When evaluating a custom vessel manufacturing partner for a new project, consider the manufacturing capabilities and experience that support the vessel’s application and sanitary requirements.
All custom design stainless vessels for the food, life sciences, pharmaceutical and health industries require sanitary construction. It is the application and automation that drives the level of sanitary componentry.
In reviewing each new custom vessel project, Apache identifies the sanitary requirements to categorize the vessel into a base, mid- or high-level design. Apache offers a standard line of vessels that qualify for various regulatory compliance agencies. However, these designs are considered a base level sanitary design, especially because the cleaning of the equipment is manual. Apache identifies a mid-level sanitary design vessel as having COP (Clean Out of Place) components.
In the video, a custom vessel is animated to walk through characteristics and examples in the highest and most automated level of sanitary design custom vessels.
High-Level Sanitary Design Characteristics Include:
- CIP (Clean in Place) Process and Components
- Continuous, crack and crevice-free welds, ground flush and polished smooth to specific RA (Roughness Average) <32 RA
- 304 or 316 stainless material, mechanically finished to <32 RA
- Electropolished and Nitric passivated finishing
- Electropolished sanitary fittings, including:
- Tri-clamp ferrules
- Tube connections
- NA Connects
- Flush mount outlet valves
- Sight glasses
- Orbitally welded j-tubes
- Polished internal coils
- Samples Ports
- Spray devices
- Control panels
- External thermal jacketing
Processes and application in high-level sanitary design vessels include heating and cooling vessels, mixing and processing tanks, WFI tanks, filtering and R & D lab equipment.
Certification requirements is an important part of the sanitary design criteria. Sanitary design standards include:
3A – A regulation of the design for processing equipment in the food and drug industries. A 3A certificate is proof of FDA compliance.
ASME U and ASME UM – A regulation of the design of boilers and pressure vessels, including traceability of materials, procedures, testing and documentation.
BPE – A standard within ASME that drives equipment design for the bio-processing, pharmaceutical and other hygienic required industries.
In qualifying design, safety, automation other application details, Apache will facilitate the required compliance for the vessel and provide well communicated delivery, cost and approvals required for a successful project.