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.
Water contamination has been recently been making headlines due to a variety of unforeseen incidents. It is becoming increasingly important to take preventive measures to ensure that such incidents are minimized or avoided altogether. At NSI, we understand the critical role that regular maintenance and monitoring of a plant’s effluent play in minimizing or avoiding these potentially catastrophic situations.
Neal System’s offers a comprehensive range of instrumentation and analyzers that are essential for efficient plant management and monitoring. Our team of experts provide installation, troubleshooting, calibration, and maintenance services for the following:
Pressure
Flow
Temperature
pH
Dissolved Oxygen
Chlorine/Chemical Feed
Gas leak detection (chlorine, hydrocarbons, ammonia, carbon monoxide, hydrogen sulfide, and oxygen)
Qualities of Water: TOC, COD, BOD, TNb
Our team is proud to say that our engineering and service teams collectively have more than 200 years of experience in water and wastewater management. We’re committed to providing the highest quality solutions that minimize the impact of any potential leaks and to help prevent them from occurring in the first place.
Automation in your industrial and municipal plants are key to ensuring your process is optimized. Neal Systems team can ensure your measurements, controls, data acquisition, and wireless networking are streamlined and running most effectively.
What are the key reasons you should have NSI evaluate your plant automations?
Increase Efficiency: Streamlining processes and reducing the time to complete a task means that repetitive and manual tasks can be decreased and workers can focus on more complex and value adding jobs.
Improved Productivity: Reduction of errors and improving the consistency and accuracy of a process will increase the productivity.
Reduced Downtime: Downtime losses money. Many of the upgraded automation equipment can predict and identify issues prior to failure, which will allow for maintenance to be performed before downtown can occur.
Improved Safety: Dangerous or hazardous tasks can often be implemented by automation equipment and monitored either remotely or from a safe location.
Cost Savings: Reduction of labor costs and improved efficiency in production will lead to cost savings overall.
Improved Quality: By ensuring the processes are running consistently and error-free, quality overall will increase due to the upgraded automations efficiency.
Is your operation currently hitting all of these 6 key points optimally? Contact our team at NSI for assistance in evaluating your current processes and to see where we can help you to increase efficiency, productivity, safety and cost savings.
A critical fresh water treatment plant, Borough of Coudersport, required an upgrade to their existing Process Automation Control (PAC) System installed at their north and east plants. Their units were reliable and running great after a decade of service. However, the main processors (T940) were obsolete and Coudersport would not have been able to replace them on failure. This is a rural plant that is two hours from the closest city so without local support, reliability is a high priority. The plant could not be taken offline for more than a few hours at a time so the majority of the upgrade work was required to be done live. Eurotherm, a division of Watlow, have shown a commitment over the last four decades to continue making hardware and programming software with backwards compatibility to previous generations. Every version of their LINTools software supports EVERY previous version of EVERY hardware variety for the last 30 years – a significant advantage over some suppliers that require a version of configuration software to exactly match with the hardware version.
In this case, an upgrade was achieved by replacing the T940 processors with T2750 racks allowing for the use of the same communications backbone and existing I/O cards. Owing to the ability to ‘port’ the majority of the code directly from the T940 to the T2750 (despite them being two generations of product development apart), the engineering time was reduced by around 70%. Since the existing I/O was retained, installation costs were reduced by 90% since no new wiring or loop checks were required. Additionally, drawing changes were minimized and because significant portions of code were re-used, the overall risk associated with a live upgrade was minimized. This is a multi-location system with 300 I/O points and the offsite work took just two weeks. Owing to the significant re-use of hardware and wiring, Neal Systems and Eurotherm were able to then remove, replace, and commission the T940 processors and update the SCADA computers in one week.
The plant never experienced downtime in excess of an hour.
During this site week, the three SCADA computers were replaced with PC’s at the latest windows version with licenses to match. A new Ethernet switch was used to connect everything together.
The majority of their existing equipment remained in place. The enclosures and screens stayed the same, and there were no field wiring changes. This reduced the total cost of the project by 70% and the risk by 80%. The operators did not require any training since the system looked and worked exactly the same as before. Interruption to plant operations was minimal and all work was performed during the day shift.
Neal Systems is pleased to announce that we are partnering with Keller America, one of the premiere names in Submersible Pressure Transmitters for the water / wastewater industry. NSI will be covering New York, Pennsylvania, West Virginia, New Jersey, and Delaware. Keller’s probes include built-in lightning protection, slim design for tight still wells, and NSF approval for new water facilities. They also feature some of the world’s premiere pressure transducers, made in Switzerland with extreme precision.
