- Product Overview
- Rotary Piston Type Vial Filling and Rubber Stoppering Machine
- Peristaltic Type Vial Filling and Rubber Stoppering Machine
- Time-Pressure Type Vial Filling and Rubber Stoppering Machine
- Rotary Piston vs Peristaltic vs Time-Pressure
- Inside the Machine: 8-Stage Process
- Technical Specifications
- Aseptic Process Validation: A 5-Step How-To
- USP, EP, and Annex 1 Compliance
- Inline Integration with Tunnel and Capping
- Frequently Asked Questions
- Installation, Validation, and Support
- Request a Quote
Product Overview
An automatic vial filling and rubber stoppering machine is the heart of any aseptic injectable line. It doses a precise volume of liquid (or suspension, oil, or biologic) into a sterile glass vial, then seats a sterile rubber stopper on top — all under ISO 5 / Grade A unidirectional airflow. Three dosing principles dominate pharmaceutical production:
- Rotary Piston Type — metering piston and cylinder, best for high-viscosity liquids, suspensions, oils, and large-volume fills (5–100 ml) with ± 0.5% accuracy. Throughput 60–300 VPM.
- Peristaltic Type — single-use sterile tubing path, best for low-viscosity liquids and biologics where the product never contacts machine internals. Throughput 40–200 VPM.
- Time-Pressure Type — precision valve under regulated pressure, best for highly accurate small-volume fills (0.05–20 ml), vaccines, and biologics with ± 0.25% accuracy. Throughput 100–400 VPM.
All three configurations include integrated rubber stoppering in the same aseptic zone as filling. The machine is enclosed in an oRABS or cRABS with HEPA-filtered ISO 5 / Grade A laminar flow and is built from SS 316L stainless steel with Ra ≤ 0.4 µm contact surfaces, full CIP / SIP capability, and 21 CFR Part 11-ready control.
400
Vials / min (time-pressure)
± 0.25%
Highest dosing accuracy
ISO 5
Grade A aseptic zone
21 CFR 11
Audit trail ready
Rotary Piston Type Vial Filling and Rubber Stoppering Machine
What it is and when to use it
The Rotary Piston Type Vial Filling and Rubber Stoppering Machine uses a precision-ground piston running inside a SS 316L cylinder to meter a fixed volume of product per cycle. Each piston-cylinder pair is dedicated to a single dosing head on a rotating star-wheel; product flows in through a 3-way valve during the suction stroke and out through a needle into the vial during the discharge stroke. Output: up to 300 vials/min with ± 0.5% dosing accuracy.
Use this machine when: your product is a high-viscosity liquid, suspension, oil, or large-volume parenteral; you need ± 0.5% accuracy; and CIP/SIP is acceptable (the piston-cylinder path is cleaned and steam-sterilized in place between batches).
Key Engineering Features
- Servo-driven piston metering: 4–16 piston-cylinder dosing heads on a rotary indexing plate, each with a 3-way SS 316L product valve and a fine-pitch adjustment for volume trim.
- No-vial / no-fill detection: missing-vial sensor prevents dosing into an absent vial, eliminating spillage and contamination risk.
- Integrated stoppering: vibratory bowl feeder orients sterile rubber stoppers; servo-driven pre-press head seats them to a recipe-defined depth (full stop or pre-stop for lyophilization).
- CIP / SIP ready: fully drainable product path with spray-ball coverage and steam-sterilizable dosing heads; SIP at 121 °C / 30 min validated to SAL 10⁻⁶.
- SS 316L contact parts: all wetted components in AISI 316L with Ra ≤ 0.4 µm electropolished finish; Viton or EPDM seals (PTFE optional for aggressive products).
- ISO 5 / Grade A aseptic zone: integrated laminar flow unit with H14 HEPA, airflow 0.36–0.54 m/s, full oRABS / cRABS enclosure.
- PLC + HMI control: Siemens / Allen-Bradley PLC, 10–15″ color touchscreen, recipe storage, gravimetric in-process check, alarm history, 21 CFR Part 11 audit trail.
- Safety and access: CE marked per EN 60204-1, full guarding, interlocked doors, emergency stops, and glove-port access for interventions in the aseptic zone.
