Equipment Page

Confidential Client -

Design and Test Clean-In-Place (CIP) and Steam-In-Place (SIP) Modifications to an 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.

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.

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

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.

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.

SoloPak Medical Products, Inc. Elk Grove Village, IL Pharmaceutical Operation -

Developed, Executed, and Certified Qualification Documentation for the Control of Seventeen Manufacturing Systems. These Control Qualifications were Independent of the Equipment Installation and Operational Qualifications.

Systems included: Water Pretreatment, WFI and other Utilities, Component Processing and Sterilization, Automatic Batch Compounding, Automated Inspection, Labeling, Packaging and In-Process Quality Monitoring Systems.

Confidential Client –

Engineering Project Management

Project Included: Development of Optimal Manufacturing Parameters Associated with the Repeatable Manufacture and Functionality of Siliconization, Sterilization, Compounding, Component Processing, and Filling.

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.

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.

Monsanto Chemical / Occidental Chemical Corp., Sauget, IL -

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.

Warner Lambert, Inc. Vega Baja, PR Consumer Operation -

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.

Parke-Davis, Co. Fajardo, PR Pharmaceutical Operation -

Documentation, Acceptance, Qualification, and System Validation of Oral Contraceptive Blister Pack Overwrapping Processing and Packaging.

Project Included: Acceptance Trip to Vendor Facility, Acceptance Protocol Development and Execution, Design Enhancements, Process and Equipment Validation, and Final Report Development.

Warner Lambert, Inc. Vega Baja, PR Consumer Operation -

Developed Specification, Purchased, Developed Standard Operating Procedures, and Qualified Three Offline Barcode Verifier Systems.

Parke-Davis, Inc. Fajardo, PR Pharmaceutical Operation -

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.

Warner Lambert, Inc. Vega Baja, PR Pharmaceutical Operation -

Designed, Installed, and Developed Documentation for the Hardware and Software of a Packaging Line Electronic Verification and Monitoring System on Lines 1, 3 and 4.

Project included: Barcode Verification, Vision Systems, Laser Coding, Production Reports, System Monitoring, Designation of Security Levels, and Label Management.

Confidential Client -

Developed Manufacturing Monitoring and Control Software Design. The Software Included Network Control, Machine and Process Monitoring, Subsystem Handshaking, Built-In-Testing, Trending Analysis Reports, Verification and Vision Systems Monitoring, Printer and Coder Setup, Production and Inventory Reports, and Other Features.

Warner Lambert, Inc. Vega Baja, PR Consumer Operation -

Development of Rolaids Specification for Barcode Electronic Verification System.

Project Included: Presentations to Client for Considering 39 or 128 Barcode Options, Size Constraints, Parity Considerations, False Read Percentages, and Expected No Read Percentages.

Warner Lambert, Inc. Vega Baja, PR Consumer Operation -

Process Automation Feasibility Study and Cost Analysis for the Efferdent Manufacturing Facility.

Many Factors were Included in the Study, such as Operation of the Equipment, Current and Projected Process Demand, Process Flexibility Requirements, Optional Semi-Automatic Operation, and Validation Requirements. In addition, Scheduled Completion and Production Downtime were Included in the Study.

Warner Lambert, Inc. Vega Baja, PR Consumer Operation -

Developed Certs and Rolaids Standard Operating Procedure (SOP) for Feeder System.

Project Included: Travel to the Vendor Location to Develop SOPs During Machine Manufacture, Coordination with Vendor to Specify Feeder Operation, and Verification Testing and Training of the Developed SOPs.

Schein Pharmacal Humacao, PR -

Performed Feasibility Study of Two New Bottle Packaging Lines.

Project Included: Development of Line Layout Options, Cost Analysis, Cost Justification, Scheduling Requirements, and Recommended Inspection and Monitoring Features.

Warner Lambert, Inc. Vega Baja, PR Pharmaceutical Operation -

Developed Definition and Specification Manual for Tablet in Bottle Packaging Line and Developed Machine Acceptance Test Protocols for Two Bottle Bundlers.

Project Included: Providing Recommendations of Shrink versus Band Technology and Material Considerations.

Johnson & Johnson Cabo Rojo, PR -

Designed Layout of Four Packaging Lines for the One- Touch Strip Blood Sugar Identification Product.

Abbott Caribe, Inc. Barceloneta, PR -

Performed Feasibility Study for New Syringe Line and Vision System Validation

Schering Del Caribe Inc. Manati, PR -

Performed Feasibility and Design Study on a Vision System and Documentation for the Manufacturing Facility.

Parke-Davis, Co. Fajardo, PR Pharmaceutical Operation -

Designed Layout of Two Dilantin Packaging Lines.

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