Core Automation is a total electrical engineering and process automation company with the proven ability to coordinate and integrate a wide range of requirements, capabilities and technologies to deliver the functionality your project requires. Whether you want to quickly complete a single-discipline project or roll out an enterprise-wide automation, development, integration or validation program, the people of Core Automation can help you get it done right. How?
- Experience with what has worked in the past
- Implementation resources to rival even the largest technology vendors
- Deep experience in applying leading technologies in many industries
- A results-focused project management style that delivers projects on time and budget while keeping you fully informed on progress and problems
Core Automation works with clients on batch and continuous process projects ranging from a single loop to plant-wide systems. Many providers seek to gain your business, and then keep you captive. Not us. We build long-lasting relationships through a powerful commitment to your independence, steering clients away from any choice that leaves your future the hostage of any technology or vendor—including us. How? We do this by:
- Recommending the best available standards-based and open systems technology and components for your product, people, and program
- Delivering solutions you can support in-house or elsewhere if you choose
- Transferring all knowledge, documentation and technology used in your project
With our fabrication facility strategically located in Central Northern California (Sacramento) and many years of experience, Core Automation is the leader in the panel building business. Core Automation sets the industry standards with its UL, C/UL and ISO compliant Quality Assurance program.
Our engineers and designers apply their extensive experience to turn contract plans and specifications into detailed designs incorporating all the codes and requirements associated with the NEC and UL508A certification. We incorporate our standard designs whenever possible to provide a value-engineered solution. In many instances this results in a more robust design than the contract plans and specifications call for. Of course we also work from conceptual narratives and provide the same value-based solutions by drawing on our experience and applying our design standards. Our engineers can provide detailed equipment designs for all aspects of electrical supply from service entrance (Transformers, Switchgear, Motor Control Centers) to detailed control (Process and Analytical Instrumentation definition and selection, PLC/RTU Control Panel design.
From design to fabrication to Quality Assurance, our attention to details and “get it right the first time” approach ensures that your job will be delivered on schedule and within budget. Whether your project is a PLC, motor control panel, operator interface station or a control console; when it comes to control panel fabrication, there is a difference – the Core difference.
- We Listen – Our goal is to understand your project and how it relates to your facility. We analyze the engineering to verify the design will work and offer enhancements based on your years of experience. Our major emphasis is on operational requirements and maintenance support. Your result is an “intelligent” panel – easy to operate – simple to maintain.
- We Attend To The Details – It’s more than beauty. Our attention to detail from heat-shrink protection on multi-conductor cable to computer printed terminal markers and interior labels, is your assurance of quality. This attention to detail blended with craftsmanship makes a Core Automation panel easy to maintain and maximizes your productivity.
- We Get It Right The First Time – Your control system will be delivered on time, ready to run the operation for which it was designed. We ensure that the prints are correct before they are released for fabrication. Quality control is achieved by testing each system, by different technicians, before it ships. In this manner, your installation and start-up time will be accomplished in the shortest period possible. We recognize your time is money.
You rely on instruments that measure a multitude of process variables and provide you with feedback on how your system is operating. If those instruments are misapplied, poorly installed, out of calibration, or unreliable, you know it can lead to serious operational problems and costs. Those same instruments are also crucial to the proper function of your control systems.
Core Automation was built by skilled engineers, control system programmers, and technicians who have many years of industrial field experience. We’ve worked in water plants, pump stations, manufacturing facilities, semiconductor fabrication plants, and the mining and power generation industries. We know what works, and we have been hired by our clients to replace systems that did not.
Ensure Maximum Availability. While no system is available 100 percent of the time, we design efficient, reliable instrumentation and control systems that enable increased availability. To prevent against potentially crippling power surges and lightning strikes, our designs include redundancy and surge protection to help keep your facility running.
Minimize Repair Costs. Our well-designed redundancy and surge protection measures help to minimize the cost of repairs when destructive forces strike your system. Plus, we prepare well-documented drawings so you can easily maintain your systems now and in the future.
Validation. Automation. Implementation and Commissioning. Integration. For pharmaceutical and biotechnology managers seeking a production improvement partner that truly knows your business, Core Automation offers a full toolbox of proven automation resources, project management skills and a get-it-done attitude difficult to duplicate elsewhere.
- Experience. More than a decade of engineering and implementing production automation projects of all sizes and types for leading pharmaceutical and biotechnology companies.
- Comprehensiveness. Extensive and proven in-house controls, software development, information integration and validation resources—and the culture and systems to apply them quickly to any project as new needs arise.