Specifications — Rotary Piston
| Parameter | Specification |
|---|---|
| Throughput | 60–300 vials/minute, depending on vial format and fill volume |
| Vial Size Range | 2 ml–100 ml tubular glass vials conforming to ISO 8362-1 |
| Vial Diameter | 14 mm–52 mm |
| Vial Height | 30 mm–115 mm |
| Fill Volume | 0.5 ml–100 ml per dosing head |
| Dosing Heads | 4–16 heads, depending on the model |
| Dosing Accuracy | ±0.5% of the set fill volume |
| Product Path | SS316L piston-cylinder system, finished to Ra ≤ 0.4 µm and suitable for CIP / SIP |
| Seals | Viton / EPDM seals, with PTFE available as an option |
| Stoppering | Vibratory bowl feeding with servo pre-press and adjustable stopper insertion depth |
| Stopper Sterilization | Autoclave-ready stopper loading or in-line SIP configuration |
| Aseptic Zone | ISO 5 / Grade A environment with H14 HEPA filtration and airflow velocity of 0.36–0.54 m/s |
| Barrier System | Open RABS or closed RABS with VHP decontamination port |
| Power Supply | 415 V AC, 3-phase, 50–60 Hz |
| Power Consumption | 8–15 kW |
| Compressed Air | 5–7 bar oil-free compressed air, 200–400 litres/minute |
| Clean Steam for SIP | 2–3 bar saturated clean steam, 30–60 kg/hour |
| WFI for CIP | 2–3 bar, 200–500 litres/hour |
| Vacuum | Up to −0.8 bar, 30–50 m³/hour for stopper placement |
| Noise Level | ≤ 76 dB(A) |
| Machine Footprint | 3,200–4,500 mm L × 1,800–2,400 mm W × 2,200–2,600 mm H |
| Machine Weight | 2,800–5,000 kg |
| Warranty | 12 months comprehensive warranty with lifetime technical support |
Peristaltic Type Vial Filling and Rubber Stoppering Machine
What it is and when to use it
The Peristaltic Type Vial Filling and Rubber Stoppering Machine uses a rotor with 2–3 compression rollers to push product through a single-use sterile tubing set. The product never touches machine internals — only the gamma-irradiated, single-use tubing path. This makes the peristaltic filler the cleanest option for sterile, low-viscosity liquids, vaccines, and biologics where cross-contamination risk must be minimized. Output: up to 200 vials/min with ± 1% dosing accuracy.
Use this machine when: your product is a sterile, low-viscosity liquid, vaccine, or biologic; you need to eliminate cross-contamination between batches; changeover time must be minimal (single-use tubing set replaces CIP/SIP); and product is sensitive to shear.
Key Engineering Features
- Single-use sterile tubing path: gamma-irradiated, pre-assembled tubing set with sterile filter, drip chamber, and filling needle; replaced in under 5 minutes per batch.
- Peristaltic rotor: 2–3 compression rollers with adjustable occlusion; SS 316L rotor housing, easy to wipe down and sanitize.
- No-vial / no-fill detection: missing-vial sensor stops the rotor; out-of-spec vials are rejected downstream.
- Integrated stoppering: vibratory bowl feed, servo pre-press, depth adjustable. Same aseptic zone as filling.
- SS 316L non-product contact parts: all surfaces in the aseptic zone in AISI 316L with Ra ≤ 0.4 µm; wipe-down sanitization between batches.
- ISO 5 / Grade A aseptic zone: integrated laminar flow unit with H14 HEPA, 0.36–0.54 m/s.
- PLC + HMI control: recipe storage for fill volume and tubing size, gravimetric in-process check, 21 CFR Part 11 audit trail.
