Hubei Kornnac Pharmaceutical Co., Ltd. is one of the most reliable manufacturers and suppliers of size 0 gelatin capsules in China, also supports customized service and OEM service. Welcome to buy bulk high quality size 0 gelatin capsules at competitive price from our factory. Contact us for samples.
Products Features
With mature process, good stability and high probability, it is the mainstream product of capsule dosage form at present. Meet the regular needs of most customers.
Size 0 Gelatin Capsules
Why Choose KornnacCaps
▶cGMP QUALITY MANAGEMENT STANDARDS
Follow cGMP to organize production and quality management, establishing a quality assurance system, and the laboratory will carry out CNAS certification.
▶SMART SOL-GEL
Fully-automatic operation of sol gel and viscosity, core technology to ensure the quality of gel liquid.Process traceability for more stable quality.
▶AIR PURIFICATION SYSTEM
The air purification system is built byinternational famous brands like Carrier, AL-KO,and ingersoll to ensure the degree of air purification and constant temperature and humidity of the environmental conditions.
▶INFORMATIZATION MANAGEMENT
Designed by lBM for the informatization management of the enterprise, including ERP,MES, SCADA, LIMS, WMS and other related systems.
Quality Control
- In order to produce high-quality, safe, healthy empty capsules, every step of the production is with strict operation procedures and quality control.
- From the choosing of raw material, to the focus on production process and the inspection of the finished capsules, all strictly in accordance with the standards.
Process Of Size 0 Gelatin Capsules
1. Raw material
2. Test raw material
3. Melting
4. Capsule production
5. Printing(be requested)
6. Inspection by machine
7. Counting and packing
8. Product inspection in lab
Certifications
Our product complies with the standards of the Chinese Pharmacopoeia and has passed international certifications such as HALAL,Kosher,FDA,ISO9001 and ISO22000.
Packaging & Storage
- PE bag+Aluminum foil bag+Six surface foam board+5 ply corrugated Carton
- Carton size 60x73x40cm,volume 0.18 cubic meters,gross weight is about 15kgs per box
- Storage Condition: Temperature: 15℃~ 25℃, Humidity: 35%~65%
- 20' Refrigerator Container: 140 cartons empty capsules.
- 40' Refrigerator Container: 345 cartons empty capsules.
Available for customization according to the customer's requirements.
FAQ
Related Extensions
What Are Advantages of Sterilization without Ethylene Oxide Tech for Empty Capsules?
Safety
The traditional ethylene oxide sterilization process has residual risks, which may affect the safety of the drugs. The new process uses hydrogen peroxide and colloidal silver ions to achieve synergistic sterilization, with no toxic residues. It complies with ISO and EU certification standards and can avoid the potential harm to the human body caused by residual ethylene oxide.
Effectiveness
The new type of disinfectant can penetrate the structure of microbial cells and achieve broad-spectrum disinfection effects, replacing the traditional ethylene oxide sterilization method. This ensures that the capsules meet the aseptic standards during the production process and no additional sterilization treatment is required.
Process Optimization
The new disinfectant can be directly added to the gel stage, simplifying the production process, maintaining the transparency and mechanical properties of the capsules, while reducing the dependence on temperature and humidity conditions and improving production efficiency.
Currently, this technology has been applied to the production of gelatin empty capsules and has achieved remarkable results.
Challenges of Ethylene Oxide-Free Sterilization
While ethylene oxide (EO)-free sterilization is increasingly preferred for its safety and environmental benefits, its implementation presents several technical, material, and regulatory challenges.
1. Material Compatibility:
Many capsule types-especially gelatin, pullulan, and other natural polymers-are sensitive to heat, moisture, or radiation. Sterilization methods such as steam autoclaving, dry heat, or gamma irradiation can alter capsule properties, causing deformation, brittleness, or color changes. Maintaining capsule integrity while ensuring sterility is a delicate balance that requires extensive testing and process optimization.
2. Limited Method Options:
Unlike EO, which can penetrate packaging and complex surfaces at low temperatures, EO-free methods often require direct exposure or higher energy. For example, steam sterilization demands high temperatures, which may not be suitable for all materials. Gamma and electron-beam sterilization require specialized facilities and must be carefully dosed to avoid damaging the product.
3. Equipment and Cost Constraints:
Advanced sterilization equipment such as gamma irradiators or dry heat tunnels involves significant capital investment. These systems also have higher operating costs, including safety protocols, validation procedures, and maintenance, which can increase the overall production cost, especially for smaller manufacturers.
4. Regulatory Compliance:
Switching from EO to alternative sterilization methods requires rigorous validation to meet GMP and international standards (e.g., USP, EU, ISO 11137). Proving sterility assurance levels (SAL) and ensuring batch-to-batch consistency are resource-intensive and require scientific documentation and often third-party certification.
5. Process Customization:
Each product type and packaging form may require customized sterilization protocols. Developing and optimizing these processes for different capsule types or formulations can be time-consuming and technically demanding.
How We Achieve Ethylene Oxide-free Sterilization?
Our factory is equipped with a Class 100,000 cleanroom, featuring a top-tier air treatment system and fully automated production equipment. Throughout the capsule production process-from material feeding, mixing, storage, to transportation-manual intervention is minimized to ensure a high level of cleanliness across the entire production line. Additionally, all personnel involved in inspection and packaging follow strict hygiene and protective measures. As a result, we are able to achieve sterilization without the use of ethylene oxide.
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