1. Overview

In pharmaceutical R&D and small-batch production, equipment often faces the issue of mismatched functionality—either overengineered (causing resource waste) or lacking precision (compromising data reliability and product quality). The JANGLI JL-100II Softgel Encapsulation Machine is developed to address this problem. It complies with GMP, FDA, and CE standards, and is specifically designed for lab-scale R&D and small-batch production, providing efficient and accurate softgel preparation solutions for pharmaceutical teams and enterprises.

2. Brand Background & Compliance

JANGLI has over 10 years of experience in refining pharmaceutical and packaging equipment. The design of the JL-100II integrates the core principles of "compliance, precision, and practicality," which are not promotional slogans but practical guidelines. Its compliance with GMP, FDA, and CE standards serves as a safeguard to reduce audit pressure and compliance difficulties for R&D teams in daily operations. The machine’s reliability is verified by repeated purchases from multiple pharmaceutical laboratories and research institutions, confirming its applicability in real pharmaceutical scenarios.

3. Core Advantages

3.1 Scenario Adaptability

The JL-100II is an upgraded lab-grade version of the classic vertical softgel machine, capable of covering three key scenarios: small-scale formula testing for new softgels, pilot production for process validation before industrialization, and small-batch commercial production for regional supply or market trials. It acts as a bridge between lab benchwork and industrial pilot production. With compact dimensions (1440×660×1350mm, H), it fits in limited lab or small workshop spaces without requiring extensive workspace rearrangement.

3.2 Performance & Configuration

• Control System: Equipped with a PLC touchscreen for intuitive operation and flexible parameter adjustment, reducing operator training time.

• Material Selection: Outer shell made of SS304 stainless steel; all fill-contact components (e.g., plungers, fluid channels) made of 316L stainless steel, meeting pharmaceutical hygiene standards, resisting corrosion, and suitable for plant-based vegetarian gelatin softgels.

• Key Specifications:

3.3 Gel Box (Pharmaceutical-Grade Tinned Brass)

As a core component in direct contact with gelatin, the gel box adopts pharmaceutical-grade tinned brass, outperforming resin and ordinary stainless steel in the following aspects:

• Compliance & Safety: Meets FDA 21 CFR Part 175; tin coating forms an inert barrier, preventing brass ion leaching and chemical reactions with gelatin, ensuring formula purity.

• Temperature Control: Brass has high thermal conductivity (~108 W/(m·K)), enabling uniform heat distribution; paired with a PLC-linked temperature module, it achieves ±1℃ control accuracy, maintaining gelatin at 50–60℃ (optimal viscosity range) to avoid lumping or brittleness.

Hygiene & Durability: Smooth, pore-free surface prevents residue buildup; cleanable via built-in CIP system without disassembly; tarnish-resistant, ensuring long-term compliance and low maintenance costs.

3.4 Structural Design

• Machine Head: Precision-machined core forming component, ensuring consistent softgel formation and high productivity/accuracy.

• Die Roller Housing: Compact and adjustable, synchronized with the PLC system to maintain stable die roller operation, enabling operator control over the forming process.

Gel Box Integration: Mounted on the machine side, connected to the head via a short food-grade tube; brass’s thermal retention maintains stable gelatin temperature during transfer, preserving gel film quality.

4. Practical Value

4.1 For R&D Teams

Accelerates small-scale testing and pilot production. The brass gel box’s precise temperature control and non-reactive surface ensure data reliability; GMP compliance allows pilot samples to directly enter filing and verification, shortening the R&D cycle.

4.2 For Small-Batch Producers

Enables market trials or regional supply without investing in underutilized large equipment. Its cost-effectiveness, space-saving design, and support for quick formula switches enhance operational agility.

4.3 Application Case

A pharmaceutical R&D team used the JL-100II to develop a sustained-release softgel. Within 2 weeks, it completed 3 rounds of formula adjustments (5,000 samples/round), maintaining ±0.4% filling accuracy (exceeding the ±0.5% standard) and over 99.5% softgel integrity, significantly shortening the product approval timeline.

5. Conclusion

The JANGLI JL-100II is a specialized tool for pharmaceutical lab R&D and small-batch production, with compliance as the foundation, precision as the core, and the tinned brass gel box ensuring gelatin purity and stable performance. It addresses the inefficiencies of overengineered or imprecise equipment, serving as a reliable link between lab research and market launch.