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Solutions > Pharmaceutical
 

To meet the growing challenges of today’s increasingly complex pharmaceutical, specialty chemical and biotechnology industries; Applitech’s experienced system engineers have designed & commissioned a wide range of customized S88 Compliant Batch and Continuous Process Control Systems. Our advanced control system designs have been installed in many large pharmaceutical production facilities to insure absolute product quality & full compliance with detailed FDA regulations. In addition, our highly flexible automation platforms have been instrumental in reducing the time to market for several new bio-technology products and because of the inherent need to support a wide variety of process formulations, each process control system is specifically designed to easily adapt to support rapidly evolving technology advancements.
From the conceptual design of our first industrial control system, Applitech has always utilized non-proprietary, open systems architectures for our automated batch and continuous process control. The ANSI/ISA-88 (S88) compliant control systems designed by Applitech’s experienced control engineers have been extremely effective in the implementation of automation strategies to sustain flexible cGMP operations not only in batch, but also in discrete and continuous industries.

Over the past 10 years, the modular structure and standard terminology of S88 compliant systems has proven to significantly improve plant-wide communications between product engineering, plant personnel and equipment vendors. Applitech’s strict implementation of S88 has always resulted in more effective control system installations at a minimum total cost of ownership. In addition, each of our customized system designs are optimized to assure ease of service, support, and future upgrades to meet changing market requirements.

Our principal batch S88 and process control system applications has been developed for pharmaceutical, chemical, biotech, industrial building automation (including clean room, HVAC, & utility system controls), and municipal water/wastewater treatment projects. In addition, most of our DeltaV, iBatch, & other S88 installations were batch operations, which required full FDA validation and compliance with 21CFR Part 11 Electronic Records/Electronic Signature regulations.

Technical Background and Project Management:

  • Applitech’s typical project responsibilities include initial engineering, electrical and field instrumentation design, control panel fabrication, system configuration, loop checkout/tests, and commissioning/start-up.
  • Our professional system engineer’s have extensive design experience with both S88 Batch and Continuous Process Control, using the latest application software, PLC/DCS hardware, field instruments and advanced I/O networks.
  • Applitech has a library of over 75 custom pre-configured, programmed, field tested, and validated Delta V batch phases to implement a wide variety of complicated process control operations. Our system engineers provide detailed documentation for these phases, including comprehensive validation protocols and testing procedures for cGMP processes.
  • As part of our standard project management cycle; Applitech generates a comprehensive Functional Requirement Specification (FRS) for each of our clients, which outlines the overall batch automation strategy, identifies specific phase/control module operations and defines the phase input/report parameters.
  • Our advanced system configuration expertise includes the setup of Thin Client Networks, multiple Batch Application Servers, and remote access capability via Virtual Private Networks (VPN).
  • To receive & transmit control data from third party support utilities and process skids (which are controlled by a wide variety of PLC’s including Allen-Bradley, Modicon and others); Applitech has designed and programmed complex industrial procedures using standardized batch software functions.

  • Applitech engineers have implemented complex field I/O networks with multiple ASI, Profibus, Fieldbus, DeviceNet, and Serial I/O protocols.
  • Installed, tested, and verified numerous physical control networks; including fiberoptic Ethernet, multi-drop RS-485 PLC networks, wide-area PC networks, and numerous Field Communications Bus technologies.
  • Our system programmers provided extensive self-diagnostic and field troubleshooting/ support/ troubleshooting tools using advanced Historical Data Collection programs & Trending modules (with data extracted from the PI Historian Database).
  • Designed/programmed customized analytical tools for each of our clients by creating customized Access & SQL report queries to extract critical report data from the Delta V Batch Historian Database. This data is then formatted to meet each customer’s specific production tracking, quality control, and historical record keeping requirements.
Applitech’s extensive pharmaceutical control system experience & project management background assures our customers that their project will be completed using proven state-of-the-art system designs, on schedule and within your planned budget costs.