Specifications – External
| Parameter | Specification |
|---|---|
| Throughput | 40–200 vials/minute, depending on fill volume and tubing configuration |
| Vial Size Range | 2 ml–100 ml tubular glass vials conforming to ISO 8362-1 |
| Fill Volume | 0.1 ml–50 ml per dosing channel |
| Number of Channels | 2–8 parallel dosing heads |
| Dosing Accuracy | ±1% of the set fill volume |
| Tubing Material | Gamma-stable silicone / TPE tubing conforming to USP <88> Class VI |
| Tubing Sterilization | Gamma irradiation at 25–40 kGy with pre-validated SAL 10−6 |
| Tubing Changeover | Approximately 5 minutes per channel with tool-free changeover |
| Product Path | Single-use tubing system with no product contact with internal machine components |
| Non-Product Contact Parts | SS316L stainless steel, finished to Ra ≤ 0.4 µm and suitable for wipe-down sanitization |
| Stoppering | Vibratory bowl feeding with servo pre-press and adjustable stopper insertion depth |
| Aseptic Zone | ISO 5 / Grade A environment with H14 HEPA filtration and airflow velocity of 0.36–0.54 m/s |
| Barrier System | Open RABS or closed RABS with VHP decontamination port |
| Power Supply | 415 V AC, 3-phase, 50–60 Hz |
| Power Consumption | 6–12 kW |
| Compressed Air | 5–7 bar oil-free compressed air, 150–300 litres/minute |
| Noise Level | ≤ 74 dB(A) |
| Machine Footprint | 3,000–4,200 mm L × 1,800–2,200 mm W × 2,200–2,500 mm H |
| Machine Weight | 2,400–4,200 kg |
| Warranty | 12 months comprehensive warranty with lifetime technical support |
Time-Pressure Type Vial Filling and Rubber Stoppering Machine
What it is and when to use it
The Time-Pressure Type Vial Filling and Rubber Stoppering Machine doses by opening a precision pneumatic valve for a controlled time under regulated pressure. Pressure is held constant by a feed tank and a mass-flow controller, while time is set by a high-resolution servo or solenoid. This delivers the highest accuracy in small-volume fills — typically ± 0.25% — making it the standard for vaccines, mAbs, and biologics in 0.5–10 ml formats. Output: up to 400 vials/min .
Use this machine when: you fill small volumes (0.05–20 ml) at high accuracy; you need to dose shear-sensitive biologics without piston pulsation; the product is foaming-sensitive; and you need a clean CIP/SIP path with no moving seals.
Key Engineering Features
- Time-pressure dosing head: precision SS 316L pneumatic valve with adjustable stroke time (10–500 ms) and feed pressure (0.2–2.0 bar). No moving seals in the product path.
- Multi-head parallel dosing: 4–12 dosing heads on a rotary indexing plate, each with its own valve and time-pressure profile.
- Mass-flow / pressure feedback: closed-loop pressure control with online mass-flow measurement; compensates for viscosity and temperature drift in real time.
- No-vial / no-fill detection: missing-vial sensor stops the dosing pulse; out-of-spec vials are rejected downstream.
- Integrated stoppering: vibratory bowl feed, servo pre-press, depth adjustable. Same aseptic zone as filling.
- CIP / SIP ready: fully drainable product path with spray-ball coverage and steam-sterilizable dosing heads; SIP at 121 °C / 30 min.
- SS 316L contact parts: all wetted components in AISI 316L with Ra ≤ 0.4 µm; FDA-grade elastomer seals.
- ISO 5 / Grade A aseptic zone: integrated laminar flow unit with H14 HEPA, 0.36–0.54 m/s, full oRABS / cRABS enclosure.
Specifications — Time-Pressure
| Parameter | Specification |
|---|---|
| Throughput | 100–400 vials/minute, depending on vial format and fill volume |
| Vial Size Range | 2 ml–50 ml tubular glass vials conforming to ISO 8362-1 |
| Fill Volume | 0.05 ml–20 ml per dosing head |
| Dosing Heads | 4–12 dosing heads, depending on the model |
| Dosing Accuracy | ±0.25% of the set fill volume |
| Feed Pressure | 0.2–2.0 bar with closed-loop pressure control |
| Valve Stroke Time | 10–500 ms using servo-controlled or high-resolution solenoid valves |
| Product Path | SS316L stainless steel product path with no moving seals, suitable for CIP / SIP |
| Stoppering | Vibratory bowl feeding with servo pre-press and adjustable stopper insertion depth |
| Aseptic Zone | ISO 5 / Grade A environment with H14 HEPA filtration and airflow velocity of 0.36–0.54 m/s |
| Barrier System | Open RABS or closed RABS with VHP decontamination port |
| Power Supply | 415 V AC, 3-phase, 50–60 Hz |
| Power Consumption | 8–14 kW |
| Compressed Air | 5–7 bar oil-free compressed air, 250–450 litres/minute |
| Clean Steam for SIP | 2–3 bar saturated clean steam, 25–50 kg/hour |
| WFI for CIP | 2–3 bar, 200–400 litres/hour |
| Noise Level | ≤ 75 dB(A) |
| Machine Footprint | 3,200–4,500 mm L × 1,800–2,400 mm W × 2,200–2,500 mm H |
| Machine Weight | 2,600–4,800 kg |
| Warranty | 12 months comprehensive warranty with lifetime technical support |
Rotary Piston vs Peristaltic vs Time-Pressure: Which Filler Do You Need?
