Safe Capsule Gelatin & Medical Gelatin Factory | GMP | Gelken
Gelken's safe capsule gelatin factory offers premium pharmaceutical & medical gelatin. GMP-certified manufacturer providing high-purity solutions. Global quality assured.
Professional Safe Capsule Gelatin: Complete Manufacturing Guide
Gelken stands at the forefront of safe capsule gelatin manufacturing, combining advanced technology with deep pharmaceutical expertise. Our cutting-edge manufacturing facility adheres to the strictest GMP standards, consistently delivering premium-quality capsule gelatin that meets the exacting needs of pharmaceutical and healthcare applications.
Product Specifications
Physical Properties
Our gelatin products exhibit exceptional physical properties, with crystal-clear transparency that meets the highest industry standards. We maintain strict control over particle size uniformity, ensuring consistent colour profiles across all batches. The surface texture is carefully monitored to achieve optimal smoothness, meeting the demanding requirements of pharmaceutical applications.
Performance Metrics
We rigorously control all performance parameters, maintaining Bloom strength between 200-280 and viscosity at 35-45 mPs. Our moisture content is strictly controlled at ≤12%, while ash content remains below ≤2%. The pH range is carefully maintained between 5.0 and 6.0, ensuring optimal performance in pharmaceutical applications.
Dissolution Profile
Our gelatin demonstrates superior dissolution characteristics, featuring rapid and uniform hydration properties. The controlled disintegration profile ensures consistent performance, while our advanced formulation promotes stable gel formation under various conditions.
Chemical Specifications
Purity Standards
We maintain exceptionally high purity standards, with strict limits on heavy metals (<10 ppm), arsenic (<1 ppm), lead (<0.5 ppm), and mercury (<0.1 ppm). These stringent controls ensure the safety and quality of our pharmaceutical-grade gelatin.
Microbiological Control
Our comprehensive microbiological control system ensures total plate count remains below 1000 CFU/g, with a complete absence of harmful organisms including E. Coli, Salmonella, and Staphylococcus, meeting the strictest pharmaceutical requirements.
GMP Production Process
Raw Material Handling
Our raw material handling process incorporates comprehensive supplier certification protocols and rigorous quality testing procedures. We maintain detailed documentation systems and continuous monitoring of storage conditions to ensure material integrity.
Production Steps
The production process involves carefully controlled extraction methods, followed by sophisticated multi-stage filtration and ion exchange purification. Our sterilization process, precision drying techniques, and particle size control measures ensure consistent product quality.
Quality Control Points
Throughout the manufacturing process, we maintain stringent quality control through continuous in-process testing, environmental monitoring, equipment validation, and careful verification of all process parameters.
Advanced Technology
Manufacturing Equipment
Our facility features state-of-the-art automated production lines housed within advanced clean room facilities. Environmental controls and a modern testing laboratory ensure consistent product quality.
Process Controls
We employ sophisticated real-time monitoring systems with comprehensive data logging and analysis capabilities. Our automated quality checks and validated cleaning procedures maintain the highest standards of production quality.
Quality Assurance System
Our operations are certified to multiple international standards including GMP, ISO 9001:2015, and ISO 15378, with an established Drug Master File (DMF). We maintain all necessary regional approvals including FDA registration, EMA compliance, and PMDA recognition.
Quality Control
Our quality control system encompasses comprehensive testing protocols for raw materials, in-process controls, and finished product analysis. We conduct regular stability studies and maintain detailed documentation including batch records, testing procedures, and validation protocols.
Pharmaceutical Uses
We offer a wide range of options for both hard and soft capsule applications, including various sizes and custom formulations. Our colour options and special requirements services cater to diverse pharmaceutical needs.
Medical Applications
Our products support advanced drug delivery systems enabling controlled release and targeted delivery mechanisms. We provide specialized formulations for medical devices and various biocompatible solutions.
Research & Development
Innovation Focus
Our R&D team continuously works on new formulations and enhanced properties, conducting extensive application testing and performance optimization studies.
Technical Support
We provide comprehensive technical support including formulation assistance, process optimization, and thorough troubleshooting services, backed by detailed technical documentation.
Global Supply Chain
Logistics Excellence
Our worldwide distribution network ensures reliable delivery with temperature-controlled shipping and advanced track and trace capabilities. All shipments include comprehensive documentation support.
Technical Services
Our expert team provides comprehensive consultation services, including application guidance, process optimization, and regulatory support. We maintain detailed technical documentation and quality certificates for all products.
Trust Gelken as your reliable safe capsule gelatin factory. Our commitment to quality, innovation, and customer satisfaction makes us your ideal partner for pharmaceutical and medical gelatin applications.
