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Development and installation of the Ignition Environmental Monitoring System at a Pharmaceutical Manufacturing Site in Chestnut Ridge, NY.

 

CNE played a key role in working with the customer and the programming group to develop the system. In-depth testing of the system and providing feedback. The Ignition system is a complete custom system that monitors temperature, humidity and differential pressures in processing suites throughout the facility, as well as utility monitoring (compressed air, carbon beds, USP water, etc).

 

The first 10 photos are of one of the control panels that CNE designed and built for one phase of the project.

Environmental Monitoring System Panel Build


Starting the layout


Differential Pressure Transmitters


Adding more din rail for components




Internal wiring and tubing complete


All tubed up


Ready for testing


Panel powered and tested. Ready to install.


Installed


Up and running

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From the earliest planning stages through its completion, it was our responsibility to manage this project. This customer was a long time user of Blue Mountain products and this project took them from Calibration Manager version 4.1 to BM RAM current version. 

 

In addition, part of the project was to expand usage from a simple calibration scheduler (CalMan was used in this way) to incorporating a full maintenance program, and expanding the calibration and maintenance program to the use of tablets and eliminating paper (going paperless).

 

 

  • Stage 1: work with the customer and with Blue Mountain project manager to determine how to use BM RAM, including reporting, inventory control, personnel and vendor management and more.
  • Stage 2: begin the configuration. Blue Mountain team did the configuration with me testing and making suggested changes to satisfy the customer.
  • Stage 3: work with the customer’s CSV (computer system validation) group to develop the qualification testing, write and edit portions of the testing and write SOPs.
  • Stage 4: execute the qualification.
  • Stage 5: responsible for ensuring all of the Preventive Maintenance checklists (over 500) were converted from Word to Blue Mountain. Also ensuring the maintenance activities were properly scheduled in CalMan prior to the final data migration. Also responsible for reviewing existing data and updating records prior to final data migration.
  • Stage 6: Training all users from Technicians, to Managers, to Super Users on proper usage of BM RAM.
  • Stage 7: ensure all tablets were properly configured and then distributed to the technicians for use.

Final stage: continued support of system.

 

End result: Successful implementation of Blue Mountain. This project was completed on time and within budget.

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Glatt GPCG-15 Installation at Par Pharmaceutical Manufacturer in Chestnut Ridge, NY.

Managed a portion of the installation. Assisted the project manager and the riggers with proper placement of the fluid bed components. Directed the electricians on all wiring of field devices, instruments and motor controls. CNE handled all of the control wiring inside the control panel and to all the field devices (including all pneumatic connections).

Once the wiring was complete, CNE executed a complete start up of the system, and also completed the validation (document written by OEM).

Fluid Bed Installation


Room under construction


Room under construction


Room under construction


Radial fan installing in mezzanine


Control panel before installation


Air handling unit in mezzanine


Fluid bed components


Fluid bed components


Fluid bed components


Fluid bed components


Fluid bed components


Tower supports installed


Filter chamber ready for installation


Filter chamber being lifted


Filter chamber being lifted


Aligning the filter chamber


Almost there…


Filter chamber installed


Explosion duct on mezzanine.


Looking good


Framing around the tower


Fume hood in the room


Hydraulic pump cabinet on mezzanine


Inlet and Exhaust ducting


More ducting (on mezzanine)


AHU piped, Exhaust filter unit installed before fan


Room framing continues


HMI Panel mounted


Inlet duct in the room


Inlet duct with air flow sensing station in room


Dew point sensor on AHU


Wurster 9″ and 12″ product bowls


Framing around bulkhead box in room


Starting to take shape…


Room looking goodFilter tower in room




Machine tower installed


Room painted and floor complete


Room painted and floor complete




Control panel wiring and tubing completed


Control panel wiring and tubing completed


Job complete


Job complete

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