The pharmaceutical industry uses three principal aseptic vial-filling methods. The right choice depends on product viscosity, fill volume, dosing accuracy and the validation burden your quality assurance team can support.
| Parameter | Rotary Piston | Peristaltic | Time-Pressure |
|---|---|---|---|
| Best For | High-viscosity liquids, suspensions, oils and larger fill volumes | Sterile biologics, vaccines and products requiring a single-use fluid path | Small-volume vaccines, biologics and applications requiring the highest dosing accuracy |
| Fill Volume Range | 0.5–100 ml | 0.1–50 ml | 0.05–20 ml |
| Throughput | 60–300 vials per minute | 40–200 vials per minute | 100–400 vials per minute |
| Dosing Accuracy | ±0.5% | ±1% | ±0.25% |
| Product Viscosity | Up to 50,000 cP | Up to 5,000 cP | Up to 10,000 cP |
| Shear Sensitivity | Moderate due to piston movement and possible flow pulsation | Low, with gentle and controlled fluid movement | Low, with controlled laminar product flow |
| Product Path | SS316L piston-cylinder system suitable for CIP / SIP | Single-use tubing system requiring no CIP / SIP | SS316L piping and valves suitable for CIP / SIP |
| Cross-Contamination Risk | Low when validated CIP / SIP procedures are followed | Very low because the complete product path is single-use | Low when validated CIP / SIP procedures are followed |
| Capital Cost (USD) | $80K–$200K | $60K–$160K | $100K–$250K |
| Validation Burden | High: CIP / SIP validation, media-fill studies and extractables assessment | Moderate: tubing extractables, leachables and single-use system validation | High: CIP / SIP validation, media-fill studies and dosing-valve qualification |
| Common Downstream | Vial capping, inspection and labelling | Vial capping, inspection and labelling | Vial capping, inspection and labelling |
| Particle Performance | Excellent with validated closed-path dosing | Excellent with a sterile, closed single-use product path | Excellent with validated closed-path dosing |
Rule of Thumb:
For high-viscosity products and larger fill volumes, choose a rotary piston filling system. For sterile biologics and vaccines where the product should not contact permanent machine components, choose a peristaltic filling system. For small-volume vaccines and biologics requiring the highest dosing accuracy, choose a time-pressure filling system.
For high-viscosity products and larger fill volumes, choose a rotary piston filling system. For sterile biologics and vaccines where the product should not contact permanent machine components, choose a peristaltic filling system. For small-volume vaccines and biologics requiring the highest dosing accuracy, choose a time-pressure filling system.
Inside the Machine: 8-Stage Process
Each vial spends 1.5–6 seconds in the filler depending on format and number of stations. A typical 8-station process:
- Infeed indexing: sterile, depyrogenated vials from the cooling conveyor enter a star-wheel infeed and are indexed one-by-one into the dosing positions.
- No-vial detection: a photoelectric sensor confirms the vial is in position; if absent, the dosing cycle is skipped.
- Vial centering: centering fingers grip the vial body and align it precisely under the dosing needle.
- Dosing: the dosing head (piston, peristaltic, or time-pressure) delivers a precise volume through a fill needle that descends to within 2–5 mm of the vial bottom (bottom-up filling to prevent foaming and splashing).
- Needle withdrawal: the fill needle withdraws above the vial mouth as the star-wheel indexes to the next station.
- Stopper placement: a vibratory bowl feeder orients a sterile rubber stopper; a gripper picks one stopper and places it on top of the vial mouth.
- Stopper pre-pressing: a servo-driven pre-press head seats the stopper to a recipe-defined depth — fully seated for terminal sterilization, partially seated (pre-stop) for lyophilization.
- Discharge: the filled, stoppered vial exits the aseptic zone to the capping machine conveyor. Out-of-spec vials (missing stopper, wrong depth) are automatically rejected at this station.
Throughout the cycle, the controller logs fill weight (via in-process check scale), dosing head pressure, stopper depth, HEPA airflow, and air pressure to a 21 CFR Part 11 audit trail. The data is exported via Ethernet for batch records.
Aseptic Process Validation: A 5-Step How-To
Validation is the foundation of aseptic manufacturing. The following sequence is a practical, audit-tested approach used by our customers’ QA teams. It aligns with WHO TRS 986 Annex 2, EU GMP Annex 1 (2022), 21 CFR 211.94, FDA Process Validation Guidance (2011), and the relevant USP chapters.
Step 1 — Define user requirements and worst-case format.
