Equipment for the production of drugs in soft gelatin capsules

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	Equipment for the production of drugs in soft gelatin capsules
	Equipment for obtaining soft dosage forms
	Equipment for the production of disposable syringes
	Equipment for making plasters
	Equipment for the manufacture of dressings
	Vaccine production equipment (roller plant, embryo infection line)

Soft gelatin capsules (softgels) are a premium dosage form ideal for liquid, paste-like, and oil-based fillers. INEX provides integrated technological lines—ranging from laboratory units to high-capacity industrial plants—engineered to handle complex formulations while strictly adhering to GMP standards.

Methods of Softgel Production

Two primary methods are utilized depending on the product requirements:

Drip (Globular) Method: Based on the principle of simultaneous formation of a gelatin drop with a liquid medicinal core inside.
Rotary Die (Pressing) Method: The most common industrial method, where gelatin ribbons are formed and capsules are punched/sealed by rotating dies, resulting in a characteristic horizontal seam.

Typical Production Line Components

A complete softgel manufacturing ecosystem includes several critical stages:

Gelatin Preparation System: Jacketed reactors and mixers with vacuum de-aeration to ensure a bubble-free, temperature-stable gel mass for continuous operation.
Filler Preparation Units: Specialized mixers and homogenizers for liquids, suspensions, and high-viscosity pastes, including filtration and buffer storage.
Encapsulation Machine (Rotary Die): The heart of the line, featuring high-precision dosing pumps and interchangeable die rolls for various shapes and sizes.
Drying Modules: Tumble dryers for initial shape setting followed by tunnel or tray drying systems with controlled dehumidification to achieve final moisture specifications.
Post-Processing: Automated washing, polishing, inspection, and sorting units to prepare capsules for final packaging.

Why Partner with INEX?

Custom Configurations: We adapt solutions for sensitive formulations, including light-sensitive or oxygen-reactive ingredients.
Turnkey Project Management: From initial 3D layouts and technical specifications to delivery, installation, and IQ/OQ/PQ validation.
System Integration: Seamless connectivity with HVAC systems, cleanroom environments, and downstream packaging lines, including CIP/WIP (Clean/Wash-in-Place) options.
Technical Support: Expert guidance on formulation parameters (gel hardness, plasticizer selection) and supply of high-precision die rolls and spare parts.

Compliance and Validation

Our equipment is designed to exceed international standards:

GMP Compliance: Ensures the highest level of hygiene and product safety.
GAMP 5 & GMP Annex 11: Software and automation validation according to ISPE guidelines to ensure data integrity and process reliability.

Technical Specifications

Encapsulation Type: Rotary Die (standard) or Drip method.
Dosing Accuracy: ≤ ±1% for liquids.
Capsule Shapes: Oval, Oblong, Round, Tube, and custom designs.
Material of Construction: Stainless steel AISI 316L (product contact) and AISI 304.
Control System: PLC with a multi-language HMI.
Safety Features: Interlocked guarding and emergency stop protocols.
Automation Level: Semi-automatic to fully integrated "lights-out" manufacturing.