Oral Liquid Line
Liquid Preparation
Oral Liquid Production Line
Equipment Technical Specification Document
Issue Date: 2026-05-08
1. Product Overview
The oral liquid production line is an integrated system designed specifically for the pharmaceutical industry, covering the full production process of oral liquid preparations including compounding, filling, capping, and labeling. The line strictly complies with GMP regulations and adopts a modular design philosophy, allowing flexible configuration according to different capacity requirements.
This production line covers the complete process chain from raw material preparation to finished product output, including compounding system, filtration system, filling system, capping system, labeling system, and inspection system. All units are interconnected through a central control system for data communication and coordinated operation, ensuring traceability and consistency throughout the production process.
The line accommodates oral liquid bottles from 5mL to 500mL with production capacity ranging from 2,000 to 30,000 bottles per hour, meeting all scenarios from small-scale R&D to large-scale commercial production.
2. Working Principle
The process flow of the oral liquid production line is as follows:
1. Compounding Section: Raw materials and purified water are mixed in the compounding tank according to the formulation. The temperature control system ensures precise temperature management for solution homogeneity.
2. Filtration Section: The solution passes through a multi-stage filtration system (pre-filtration → fine filtration → sterile filtration) to remove particles and microorganisms, meeting sterile or low-bioburden requirements.
3. Filling Section: Precision metering is performed using peristaltic pumps or ceramic pumps with filling accuracy of ±0.5%, supporting rapid changeover between bottle types.
4. Capping Section: Capping machines apply screw or roll-over caps with adjustable capping torque to ensure reliable seal integrity.
5. Labeling Section: The automatic labeling machine applies labels with centering, skew detection, and inkjet coding capabilities.
6. Inspection Section: Integrated light inspection or vision inspection systems perform in-line inspection of bottle appearance, fill level, and seal quality, rejecting non-conforming products.
Each section is connected via conveyor belts or star wheels for smooth bottle transfer. The central PLC control system monitors all sections in real time and records critical process parameters, ensuring full production traceability.
3. System Classification
Classification by Capacity
| Capacity Range | Application | |
|---|---|---|
| Small Line | 2,000-5,000 bph | For R&D pilot and small batch production |
| Medium Line | 5,000-15,000 bph | For mid-scale commercial production |
| Large Line | 15,000-30,000 bph | For large-scale continuous production |
Classification by Bottle Type
| Material | Features | |
|---|---|---|
| Glass Bottle Line | Soda-lime/Borosilicate glass | Traditional oral liquids, high-temp sterilization |
| PET Bottle Line | PET material | Lightweight and portable, suitable for OTC |
| Plastic Bottle Line | HDPE/PP material | Lower cost, suitable for high-volume production |
Classification by Automation Level
| Description | Application | |
|---|---|---|
| Semi-Automatic Line | Some sections require manual operation | Lower investment, for multi-product small batches |
| Fully Automatic Line | Full-line automatic operation | High efficiency, for large-batch continuous production |
4. Detailed Technical Parameters
4.1 Basic Parameters
| Parameter | Specification Range | Remarks |
|---|---|---|
| Production Capacity | 2,000-30,000 bph | Depending on configuration |
| Bottle Volume | 5-500 mL | Custom sizes available |
| Filling Accuracy | ±0.5% | Metering pump accuracy |
| Capping Qualification Rate | ≥99.5% | Adjustable torque |