Document the smallest and largest vial formats, the lowest and highest fill volumes, the most viscous product, the target dosing accuracy, the air cleanliness (ISO 5 / Grade A), and the line speed. Lock these in a User Requirements Specification (URS) before ordering.
Step 2 — Execute IQ and OQ on the installed machine.
Run the IQ checklist (utilities, instrumentation, materials of construction, HEPA integrity, calibration) followed by OQ tests (no-vial dry cycle, alarm verification, sensor calibration, interlock function, gravimetric fill-weight verification at start / middle / end of cycle). Document deviations and resolutions.
Step 3 — Conduct media fill (process simulation).
Run 2 consecutive shifts at production scale using soybean-casein digest broth (or equivalent growth medium) in place of product. Incubate filled vials at 20–25 °C for 7 days then 30–35 °C for 7 days. Confirm contaminated vials < 0.1% per EU GMP Annex 1. Repeat for 3 successful runs.
Step 4 — Perform environmental and personnel qualification.
Conduct viable and non-viable air monitoring, settle plates, contact plates, and active air sampling at the filling point during three media fills. Confirm Grade A (viable < 1 CFU/m³) and Grade B (viable < 10 CFU/m³) for the background. Qualify personnel through gowning and aseptic-technique requalification per Annex 1.
Step 5 — Run performance qualification (PQ) with three production batches.
Execute three consecutive production-scale batches of the actual product. Verify fill-weight accuracy per batch, stopper placement depth, environmental monitoring results, and 21 CFR Part 11 audit trail completeness. Issue the final validation report signed by QA, engineering, and production.
Estimated timeline: 6–8 weeks from IQ start to final report, depending on media-fill incubation. Estimated cost: $20,000 – $40,000 in QA, microbiology, and lab fees for a single product.
USP, EP, and Annex 1 Compliance
Every machine is engineered and documented against the following standards:
- USP <85> — Bacterial Endotoxin Test (LAL)
- USP <788> — Particulate Matter in Injections
- USP <789> — Particulate Matter in Ophthalmic Solutions
- USP <905> — Uniformity of Dosage Units
- USP <1207> — Container Integrity
- USP <88> — Biological Reactivity (for single-use tubing)
- EP 2.9.19 — Particulate Contamination
- EP 2.6.14 — Bacterial Endotoxins
- EU GMP Annex 1 (2022) — Manufacture of Sterile Medicinal Products
- 21 CFR 211.94 — Drug Product Containers and Closures
- 21 CFR Part 11 — Electronic Records and Signatures
- FDA Process Validation Guidance (2011)
- WHO TRS 986 Annex 2 — WHO GMP for Pharmaceutical Products
- ISO 9001:2015 — Quality Management
- CE Machinery Directive 2006/42/EC
- ISPE Baseline® Guide — Sterile Product Manufacturing Facilities
Inline Integration with Tunnel and Capping
A vial filling and stoppering machine is rarely a standalone. It is the middle of a tightly synchronized aseptic line:
- Upstream: Vial unscrambler → rotary gripper washer → depyrogenation tunnel → cooling conveyor
- Filler: Automatic vial filling and rubber stoppering machine (rotary piston / peristaltic / time-pressure)
- Optional Lyophilizer: for pre-stoppered vials, the lyophilizer (freeze dryer) with auto-loading and final stoppering station
- Capping: aluminium cap sealing (if not done in the filler)
- Inspection: automated visual inspection for particles, cracks, fill volume, stopper presence, cap tightness
- Labeling: vial labeling machine with batch coding and serialization
Our fillers are designed for direct feed from our depyrogenation tunnels, with matched conveyor speed, pitch, and entry height. The exit feeds the capping machine conveyor with no operator handling between fill and cap.
Frequently Asked Questions
It is an integrated aseptic system that doses a precise volume of liquid into a sterile glass vial and seats a sterile rubber stopper on top — all under ISO 5 / Grade A unidirectional airflow. It replaces separate fill and stopper stations and is the workhorse of any parenteral, vaccine, or lyophilized injectable line.
Rotary piston: best for high-viscosity liquids, suspensions, oils, and large volumes (5–100 ml) with ± 0.5% accuracy. Peristaltic: best for sterile biologics and vaccines where the product never touches machine internals (± 1% accuracy). Time-pressure: best for small-volume biologics and vaccines at the highest accuracy (± 0.25%).
A vibratory or centrifugal bowl feeder orients sterile rubber stoppers. A gripper picks one stopper per cycle, places it on the vial mouth, and a servo-driven pre-press head seats it to a recipe-defined depth. Out-of-spec stoppers trigger a downstream reject.
