Nasal Spray Filling Production Line
The fully automatic nasal spray filling line is an integrated turnkey production system designed for continuous, fully automated operation. It is suitable for a wide range of water‑based spray products, including medical nasal sprays, physiological saline, nasal care solutions, and antibacterial sprays.
- Product Description
- Technical Features
- Technical Parameters
- Optional Systems
- Application Scenarios
- Video
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Introduction
Engineered for aseptic fill-finish of nasal spray and intranasal drug products, this nasal spray filling line is designed in line with EU GMP Annex 1, FDA cGMP and 21 CFR Part 11 requirements, and carries CE marking under the applicable EU Machinery Directive (2006/42/EC), Low-Voltage Directive (2014/35/EU) and EMC Directive (2014/30/EU). It can be delivered with an integrated contamination control strategy—an isolator or restricted access barrier system (RABS) with vaporized hydrogen peroxide (VHP) bio-decontamination—achieving a sterility assurance level of SAL 10^-6 and maintaining an ISO 5 (Grade A) critical zone compatible with ISO 7 (Grade B) backgrounds. Servo-driven filling with precise metered-dose pump insertion and controlled capping, together with electronic records and electronic signatures (ER/ES) and ALCOA+-aligned audit trails, secures dosing accuracy, consistent shot weight and complete data traceability. Backed by MARYA's end-to-end DQ/IQ/OQ/PQ validation and FAT/SAT, the line delivers performance comparable to the world's leading fill-finish equipment suppliers.
The line integrates the complete process: bottle unscrambling and feeding, internal and external spray washing with purified water or water for injection, far‑infrared tunnel sterilization and drying, aseptic filling, capping, visual inspection and rejection, and labeling and coding — enabling continuous, unattended mass production. The core filling and capping stations can be equipped with Class 100 laminar flow hoods, providing ISO 5 (Grade A) unidirectional airflow protection and making the line suitable for use in Grade B cleanrooms. The complete line fully complies with current GMP requirements and meets the high production standards required by the pharmaceutical and medical device industries as well as export markets.
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Washing Machine:
(1) Adopts a two-water-one-air alternating spray rinsing method for thorough bottle cleaning with no residual liquid and no hard-to-clean areas.
(2) An optional ultrasonic cleaning module is available for high-cleanliness aseptic production, effectively removing particulates from bottle surfaces to ensure filling cleanliness.
Tunnel:
(1) Equipped with far-infrared electric quartz heating tubes for high thermal efficiency, energy savings, and reliable sterilization and drying performance.
(2) Features a stainless steel mesh belt driven by a variable frequency drive, ensuring smooth operation and adjustable speed to meet various capacity requirements.
(3) Partitioned design with independent heating and cooling sections, plus a thickened aluminum silicate fiber insulation layer for effective heat retention and lower energy consumption.
(4) A dedicated top moisture exhaust system rapidly removes water vapor, improving drying and sterilization efficiency and supporting aseptic production quality.
Filling & Capping Machine:
(1) Equipped with a servo control system and high-precision photoelectric detection, it automatically implements no-bottle-no-fill, no-bottle-no-cap, and no-bottle-no-capping logic to prevent defective products at the source.
(2) Servo-driven metering pumps ensure precise filling. Combined with anti-drip suck-back and submerged bottom filling, the system reduces bubble formation and delivers high accuracy with consistent product appearance.
(3) Optional CIP/SIP modules for the filling system allow in-place cleaning and sterilization.
(4) An optional nitrogen purging system effectively protects the product from oxidation.
(5) Independent servo-driven capping with precisely adjustable torque prevents thread stripping, bottle breakage, and poor sealing.
(6) Compatible with 5-30 ml glass bottles and various spray pump heads, supporting tool-free quick changeover.
(7) Integrated functions include leakage rejection, online seal integrity inspection, and automatic interlock shutdown on alarm under abnormal conditions.
(8) Can be equipped with laminar flow hoods or isolators to meet aseptic production requirements in high-grade cleanrooms.
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Items Parameters Production Capacity 10,000 – 12,000 bottles/hour Applicable Bottles 5 – 30 ml glass / plastic bottles Filling Heads 18 heads Capping Heads 12 heads Filling Accuracy ≤±1% Product Qualification Rate ≥99.9% Sterilization Temperature 300-350℃ Water Consumption 0.6-1t/h Air Consumption 20 m³/h, working pressure 0.3 – 0.6 MPa Power Supply / Total Power 220/380 V, total power ≤ 90 kW -
(1) Pharmaceutical Products
Production of sterile pharmaceutical spray formulations, including sterile saline nasal sprays, prescription nasal solutions, anti-allergic nasal preparations, and anti-inflammatory nasal care liquids.
(2) Medical Devices
Mass production of medical device products such as Class II seawater nasal irrigation solutions, children-specific nasal sprays, and physiological seawater nasal care sprays.
(3) Daily Chemical & Disinfection Products
Production of daily care spray products, including nasal moisturizing care sprays, antibacterial protective sprays, and mild household disinfection sprays.
(4) Production Scenarios
Suitable for a full range of production environments, including GMP‑certified aseptic cleanrooms and high‑grade medical workshops, as well as for export‑oriented mass production and OEM/ODM contract manufacturing.
Production Bases
Successful Projects in 70 Countries
Loyal Clientele
Invited to the Embassy of the United Republic of Tanzania in Guangzhou to discuss projects
Tanzanian Vice President Visits Marya Pharmaceutical EPC Project
NBA (Zimbabwe National Biotechnology Authority) conducts FAT at MARYA’s Factory
NOVO NORDISK client Visit
Clients visit the factory's liquid preparation system
Argentine client visits for FAT in MARYA
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Full-process Consulting Services
Whether you are preparing to build a new pharmaceutical factory, build a cleanroom that complies with local GMP regulations, or purchase pharmaceutical equipment to develop a new production line, whether it is a separate cleanroom or pharmaceutical machine project, or a one-stop solution, Marya's professional teams in the fields of pharmaceutical technical process, process equipment, decoration engineering, HVAC engineering, pipeline engineering, utility equipment, intelligent automatic control systems, project cost and other fields can provide you with full-process technical consulting services, and solve your needs one-on-one.
2D/3D Design Modeling Services
Marya project design team is composed of professional CAD and BIM engineers with more than 20 years of comprehensive industry experience and can provide you with comprehensive design services, including but not limited to process layout drawings, technical process charts, 3D models and animations, air conditioning system scheme design, construction drawing design, plant/pharmaceutical machine layout drawings, etc.
Machine Customization Services
Based on the individual needs of clients in different countries, Marya helps you clarify specific needs, match appropriate models, and customize one stop filling solutions for sterile small-volume preparations, large-volume injections, oral liquids/syrups, solid preparations, etc.
Validation Services (FAT/SAT)
Marya will appoint an engineer with rich project management experience as the person in charge, who will be fully responsible for project management and liaison work. After the equipment is manufactured, our engineers and the buyer's representatives will participate in the FAT test. After the equipment arrives at the buyer's site, it will be installed and debugged. After the equipment reaches optimal operation, the buyer will conduct SAT testing and inspection.
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