High Purity Gelatin for Pharmaceutical and Medical Applications
At Gelken, we specialize in producing high purity gelatin and GMP grade gelatin for the pharmaceutical and medical industries. Our commitment to quality and innovation has positioned us as a leading supplier of medical gelatin and pharmaceutical gelatin worldwide.
Product range includes
1. Pharmaceutical Gelatin
Our pharmaceutical gelatin meets the highest industry standards, ensuring optimal performance in various drug delivery systems. This GMP-grade gelatin is carefully processed to achieve maximum purity, making it ideal for: Hard capsules, Soft gel capsules, Tablet coatings, Micro-encapsulations.
2. Medical Gelatin
Our medical gelatin is designed for a wide range of healthcare applications. With its high purity and biocompatibility, it's perfect for:Surgical sponges, Wound dressings, Tissue engineering scaffolds, Dental applications.
3. GMP Grade Gelatin
Our GMP grade gelatin is manufactured under strict Good Manufacturing Practice guidelines. This ensures: Consistent high quality, Traceability, Compliance with pharmaceutical regulations.
4. High Purity Gelatin
Our high purity gelatin boasts an exceptional level of purity, typically exceeding 99.9%. This makes it suitable for the most demanding pharmaceutical and medical applications, including: Advanced drug delivery systems, Biomedical research, Regenerative medicine.
Product Specifications
- Gel strength: 80-300 Bloom (customizable)
- Viscosity: 20-60 mps
- pH: 4.5-6.5
- Moisture content: <12%
- Ash content: <2%
Research and Innovation
Our R&D team continually works on enhancing our gelatin products. Recent developments include: Ultra-high purity gelatin (99.99%+) for specialized pharmaceutical applications, Novel crosslinking techniques for extended-release formulations, Gelatin-based nanoparticles for targeted drug delivery.
Market Trends
The global demand for pharmaceutical gelatin and medical gelatin continues to grow. Key drivers include: Increasing use of gelatin in novel drug delivery systems, Growing preference for gelatin-based materials in tissue engineering, Rising demand for GMP grade gelatin in emerging markets.
At Gelken, we're committed to providing the highest quality pharmaceutical gelatin, medical gelatin, GMP grade gelatin, and high purity gelatin. Our products are designed to meet the evolving needs of the pharmaceutical and medical industries, ensuring optimal performance and patient safety.
Contact us today to learn how our gelatin solutions can enhance your pharmaceutical or medical products.
Headquarters：1203-1, No. 597 Sishuidao, Huli District, Xiamen 361016 China
Customer Service：+86-592-5627447
Email：gelatin@gelken.cn
Recommended reading
Medical application – Gelken
Xiamen Gelken Gelatin Co., Ltd founded in 2012,is located in the beautiful city of Xiamen, Fujian. Our main products including Hydrolyzed Collagen, Edible Gelatin, Gelatin Leaf and Pharmaceutical Gelatin, etc.
High quality Pharmaceutical Gelatin supplier & manufacturer – Gelken
Gelken is a High quality Pharmaceutical Gelatin supplier & manufacturer. Our products are popular among Chinese clients and international clients. After many years′ accumulations and developments, we have developed perfect and widespread sales networks all over the world.
High quality Fish Gelatin For Food suppliers & factories – Gelken
Gelken is a High quality Fish Gelatin For Food suppliers & factories. Information for Fish Gelatin For Food: Fish Gelatin is usually used as a kind of important ingredient for food industries, especially for gummies, jelly and nutrition bar. Gelken usuall...
Gelatin for Hard Capsules
Hard capsule refers to a certain amount of medicinal material extract and powder or auxiliary materials into uniform powder or particles. Gelatin is used as the packaging of medicine.
Gelatin for Softgel Capsules
Pharmaceutical gelatin is the main raw material of capsule, microcapsule, substitute plasma and sponge.
Gelatin for Tablet
When medicinal gelatin is used in tablet production, it can be used as tablet adhesive or tablet coating. Because of gelatin’s adhesive effect, tablets have adhesive, temperature resistance and hardness.
Gelatin For Mircro-Encapsulations
Gelken’s gelatin is both a great binding and coating agent for protecting active ingredients. Through its emulsifying properties microcapsules are formed naturally. Great solubility improves point of use delivery.
Gelatin For Medical Use
Our gelatin in medical applications is not only for capsules and tablets, but also for surgical obturators, haemostatic sponges, ostomy bags and more.
Thanks to our GMP standard,our gelatin can be delivered to most pharmaceutical application which need gelatin.