| Labeling Accuracy | ±1.0 mm | Label centering deviation |
| Power Supply | 380V/50Hz 3-phase | Other voltages available |
| Compressed Air | 0.5-0.7 MPa | Clean compressed air |
| Purified Water Consumption | 0.5-2.0 m³/h | Depending on capacity |
| Total Power | 15-85 kW | Depending on configuration |
| Noise Level | ≤75 dB(A) | At 1m from equipment |
4.2 Production Line Configuration
| Item | Standard Configuration | Optional Upgrade |
|---|---|---|
| Compounding System | Single tank 200L | Dual tank 300L/500L |
| Filtration System | 2-stage filtration | 3-stage sterile filtration |
| Filling Heads | 8 heads | 12/16 heads |
| Capping Method | Screw capping | Roll-over capping / Tamper-evident |
| Labeling Method | Single-side labeling | Double-side / Wrap-around labeling |
| Inspection Method | Manual light inspection | Automatic vision inspection |
| Conveying Method | Conveyor belt | Star wheel / Dial |
| Control System | PLC + Touch screen | SCADA system |
4.3 Filling Parameters
| Parameter | Value | Description |
|---|---|---|
| Filling Method | Peristaltic/Ceramic pump | Selected by solution properties |
| Number of Heads | 8/12/16 heads | Affects capacity |
| Filling Speed | Adjustable | Variable frequency control |
| Filling Accuracy | ±0.5% | 20mL standard bottle |
| Suction/Dispensing | Automatic | Anti-drip design |
| Bottle Changeover | ≤30 minutes | Tool-free quick changeover |
| CIP Cleaning | In-line cleaning | With CIP connections |
| SIP Sterilization | In-line sterilization | With SIP connections |
4.4 Dimensions
| Equipment | L(mm) | W(mm) | H(mm) | Weight(kg) |
|---|---|---|---|---|
| Compounding System | 2500 | 1500 | 2800 | 1200 |
| Filtration System | 1200 | 800 | 1600 | 350 |
| Filling Machine | 2200 | 1200 | 1800 | 950 |
| Capping Machine | 1800 | 1000 | 1700 | 600 |
| Labeling Machine | 2000 | 900 | 1600 | 450 |
| Inspection Machine | 1500 | 900 | 1700 | 380 |
| Conveyor System | Custom | 600 | 900 | Custom |
4.5 Material Characteristics
| Component | Material | Standard | Surface Treatment |
|---|---|---|---|
| Compounding Tank | SUS316L | GB/T 3280 | Inner wall Ra≤0.4μm |
| Piping System | SUS316L | ISO 2037 | Inner wall Ra≤0.5μm |
| Filling Pump | Ceramic/SUS316L | FDA Standard | Precision polished |
| Seals | PTFE/Silicone | USP Class VI | Pharmaceutical grade |
| Product Contact Parts | SUS316L/PTFE | GMP | Ra≤0.4μm |
| External Housing | SUS304 | GB/T 3280 | Brushed finish |
5. Core Component Selection
Compounding Tank
- Volume: 200L/300L/500L optional
- Material: SUS316L, inner wall Ra≤0.4μm
- Agitation: Variable frequency, anchor/paddle agitator
- Temperature control: Jacketed heating/cooling, ±1°C accuracy
- Connections: CIP/SIP, sanitary clamp fittings
Filtration System
- Filter ratings: 5μm → 0.45μm → 0.22μm
- Material: PP/PES/Nylon filter cartridges
- Housing: SUS316L sanitary grade
- Integrity testing: In-line detection capability
- Sterilization: In-line steam sterilization
Filling Machine
- Filling method: Peristaltic/ceramic pump metering
- Heads: 8/12/16 optional
- Accuracy: ±0.5% (20mL standard bottle)
- Anti-drip: Needle insertion filling with suck-back
- Control: Servo-driven, touch screen parameter setting
Capping Machine
- Method: Screw capping / Roll-over / Tamper-evident
- Torque: 0.3-2.5 N·m adjustable
- Qualification rate: ≥99.5%
- Detection: In-line torque monitoring
- Cap compatibility: Screw caps / Aluminum caps / Tamper-evident caps
Control System
- Main controller: Siemens S7 series PLC
- Interface: 15-inch touch screen
- Communication: Profinet/Ethernet
- Data: SCADA system optional
- Records: 21 CFR Part 11 compliant electronic records
6. Typical Application Areas
Pharmaceutical Oral Liquids: Production of various chemical oral liquid preparations including solutions, suspensions, and emulsions
Health Supplements: Production of nutritional supplements, vitamin oral liquids, collagen liquids, etc.
