Process Design Consultation

ESC Process Design and Consulting Capabilities

Electrol Specialties Company (ESC) is a 50 plus year old employee owned company.  ESC is the recognized leader in clean-in-place (CIP) technology, and has been working in this field for over 40 years.

As a full service resource to the biopharm industry, ESC offers consulting services as well as equipment and start up services to assure the client optimal results by proper integration of process and CIP.  This capability was publicly recognized when ESC was named as a primary project partner by two of the 2007 ISPE Facility of the Year award winners.

IQ/OQ/DQ Documents from Leaders in CIP TechnologySanitary Design & CIP Consulting Core Competency

The ESC Process Design Consulting Group performs fee-based technical consulting to ensure optimized integrated cleaning of biopharm processes.

Consulting capabilities include the following:

  • Integrated sanitary design and CIP/SIP for new projects, as well as retrofit facility upgrades.
  • P&ID and specification review to ensure optimized effective process/CIP/SIP integration.
  • Piping model and installation drawing reviews to ensure proper CIP/SIP concept.
  • Vendor drawing reviews for equipment cleanability, spray device placement and spray specification.
  • Develop an overall process/CIP schematic flow diagram, depicting the integrated cleanable process design.
  • Develop CIP circuit designs and valve sequence matrices.
  • Produce sequential process/CIP/SIP schematic extractions to facilitate and simplify project communication through the design, software development, documentation, and commissioning phases.
  • Create/review user requirement specifications (URS), functional requirement specifications (FRS), software detailed design specifications (SDDS), software factory acceptance testing (SFAT), site acceptance test (SAT), design qualification (DQ), installation qualification (IQ), and operational qualification (OQ) documents.
  • Develop cGMP process and CIP software (21 CFR Part 11, GAMP, S88).

Field service on-site engineering capabilities include the following:

  • Facility site observation of existing or under-construction facilities to ensure proper sanitary installation.
  • Process/CIP/SIP operations audits to optimize system performance while minimizing utility and chemical usage and waste generation.
  • Conduct spray performance and riboflavin tests, evaluate results, and define remediation to obtain the desired cleanability results.
  • Provide start-up, commissioning, and execution of qualification protocols.
  • Process/CIP/SIP training, providing both classroom and hands-on experience.

Lead Consultants

Project work by the ESC Sanitary Design & CIP Consulting Group is under the direction of the following lead consultants:

Dale Seiberling-VP and Technical Advisor.  Over a period of nearly sixty years Dale has been a leader and innovator in the field of sanitary process/CIP engineering design for the dairy and food processing industries initially.  He has over 30 years of biopharm facility and process design experience, including the design of highly automated new facilities and the planning and implementation of major renovation projects, both with an emphasis on economies of capital and overall system operation.  He is the holder of several patents , including the first for permanently installed CIP Spray devices, and his accomplishments are widely recognized through both his work on leading edge projects and via numerous speaking and teaching engagements as well as prolific publications.  Though nearly two decades beyond the normal retirement age Dale is still active and continues to teach the CIP session of the PDA Aseptic Process Course up to five times per year.

Lyle W. Clem-Director of Engineering and Consultant.  Lyle has close to 30 years of in-depth process design and project management experience in the life sciences industry.  His expertise in engineering and technological innovation for clean in place processes has proven quite valuable for clients by providing products and services that reduce their overall costs and increase their efficiency.  He brings extensive experience in process engineering, process automation, and project management for fluid handling in pharmaceutical and biotechnology applications.  He also offers in-depth experience in system design, construction and commissioning CIP and related systems in the life sciences industries.  He participates in several sanitary design standards committees, including 3A and ASME BPE.

Sam Lebowitz-Technical Services Manager.  Sam has 20 years of biopharm experience.  Prior to employment with ESC, he was with a major A&E firm as a Biopharmaceutical Process Engineer.  He provides technical information in the preliminary design phase, coordinates detailed design, and provides field engineering, commissioning and validation services.  He has several publications on the subject of integrated sanitary design with CIP and has frequent speaking and teaching engagements.  He participates in several sanitary design standards committees, including 3A and ASME BPE.

Colin Riley-Process Engineer.  Colin has 20 years of biopharm experience in rolls of application engineering, process design and project management.  Prior to ESC, Colin worked with several of the leading OEM providers of CIP and process systems, taking projects from conceptual design through to system validation and start up.

APPLICATION ENGINEERING SUPPORT

During nearly 40 years of experience in fabricating first, CIP system components, and then “CIP skids“, for jobbers, distributors and users, Electrol Specialties Company has had the opportunity to observe much of this equipment in it’s installed application. Field observations and experiences provide a sound basis on which to base Application Engineering Recommendations.  ESC can support the jobber, the A&E having design responsibility, and the final user with expertise in equipment areas including:

  • CIP Units – Questions regarding numbers of tanks, method of return flow motivation, HXR sizing, Pump sizing, chemical feed systems, and applicable control systems  can be answered by ESC’s design and Application Engineers.  Assistance can be offered regarding preferred CIPS/R system design concepts,  and relative of each type.
  • Spray Device Selection and Application – Assistance can be provided to determine number and type of sprays, preferred tank head nozzle locations,  and  required delivery flow rates and pressures.
  • Control System Criteria – ESC’s Software Engineers can assist by providing information about the relative merits of various control systems for each individual application.
  • Transfer Panel Design – As a pioneering supplier of both small scale and large scale transfer panels,  ESC has developed an unusually broad background of experience in this manufacturing area and is prepared to convert the user’s operating requirements to well organized transfer panel designs.