JLJW FDA Compliant Automatic Soft Capsule Inspection Machine: Smarter Quality Control

In the global production of health supplements and pharmaceutical soft capsules, appearance defect inspection is a critical part of quality control. Traditional manual inspection suffers from low efficiency (800-1200 capsules per hour per worker), high miss rate (3%-5%), and high risk of cross-contamination, failing to meet stringent requirements of international regulatory authorities like FDA and EMA. To address these industry pain points, the JLJW FDA Compliant Automatic Soft Capsule Inspection Machine was developed. As a professional soft capsule inspection equipment, it features "360° defect detection, full-process intelligence, and multi-scenario adaptability", fully complies with FDA, GMP and EMA standards, becoming a core quality control tool for global enterprises.

1. Core Functions: Accurate Inspection & FDA Compliant Intelligent Control

Tailored to the characteristics of soft capsules, the JLJW Inspection Machine achieves full-link control through a multi-dimensional intelligent system:

• 360° Defect Detection: Accurately identifies common defects such as breakage and irregular shape, as well as hidden defects like color difference and micro-cracks, with a minimum detectable defect size of 0.05mm. It is compatible with transparent, colored, plant-based and other materials, automatically switching detection modes to ensure accuracy.

• Intelligent Graded Sorting: Supports customization of three-level defect classification standards (rework for minor defects, rejection for serious defects, temporary storage for suspicious defects). High-speed pneumatic sorting valves execute precisely with an accuracy rate of 99.9%, ensuring product uniformity.

• Data Traceability & FDA Compliance: Real-time records batch inspection data (defect type, quantity ratio, inspection time) and automatically generates compliance reports. Supports local export and cloud encrypted storage, with single-capsule inspection image traceability, fully meeting the audit requirements of FDA, EMA and other international regulatory authorities for soft capsule inspection.

2. Equipment Configuration: Robust Hardware for Stability & Global Compliance

From core inspection components to body design, the equipment is built around "high precision, stable operation and global compliance" to meet industrial-grade production needs worldwide:

• Visual Inspection Core: Equipped with 4 sets of high-definition color line-scan cameras (from global brand Basler) + AI deep learning module, combined with customized ring light system for 360° dead-angle-free shooting. The AI algorithm, trained with 1 million+ global soft capsule defect samples, continuously optimizes recognition accuracy for new defects.

• Intelligent Control Unit: 10-inch HD touch screen supports . New product specifications can be configured in 3 steps, and mold change debugging takes only 15 minutes. Fanless design adapts to dusty workshop environments, with MTBF (Mean Time Between Failures) of 10,000 hours.

• Compliant Body Design: Made of 304 food-grade stainless steel (compliant with FDA 21 CFR Part 11), mirror-polished without hygiene dead corners, and compatible with high-pressure spray cleaning. Shock-absorbing feet adapt to Class 10,000 cleanrooms common in European and American factories.

• Stable Conveying System: 50L large-capacity hopper reduces feeding frequency; frequency-modulated vibrating plate sorts capsules + vacuum adsorption conveyor belt fixes them, avoiding deformation and deviation to ensure stable conveying.

• Safety Protection Configuration: Electrical isolation between imaging and transmission systems, equipped with multiple protections such as material shortage alarm and fault shutdown; explosion-proof glass observation window balances monitoring and safety.

3. Working Process: Fully Automatic Operation

Adopting modular design, the equipment realizes fully automatic operation from feeding to discharging without manual intervention. The process meets international audit requirements as follows:

• Feeding Stage: Soft capsules enter the equipment through a closed feeding hopper. The 50L large-capacity hopper supports continuous feeding, greatly reducing manual feeding frequency.

• Sorting Stage: The frequency-modulated vibrating plate arranges messy soft capsules in order and adjusts their posture through guide rails to ensure each capsule enters the conveying system in a unified direction.

• Inspection Stage: The vacuum adsorption conveyor belt smoothly conveys soft capsules to the inspection area. 4 sets of line-scan cameras shoot from multiple angles simultaneously, and the ring light provides uniform shadow-free illumination. Image data is transmitted to the AI processing module in real time, completing defect identification and judgment within 0.1 seconds.

• Sorting & Classification Stage: According to AI inspection results, the high-speed pneumatic sorting valve accurately rejects unqualified products into a dedicated collection box, temporarily stores suspicious products in an independent isolation area, and smoothly outputs qualified products through a sterile conveyor belt.

• Data Recording Stage: Automatically generates visual reports with defect distribution charts and pass rate trends, supporting local printing and cloud upload. All data meets the electronic record requirements of FDA 21 CFR Part 11 for easy international regulatory audits.

4. Product Advantages: FDA Compliant Soft Capsule Inspection for Global Markets

Compared with traditional manual inspection and ordinary equipment, the JLJW Inspection Machine has five core advantages tailored for global customers, especially those in high-labor-cost regions like Europe and America:

• Significant Cost & Efficiency Benefits: Inspection speed reaches 8,000-15,000 capsules/hour, 15-20 times faster than manual work. A single machine replaces 12-15 inspectors, saving $120,000-$180,000 in annual labor costs (based on $15/hour in the US). 24/7 continuous operation effectively improves production line capacity.

• Accurate & Reliable Guarantee: The inspection accuracy is as high as 99.9%, and the miss rate is controlled below 0.05%, completely solving the problem of miss and false inspections caused by manual fatigue and subjective judgment. The AI defect recognition algorithm supports continuous learning and iteration, and the recognition accuracy for new defects can be gradually improved.

• Flexible Adaptation to Multiple Scenarios: Compatible with all specifications of 00#-4# soft capsules, widely used in health supplements, pharmaceuticals, functional foods and other industries. For different product characteristics such as fish oil, vitamin E and Traditional Chinese Medicine (TCM) soft capsules, inspection parameters can be quickly switched to meet the needs of multi-category flexible production.

• Hassle-free Compliance: Fully complies with FDA, EMA, GMP and ICH Q9 standards. The equipment material, inspection process and data traceability can directly connect to international QMS systems (e.g., SAP, Oracle), greatly reducing the risk of non-compliance in overseas market access.

• Low Consumption & Easy Maintenance: Core components are selected from well-known imported brands, with a mean time between failures (MTBF) of 10,000 hours, significantly extending the maintenance cycle. The equipment adopts a modular design, allowing quick disassembly and replacement of key components. Daily cleaning can be completed in only 30 minutes, and maintenance costs are 30% lower than similar equipment.

5. Core Technical Parameters

6. Application Scenarios & Cases of FDA Compliant Soft Capsule Inspection Machine

Application Scenarios

• Pharmaceutical Industry: Inspection of intermediate and finished products (e.g., Traditional Chinese Medicine (TCM) soft capsules, chemical soft capsules) to meet GMP standards required by FDA and EMA.

• Healthcare Industry: Defect inspection of popular global products (e.g., Omega-3 fish oil, vitamin D3, probiotic soft capsules) to protect brand reputation in international markets.

• Food Industry: Quality control of functional food soft capsules (e.g., collagen, phytosterol) to avoid customer complaints in European and American markets caused by breakage or foreign objects.