Design of Pharmaceutical Manufacturing EquipmentBusiness Introduction

Design of Pharmaceutical Manufacturing Equipment

Design of Pharmaceutical Manufacturing Equipment

Pharmaceutical manufacturing plants require numerous processes, ranging from the production of the medicine itself to its packaging, and must incorporate various functions.

Tokyo Densei Industrial leverages its accumulated technology and expertise to provide not only the functions that customers want as standalone machines or systems, but also to enhance them with added value, ensuring superior operability and maintainability.

Furthermore, we adhere to strict guidelines for verification and documentation (validation) and offer comprehensive support throughout the entire process—from engineering and design to manufacturing, construction, supervision, and maintenance.

Service Offerings

Features

  1. Compliance with CSV (Computerized System Validation)
    We establish and implement rules for the development, verification, operation, and decommissioning of computerized system validation, ensuring all activities are conducted accordingly and results are documented.
  2. Compliance with 21 CFR Part 11 (Title 21 Code of Federal Regulations, Part 11)
    We support electronic records and electronic signatures in accordance with regulatory requirements.
  3. Compliance with DI (Data Integrity)
    Our DI-compliant manufacturing data management system provides a comprehensive solution for key DI compliance challenges, including ID and password management, time synchronization, audit trails, and data management.

The Process from Design to Operation

The Process from Design to Operation

We provide comprehensive support throughout the entire process—from design and production to construction, supervision, and maintenance—ensuring verification and documentation (validation) in compliance with strict guidelines.

Common Inquiries

We frequently receive inquiries such as the following.
If you have any issues or concerns regarding your production or ancillary equipment, please feel free to contact us.

Track Record of Implementation