English
Views: 145 Author: Liangke Machinery Publish Time: 2026-09-15 Origin: Liangke Machinery
Subtitle: From FAT to Delivery — An Integrated Coating and WIP System Package
Hunan Grand recently completed the factory acceptance test (FAT) and shipment of a BG-150E high-efficiency tablet coating machine together with a 500L cleaning hot water tank for the coating machine's WIP system. The project required the equipment to meet CE marking, explosion-proof ratings, GMP material contact standards, and automated cleaning support — a combination of requirements that demanded close coordination from technical confirmation through to final documentation.
Drawing on the project's technical confirmation file and production task order, this case study reviews the key points of the integrated package across configuration, process control, and acceptance testing. The FAT video is included for reference.
The hot air cabinet adopts a three-stage filtration structure: primary (G4) + medium (F8/F9) + HEPA (H13/H14). Air passes through each stage sequentially, removing large, medium, and fine particles to deliver clean air into the coating drum at ISO 8 (Class 100,000) cleanliness — fully compliant with oral solid dosage coating requirements.
Combined with variable negative pressure regulation, the system maintains a stable drum negative pressure of –0.03 to –0.05 MPa, preventing dust escape while ensuring proper droplet contact with the tablet bed.
Further reading: What Is The Three-Stage Filter of A Tablet Coating Machine?
PLC and touch screen: The original configuration specified a Siemens PLC with a 9-inch Siemens touch screen. Since the TP series has been discontinued, the project was upgraded to a Siemens MTP1000 10-inch touch screen, with USB data export explicitly required for batch record retrieval.
Explosion-proof design: The touch screen is housed in a positive-pressure explosion-proof cabinet. All electrical components on the main unit — including the PLC and frequency converters — were relocated to a dedicated explosion-proof electrical cabinet. All solenoid valves and probes are explosion-proof rated.
Earthing and safety: The machine is equipped with a standard earthing network and two emergency stop switches (one on the touch screen control cabinet, one on the main machine).
Product contact parts: All SUS316 construction, in strict compliance with GMP standards.
Peristaltic pump: Standard configuration is a frequency-controlled peristaltic pump with a 10-meter corrosion-resistant silicone hose; this project was upgraded to a Watson Marlow pump with three pump heads, replacing the standard single peristaltic pump.
Spray guns: Standard supply is 3 guns; this project was upgraded to 3 Schlick spray guns. A sugar-coating dropper is also included.
Mixing drum: 80L thermostatic double-layer mixing drum, maintaining stable coating solution temperature and continuous agitation.
The quality of high-efficiency film coating depends on the dynamic balance among tablet bed temperature, spray rate, and pan speed. Based on validated production data:
| Parameter | Typical Range | Control Logic |
|---|---|---|
| Inlet air temperature | 49–54 °C | Water-based systems require higher inlet temperature to offset evaporative cooling |
| Outlet air temperature | ~38 °C | Reflects drying efficiency; excessive ΔT indicates over-drying |
| Tablet bed temperature | 30–35 °C (critical control point) | Must be 10–20 °C above the polymer's minimum film-forming temperature |
| Pan negative pressure | –0.03 to –0.05 MPa | Maintains airflow path and droplet contact |
| Peristaltic pump speed | 27–34 RPM | Increase to cool the bed; decrease to raise bed temperature |
| Atomizing air pressure | Gun 1: 0.26 MPa; Gun 2: 0.16 MPa | Too low → coarse spray; too high → dry mist |
| Gun-to-bed distance | ~25 cm | Too close → over-wetting; too far → premature drying |
Further reading: Optimizing Tablet Bed Temperature and Atomization Pressure for High-Efficiency Film Coating – A QbD Approach
Exhaust cabinet uses filter bags;
Discharge direction: clockwise rotation;
Power supply: 3P 380V 50Hz, electric heating;
Air duct length to be confirmed per final layout drawing;
Equipped with differential pressure probe (i.e., the coating drum differential pressure sensor, already included);
WIP cleaning system, 1 set.
As the hot water supply unit for the coating machine's WIP system, the 500L tank was designed to CE certification requirements. Key parameters:
| Item | Specification |
|---|---|
| Equipment name | 500L cleaning hot water tank for coating machine |
| Quantity | 1 unit |
| Vessel category | Atmospheric pressure equipment |
| Jacket / design pressure | Atmospheric |
| Working / design temperature | <100 °C / 100 °C |
| Product name | Pharmaceutical solution |
| Main pressure-retaining material | S31603 |
| Heat exchange area | 2.5 m² |
| Effective volume | 0.5 m³ |
| Electric heating power | 2×12 = 24 kW |
Control cabinet functions:
Electric heating temperature control, jacket heating type;
Level indication;
Inlet solenoid valve control, automatic replenishment.
Delivery requirements:
Power supply: 3-phase 380V 50Hz;
CE marking;
Nameplate ;
Manual ;
After commissioning and before/during shipment, the following must be photographed and video-recorded for archival purposes: Full specifications for the touchscreen；complete equipment operation video; individual stations, electrical cabinet, overall equipment, and finished sample photos.
A complete FAT was carried out before shipment, focusing on:
Three-stage filtration differential pressure monitoring: normal readings across primary, medium, and HEPA stages; no leakage in HEPA filter;
Explosion-proof system integration: positive-pressure cabinet, explosion-proof electrical cabinet, solenoid valves, and probes all functioning reliably;
Liquid delivery system: Watson Marlow three-head pump and Schlick spray guns delivering uniform atomization with no dripping;
WIP cleaning integration: 500L hot water tank automatic replenishment, jacket heating, level indication, and interlock with the coating machine cleaning program;
Safety interlocks: two emergency stop switches, door interlock, temperature probes, and pressure sensors verified.
The FAT video is published alongside this case study, providing a direct view of the equipment in operation and the integrated package.
✅ Integrated package: 150E coating machine + 500L cleaning hot water tank + WIP system, delivered as one solution;
✅ Explosion-proof compliance: positive-pressure cabinet + explosion-proof electrical cabinet + explosion-proof valves/probes;
✅ GMP materials: SUS316/S31603 product contact parts, meeting pharmaceutical hygiene standards;
✅ Brand upgrades: Watson Marlow pump + Schlick spray guns + Siemens MTP1000 touch screen;
✅ Process control: three-stage filtration + variable negative pressure + differential pressure monitoring for tablet bed temperature and coating uniformity;
✅ Complete documentation: bilingual technical confirmation, CE nameplate, translated manual, FAT video archive.
From the item-by-item sign-off in the technical confirmation file, through the CE and explosion-proof requirements in the production task order, to the integrated system testing at FAT — this 150E high-efficiency coating machine + 500L cleaning hot water tank package demonstrates Hunan Dage's engineering capability in integrated solid dosage coating lines. We will continue to focus on QbD process control and GMP-compliant design to deliver more stable and verifiable coating solutions to customers worldwide.