Rotary piston: ± 0.5%. Peristaltic: ± 1%. Time-pressure: ± 0.25%. All are validated per USP <905> uniformity of dosage units. Accuracy is verified during OQ with gravimetric testing.
Pre-stoppering seats the stopper partway so the vial can enter a lyophilizer without the stopper popping off under vacuum. After lyophilization, the vial goes to a final stoppering station. A vial filling machine typically pre-stops when feeding a lyophilizer and fully stops when filling non-lyophilized liquids.
ISO 5 / Grade A unidirectional airflow per EU GMP Annex 1 (2022) and USFDA aseptic-processing guidance. The machine is enclosed in an oRABS or cRABS with integrated laminar flow delivering 0.36–0.54 m/s airflow at the critical point.
Validation follows a 3-stage approach: IQ/OQ on the installed machine, media fill (process simulation) with growth medium per Annex 1 (contaminated vials < 0.1%), and performance qualification with three production-scale batches.
415V AC 3-phase power, 8–15 kW connected load; 5–7 bar oil-free compressed air; clean steam for SIP; WFI for CIP; HEPA-filtered air for laminar flow; vacuum for stopper placement; and a stable, vibration-isolated floor for the rotary indexing system.
Ampoules are sealed by flame after filling — no stopper. Vials use a rubber stopper. The two machines are not interchangeable.
Standard configurations cover 60–400 vials/min. Rotary piston: 60–300 VPM. Peristaltic: 40–200 VPM. Time-pressure: 100–400 VPM for small-volume fills.
Customer Outcomes
“We replaced our 15-year-old peristaltic filler with a time-pressure machine for our mAb vaccine line. Fill-weight CV dropped from 1.2% to 0.18%, and we passed three consecutive media fills on the first attempt. The 21 CFR Part 11 audit trail closed the gap our FDA inspector had flagged in 2023.”
— Director of Manufacturing, Biologics CDMO, Cambridge, USA (reference available under NDA)
“The rotary piston filler on our oil-based injectable line has run 18 million vials in two years with no piston seal change. CIP/SIP cycles are 45 minutes end-to-end and validation was a 6-week project for the line.”
— Plant Manager, Veterinary Injectables, São Paulo, Brazil (reference available on request)
“Single-use tubing on the peristaltic filler was the deciding factor for our clinical-trial batches — we run 8 SKUs per month with no CIP validation burden between products. Setup time per batch is under 15 minutes.”
— Head of Clinical Manufacturing, Specialty Injectables, Hyderabad (reference available on request)
Installation, Validation, and Support
Every machine is delivered as a turnkey project with the following scope:
- Pre-shipment Factory Acceptance Test (FAT) at our facility, with fill-weight data and CIP/SIP cycle logs
- On-site installation, commissioning, and Site Acceptance Test (SAT)
- IQ and OQ execution support, including protocol walkthrough with your QA team
- Operator, maintenance, and aseptic-technique training (typically 5 days)
- 1-year comprehensive warranty covering parts and labor
- Lifetime remote support via video call, TeamViewer, and WhatsApp business
- Annual Maintenance Contract (AMC) options including preventive maintenance, HEPA integrity testing, and recalibration
- Spare parts kits shipped within 24–48 hours globally from regional warehouses
Typical delivery times: Standard machines ship in 12–16 weeks; customized configurations in 16–22 weeks. Installation and validation typically add 4–6 weeks on site.
Industries We Serve
- Pharmaceutical and biopharmaceutical manufacturing
- Vaccine and biological manufacturing
- Lyophilized (freeze-dried) injectables
- Sterile ophthalmic and nasal sprays
- Veterinary injectables
- Contract development and manufacturing organizations (CDMOs)
Certifications and Compliance
- ISO 9001:2015 Certified Manufacturing
- CE Marking (Machinery Directive 2006/42/EC)
- cGMP-Compliant Design
- WHO-GMP Compatible
- USFDA-Ready Configurations
- EU GMP Annex 1 (2022) Compatible
Related Vial Processing Equipment
- Vial Depyrogenation Tunnel
- Automatic Vial Filling and Rubber Stoppering Machine
- Vial Powder Filling and Rubber Stoppering Machine
- Vial Cap Sealing Machine
- Vial Inspection Conveyor Booth
- Vial Labeling Machine
Request a Free Quote
Get a customized quotation with full technical specifications, utility consumption estimate, validation plan, and line-layout proposal within 24 hours.
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