- Commitment. To being effective and efficient; to independence, placing your best interest above all others; to vision, to considering how today’s goals and efforts will impact the future.
With Core Automation on your team, you can go confidently from requirements to post-implementation audit. We make sure we understand the philosophies and objectives behind your specifications and how the current project fits into your overall needs, current systems and potential opportunities. And we back it up with world-class automation and integration capability, extensive validation experience and the proven ability to implement and support our work.
Validation and Automation Capabilities…
To meet the need of pharmaceutical companies for advanced validated process automation systems and services, Core Automation provides the following according to Good Automated Manufacturing Practice (GAMP) and other relevant guidelines and regulations:
- Initiating and moving projects from validation requirement development all the way to validated and functioning production
- Collaborating with your corporate or outside compliance resources to engineer and implement the systems you need to achieve your objectives
- Performing the individual engineering, documentation or implementation work you specify
Typical projects include: design and documentation, implementation, validation, process description, functional requirements, specification, implementation and integration.
Design for validatable processes requires knowledge of how things work in actual production. Every Core Automation project team is staffed by engineers with expertise in the processes used in pharmaceutical and biotechnology production. We know the equipment, we know the techniques, we know the steps, and we know the requirements.
The experience gained designing, implementing and supporting innovative solutions across many applications produces more effective designs for you. We can help you determine how to control your facility, then design systems that perform and are documentable.
We do better work when we can clearly see the people, processes and places for the project. Your staff is lean and time is precious. We want to gain quality information about your requirements in the most time-effective way. For these reasons, we make it a point to come to your facility, sit down with your engineers and other key staff and make sure we understand how you want your processes and projects to work. Only then will we begin to create process descriptions and functional specifications—almost always the most important documents in a project
Pharmaceutical and Biotech Design Services Include:
- User requirements specification
- Process descriptions
- Functional requirements specification
- Design of validatable control systems
- Programming standards development
In the highly regulated world of pharmaceutical and biotechnology production, documentation can easily consume 25 to 50 percent of the resources for any given project. Often, the documentation is a project unto itself. It is also something you cannot do without, as the best system in the world is unusable without proper documentation.
From user requirements to qualification documents and every step between in the GAMP lifecycle, we shoulder the documentation load for clients. We understand for what each document is supposed to be used and what information goes in them. And we understand how managing early documentation steps can make later documentation validation easier to execute.
Documentation Services Include:
- Compliance analysis
- Quality and project plans
- Documentation for requirements, design, commissioning, validation and qualification
- User requirements specification
- Process descriptions and operators manuals
- Functional requirements specification
There are wishes. There are requirements. There are designs. There is engineering. And then there is making sure each piece of equipment, each step and each process, as well as the overall production scheme, works as described and designed.
This is commissioning.
Completed before handing the process over for the verification phase of validation, commissioning usually take months. With thousands of I/O points to check, millions of dollars of equipment to install and test and complex sequences to establish within specification performance, it can feel like years..
Equipment can be delivered behind schedule. Parts or functionality can be missing. Wiring can be misrouted. Code can need changes. Tweaks and adjustments are standard.
Some analyze. Some plan. Some design. Some engineer. Some implement. Some support. We do them all. We’ve always believed that living through the life cycle with what you engineer and install makes you a better provider. Such beginning-to-end-to-renewal insight (we’ve worked with many of our clients long enough to assist them with upgrading or replacing our previous work) is valuable during commissioning.
Commissioning Services Include:
- Validatable control system implementation (including complex batch integration)
- Factory acceptance test
- Site acceptance test
- Loop checks
- Customer software acceptance test
Our engineers are well versed in in the design of communication networks. Whether it’s a factory floor device level network, a peer to peer Ethernet network using microwave communication, or a licensed (FCC) wireless Wide Area Network (WAN), Core has the resources and manpower to achieve your goals.
We refer to them, our engineers, as network architects because of their ability to visualize robust networks and deliver solutions that incorporate the latest developments in technology. We provide wired and wireless solutions for varying types of data and varying throughput requirements. Our designs take into account future requirements such as video (for security).
Most process control systems require periodic preventative maintenance. Field instruments require service such as calibration, cleaning, purging, and replacing sensors and spent materials. SCADA system computers need their files backed up, hard drives de-fragmented, and internal cooling fans cleaned and dusted. Human Machine Interface software always has room for improvement, new trends and screens need to be created, and historical data and alarm logs need to be archived so valuable data is not lost forever. PLC programs often need to be modified and expanded when new equipment is added and when instruments are rescaled. For example, a PLC analog input scale needs to be adjusted to correctly execute logic based on analog inputs and setpoints. For these reasons, our clients rely on us to provide continuing support services to maintain their SCADA systems.
