Vendor (Source) Inspections
We specialize in equipment to be used in the high-purity industries.
Whether your business is biotechnology, pharmaceuticals or both, we train inspectors to understand the unique features of the your process equipment and components:
- Tubing, Fittings & Valves
- Code and Non-Code Vessels
- Glass Washers
- Filter Housings
- Agitators / Mixers
- Modules, e.g. Clean-In-Place (CIP), Water-For-Injection (WFI), Fermentation and Bioreactor skids
- Transfer and Penetration Panels
- Heat Exchangers
- Valve Manifolds
- Spray Ball
What we provide:
- Coordinate pre-inspection meetings between the end-users, vendors and the engineering firm.
- Help identify the equipment which should be inspected and factory acceptance tested at vendors' facilities.
- Serve as a single point of contact between the end0user and the engineering firm to monitor the progress of the equipment fabrication.
- Schedule in-progress and/or final inspections.
- Supply inspectors only when equipment is ready to be inspected, doing the leg work for the engineering company and saving the end-user time and money.
- Document the inspection in a format that can be leveraged for commissioning and qualification.
- Complete owner IQ documentation at suppliers' facilities.
- Mark-up vendor drawings to identify compliant and non-compliant items.
- Generate Inspection Release Certificates showing that the equipment has passed inspection and is ready to be shipped to the end-user.
- Review vendor turnover packages to ensure that all required documentation has been provided by the vendor.
- Archive inspection documentation as a backup for the engineering firm or end-user.
In addition, we can oversee factory acceptance testing, including:
- Spray-ball coverage
All inspectors are American Society of Nondestructive Testing Level II Visual Testing certified. Our inspectors recieve additional classroom and on-the-job training per equipment category.
- Purity Systems, Inc. has more than 25 years experience in the high-purity inspection industry.
- Our inspection is backed up with an experienced training and support staff with extensive knowledge of:
- The ASME BPE Standard
- Fabrication Process
- GMP Requirements
- Commissioning & Qualification Requirements