Key Equipment: Vacuum Emulsifier / (Jacketed) Mixing Tank
This document describes the process flow and equipment configuration of the pharmaceutical ointment production line, focusing on the line layout built around the core paste-making equipment — the Vacuum Emulsifier / (Jacketed) Mixing Tank.
Ointments are semi-solid preparations made by uniformly mixing drugs with suitable bases (petrolatum, lanolin, liquid paraffin, emulsifiers etc.), divided into oleaginous type and cream (emulsion) type. The core process is to melt, emulsify, mix and homogenize the drugs and bases in the vacuum emulsifier with heating, so that the drugs are uniformly dispersed in the base. The uniformity of drug dispersion and the stability of the base system directly determine the efficacy, spreadability and stability of the ointment, and are the key links of the whole production line.
By material flow, the pharmaceutical ointment production line is divided into four functional zones — pretreatment, preparation, post-treatment, and filling & packaging — organized around the core paste-making equipment (Vacuum Emulsifier / (Jacketed) Mixing Tank):
| Functional Zone | Main Processes | Main Equipment | Function |
|---|---|---|---|
| Pretreatment zone | Raw material inspection, weighing & batching | Electronic scales, batching containers, purified water system | Inspect and weigh the drugs, bases and excipients |
| Preparation zone (core) | Oil-phase preparation, water-phase preparation, emulsification, mixing, defoaming | Vacuum Emulsifier / (Jacketed) Mixing Tank | Emulsify, mix and homogenize the oil phase and water phase in the jacketed mixing tank and vacuum-degas to make the ointment |
| Post-treatment zone | Cooling, intermediate inspection | Cooling jacket, inspection equipment | Cool down, stabilize the base system and complete intermediate inspection |
| Filling & packaging zone | Filling, packaging, finished product inspection | Tube filling machine, packaging machine, coding equipment | Metered filling into tubes, packaging and labeling; inspect finished products before warehousing |
Materials flow sequentially from the pretreatment zone into the preparation zone, post-treatment zone and filling & packaging zone, forming a continuous, closed and traceable pharmaceutical production flow.
The typical process flow of pharmaceutical ointments is: raw material inspection → weighing & batching → (oil-phase preparation and water-phase preparation in parallel) → vacuum emulsification → cooling → intermediate inspection → filling → packaging → finished product inspection & warehousing. Each step is described as follows:
| No. | Process Step | Step Description | Key Control |
|---|---|---|---|
| 1 | Raw material inspection | Inspect the drugs, bases and excipients; store them for later use after they pass | — |
| 2 | Weighing & batching | Accurately weigh the drugs, bases and excipients according to the formulation | Accurate proportioning |
| 3 | Oil-phase preparation | Heat and melt the oil-phase components such as petrolatum, lanolin, liquid paraffin and oil-soluble drugs evenly | Oil-phase temperature ★ |
| 4 | Water-phase preparation | Heat and dissolve the water-phase components such as purified water, emulsifiers and water-soluble drugs evenly | Water-phase temperature ★ |
| 5 | Vacuum emulsification | Add the oil phase and water phase into the vacuum emulsifier; heat, emulsify, homogenize and mix with vacuum defoaming to make a uniform ointment | Emulsification ★ (core) |
| 6 | Cooling | Cool to the set temperature through jacket cooling water | Cooling speed |
| 7 | Intermediate inspection | Test semi-finished products on content, uniformity, particle size and other indicators; transfer to the next process after they pass | Pass/fail judgment |
| 8 | Filling (tubes) | Quantitatively fill via the tube filling machine | Filling metering |
| 9 | Packaging | Sealing, boxing, coding, cartoning | Sealing integrity |
| 10 | Finished product inspection & warehousing | Inspect finished products against pharmacopoeia standards; warehouse them after they pass | Pass/fail judgment |
Note: The steps marked with ★ in the table (oil-phase temperature, water-phase temperature and vacuum emulsification) are key process control points, among which vacuum emulsification is the core control link of the whole production process.
The Vacuum Emulsifier (also called vacuum homogenizing emulsifier) is the core equipment of the pharmaceutical ointment production line. Its main body is a mixing tank with a heating/cooling jacket, integrated with a vacuum system, a homogenizing emulsifying head and a wall-scraping stirring device, combining heating, emulsification, mixing, homogenization, defoaming and other functions in one unit, ensuring uniform dispersion of the drugs in the base.
| Item | Description |
|---|---|
| Function | Emulsification of the oil phase and water phase, drug dispersion, homogenization and vacuum defoaming — the key process that ensures the uniform efficacy of ointments |
| Main structure | Mixing tank with a heating/cooling jacket; steam or cooling water circulates in the jacket for temperature control |
| Stirring system | A central paddle works with a wall-scraping paddle to ensure thorough mixing of the high-viscosity base and prevent wall sticking |
| Homogenizing system | A high-speed homogenizing emulsifying head achieves micro-level shear refining and uniform dispersion of drugs in the base |
| Vacuum system | The tank is evacuated to remove air and reduce oxidation, improving the fineness and stability of the ointment |
| Temperature control | Heating and cooling through the jacket, combined with temperature sensors for precise process temperature control |
| Advantages | Closed operation, good hygiene, high emulsifying efficiency, stable product quality, easy cleaning (CIP) |
In the production line, the Vacuum Emulsifier / (Jacketed) Mixing Tank receives materials from the oil-phase pot and water-phase pot and completes emulsification under vacuum, heating and high-speed homogenization, producing a stable and fine ointment, which then passes through cooling and intermediate inspection into the subsequent filling and packaging processes.
Step 3 · Oil-phase preparation
Heat and melt the oil-phase components such as petrolatum, lanolin, liquid paraffin and oil-soluble drugs evenly
Oil Phase Tank & Water Phase Tank |
|
Step 4 · Water-phase preparation
Heat and dissolve the water-phase components such as purified water, emulsifiers and water-soluble drugs evenly
RO Water System
Step 5 · Vacuum emulsificationCore Equipment
Emulsification of the oil phase and water phase, drug dispersion, homogenization and vacuum defoaming — the key process that ensures the uniform efficacy of ointments
Vacuum Emulsifier Mixing Tank |
|
Step 8 · Filling (tubes)
Quantitatively fill via the tube filling machine
Tube Filling and Sealing Machine
Step 9 · Packaging
Sealing, boxing, coding, cartoning
Cartoning Machine
Supporting Equipment
Rotary Lobe Pump
The figure below shows the production process flow of pharmaceutical ointments. The core equipment highlighted in orange, the “Vacuum Emulsifier / (Jacketed) Mixing Tank”, sits at the vacuum emulsification step after oil-phase and water-phase preparation, and is the key equipment of the whole line.
Figure: Process flow of pharmaceutical ointments (★ key equipment: Vacuum Emulsifier / (Jacketed) Mixing Tank; labeled in both Chinese and English)