To provide continuing service to our clients, Core Automation offers control system support service contracts for scheduled and unscheduled maintenance. Rather than face the urgent problem of finding qualified technicians to repair hardware and software issues when the plant is down, it is more cost-effective and efficient to have Core Automation perform preventative maintenance to ensure facility optimization. A regular preventative maintenance program may help identify potential problems before they grow into serious system failures.
Customized Preventive Maintenance and Annual Support Services Plans
A critical system failure that shuts down plant operations is not the time to begin seeking qualified and costly hardware and software technicians. Let Core Automation provide a preventive maintenance program to tackle problems before they grow into serious system failures. We offer a cost-effective support service contract to provide the following scheduled and unscheduled maintenance activities:
- Field Instruments: Perform calibration, cleaning, purging, and replacement of sensors and spent materials.
- SCADA System Computers: Complete file backups, defragment hard drives, clean and dust internal cooling fans and motherboards.
- Human-Machine Interface Software: Perform ongoing improvements and create new screens and process variable trends; archive valuable historical data and alarm logs.
- PLC Programs: Modify and expand when new equipment is added and when instruments are rescaled. For example, a PLC analog input scale needs to be adjusted to execute logic correctly based on analog inputs and setpoints.
Water distribution and flood/wastewater collection and conditioning are an integral part of every community’s well-being. With so much at stake, monitoring and control of plant operations can never be taken lightly. Your system needs to operate worry free, without interruption, while providing an optimum return on your investment. Core Automation provides detailed SCADA strategies and architecture services for our clients.
We listen to your needs. Through coordination with you and your staff, we will determine your key requirements and design a safe, cost-effective, and reliable solution for monitoring and controlling your water distribution, floodwater collection, and wastewater collection and treatment systems.
When you hire Core Automation, you gain access to a vast resource pool of professionals with decades of experience in telemetry applications. We specialize in wireless communication systems for your remote monitoring and control needs. With our custom designed wireless systems, you no longer need to be at your computer terminal to monitor your SCADA system. We can create a mobile wireless SCADA system that allows you to move freely around your plant, city, state, or even around the world, and still stay in contact with your process using your laptop or palmtop computer.
- Improve Reliability. Our designs focus on providing primary and backup monitoring and control around the clock. Our SCADA system designs can provide you with early detection of impending equipment failures, protection against operational errors, and timely notification of process problems.
- Decrease Costs. We design centralized SCADA solutions that help you significantly reduce operation and maintenance costs by requiring fewer personnel to monitor field activity, and fewer daily maintenance trips. A well
automated process can free your operators to do more preventive maintenance, which may extend the life of your equipment, reduce lifecycle costs, and increase the quality of your finished product.
- Protect Existing Investments. We strive to devise solutions that help you make the most of your investments in plant operations. Whenever possible, we consider your future when designing a SCADA system, making sure to incorporate a migration path that will enable you to meet growing population and regulatory demands. We give system security a high priority to ensure your SCADA system is protected from unauthorized access. We will work closely with your IT staff to coordinate the network administration needed to limit system access to only those individuals you designate
Creating effective PLC and HMI (human-machine interface) solutions requires a clear understanding of available technologies, a plant’s processes, and the regulations under which it operates. Core Automation draws on its experience in all three of these areas to develop a highly effective solutions that fit your needs.
Our specialty is in developing solutions with an eye toward your future. By integrating a variety of vendor’s software and hardware, we will provide a stable system that meets your needs today with the flexibility to accommodate emerging requirements.
Core Automation programmers are trained and certified to program a wide variety of PLC and HMI software. We’ve developed a huge library of tried and tested program elements for controlling a wide variety of control systems. Our library of logic allows us to create programs more efficiently, and then test them in our offices before we deploy them in the field. This combination of program building blocks, and simulation testing before deployment helps us to dramatically reduce the startup and debugging time in the field. It also helps to ensure that your project starts up on time, and your control system will be dependable from the start.
Biotechnology and Pharmaceutical Automation Validation
When it comes to validation, there is no winging it. To create documented verification that a process will produce per the predefined specification, you have to know how to execute fully validatable designs.
You have to know in advance that what you describe will function as detailed. And there are plenty of details to cover. Validation impacts practically every area and phase of an automation project for pharmaceutical and biotechnology companies.
