April 3, 2023 | Company NewsTemperature
Temperature control is critical for the pharmaceutical industry. Proper temperature control ensures safety, efficacy, and quality. There are a variety of temperature requirements for pharmaceutical products depending on the product type and storage conditions. The US FDA regulates the temperature control requirements in the pharmaceutical industry through the Code of Federal Regulations (CFR). Neal Systems has extensive experience with ensuring our customers are able to adequately follow sections 211.42.3.10 and 211.142 of the CFR.
CFR Section 211.42.3.10 outlines the temperature and humidity control requirements for drug product storage areas. Drug product storage areas must be designed to maintain proper temperature and humidity levels suitable for the products being stored. These temperatures and humidity levels must be monitored, recorded, and controlled. Any data outliers need to be investigated. This section also requires a written record, that can be made available to the FDA, of temperature and humidity monitoring, to include the date, time, temperature, and humidity readings.
CFR Section 211.142 outlines the temperature control requirements for drug products during manufacturing, processing, and packaging. Drug products must be manufactured, processed, and packaged under appropriate temperature and humidity conditions. This section also states that any equipment used in the manufacturing, processing, or packaging of drug products must be capable of controlling the temperature and humidity levels required for the products.
How can Neal Systems help?
Neal Systems can ensure your equipment is calibrated and maintained to ensure humidity and temperature are controlled within the appropriate ranges. We provide monitoring and recording instrumentation that allow for accurate record keeping, as well as monitoring to alert to any temperature or humidity outliers that may require investigation. Our recording instrumentation can provide both an audit trail of any changes (to ensure compliance) as well as 21 CFR 11 electronic signatures.
Our team works one-on-one with our customers to find their specific needs and recommends the best product and solution for their unique situations.
Are you looking for an easier and more efficient way to ensure you are within regulatory requirements? Our team of engineers and service technicians are here to answer your questions.
October 18, 2022 | Company NewsTemperature
Problem: An industrial gas company had ten ovens with 1980’s technology. None of the ovens were networked together and there were no drawings for most of the ovens. Over the decades, multiple minor wiring modifications had turned each enclosure into a bird’s nest of unintelligible wiring. When something went wrong, it took maintenance hours to troubleshoot.
Each of the ovens had the following specifications:
34″ x 22″ x 44″ Chamber
2350 degrees F Max Temp +/-20 degrees F Uniformity
Electric Heating Elements with Solid State Power Controllers
48KW @ 480/3/60 60 Amps
Vertical door with Electric Gear Motor
Solution: NSI worked in conjunction with L&L Furnace of Aston, PA to upgrade the entire control system. The chosen solution involved supplying controller / recorder solutions with the Eurotherm Nanodac, adding power monitoring with the M-System 53U power meter, networking all the ovens together and displaying all SP’s, PV’s and alarms on a centralized 15” Weintek OIT, generating a powerful local notification system using the M-System IT60SRE Modbus TCP driven stacklight, and providing a cloud–based historian and remote alarming using a SCADACore Viacell edge device. Everything was then tied together with Eurotherms’ ‘out-of-the-box’ oven SCADA system. All of this had to be done for a budget that wouldn’t break the bank.
The Nanodac is a large I/O count, cyber–hardened two loop controller with built-in setpoint profiling, function block programming, encrypted data logging and Modbus TCP communications.
Three CT’s were added to each oven and connected to the M-System 53U power meter, which has a Modbus RTU interface. This was connected to a Lantronix converter, thus providing a Modbus TCP interface, allowing massive amounts of power data to be extracted, stored and analyzed.
The Weintek display is used as a central operator station to show profile status, alarms and current oven temperatures for all ten of the ovens.
The M-System IT60SRE Modbus TCP stacklight was delivered with four lights. Each light can be off, solid or flashing and all driven by Modbus commands. This gives the operator a wealth of available messages using combinations of lights and light states and all done with just power wiring and a Cat5 cable. This again, reduces installation time, materials and subsequently cost.
