Engineering service

Based on our years of experience as a pharmaceutical manufacturer and our experience in supervising design work, we deliver engineering support to our users with priority on customer satisfaction. Our engineers with full knowledge of pharmaceutical manufacturing will work with you side by side from basic design work, design control and to validation.

Investigation, master plan, basic design, detailed design, plant inspection, construction work supervision, construction, test operation / adjustments, validation (VMP, DQ,IQ,OQ and computer validation), calibration and others

We create master plan and basic design for pharmaceutical related equipment and facilities that meet standard requirements of PIC/S GMP, J-GMP, c-GMP and EU-GMP)

• ・Layout (Equipment layout)
• ・Productivity (operability)
• ・Production Volume (size of equipment capacity)
• ・Maintainability (ease of maintenance)
• ・Selection of detailed specifications for equipment
• ・Countermeasures against foreign matter contamination
• ・Safety of workers
• ・Containment (of chemical hazards)

• ・Construction of plant (pharmaceutical manufacturing Facility) at the time of new product market introduction
• ・Improvement work for current facility (new installation, updates and other activities of facility and equipment)
  API Facility, Formulation Facility (Solid Formulation, Injectable Formulation, Liquid Formulation, Ointment, Eye drops etc.), Containment Facility, Packaging Facility, Buildings, HVAC Facility, Pharmaceutical use Water Facility, Utility Facility, Quality Control Facility, Logistics Facility etc.

• ・Construction of new production building
  　Comprehensive engineering work including building to production line and manufacturing support system
• ・Construction of new production line
  　Efficient construction of production area and production line in existing building
• ・Modifications to existing line and existing production equipment
  　Modification, enhancement and relocation work for improving productivity and meeting GMP compliance
• ・Modification, removal and renovation work involving HVAC facility, pharmaceutical use water facility and other utility facilities

We offer services to help you improve quality, safety and productivity based on our rich experience and high technical competencies garnered through years of our work in maintaining pharmaceutical manufacturing facilities. We can also proactively provide improvement proposals for your existing systems.

We can provide consolidated maintenance work for your entire plant, including manufacturing facilities (API, formulation, packaging etc.) and manufacturing support facilities (HVAC, pharmaceutical use water, utility facilities etc.).

We draft periodic re-validation schedule and conduct actual work for pharmaceutical manufacturing facilities and provide you a report.

Various control / instrumentation systems, quality control facility, monitoring system etc.

Create SOP for periodic maintenance (establish inspection points, inspection cycle, standards)
Proposal around maintenance cost reduction through risk assessment.

Confirm facility audit and facility related documentation through plant tour.