Seamless Turnkey Oral Dosage Package Turnkey / Holistic OSD Manufacturing Project

Product Description

Seamless Turnkey Oral Dosage Package Turnkey / Holistic OSD Manufacturing Project

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.

 

 

Turnkey Project Stages

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.
 

Product Parameters

Technical Parameters

Product Name	Auto Gelatin Softgel Soft Gel Capsule Filling Machine
Output	150000 Capsules/hr.
No. of bores	18
Suitable for Capsule	00#,0#,1#,2#,3#,4#,5#
Power	380/220V 50Hz
Overall Weight	1500KG
Machine Dimension	1350×1370×2035mm
Filling error	±2.5% - ±3.5%
Accuracy	+ 1% Depending upon the consistency, uniformity & bulk density of powder under the controlled level of humidity.

Company Profile

 

IVEN Can Do !

IVEN provides integrated engineering solution for worldwide pharmaceutical and medical factory include the clean room, auto-control and monitoring system, pharmaceutical water treatment system, solution preparing and conveying system, filling and packing system, automatic logistics system, quality control system and central laboratory and etc. According to the pharmaceutical industry's regulatory requirements of different countries and customer's individual demand, IVEN carefully customizes engineering solutions of turnkey projects and helps customers to win the target markets, IVEN creates value to customers.

 

Turnkey Project for IV Solution Plant from A to Z

• Project Design
• Pharmaceutical Water Treatment
• Solution Preparation
• IV Solution Production Line
• Sterilization
• Inspections Packing
• Clean Room & HVAC
• Stability Chamber
• Laboratory Instruments
• Utilities
• Documentation & Qualification
• Installation, Commissioning, Training
• Service