Engineering Services - Pharmaceutical and Biotech Industry

Basic/Conceptual Design

• Process/CIP/SIP block flow diagrams

• Process material balances and CIP system utilization studies

• Process/CIP/SIP integration study sheets with illustrated flow paths

• Develop process/CIP/SIP schematic flow diagrams based on study sheets

• Process/CIP/SIP integration strategy document to define design foundation

• Review of building and equipment layout

• Conceptual budgetary cost estimate +/- 20%

Preliminary Design

• Develop process and clean utilities P&ID's based on process/CIP/SIP schematic flow diagrams

• Develop system based user requirements

• Preliminary utility requirements

• Preliminary equipment, piping and automation specifications

• Develop system based process descriptions

• Preliminary budgetary cost estimate +/- 10%

Detailed Design

• Refine clean equipment specifications to issue for bid and purchase

• Development of piping specification for hygienic systems

• 3-D modeling of hygienic systems modules and skidded equipment

• Process/CIP/SIP operations isometric piping details for weld mapping

• Confirmation of clean process utility loads

• Develop process/CIP/SIP functional requirements

• Develop color coded sequential process/CIP/SIP operations to support functional requirements

Commissioning and Qualification (C&Q)

C&Q Planning

• Development of factory and site acceptance test (FAT, SAT) protocols for vendor supplied equipment

• Development of system start-up protocols (SSP)

• Development of functional test (FT) acceptance criteria and test protocols

• Coordinate or participate in the development of C&Q schedule

Factory Acceptance Testing (FAT)

• Participate in pre-FAT coordination and conduct vendor visits

• Act as expeditor to ensure equipment delivery schedule

• Participate/direct factory acceptance testing of vendor equipment

• Finalize and issue FAT reports

Installation Verification

• Coordination of hygienic piping installation and automation system execution

• Perform periodic reviews of installation to ensure compliance with clean and sterile process requirements

• Maintain/distribute/resolve installation deficiencies punch list

C&Q Execution

• Follow up with installation site (SAT), confirm close out of all FAT punch list items

• Execution of system start-up, functional test and operational qualification protocols

• Preparation of weekly project metrics reports

• Develop, maintain and communicate C&Q punch list

Project Specific Training

• On-the-job training of operators and maintenance personnel

• In-house instruction programs with simulation equipment

Continuing Support

• After hours support (Call 608-313-1235)

This listing is not comprehensive; if the support you desire is not listed, please contact us to determine if we can serve you in a beneficial capacity.

Services

Engineering

Pharmaceutical and Biotech

Automation

Technical Consulting