| Certification: | CE, GMP, ISO |
|---|---|
| Warranty: | Field Installation, Commissioning and Training |
| Machinery Capacity: | 2000bph;Customized |
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IVEN Oral Solid Dosage (OSD) Turnkey Project is a comprehensive solution offered by Shanghai IVEN pharmaceutical engineering and manufacturing companies to design, develop, and set up a complete manufacturing facility for producing oral solid dosage forms of pharmaceutical products. This can include tablets, capsules, and other solid forms that are intended for oral
consumption.
IVEN "turnkey" means that the project is designed to be ready for operation once handed over to the client. In other words, the client can simply "turn the key" and start using the facility without having to worry about the intricate details of setting up the manufacturing process and equipment.
1.Comprehensive Solution: Offers a complete package that includes facility design, equipment procurement, installation, and training, ensuring a seamless setup.
2.Time Efficiency: Saves time by streamlining the entire project, from planning to operational launch.
3.Cost Savings: Reduces costs associated with individually sourcing equipment and services, as turnkey projects often provide bundled pricing.
4.Expertise: Leverages the expertise of professionals experienced in pharmaceutical facility design, setup, and regulatory compliance.
5.Faster Deployment: Facilitates faster facility deployment and product manufacturing, leading to quicker market entry.
6.Regulatory Compliance: Ensures that the facility is designed and set up to meet regulatory requirements, reducing the risk of compliance issues.
7.Quality Control: Incorporates standardized quality control procedures, ensuring consistent and high-quality product output.
8.Validation Support: Offers support in the validation of processes and equipment, aiding in regulatory approvals.
9.Documentation Assistance: Provides guidance in creating comprehensive and compliant documentation.
10.Risk Management: Addresses potential risks in facility design and setup, leading to smoother operations and regulatory compliance.
11.Process Optimization: Optimizes production processes and workflows for increased efficiency and reduced waste.
12.Customization: Offers tailored solutions to match specific manufacturing needs and goals.
13.Single Point of Contact: Simplifies communication and accountability by providing a single entity responsible for the entire project.
14.Scalability: Designed to accommodate future expansion and increased production demands.
15.Energy Efficiency: Incorporates energy-saving strategies in facility design to reduce operational costs.
16.Waste Reduction: Implements waste reduction practices for environmentally responsible manufacturing.
17.Training Provided: Offers comprehensive training programs to ensure operators are proficient in facility operations.
IVEN OSD Turnkey Project typically involves the following stages:
1.Conceptual Design: This stage involves discussions between IVEN and the customer to understand the customer's requirements, production capacity, compliance needs and budget constraints. Initial plans and layouts for the manufacturing facility are prepared.
2.Detailed Engineering: Once the conceptual design has been approved, detailed engineering takes place. This includes the preparation of detailed process and instrumentation diagrams, equipment specifications, facility layout designs, and more. The goal is to design a facility that meets regulatory standards and efficiently produces high quality products.
3.Procurement and Installation: During this phase, the necessary equipment and machinery is procured, delivered and installed at the facility. This includes various manufacturing equipment such as granulators, mixers, tablet presses, capsule fillers, coaters and packaging lines.
4.Commissioning and Qualification: After installation, the equipment is commissioned, which involves testing to ensure that each component works as intended. Once commissioning is complete, the equipment undergoes a qualification process to demonstrate that it meets regulatory requirements and is capable of producing consistent products.
5.Validation: The manufacturing processes and equipment are validated to ensure that they consistently produce products that meet predetermined quality standards. This involves comprehensive testing to demonstrate the reliability and reproducibility of the manufacturing process.
6.Training: The customer's personnel are trained to operate the equipment, follow procedures, maintain hygiene and safety standards, and address any issues that may arise during production.
7.Regulatory Compliance: Regulatory compliance is a critical consideration throughout the project. The facility and processes must comply with guidelines set by health authorities such as the FDA (US Food and Drug Administration) or the EMA (European Medicines Agency), depending on the region.
8.Handover: Once the facility is fully operational and validated, it is handed over to the customer. At this point, the customer can start manufacturing their oral solid dosage products.
The IVEN OSD Turnkey Project provides pharmaceutical companies with a complete solution, saving them the hassle of coordinating various aspects of facility set-up and manufacturing process development. It ensures that the manufacturing facility is compliant, capable of producing high quality products and equipped with efficient processes.
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Structure |
Name |
Note1 |
Note2 |
|
Filling part
|
Filling device servo filling system |
Famous brand in Germay |
The standard configuration |
|
Filling pump head (7 - note the plug type |
Pneumatic components brand:AirTAC Filling servo adjustment, Simple, no wall, filling volume stable |
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|
T he filling is individually fine-tuned |
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|
70LMaterial barrel(stirring motor) |
|||
|
Material barrel cycle pump(supporting cylinder 1pc) |
|||
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Filling part box vessel(content internal frame) |
material:aluminum,stainless steel |
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Organic glass cover |
Self-made |
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