In executing large and small scale projects for some of the world’s leading pharmaceutical and biotechnology companies during the last decade, we’ve became validation savvy. We work with your validation requirements and staff to produce the validatable systems, descriptions and documents you need to move your project forward. And as the requirements call for the creation of significant amounts of documentation, it also helps to know how early steps can make ongoing validation documentation easier to execute.
We base the engineering effort required to create validation protocols and documents on the GAMP guidelines, our validation experience and the clients’ method for validation. These documents incorporate the requirement, design, implementation and test and verification phases. The documents that make up these phases will ensure validation compliance of the completed system implementation. They include:
- Requirements Specification
- Quality and Project Plan
- Functional Specification
- Design Specification
- Test Protocols (Development, FAT, SAT)
- Qualifications (IQ, OQ, PQ)
Complete Validation Services Include…
- Verification and qualification documentation
- Verification and qualification execution
Requirements Specification (RS)…
The Requirements Specification (RS) defines what the system is supposed to do as determined by the user. It defines the functions to be carried out, the data on which the system will operate and the operating environment. The RS also defines any non-functional requirements including constraints such as time and costs and what deliverables are to be supplied. The emphasis is on the required functions and not the method of implementing those functions.
Core Automation can provide support in creating these documents by meeting with the customer and understanding your needs and wants. From these meetings, Core Automation will create a GAMP compliant RS document suitable for the user to distribute for peer review and ultimately for bid packages.
Quality and Project Plan…
This document provides direction and focus for execution of the project. Per the GAMP guidelines, this document defines how Core Automation will meet the user quality requirements. It defines the project activities to be performed, timing, who will perform each activity, the control mechanisms to be used and the deliverable items. This document helps define how all the documentation requirements for the project will be met and leveraged from task to task. For example, possibly using the design specification for the bases of the field acceptance test protocol will be resolved in this document.
Functional Specification (FS)…
The functional specification defines what the system will do based on the RS. The importance of the FS cannot be understated. It is the basis for design for the entire system and drives the focus for the design specification
Design Specification (DS)…
The design specification provides a technical description of how functionality described in the FS will be implemented. This document will be the leading document used by project engineers to implement the control strategies. Details on alarms, interlocks, control modules, regulatory control and batch control are defined using tables and flow diagrams. Traceability between the FS and DS may be in the form of the traceability matrix described above or via a template that matches the FS and DS documents.
Three (3) specific areas of testing are required to demonstrate implemented design conforms to the requirements of the FS and DS. Test protocols require thoroughly testing the software structurally and functionally with sign-offs and expected results. These tests include the following:
- Development Testing – This testing is done by Core Automation without a customer witness to help discover and fix any errors before the FAT. Typically, the test document to be used for the FAT is used in this testing to make sure the system is ready for customer review.
- Field Acceptance Testing (FAT) – The FAT is typically completed at Core Automation with all the I/O simulated. This form of testing will ensure the software complies with the requirements. If the FAT is performed at a skid vendor’s site where the equipment is available, the testing will include instrumentation with less process simulation. Many times the items tested at FAT undisturbed for shipping to the site will not require SAT.
- Site Acceptance Testing (SAT) – The SAT is usually the first time when the software interacts with all the equipment. Typically the SAT repeats the FAT. Once again the test documents will require sign-offs and expected results.
Core Automation writes and executes qualification protocols. Qualification activities formally verify the suitability of the system for use in the user’s facility. The qualification process is made up of the following components:
- Installation Qualification – The IQ will formally verify the software is properly loaded, hardware installed correctly, instrumentation installed and calibrated correctly and basic system functions operate on power-up.
- Operational Qualification – The purpose of the OQ is to demonstrate conformance to the FS by testing under normal operating conditions and abnormal conditions as required.
- Performance Qualification – The PQ demonstrates system requirements have been met and the system is capable of performing the activities according to the RS while operating in its specified operating environment.
These days, no system or process stands alone. At least, not if your goals are to be efficient, responsive, flexible and competitive or if you are looking for opportunities and possibilities.
In the world of our clients, integration has moved beyond merely connecting things to using information to keep your systems available, measure performance and results in real time and improve communications and interaction with customers, suppliers and top management.
Possibilities include using information to:
- Improve process compliance
- Support integrated HMI historical data process control
- Provide operators and supervisory personnel with relevant real-time information as key processes are produced
- Maintain complete and accurate records of process and quality data
- Summarize production reporting using automated reports
- Measure overall performance, including availability, throughput and quality
- Increase availability and reduce maintenance costs by tracking actual equipment use, performance and wear