Vial Filling
マシン
Aseptic vial filling lines for injectables, biologics, vaccines, ophthalmics, and oral liquid pharmaceuticals. Peristaltic and time-pressure filling options, integrated stoppering and capping, RABS or isolator-based aseptic processing, 21 CFR Part 11 PLC, and full GMP Annex 1 documentation.
Vial Products We Fill
From small-volume injectables to multi-dose vaccine vials to large-volume parenteral formats — every aseptic liquid pharma vial.
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Vial Filling Solutions
Three configurations: peristaltic for biologics and sensitive products, time-pressure for high-volume injectables, and isolator-based for the most stringent aseptic.
Peristaltic Vial Filler
Biologics · Monoclonal Antibodies · Vaccines · Sensitive Aseptic · 6k–15k Vials/Hour
Peristaltic pump filling — the gold standard for shear-sensitive biologics where any product damage destroys efficacy. No product contact with metal pumps or valves; only a disposable silicone tube touches the product. Single-use fluid path supports rapid product change without cleaning validation between batches. Optional in-line vial weight check.
Time-Pressure Rotary Vial Filler
High-Volume Injectables · Veterinary · Saline · Standard Pharma · 15k–30k Vials/Hour
Time-pressure filling on a rotary platform for high-volume injectable production. Pressurized bulk holding pushes product through calibrated nozzles for precise dose at high speed. SUS316L wetted parts throughout, full CIP/SIP capability. Integrated bunghole stoppering at fill station then aluminum crimp cap downstream. Sustainable 30,000 vials/hour on smaller vial formats.
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Complete Pharma Packaging Line
From primary blister/vial to serialized, leafleted, cased retail unit — fully validated under GMP.
Common Challenges in Vial Filling
Customization & Validation Capabilities
Pharma machines aren't bought — they're validated. We supply full IQ/OQ/PQ documentation, 21 CFR Part 11 compliant controls, and serialization integration as standard.
GMP-compliant, validated, serialization-ready
Every pharma machine ships with full design qualification documentation, material certificates, electrical schematics, and IQ/OQ protocol templates. Track-and-trace serialization (GS1 DataMatrix, parent-child aggregation) is built in, not bolted on.
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Isolator Aseptic Option
Grade A maintained continuously with H2O2 decontamination — the only acceptable standard for non-terminally-sterilized biologics.
Biologic-Safe Peristaltic
Disposable silicone tubing means no metal product contact — preserves mAb, vaccine, and cell-therapy efficacy.
Latest GMP Annex 1
Configurations validated to the 2023 GMP Annex 1 revision — your line stays compliant through regulatory evolution.
100% Weight Verification
Inline checkweigher on every vial — auto-reject + closed-loop pump correction maintains dose-accuracy compliance.
Lyo-Ready Stoppering
Servo-controlled partial stoppering for freeze-dry workflow + full closure post-lyo at correct station.
Aseptic Pharma Experience
75+ aseptic vial lines from Indian biosimilar manufacturers to EU vaccine producers to US biologic specialists.
技術特長
Engineering and validation specs for pharma quality assurance teams.
Isolator / RABS Option
Grade A continuous + H2O2 decontamination
蠕動ポンプ
Disposable tubing, biologic-safe, zero metal contact
100% Weight Verify
Inline check + closed-loop pump correction
Lyo Partial Stoppering
Servo position for freeze-dry workflow
GMP Annex 1 (2023)
Compliant per latest revision
Vial Serialization
GS1 DataMatrix print + verify + EPCIS export
CIP / SIP Sanitary
Triclamp, polished Ra ≤ 0.4μm, validated
21 CFR Part 11 PLC
Full audit trail, e-signature, validated
Aseptic Pharma Success Stories
Real results from biologic manufacturers, vaccine producers, and injectable specialty pharma.
Indian Biosimilar Manufacturer Preserves mAb Efficacy
An Indian biosimilar monoclonal antibody manufacturer was losing 12% of batches to QC release failure — mechanical pump shear was damaging the protein structure. Switching to peristaltic pump with disposable silicone tubing eliminated mechanical shear entirely, dropping QC release failures to under 1% and restoring batch release reliability worth $30M annually.
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よくある質問集
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The 2023 revision is much stricter than the previous version. Key requirements: isolator-based aseptic (RABS only acceptable in limited cases), contamination control strategy (CCS) document, contamination risk assessment, intervention minimization (essentially fully automated), enhanced environmental monitoring with continuous viable + non-viable particle counts, and tightened microbial limits. Our isolator configurations are designed specifically to meet the 2023 requirements.
Can the same machine handle multiple drug products?
Yes for similar product types and aseptic profiles. SKU change between aseptic-fill drugs typically involves: bulk product change, fluid path SIP cycle, environmental monitoring re-validation, and recipe load. Total typical 4–8 hours including cleaning verification. For biologic CMOs running 6–10 drug products on one line, dedicated single-use fluid paths per product allow much faster changeover (1–2 hours) by simply swapping the disposable tubing.
How does the lyophilization workflow work?
For lyophilized products: vial fills with liquid product, then the stopper is partially inserted (raised position — gas channels open for sublimation water vapor escape). Vials transfer to freeze-dryer for lyophilization cycle (typically 24–72 hours). Post-lyo, vials return to the line where the stopper is pressed fully closed, then aluminum crimp cap applied. Our machine handles partial stoppering with servo precision and integrates with major freeze-dryer suppliers (IMA Life, GEA, Telstar, etc.).
What sizes of vials do you support?
Standard pharma vial range: 2R (2ml), 6R (6ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml), 100R (100ml). 'R' is the international standard ISO designation. Vial format change is supported via quick-change tooling — typically 90 minutes between formats. For unusual vial geometries (cartridges, dual-chamber vials, pre-filled syringes) we offer specialty configurations — discuss with our engineering team.
Can you support vaccine track-and-trace serialization?
Yes — vaccine serialization is mandatory in most markets (US DSCSA, EU FMD, India NDPS, China NMPA, Russia Chestny ZNAK). We integrate GS1 DataMatrix printing on the vial label + camera verification + parent-child aggregation to carton and shipper case. EPCIS data export ready for direct upload to government tracking systems. Serialization adds ~10–15% to line cost but is non-negotiable for commercial vaccine markets.
What's the FAT and validation process for aseptic vial filling?
FAT (Factory Acceptance Test) at our facility: 1–2 weeks including mechanical run, media fill simulation (using growth media instead of product to verify aseptic capability), environmental monitoring qualification, and operator training. SAT (Site Acceptance Test) at your facility: 2–3 weeks including installation verification, system commissioning, IQ/OQ execution, and PQ support. Process Validation (PV) including 3 consecutive successful media fills is your QA team's responsibility but we provide protocol templates and on-site support.
What's the typical project lead time?
Standard aseptic vial line (peristaltic or time-pressure with RABS): 28–36 weeks from PO to commercial production approval. Isolator-based line: 36–48 weeks (isolator engineering and qualification adds time). Breakdown: engineering 8–10 weeks, manufacturing 14–18 weeks, FAT 2 weeks, shipping 4–8 weeks, installation 4–6 weeks, validation 4–8 weeks. We offer stock RABS-based base machines for 20-week accelerated delivery.
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