Process Design of Sanitary and Hygienic Process Systems
EPIC utilizes an isolated hygienic fabrication shop and a team of highly experienced engineers to design, build and validate hygienic process systems. From the first design stages through equipment selection, fabrication, installation and startup, EPIC is committed to properly validating process systems that will meet all applicable standards for years to come.
When validating hygienic process systems, EPIC considers the following: proper slope & drainage, microbial elimination, FDA requirements, IQ/OQ standards, 3-A, USDA, cGMP, ASME 9U&R), BPE, API standards.
Hygienic Process System Examples
EPIC designed and fabricated ten sanitary process systems for a multinational pharmaceutical company that recently announced a $2-billion expansion of their medicine-manufacturing operations. EPIC provided design-build services for two solvent recovery hygienic process systems and eight mixing sanitary process systems. All sanitary and hygienic process systems were designed at EPIC and subsequently fabricated, inspected and Factory Acceptance Tested (FAT) in EPIC’s isolated sanitary fabrication shop.
- Key Features: special consideration was given to ASME BPE requirements, materials of construction, traceability, inspection and physical design restrictions.
EPIC designed an automated process to assemble medical devices without human interaction. Our team handled the 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
This project posed the unique challenge of re-engineering 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
Advantages of Working With EPIC
The advantages EPIC brings to any sanitary or hygienic process systems project include:
- Experienced sanitary process engineers – We’ve worked as integrators and clients in hygienic manufacturing environments, giving us a better understanding of the complex chemical interactions involved in your process.
- A dedicated sanitary fabrication shop – Built to fabricate hygienic and sanitary process equipment, our shop is staffed with a team of skilled craftsmen who deliver high-quality work in a controlled manufacturing environment.
- An in-house quality team – Our QA 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.
- Thorough specification & documentation process – We ensure a safe, quality system ready for validation covering everything from welds to electrical wiring.
- Proven solutions & a design-build process – This means your process systems maintain tightly specified recipes during production and the high-quality standards expected by the FDA and other regulatory bodies.
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:
- Detailed project specification
- Front-End Engineering Design & Detailed Quotation
- Detailed Design
- Controls Engineering
- Fabrication & Assembly
- Validation & Documentation
- Startup & Commissioning
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)
- 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
Hygienic Process Systems
- Batching mixing and blending systems
- Formulation systems
- Bulk pasteurization
- Clean-In-Place (CIP) systems
- Clean-Out-of-Place (COP systems)
- Components and finishing
- Continuous mixing or blending systems
- Agitation systems
- Formulation systems
- Heat transfer
- High-purity piping
- HTST (High Temperature Short Time)
- In-line blending systems
- Liquid biotech handling systems
- 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.
What Products Do 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
- Solids processing
- Liquids processing
- Suspensions & Emulsions
- Assays and reagents
- 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.