Facility Design/Management Division - Capabilities
Constructing highly-specialized facilities requires highly-specialized knowledge. CSCS Corp.'s Facility Design/Management Division is made up of CSCS Corp. employees who have extensive experience in the pharmaceutical and biotechnology industries. In fact, our employees are chemists with hands-on plant experience, so they have first-hand knowledge of equipment that is used and issues that can arise within the plant.
The following is a sample of our scope of services:
Design:
- Value engineering studies
- Qualified technical resources for design and 3D review
- Audited and approved contractors
- Feasibility studies & contract negotiation
- Conceptual cost estimations & permitting
- Constructability review and bid analysis
- Project scheduling, including timelines and milestones
- Site supervision/quality control
- Project management
- Project cost control & detailed cost estimates
- Equipment procurement
|
Start-Up/Commissioning:
- Walk down and red line of P&ID’s
- Equipment installation verification per approved P&ID’s
- Creation of validation documentation, IQ, OQ and PQ protocols
- Process and utility equipment functionality troubleshooting
- Preparation of equipment maintenance procedures and frequencies
- Compilation of vendor turn over packages
- Valve tagging per approved P&ID’s
|
Regulatory Compliance :
- FDA inspections, pre-approval FDA inspections (prep for FDA)
- Process and out-of-specification (OOS) investigations
- Internal auditing, purified water validation and equipment qualification
- Process validations, site transfer and compliant equipment cleaning
- Instrument Qualifications (IQ) and Operations Qualifications (OQ)
|
Maintenance:
- Biotech/Pharmaceutical maintenance staffing
- Creation of equipment maintenance SOP’s
- Preparation of required equipment spare parts lists
- Spare parts inventory auditing
- Assistance setting up preventative maintenance programs
- Technical spare parts replacement procedures training
|
For more information about the CSCS Corp. Facility Design/Management Division, visit:
- About the Facility Design/Management Division
|
