All-Inclusive Solid Dosage Manufacturing Project (Tablet Machine/ Capsule Machine/ Granulator etc.)

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.

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.