EPIC performs detailed documentation and validation of all our hygienic systems as a part of our larger design/build process. Our protocols ensure that all the appropriate best practices and regulations for sanitary and hygienic process skids were followed, and your system will pass validation and documentation requirements upon startup.
We begin every project with a stringent review of applicable standards, regulations and quality assurance concerns. Coming out of this review, we develop the following:
- A detailed URS (User Requirement Specification) that outlines all procedures and standards for:
- Procuring equipment
- P&ID development
- Parts receiving and handling practices
- Fabrication QA guidelines
- QA audit procedures at every step of the process
- Design considerations for validation, including any applicable guidelines for:
- Cleaning Validations
- Pressure and liquid systems validation
- FDA records and validations
- System qualification protocols
- FDA validation of computer-controlled manufacturing equipment
Automation validation (medical and other)
- Fill system validation
- Electronic recordkeeping validation
- Signature system validation
- Risk assessments
- Analytical method validation
- All validation related equipment and instrumentation specifications such as:
- Purpose for the equipment
- Output and speed
- Quality standards
- Materials of construction
- Surface finish standards
- Sanitary valve types to used
- Required vendor documentation for parts acceptance
- Thoroughly outlined quality assurance procedures for each stage of the project and link in the material handling chain of custody
- Technical design standards documentation as part of a detailed design basis, for use during engineering design
- Fabrication QA checklists
- Piping expectations
- Correct slope tolerances
- No dead legs
- Correct minimum distances
- Proper ability to drain
- Acceptable materials of construction (MOC)
- Approved methods of fabrication (e.g., fully
- No tri-clamps can be used here!)
- Proper internal surface finish
- Typical QA design parameters
- Outline of your ETOP (Electronic Turnover Package) to be completed upon delivery of the system
- Piping expectations
Major Categories Covered by EPIC’s Validation Program
Each validation program and URS document are customized for individual projects, but some major areas we commonly cover include:
1. Sourcing Parts and Materials—The most important aspect of project management for passing validation is properly sourcing parts and materials and recording documentation about those sources. To ensure proper material sourcing, EPIC does the following.
a. Outlines strict procedures that dictate proper handling of all parts and materials, including documenting specific information from suppliers such as the source of every material and the required specifications that parts and materials must meet.
b. Acquires and organizes material tracking reports (MTR) with certificates of conformance (COC) for every part and raw material. This includes chemical composition details, and verification of those properties upon receipt through documented testing.
2. Shipping and Receiving—Once parts have been ordered, we take responsibility for ensuring proper handling from supplier to installation at your site. This includes:
a. Carefully logging all documentation upon receipt for reference and validation throughout the project.
b. Reviewing all shipping and handling procedures to verify proper handling during shipment, upon receipt, in storage, and during installation.
c. When parts arrive at EPIC, using a standardized system to identify and catalog all parts and accompanying documentation, verify mill test report (MTR) and log the part for tracking
d. Providing clean, organized conditions for parts and material storage that helps ensure the integrity and quality of the materials.
3. Design Reviews—We conduct regular, formal design reviews throughout the project with all engineering and quality assurance professionals on both our team and yours. Major stages that usually involve a design review are during project scoping, before final project plan sign-off by the customer, and at the conclusion of detailed design. Every review includes the design basis, all technical design documents, and all documented procedures.
Once the hygienic skid fabrication begins, at least three additional audits are conducted to eliminate mistakes and review documentation. During these reviews, we use the URS as our authoritative guide to ensure we are properly following and documenting the project. Examples of things we might review include:
- Proper equipment and materials sorting—we review equipment lists, brands, serial numbers, types and properties
- Piping and Instrumentation Diagrams (P&ID’s)—are slope ratios properly documented and have they been followed?
- QA forms—are we properly recording details such as part handler name, percentage of oxygen used during welding, and internal finish verification?
4. Fabrication and Assembly—The fabrication and assembly process follow agreed upon procedures and all important aspects are thoroughly documented. Figure 1a shows an example of a QA log we use during this stage of the process. Major elements of properly documenting fabrication for validation include:
- Establishing a procedure that documents and ensures all parts are materials are approved for use, fabricated, welded, and tested correctly.
- Having a third-party Level-2 certified welding inspector (CWI) inspect all welds
- Thoroughly documenting all in-house welding activity, such as: welder’s name, when the weld was performed, what materials were used, weld procedure performed, who inspected the weld, etc.
- Assembly documentation. Ex. The type of gaskets used, their location on the process equipment, the date installed, and a post-assembly audit of all joints verifying correct gaskets are present.
- Fabrication validation, referencing back to design documents. For example, checking all slopes, internal finishes, and other specifications were actually achieved during fabrication and verified before shipment.
5. Project Documentation—Along with proper validation, we also include full documentation with every hygienic process skid, including but not limited to:
iii. Data Sheets
iv. Procedural and functional specifications
v. Labels and Lists
vi. Assurance plans
vii. Project specifications
viii. Software specifications
x. Data logs/reports
xi. Check-out checklists and procedures
xii. Test results
xiii. Instruction manuals
xiv. Operator Manuals
xv. And more
If your custom project requires any additional documentation, we will work closely with you to make sure your needs are met.
At the completion and successful startup of your new sanitary or hygienic skid, we provide a fully completed ETOP (Electronic Turnover Package). We also offer on-going support should you need it, from additional operator training to future system expansion planning.