, 20+ years pharmaceutical machinery, 100+ regulated factories
Website: https://hijpackingmachine.com
Contact: [email protected] | WhatsApp: +86 13868822120
Specialization: Eye drops blister packaging, 0.3-1ml unit doses, Class 100 ISO 5 compatible
Compliance: EU GMP Annex 1 (2022), cGMP 21 CFR 210/211, USP <771>, USP <1207>
Founder: Forester Xiang, 20+ years pharmaceutical machinery, 100+ regulated factories
Website: https://hijpackingmachine.com
Contact: [email protected] | WhatsApp: +86 13868822120
👁️ STERILE OPHTHALMIC CONSULTATION
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Annex 1
(2022) Ready
NDA Standard — Your formulation stays confidential
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Forester's Team — 20+ years pharma expertise
Frequently Asked Questions
Sterile ophthalmic packaging answers for pharma buyers
Can the machine package preservative-free eye drops?
Yes. HIJ eye drops blister machines with isolator/RABS configuration enable preservative-free single-dose ophthalmic packaging. The Class 100 (ISO 5) sterile filling environment with HEPA filtration eliminates the need for preservatives like BAK (benzalkonium chloride) that cause irritation in 30% of users. Each blister maintains sterility for 24 months without any preservatives.
Is the machine compliant with EU GMP Annex 1 (2022 revision)?
Yes. HIJ eye drops blister machines fully comply with EU GMP Annex 1 (2022 revision) for sterile medicinal products manufacturing. Includes Contamination Control Strategy (CCS) compatibility, Grade A air supply over open product, continuous viable and non-viable particle monitoring, and integrated barrier systems (RABS or isolator). Validation documentation package includes Annex 1 compliance evidence.
What is the production capacity for unit dose eye drops?
HIJ eye drops blister machines produce 300-400 unit-dose ophthalmic blisters per minute, depending on cavity count. Daily output: 144,000-192,000 sterile eye drop doses per 8-hour shift. High-speed configurations available up to 600 units/min for large pharmaceutical manufacturers. Multi-cavity tooling (up to 12 cavities) maximizes output.
How accurate is filling for 0.3-1ml eye drop doses?
HIJ achieves ±1% filling accuracy across the 0.3-1ml ophthalmic range. Servo-driven micro-volumetric or peristaltic pumps with photoelectric verification ensure each unit dose meets USP <905> uniformity of dosage units requirements. Repeatability RSD ≤ 0.5% per ICH Q2(R1). This precision exceeds FDA, EMA, and WHO requirements for ophthalmic unit-dose products.
What sterilization methods are supported?
HIJ machines support multiple aseptic processing approaches: terminal sterilization compatible blister formats (autoclave-resistant materials), aseptic filling under Class 100/ISO 5 with sterile-filtered drug solution (0.22μm), VHP (vaporized hydrogen peroxide) decontamination of isolator achieving 6-log sporicidal reduction, and gamma-compatible packaging materials. Aseptic Process Simulation (Media Fill) protocols included.
What ophthalmic formulations are compatible?
HIJ machines package: artificial tears (CMC, hyaluronic acid, HPMC), allergy eye drops (antihistamines, mast cell stabilizers), glaucoma medications (prostaglandins, beta-blockers, carbonic anhydrase inhibitors), antibiotic eye drops (moxifloxacin, ofloxacin), anti-inflammatory drops (NSAIDs, steroids), dry eye treatments (cyclosporine, lifitegrast), pediatric eye drops, and post-surgical eye drops. Volume range 0.3-1ml. pH range 3-9 compatible.
What validation documentation is included?
Complete validation package: DQ/IQ/OQ/PQ protocols, Aseptic Process Simulation (Media Fill) protocols per FDA Aseptic Processing Guide, Container Closure Integrity (CCI) testing protocols per USP <1207>, environmental monitoring program, sterility testing per USP <71>, particulate matter testing per USP <788>, and FAT/SAT documentation. All audit-ready for FDA pre-approval inspection (PAI), EMA, and WHO prequalification.
What is the price range for sterile eye drops blister machines?
Price ranges (FOB Wenzhou):
• Standard Class 100 compatible with RABS: USD 120,000-180,000
• Full isolator configuration with VHP decontamination: USD 200,000-280,000
• High-speed multi-cavity (600 units/min): USD 250,000-380,000
All prices include CE certification, complete validation package, EU GMP Annex 1 documentation, and one mold format. ROI typically 18-30 months for ophthalmic manufacturers based on premium pricing of preservative-free products.
• Standard Class 100 compatible with RABS: USD 120,000-180,000
• Full isolator configuration with VHP decontamination: USD 200,000-280,000
• High-speed multi-cavity (600 units/min): USD 250,000-380,000
All prices include CE certification, complete validation package, EU GMP Annex 1 documentation, and one mold format. ROI typically 18-30 months for ophthalmic manufacturers based on premium pricing of preservative-free products.
How does Aseptic Process Simulation (Media Fill) work?
Media Fill validates aseptic processing capability by replacing the drug solution with sterile microbiological growth media (e.g., Tryptic Soy Broth) and running the machine under normal production conditions. Filled units are incubated 14 days, then inspected for contamination. Acceptance criterion: ≤1 contaminated unit per 5,000-10,000 unit fill per FDA Aseptic Processing Guide. HIJ provides Media Fill protocols, training, and on-site execution support.
Can HIJ eye drops machines pass FDA pre-approval inspection?
Yes. HIJ ophthalmic machines are designed to pass FDA pre-approval inspections (PAI), EMA inspections, and WHO prequalification audits. Multiple HIJ-equipped ophthalmic facilities have successfully passed regulatory inspections. We provide pre-inspection support including documentation review, mock audit, inspector Q&A preparation, and on-site engineer support during actual inspections.
What is the lead time for sterile eye drops blister delivery?
Standard lead time for sterile ophthalmic machines: 16-22 weeks from order confirmation to FOB Wenzhou. Includes manufacturing, isolator integration (if specified), validation documentation preparation, FAT execution with VHP cycle validation, and pre-shipment inspection. Full isolator configurations: 20-26 weeks. Shipping to most ports adds 2-4 weeks. Site preparation and SAT add 4-8 weeks for total project timeline.
Can I send my eye drop sample for sterile filling test?
Yes. Free sterile filling trials available at HIJ Wenzhou facility. Send 500ml-2L of your formulation under NDA. We test: viscosity behavior, fill accuracy, sterile filtration compatibility (0.22μm), CCI integrity per USP <1207>, and sealing parameters. Trial includes limited Aseptic Process Simulation with growth media fill. Results delivered as comprehensive report with video documentation. Typical turnaround: 14-21 days.
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