SAVIS, INC. - Automation

The following is a partial list of SAVIS, Inc. projects associated with automation:

Managed, designed, implemented and oversaw engineering effort on a number of projects.
Including: Lyophilizer SIP cycle development and time reduction, Lyophilizer Refrigeration skid improvements, Lyophilizer auto-loader redesign, Lyophilizer piping modifications per audit, bottle rinser skid enhancements, automated glass inspection system design, stopper washer layout, installation and commissioning. Worked with Validation team during Lyophilizer OQ and PQ development and execution.

Turnkey Electrical, Automation and Qualification Design and Implementation: Investigating and upgrading corporate and city codes and regulations (ADA, OSHA, NEC, ANSI, NFPA, etc) to meet and exceed requirements. Automation and electrical engineering design across 7 Colorado Buildings.
Automation activities for Allen Bradley PLC5 (RSLogix5), Allen Bradley PLC5000(ControlLogix5000), Johnson Controls BMS, and Andover BMS systems consisted of creation of new PLC and BMS as-built drawings, modification of existing automation drawings, design and landing of I/O points, procurement of necessary automation equipment for implementation.
Electrical engineering activities consisted of creation of new electrical as-built drawings, modification of existing electrical drawings, design and procurement of necessary electrical equipment (relays, enclosures, selector switches, lights, horns, etc) for implementation.
Document deliverables consisted of the following: URS, FRS, DDS, RFPs, Basis of Design document, Gap Analysis documents, Options Analysis Reports, Electrical and Construction Detailed Design Specifications, Automation Detailed Design Specifications, and Commissioning and Validation Strategy and Plan.

HVAC System and Deionized Water System Integration
Design, Purchase, Installation, Management, Documentation, and Qualification of a Clean Room Manufacturing Environment Including New Utilities, DI Water System, and Environmental Control System.

Design and Test Clean-In-Place (CIP) and Steam-In-Place (SIP) Modifications to a Galaxy I.V. Bag Filling Machine.
Project Included Developing Specifications for New Equipment, Contacting Vendors, Purchasing Equipment, Installing New Equipment, Developing Acceptance Test Protocols, and System Qualification.

Development and Execution of Complete Facility Validation.
The Initial Phase Included Development of the Process and Facility Validation Master Plan.
The Second Phase Included the Review and Development of Specifications and Qualification Protocols for the Facility, HVAC System, Laboratory Equipment, Purified Water System, Utilities, Label Room, Security Access System, Compressed Air, and Process Equipment.
The Third Phase Included the Execution of the Protocols and Development of Summary Reports. In addition, the Completion of the Process, Cleaning, and Test Method Validation was also Included in the Third Phase.

Performed Feasibility Study, Concept Design and Cost Analysis of Four New Product Manufacturing Sites.
Accelerated Project Included: Contacting Vendors, Determining Budgetary Estimates, Presentations, Justifications, Designing Optional Layouts, and Presenting Recommended Decisions.

Development and Execution of Complete Facility Validation
The Initial Phase Included Development of the Process and Facility Validation Master Plan.
The Second Phase Included the Review and Development of Specifications and Qualification Protocols for the Facility, HVAC System, Laboratory Equipment, Purified Water System, Utilities, Security Access System, Compressed Air, and Process Equipment for Liquid, Powder, Tablet, and Capsule Products.
The Third Phase Included the Execution of the Protocols and Development of Summary Reports. In addition, the Completion of the Process, Cleaning, and Test Method Validation was also Included in the Third Phase.

Developed Equipment Specification Files for the Process Equipment that no Longer had Manufacturer Documentation Existing. The Process Equipment was used for the Manufacture of Bio-indicators, Liquid Ampules and Vials, Blister Packs, Swab Application Devices, and Glass Cutting Operations.
Project Included Automation of Ampulizing Process to Improve Process Control. In addition, Qualification Protocols were Developed and Executed to Demonstrate that the Improved Process would Remain in a Validated State in a Manufacturing Environment.

Designed, Installed, Qualified, and Drafted Software and Hardware for New Nitrostat Marchesini Cartoning Machine.
Project Included: Upgrading the Control of a Conveyor and Accumulation Table Line. The Upgrade Enabled the System to Use Either of Two Cartoning Machines Based on the Type of Product Selected at the Main Line Operator Interface Terminal (OIT). Graphics and Alarm Updates were Added to the OIT, as well as a One-Touch, Automatic Enabling System. The Enabling System would only Operate the Correct Cartoner for the Product Type Selected.

Rolaids Label Room Turnkey Project for a Roll Label Inspection/Counter System, a Cut Label Verification/ Counter System, and a Label Disposal System.
Project Included: Specification, Purchasing, Installation, Qualification, and Standard Operating Procedure Development for the Different Systems. Facility Design and Startup were also Included in the Project.

Designed, Installed, and Validated the Hardware and Software of a Packaging Line Electronic Verification and Monitoring System on Four Packaging Lines.
Project included: Barcode Verification, Ethernet Networking, System Backups, Production Reports, System Monitoring, Designation of Security Levels, and Label Management.

Designed, Installed, and Developed Documentation for the Hardware and Software of a Packaging Line Electronic Verification and Monitoring System.
Project included: Barcode Verification, Vision Systems, Laser Coding, Printing and Applying Labels, Production Reports, System Monitoring, Designation of Security Levels, and Label Management.