TCM Preparations: Production of traditional Chinese medicine oral liquids, mixtures, and syrup preparations
Syrup Products: Production of cough syrups, vitamin syrups, and other syrup-based pharmaceuticals
7. Design Standards & Certifications
- GMP (Good Manufacturing Practice) - China 2010 GMP and EU GMP
- FDA 21 CFR Part 210/211 - US FDA drug manufacturing regulations
- FDA 21 CFR Part 11 - Electronic records and signatures compliance
- ISO 9001:2015 - Quality management system certification
- CE Certification - EU Machinery Directive 2006/42/EC
- Chinese Pharmacopoeia (2020 Edition) - Oral liquid preparation standards
- ISPE GAMP5 - Automated system validation guide
- USP <661> - Plastic packaging system standards
8. Customizable Optional Configurations
| No. | Configuration Item | Standard | Optional Upgrade | Remarks |
|---|---|---|---|---|
| 1 | Compounding Tank Volume | 200L single tank | 300L/500L dual tank | Select by capacity needs |
| 2 | Filtration Grade | 2-stage filtration | 3-stage sterile filtration | Select by product requirements |
| 3 | Filling Heads | 8 heads | 12/16 heads | Affects capacity |
| 4 | Filling Pump Type | Peristaltic pump | Ceramic/SS pump | Select by solution properties |
| 5 | Capping Method | Screw capping | Roll-over/Tamper-evident | Select by bottle type |
| 6 | Labeling Method | Single-side labeling | Double-side/Wrap-around | Select by requirements |
| 7 | Inspection System | Manual light inspection | Auto vision inspection | Select by QC requirements |
| 8 | Checkweighing | None | In-line weight check | 100% weight verification |
| 9 | Data Management | Basic records | MES/SCADA integration | Traceability requirements |
| 10 | Environmental Control | Grade D cleanroom | Grade C/B cleanroom | Select by product needs |
9. Warranty Terms
- Equipment warranty period: 12 months (from acceptance date)
- Major components warranty: 24 months (including PLC, servo motors, sensors, etc.)
- Consumable parts warranty: 6 months (including seals, filter cartridges, pump tubing, etc.)
- Free repair and replacement during warranty; lifetime paid technical support after warranty
- Response time: Acknowledgment within 2 hours, on-site arrival within 48 hours
- Complete operation manual, maintenance manual, and spare parts list provided
10. Packaging & Delivery
- Packaging: Wooden crate with moisture barrier film and shock-absorbing materials
- Transportation: Truck or rail transport (air freight available on request)
- Delivery time: 60-90 working days after contract signing
- Installation & commissioning: Supplier responsible; buyer provides necessary conditions
- Acceptance: FAT/SAT per technical agreement and GMP requirements
- Training: 5-10 working days of operation and maintenance training
- Documentation: Operation manual, maintenance manual, electrical drawings, spare parts list
11. Information Required for Inquiry
| No. | Information Item | Description | Example |
|---|---|---|---|
| 1 | Product Name & Specifications | Full product name and fill volume | XX Oral Liquid 10mL/bottle |
| 2 | Expected Capacity | Hourly/daily production requirement | 10,000 bph |
| 3 | Bottle Type & Material | Bottle shape, dimensions, and material | 10mL tubular glass bottle |
| 4 | Cap Type | Cap type and dimensions | Aluminum screw cap |
| 5 | Solution Properties | Viscosity, density, temperature requirements | Viscosity ≤50cP, Density 1.1g/cm³ |
| 6 | Cleanroom Grade | Production environment cleanliness level | Grade D/C cleanroom |
| 7 | Regulatory Requirements | Applicable regulations and certifications | GMP/FDA/CE |
| 8 | Special Requirements | Other customization needs | Explosion-proof/Checkweighing/MES |