Pharmaceutical Water System Consulting ServicesProducts

Pharmaceutical Water System Consulting Services

We leverage our industry-leading equipment delivery record and our advanced technical skills accumulated through experience in development and design (D2EDI, pure steam generation equipment and injection water generators) in crafting proposals for a broad range of requirements, from support for new adoption of pharmaceutical water systems to added equipment installations for increased productive capacity, S&B for wear and tear, and various reconfiguration options with an eye toward meeting inspection standards. We provide customers with comprehensive support, conducting seminars on the latest regulations after equipment delivery and introducing inspection findings.

Support for New Equipment Introduction

We propose the ideal pharmaceutical water system with consideration for the latest regulations.
In addition to optimizing systems according to raw water analysis results, we provide advice on sizing from point-of-use water consumption through productive capacity and tank capacity. We also support customers in considering future system expansion capability based on requirements, and in creating user requirement specification (USR) documents.

Planning flow Organo support
Basic plan
  • Consider system optimization based on raw water analysis results
  • Consider productive capacity and tank capacity sizing in light of point-of-use water consumption
Basic design
  • Conduct seminar on latest regulations
  • Consider specifications (materials, internal finish, interior flow rate, sanitization) in light of regulations
  • Cooperate in creation of budget application documents (flow sheet, installation schematics, utility usage volumes)
Detailed design
  • Assist in creation of requirement specifications (URS) 
Construction
  • Provide construction team comprising specialists with pharmaceutical experience to perform adjustment
Trial operation
  • Construction by team comprising specialists with pharmaceutical experience
Maintenance
  • Provide support after equipment delivery

When Reconfiguring Existing Equipment

We propose the ideal equipment reconfiguration with consideration for the latest regulations.
We visualize concerns and existing equipment risks using an equipment diagnostic service that employs FMEA risk assessment. We support added equipment installations for increased productive capacity, S&B for wear and tear, and various reconfiguration options with an eye toward meeting inspection standards.

Planning flow Organo support
Risk assessment
  • Implement equipment diagnostic service employing FMEA risk assessment
Improvement proposal
  • Propose equipment reconfiguration based on risk assessment sheet
  • Assist in creating budget application documents
Detail consideration
  • Create instruction manual, drawings
  • Assist in creation of requirement specifications (URS) 
Construction
  • Provide construction team comprising specialists with pharmaceutical experience to perform adjustment
Maintenance
  • Provide support after equipment delivery

Support After Equipment Delivery

We create maintenance cycle charts and propose maintenance plans for stable equipment operation. We conduct wrap-up meetings with customers after maintenance in order to share equipment status and present the maintenance plan for the following fiscal year.
We also support customers by introducing examples of inspection findings and periodically distributing the latest regulation trends, even after delivery.

Planning flow Organo support
Maintenance plan
  • Perform equipment risk analysis using equipment diagnostic service
  • Create maintenance plan table
  • Report maintenance expenses based on maintenance plan table
Maintenance
  • Provide maintenance service team comprising specialists with pharmaceutical experience to perform work
After maintenance
  • Submit report
  • Conduct post-maintenance wrap-up meeting
  • Propose maintenance plan for following fiscal year
Information broadcast
  • Conduct seminar on latest regulations
  • Introduce examples of inspection findings

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