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Pharmaceutical Industry

Process Design and Fabrication of Sanitary Hygienic Systems

a line operator inspects a pharma-grade process systemWe offer both an isolated hygienic sanitary fabrication shop and a highly experienced engineering team for designing, building & validating highly sterile process systems. Proper slope & drainage, microbial elimination, FDA requirements, IQ/OQ standards, 3-A, USDA, cGMP, ASME 9U&R), BPE, API standards; all must be considered from the first design stages and correctly addressed throughout equipment selection, fabrication, installation, and startup to result in a properly validated system that will meet all applicable standards for years to come.

Our team handles design all the way through implementation, including a thorough checkout process, extensive documentation for certification approval, and sanitary considerations. The advantages EPIC brings to any sanitary hygienic process project include:

  • Highly experienced sanitary process engineers that have worked both on the client side in manufacturing environments and as integrators. Our project managers understand the complex chemical interactions involved in your process and apply practical manufacturing solutions that work right at start-up and allow for many years of compliance.
  • A dedicated sanitary fabrication shop built for fabricating hygienic sanitary equipment and systems. Our dedicated team of skilled craftsmen provide high quality work in a controlled manufacturing environment, and our off-site modular fabrication typically reduces product timelines by 40% while improving quality and safety.
  • Our in-house quality team inspects every weld and performs system testing before shipment. Our detailed green-tag process ensures every aspect of your project has been reviewed and meets all applicable quality standards.
  • A thorough specification & documentation process throughout the project for everything from welds to electrical wiring ensures a safe, quality system ready for validation.
  • Proven solutions & a design build process that means your systems maintain tightly specified recipes during production and the high quality standards expected by the FDA and other regulatory bodies.

Learn more about our hygienic sanitary system capabilities below or contact us (314) 845-0077 to start discussing your specific project.

What specifically can EPIC do for your sanitary hygienic system?

EPIC designs, automates and fabricates your custom sanitary process systems with decades of company experience and access to modular systems that get the job done efficiently and accurately. With a single point of contact to keep things moving forward, you will always feel in control as you move through the process.

We develop both batch and continuous systems through a proven development process that includes:

  1. Detailed project specification
  2. Front-End Engineering Design & Detailed Quotation
  3. Detailed Design
  4. Controls Engineering
  5. Fabrication & Assembly
  6. Installation
  7. Validation & Documentation
  8. Startup & Commissioning
  9. Training

During project development, we help you address challenges such as:

System design, including:

  • Optimal distributions and feed rates for raw materials using predictive models of unit operations
  • Optimal operating ranges to achieve product CQA through modeling of degradant formation & polymorphs and all other relevant chemical interactions
  • Modeling and calibration of internal process variables such as formula composition, particle size distributions, powder properties, heat transfer, slope-to-drain load, etc.
  • Development of practical controls strategies based on the range of expected manipulated variables, production risks, budget, and safety standards.
  • Refinement of product quality standards and sampling point baselines
  • Finite Elemental Analysis (FEA) upon request

Equipment selection, designed to:

  • Prevent cross contamination
  • Allow for optimal clean-in-place capabilities
  • Promote drainage and discourage bacterial/microbial growth
  • Handle the operating objectives and ranges for optimal process design
  • Meet your budget
  • Ingrate well with other equipment and the optimal controls strategy
  • Be highly accessible once installed

Hygienic fabrication to ensure:

  • No cross-contamination
  • No fabrication and assembly contamination
  • Inspected and guaranteed welds
  • Total drain-ability
  • Stainless steel, hygienic construction
  • No crevices or cavities
  • Dead leg elimination
  • 20 RA finish (when required)

Documentation, including:

  • Quantification of process uncertainties
  • Thorough explanation of risk of product failure for each design space
  • Design space methodology
  • Enterprise wide decision problems
  • MTR verification & PMI

 

Products We Work With

We work with sanitary hygienic products. Our full list of products we work with, please visit our sanitary processes page here.

Major categories of products we work with include:

  • Active ingredient production
  • Organic chemicals
  • Topicals – creams, lotions, ointments
  • Inhalables
  • Solids processing
  • Liquids processing
  • Suspensions & Emulsions
  • Antimicrobials
  • Detergents
  • Enzymes
  • Assays and reagents
  • Extracts
  • Medical devices
  • Infection control products
  • Edibles – Probiotics, Supplements, Nutrients, Syrups

We do not work with vaccines, pills, or some high-grade pharmaceutical products. For clarification in this area, please contact EPIC (314) 845-0077 to discuss your specific application.

The types of systems we work with are wide in scope and comprehensive, from engineering liquid biotech handling systems to designing automated processes for medical based assembly lines. We automate, engineer and implement pilot plant scale to production scale sanitary hygienic systems that include:

  • Batching mixing and blending systems
  • Formulation systems
  • Bio-reactors
  • Bio-storage
  • Blending
  • Bulk pasteurization
  • Chromatography
  • Clean-In-Place (CIP) systems
  • Clean-Out-of-Place (COP systems)
  • Components and finishing
  • Continuous mixing or blending systems
  • Agitation systems
  • Evaporation
  • Filtration
  • Formulation systems
  • Heat transfer
  • High-purity piping
  • HTST (High Temperature Short Time)
  • In-line blending systems
  • Liquid biotech handling systems
  • Malting
  • Medical device formation and assembly systems
  • Pharmaceutical ingredient delivery systems
  • Pilot plants
  • Portable transfer systems
  • Process modules
  • Process vessels
  • Purified water distribution
  • Purified water generation
  • Reactor systems
  • Sanitary dosing systems
  • Storage tanks and mix systems
  • Super skids
  • Tanks and Vessels
  • Transfer/utility Panels
  • Vacuum Liquid Processing Systems
  • Heat transfer
  • Waste treatment
  • Water for Injection Systems (WFI)
  • Water Purification Units (WPU)

Whether you need a semi-automated batching system or a continuous process systems, our team can help. Contact us to discuss your project or call (314) 845-0077 to talk with one of our sanitary process experts. 

Turnkey Medical Device Assembly Machine:

EPIC designed an automated process to assemble medical devices without human interaction. Our team handled design, assembly, transport, installation, and integration of the device into our client’s existing manufacturing ecosystem. The completed system assembled several parts of an injectable device into a complete unit in a fully automated hygienic assembly system.

  • Key features: Hygienic assembly and packaging for 20ppm, Custom rotary table, conveyors and loading stations, Custom air control system, machine vision inspection system

CIP System Industrial Automation System Design, Control Modification, & Expansion:

This project posed the unique challenge of reengineering a faulty control system while ensuring a pharmaceutical grade operating environment. EPIC handled the 8,000 pages worth of documentation, checkout process, and ad validation for the operating environment, and completely redesigned the control system. The result was a fully automated, highly efficient CIP system that increased productivity, corrected all control errors, and complied with FDA regulations.

  • Key features: 2 integrated clean-in-place systems, 3 Allen Bradley control panels, InBatch by WonderWare software, validation documentation
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EPIC Modular Process Systems
4134 Meramec Bottom Rd
St. Louis, MO 63129, US
(314) 845-0077