The following is a partial list of SAVIS, Inc. projects associated with validation:
Confidential Client
- Development and execution of Commissioning and Validation Project Plan through Validation Summary Report.
- Phase 1: Obsolete specification documentation was upgraded to meet 21 CFR 210 and 211 requirements. Developed and executed FMEA risk assessment and validation testing of gaps found during the documentation upgrade as well as the processor upgrade from a PLC 5 to ControLogix and concurrent CIP software modifications.
- Phase 2: Included protocols for commissioning and validating 43 modified and new CIP equipment, cycles and process controls. Project also required CIP robustness C&Q and tank dives for spray coverage testing where engineers would follow OSHA, EH&S, Confined Space Entry, and LOTO procedures and regulations.
Talecris Biotherapeutics, NC- Biologics Processing Facility
- Turnkey Validation Project: Management, development and execution of complete equipment, process and cleaning validation for a product transfer from multiple facilities.
- Included protocol development, protocol review sessions, execution, exception resolution and final reports. Equipment included: buffer and process vessels, chromatography skids, UFDF skids, nanofiltration skids, CIP skids, analytical instruments, blast freezers, and sterile bulking operations. Testing included temperature mapping, mixing studies, spray coverage, CIP/SIP verification, media fill testing, clean and dirty hold time determination, and process validation.
Confidential Client
- Draft and execution of Performance Qualification (PQ) documents to qualify the temperature distribution of three (3) roller bottle warm rooms. Project also included engineering studies to collect temperature data (via Kaye Validator 2000) to fine tune parameters before the execution of the PQ protocols.
Centeon - Kankakee, IL Plasma Manufacturing
- Developed and Executed Computer Validation Qualification Protocols for Building Monitoring Systems, a Laboratory Information Management Systsem, Filter Integrity Testers, Water for Injection Control Systems, Lyophilization Process and Steam in Place Cycles, and Various Other cGMP Related Systems.
- Project Involved Working with a Project Team Consisting of Representatives of the Engineering, Validation, Quality Assurance, Regulatory, and Manufacturing Departments.
Confidential Client
- Development of Software Validation Protocols for MP2 Quality Control Software, Microbiology Lab Equipment Software, and a Waters Corp. HPLC System Client/Server Network.
Centeon - Kankakee, IL Plasma Manufacturing
- Managed Project Team for Implementation of Automated Environmental Monitoring System.
- Project Included Management of Project Plan, Timeline, and Working Closely with the Various Disciplines to Implement the System in a Timely Fashion.
- Project also Included Development of Requirements, Specifications, Detailed Drawings with Sensor and Controller Layouts, Man/Machine Interface Program Development, and Database Support with the Information Technology Department.
Confidential Client
- Execution of Facility Commissioning Documents for Reverse Osmosis Water System, Water for Injection System, Pure Steam System, Compressed Air System, Nitrogen Gas System, Terminal Sterilizer and Laboratory HPLC Systems with the associated Client/Server Network.
- Development of Facility Validation Documentation Including Equipment Specifications, Standard Operating Procedures, and Qualification Protocols for the HVAC System, Reverse Osmosis Water System, Water for Injection System, Pure Steam System, Compressed Air System, Nitrogen Gas System, and a Terminal Sterilizer.
Confidential Client
- Execute IOQ protocol to qualify the cycles and alarms of the Seed Lab Autoclave.
- Project also included drafting and approval of the Requirements Traceability Matrix (RTM) and updates to a Steaming Master Plan and a Facility Validation Master Plan.
Confidential Client
- Cleaning Validation Study to Remove Residues from Compounding Room Tanks and Transfer Lines.
- Project Included Determination of the Residue Removal Method, Development of a Swabbing Procedure, and Determination of the Detergent for Regular Use.
Aviron, Inc. Mountainview, CA Biomedical Division
- Engineering System Development and Material Management. Developed Detailed Specifications for Aseptic Manufacturing Components, Processes, and Materials.
- Projects Included: Consultations with Suppliers, Collection of Data, and Documenting Results in an Approved Format.
Packaging Coordinators, Inc. Philadelphia, PA Pharmaceutical Manufacturing
- Aseptic Manufacturing Material Flow Development.
- Project Included: Definition of Procedures for Control of the Receiving, Incoming, Inventory, In-Process, and Shipping of Components and Materials. The Facility is Responsible for the Aseptic Manufacture and Control of Filled Syringes
Talecris Biotherapeutics, NC- Biologics Processing Facility
- Validation project management for a multiple process tank validation effort.
- Included resource management, protocol development, protocol review sessions, execution, exception resolution and final reports for equipment and cleaning validation. Testing included mixing studies, spray coverage and CIP verification.
North Safety Products, Providence, RI Pharmaceutical and Medical Devices
- Developed Acceptance Test Protocol for a New Deionized Water System
- Project Included: Specification Development, Data Collection, and Protocol Development for the New Purified Water System.
Aviron, Inc. Mountainview, CA Biomedical Division
- Quality Assurance System Development for Aseptic Filling.
- Project Included: Developed a Quality System for the Monitoring and Control of the Manufacture of Pre-Filled Aseptic Syringes. Developed Several Sampling and Inspection Plans for the Different Inspection Phases Including Incoming, In-Process, and Finished Goods. Developed Associated Documentation and Procedures to Provide Forward/Reverse Traceability for Product Delivery and Regulatory Recalls.
North Safety Products, Providence, RI Pharmaceutical and Medical Devices
- 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.
Confidential Client
- Developed Acceptance Test Protocols for New Systems.
- Project Included: Specification Development, Data Collection, and Protocol Development for Filling Machines, New Facility, and HVAC System. In addition, the Protocols were Executed and Detailed Punch Lists were Developed to Provide Documented Closure of any Open Issues Prior to Validation.
North Safety Products, Providence, RI Pharmaceutical and Medical Devices
- 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.
Confidential Client
- 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.
Talecris Biotherapeutics, NC- Biologics Processing Facility
- WFI validation protocol development, execution and closeout for pump replacement and point of use additions. Performed during plant shutdown. Required high resource demand at peak to meet accelerated shutdown timeline. Testing included MOC verification, weld verification, pump capacity testing, and a 30 day point of use sampling plan.
Confidential Client
- Development and review of CBER (Center for Biologics Evaluation and Research) submissions for new and existing process control systems.
North Safety Products, Rockford, IL Pharmaceutical and Medical Devices
- 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.
SoloPak Medical Products, Inc. Elk Grove Village, IL Pharmaceutical Operation
- Developed and Executed Validation Protocols for Syringe Inspection Process.
- Project Included: Requirement Identification for Software Security Levels, Development of Standard Operating Procedures, and Development of Software Specifications for Product Enhancements.
SoloPak Medical Products, Inc. Chicago, IL Pharmaceutical Operation
- Validation, Regulatory, and Engineering Project Management.
- Project Included: Completion of a Compliance Enhancement Initiative for a Syringe Manufacturing Facility to Address Internal and FDA Regulatory Observations.
- Systems Included: Automated Inspection, Water For Injection, Labeling, Label Reconciliation, Component Processing and Compounding.
Confidential Client
- Provided Integration and Validation Support using an Enterprise Document Management System (EDMS) and Tools. The EDMS managed documents with a variety of formats, including text and CAD documents, and integrated the document management across multiple sites.
Parke-Davis, Co. Fajardo, PR Pharmaceutical Operation
- 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). Added Graphics and Alarm Updates 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.
Warner Lambert, Inc. Vega Baja, PR Consumer Operation
- 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.