ESC CIP Process Design and Consulting Capabilities
We at ESC offers consulting services along with the equipments and start up services to assure the client optimal results with proper integration of process and CIP.
Our Process Design Consulting Group performs fee-based technical consulting in order to ensure optimized integrated cleaning of biopharm processes.
Consulting capabilities include the following:
Read Original Source: http://www.esc4cip.com/process-design-consultation/
Our Process Design Consulting Group performs fee-based technical consulting in order 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.
Read Original Source: http://www.esc4cip.com/process-design-consultation/