CYBERNET SYSTEM MANAGEMENT, INC.
Pharmaceutical Previous Work

Tray and Case Labeler Validation
The objective of this project is to validate three (3) new Tray Labelers, three (3) new Case Labelers and one (1) new Control System. CSMI scope of work under this proposal will involve equipment and computer software validation engineering services to generate and execute the required FAT/IQ/OQ/PQ for the three (3) new tray labelers, three (3) new case labelers and one (1) new control system.

Environmental Monitoring System Expansion
The objective of this project is successful implementation of 21 additional sensors into existing environmental monitoring system.

Hull Lyophilizers
The objective of this project is to address issues discovered with existing Hull Lyophilizer Freeze dryers.

CSMI scope of work under this proposal will involve engineering services for the control system modifications on Hull Lyophilizer Freezer Dryers. Modifications to control systems will accomplish operational requirements as indicated in Client User Requirements Specification:

  1. System Design Documentation – Develop system documentation as required in User Requirements Specification and Quality Control Plan.
  2. Programming Development
  3. PLC Programming – Modify SLC 5/04 programs for Hull Lyophilizer Freeze Dryers to meet operational requirements.
  4. HMI Development – Modify Intellution Fix32 Applications for Hull Lyophilizer Freeze Dryers to meet operational requirements through addition of a bypass button.
  5. Sytech Report Manager - Modify Sytech Report Manager Application for Hull Lyophilizer Freeze Dryers to meet operational requirements in recording door position.
  6. FAT - Provide FAT prior to commissioning

Line 2 HMI Upgrade
The objectives of this project are to upgrade existing operator interface and PLC on Packaging Line and interface with new pick and place unit.

CSMI scope of work under this proposal will involve engineering services for the control system modifications on packaging line controls system. Development of the following:

  1. Functional Specification – This document will outline functional description of upgraded HMI unit and PLC interface with Pick and Place Unit. HMI upgrade will be designed as a panel conversion.
  2. PLC – Modify Plant PLC program for interface with New Pick and Place Unit
  3. HMI Development – CTC Application will be developed from Approved Functional Specification.
  4. FAT - Provide FAT prior to commissioning
  5. SAT Documentation Preparation
  6. Startup
    • Pre-Commissioning – Installation / I/O checkout
    • Commissioning
    • Production Support
    • Completion of Required Validation Documentation
  7. Develop As-Built documentation
Specific equipment to be installed includes the following:
  1. New CTC HMI Station
  2. New ControlLogix PLC, PLC rack, and respective I/O
  3. Pick and Place unit
Electrical Schematics
The objective of this project is to provide an updated set of electrical schematics for lyophillizer. CSMI scope of work under this proposal will involve Review Electrical schematics to provide consistent and accurate nomenclature, symbology, labeling/tagging, and referencing throughout electrical schematics, and execute changes and update schematics.

Retrospective GAMP Document – PD Lyophilizer
The objective of this project is to provide a Retrospective GAMP Document (System Specification) for the PD Lyophilizer being transferred.

CSMI scope of work under this proposal will involve project management and engineering services required to complete Retrospective GAMP Documentation for the PD Lyophilizer being transferred.

Maintenance Training Manual
The objective of this project is to provide a document template for maintenance training on equipment.

Scope of work involves the development of a maintenance training manual for Literature Placer equipment. This document shall be utilized as a template for future documents. The intent of the document is to provide an overview operation of the piece of equipment for maintenance training and troubleshooting.

Engineering Standards
The objective of this project is to develop template engineering design standards for the client. Some of the goals for this engineering design standard are as follows:
  • Engineering Consistency
  • Facilitate implementation of projects utilizing standards
  • Reference for maintenance
  • Recognized company standard
CAD Standards
CSMI scope of work under this proposal will involve development of a Phase I Gap analysis (Identify Gaps) on existing CAD design standards to industry standards and to meet the needs of the client, develop final draft and implement.
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CSMI is a specialized Engineering Consulting Firm whose primary focus is in the Engineering and Design Services specifically for the regulated industries

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