Key Process Controls and Quality Assurance in Softgel Production

As a technical engineer with extensive experience in softgel production lines, I believe the essence of oral softgel manufacturing lies in “precise control” and “systemic protection.” Quality is never accidental but a systematic outcome embedded in every technical detail. Below, I outline key control points from a core process perspective and how leveraging factory capabilities ensures stable output.

I. Core Raw Material Control: The Foundation of Quality

1. Gelatin System: Gelatin's gel strength, viscosity, and isoelectric point directly determine the mechanical properties and dissolution behavior of the capsule shell. Our factory maintains long-term partnerships with premium raw material suppliers and operates an incoming inspection laboratory. Every batch of gelatin undergoes comprehensive testing against all specified indicators to ensure compliance with internal control standards.

2. Filling Materials: Whether solutions, suspensions, or emulsions, their rheological properties, stability, and compatibility with gelatin are critical. Our comprehensive pre-formulation research system employs rheometers and accelerated testing to pre-screen and optimize formulations, ensuring filling stability and smooth filling operations throughout the shelf life.

II. Process Control: Precision is Key

1. Gelation Process: Temperature, time, and vacuum control are fundamental. Our fully automated closed-loop gelation system enables programmed heating and constant-temperature degassing, ensuring uniform, bubble-free gel. This is essential for achieving consistent capsule wall thickness and defect-free capsules.

2. Pellet Pressing: This is the true core process.

3. Mold Precision: Molds machined with high-precision CNC equipment guarantee tight capsule seams, secure locking, and zero leakage.

4. Environmental Control: The enclosed forming room with an integrated drying system maintains constant temperature (20-24°C) and humidity (20%-30% RH), ensuring smooth capsule formation without sticking or deformation.

5. Parameter Synchronization: The thickness of the capsule shell, the filling volume of the contents, and the speed of the dual conveyor belts must be synchronized with millimeter precision. Our tablet presses are equipped with an online monitoring and feedback system that makes real-time adjustments, ensuring minimal variation in filling volume and consistent appearance for each capsule.

6. Directional Drying: Employing a stepwise gradient drying process, the automatic conveying system slowly and uniformly removes moisture across distinct temperature and humidity zones. Improper control during this stage can easily cause capsule collapse, deformation, or surface “orange peel” texture. Our drying tunnel features online moisture monitoring points that dynamically adjust parameters, enabling smooth moisture migration from the interior to the exterior.

III. Quality Assurance System: Data-Driven and Full-Process Protection

1. Online Inspection and Rejection: High-precision vision inspection systems integrated at the post-drying stage and pre-packaging automatically reject non-compliant products—those with incorrect dimensions, abnormal shapes, foreign objects, or printing defects—ensuring 100% appearance compliance of outgoing products.

2. Full Process Cleanliness and Cross-Contamination Prevention: From gelation to packaging, equipment employs CIP/SIP (Clean-in-Place/Sterilize-in-Place) design. Workshop layout strictly adheres to personnel and material flow separation principles, with critical zones maintained at relative positive pressure. This integration of hardware and management systems is fundamental to achieving microbial indicators and safety standards exceeding national requirements.

3. Data Integrity: All critical process parameters (temperature, humidity, pressure, speed, fill volume) are automatically recorded, stored, and compiled into batch reports by the SCADA system. This achieves full traceability throughout production, providing a robust data foundation for quality analysis.

The exceptional quality of our factory's oral soft capsules stems from the deep integration of precision process design, highly automated equipment, stringent environmental control, and a data-driven management system. This achievement tests not only the sophistication of individual equipment but also the entire factory's system integration capabilities and depth of process understanding. Only by ensuring “clear definitions, precise controls, and traceable records” in every seemingly ordinary step can we consistently produce oral softgel capsules that are aesthetically refined, accurately dosed, and reliably safe. This represents the silent embodiment of a modern factory's core strength.

Guangzhou Changshengkang Biotechnology Co., Ltd. was established in 2008. Changshengkang is founded on honesty, based on quality and empowered by technology. Our company's products cover three major sections of health food, nutritional food and cosmetics, layout research and development, production, sales of the whole chain closed loop, We provide health food OEM and cosmetics OEM services, welcome to inquiry and visit our factory, please email to gzcsk2@163.com.