The SCADACore Viacell communicates to all ten Nanodacs over Modbus TCP and sends status, temperature and alarm information to the cloud. This is used as a back-up historian and to alert supervisors to any alarms.
The Eurotherm Oven SCADA system automatically recognizes the Nanodac controller and all relevant parameter addresses are pre-programmed. With its pre-built graphical interfaces, this means that a complete SCADA system can be developed in a day and commissioned over a second day thus reducing the project costs drastically.
During the installation process, all the surplus wiring was removed, remaining wiring tidied up and traced. ‘As-built’ AutoCAD drawings were then developed and delivered to the customer as part of the sign-off package.
End Result: The customer is now able to see both temperature controls and energy meters from every networked furnace from their control room. Within the first month, they were able to quickly see broken heater elements such that they did not have to start / restart oven runs multiple times.
Contact us today if you have old furnaces or ovens with controls that need to be networked and upgraded!
August 31, 2022 | Company NewsTemperature
NSI provides advanced temperature control and hazardous area expertise to production of clean energy solutions from heavy oil feedstock. NSI was chosen for two excellent reasons:
- Expertise in advanced temperature control
- Process visualization in a hazardous area environment
From a temperature perspective, the electric heaters will be fired by over 100 Eurotherm EPack power controllers for electric heaters, all of which will feature partial / full load failure break detection with associated alarming through Modbus TCP communications. Control will be handled by the powerful Eurotherm 2750 Multi-loop control system.
From a hazardous area perspective, the SCRs will be housed in a purged panel, using a purge system made by EXPO Technologies. The thermocouples for the project will be brought into the system through intrinsic safety method, using the MTL 831C for over 150+ thermocouples. The remaining 4-20 mA and I/O will be handled via intrinsic safety by the unique MTL SUM5 series, a digitally-programmable IS system.
Our expertise is known in the industry.
April 19, 2022 | Company NewsTemperature
Problem: Customer had ten ovens with 1980’s technology. None of the ovens were networked together and there were no drawings for most of the ovens. Over the decades, multiple minor wiring modifications had turned each enclosure into a bird’s nest of unintelligible wiring. When something went wrong, it took maintenance hours to troubleshoot.
Solution: NSI upgraded the entire control system and chose to use the Eurotherm Nanodac, adding power monitoring with the M-System 53U power meter, networking all the ovens together and displaying all SP’s, PV,s and alarms on a centralized 15” Weintek OIT, generating a powerful local notification system using the M-System IT60SRE Modbus TCP driven stacklight , providing a cloud based historian and remote alarming using a SCADACore Viacell edge device and tying everything together with Eurotherms’ ‘out-of-the-box’ oven SCADA system. All of this had to be done for a budget that wouldn’t break the bank.
The Nanodac is a large I/O count two loop controller with built-in setpoint profiling, function block programming, encrypted data logging and Modbus TCP communications.
Three CT’s were added to each oven and connected to the M-System 53U power meter, which has a Modbus RTU interface. This was connected to a Lantronix converter, thus providing a Modbus TCP interface, allowing massive amounts of power data to be extracted, stored and analyzed.
The Weintek display is used as a central operator station to show profile status, alarms and current oven temperatures for all ten of the ovens.
The M-System IT60SRE Modbus TCP stacklight was delivered with four lights. Each light can be off, solid or flashing and all driven by Modbus commands. This gives the operator a wealth of available messages using combinations of lights and light states and all done with just power wiring and a Cat5 cable. This again, reduces installation time and materials and subsequently cost.
The SCADACore Viacell communicates to all ten Nanodacs over Modbus TCP and sends status, temperature and alarm information to the cloud. This is used as a back-up historian and to alert supervisors to any alarms.
The Eurotherm Oven SCADA system automatically recognizes the Nanodac controller and all relevant parameter addresses are pre-programmed. With its pre-built graphical interfaces, this means that a complete SCADA system can de developed in a day and commissioned over a second day thus reducing the project costs drastically.
During the installation process, all the surplus wiring was removed, remaining wiring tidied up and traced. ‘As-built’ AutoCAD drawings were then developed and delivered to the customer as part of the sign-off package.
