This specification outlines material, fabrication and testing for process vessels.
1.2 Responsibility
The manufacturer shall be responsible for the materials, workmanship, and
fabrication to specifications, if supplied.
The installer shall be responsible for the installation and protection against damage during installation.
2.0 CODES, SPECIFICATIONS AND STANDARDS
The fabrication, assembly, installation and operation of all sanitary process vessels shall be in accordance with, as of the date of this specification, applicable sections of the latest editions of the codes and standards referenced below.
ASME – The American Society of Mechanical Engineers, Boiler and Pressure Vessel Code, Section VIII Div. I, Section IX, and all sections referenced in these sections
ASME – BPE – The American Society of Mechanical Engineers, Bioprocessing Equipment
CGMP – Current Good Manufacturing Practices as proposed or approved by the Food and Drug Administration
3.0 SANITARY VESSEL SPECIFICATIONS
3.1 Sanitary Vessel Design
Process vessels will be manufacturered in accordance with this specification.
For all drug and drug related processes, the vessel will be of sanitary design, unless otherwise required by customer specifications, and will be constructed of 316L stainless steel product contact as a minimum. Other higher alloys may be used dependent upon the process.
All product contact surfaces shall be cleanable, free of hold-up areas, pockets and crevices. Drainability testing will conform to ASME BPE standards.
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Tank Manual Tri-clamp style sanitary fittings will be used on all product contact connections unless specified otherwise by customer-supplied specifications.
3.2 Sanitary Vessel Manufacture
All welding will be done in accordance with section IX of the ASME Boiler and Pressure vessel code as well as ASME BPE standards.
Joint efficiencies will be as follows:
a. 100% - 100% Radiography Required b. 85% - Spot Radiography Required c. 70% - No Radiography Required
All pressure testing shall be done in accordance with section VIII Div 1 of ASME code. Hydrostatic testing is preferred.
Final rinse water will be deionized water.
3.3 Sanitary Vessel Finishes
Finishes shall be specified by the user based on the process requirements. The preferred method of specifying finishes is with Ra or RMS since these can be measured. If a grit designation or number (i.e. #4) designation is used, an Ra or RMS will also be specified.
All specified finishes shall be prior to electropolishing. Electropolishing should not be
expected to improve the surface finish.
Polished surfaces shall be devoid of any defects as visible to unassisted eye. There are to be no crevices, pits, voids, dents, etc. per ASME BPE standards.
4.0 INSPECTIONS AND CERTIFICATIONS
The responsibility for inspection of the vessel rests solely with the manufacturer.
The manufacturer shall have a written Quality Control Procedure in place.
The purchaser reserves the right to inspect the vessel at any time during the manufacture with a minimum of 48 hours previous notice to manufacturer.
Upon request, the manufacturer shall submit to the purchaser for review certifications of pressure testing and finish.
5.0 INSTALLATION OF VESSELS
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Tank Manual 5.1 Connection Protectors & Caps
All vessel openings should be inspected for foreign material. Protective plugs and covers & caps should not be removed until just prior to installation. Shipping gaskets & O-rings should be replaced prior to placing vessel into service.
5.2 Cleaning Facilities
Convenient means should be provided for cleaning the vessel as suggested under "Maintenance of Vessels".
5.3 Fittings and Piping
5.3.1 By-pass Valves
By-pass valves in piping systems should be supplied in critical systems in order to provide ease of preventative maintenance, inspection, and repairs.
5.3.2 Vent filters
Vent filters may be provided so units can release vapor or gas as necessary. Special consideration must be given to discharge of hazardous or toxic fluids.
5.3.3 Safety Relief Devices
ASME Code defines the requirements for safety relief devices. When specified by the purchaser, the manufacturer will provide the necessary connections for the safety relief devices and will supply such devices if defined by purchaser. Otherwise, the purchaser will provide and install the required relief devices.
6.0 OPERATION OF VESSELS
6.1 Design and Operating Conditions
Vessels must not be operated at conditions that exceed those specified on the name plate(s).
6.2 Operating Procedures
Before placing any vessel in operation, reference should be made to the vessel drawings, pressure & temperature ratings, and the ASME data plate welded to the vessel. Local safety and health regulations must be considered. Improper start-up or shutdown sequences may cause damage to the vessel.
6.3 Start-up and Shut-down Guidelines
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Tank Manual Extremely cold or hot fluids or vapors should be introduced slowly into the vessel or vessel jacket (if applicable). Hot fluid must not be suddenly introduced when the vessel is cold, nor cold fluid suddenly introduced when the vessel is hot. This will help eliminate excessive thermal expansion and reduce the risk of damage to the vessel.
7.0 MAINTENANCE OF VESSELS
7.1 Inspection of Vessel
At regular intervals and as frequently as experience indicates, an examination should
be made of the interior and exterior condition of the vessel. Inspection of gasketed ports should be checked for possible replacement of the elastomers.
7.2 Cleaning of Vessel
The vessel surface should be kept reasonably clean to assure satisfactory
performance. Convenient means for cleaning should be made available. Vessels may be cleaned by either chemical or mechanical methods. The method selected must be the choice of the operator of the plant and will depend on the type of cleaning required and the facilities available in the plant. Cleaning methods normally performed for sanitary vessels are as follows:
a. CIP (Clean in Place)
b. SIP (Steam in Place) c. Mechanical cleaning (When mechanically cleaning a vessel, care should be exercised to avoid damage to the product contact surfaces.)
Cleaning should be performed to purchaser’s standard PM schedule based on vessel
use and service.
7.3 Disassembly for Inspection and Cleaning
Before disassembly, the user must confirm that the unit has been depressurized, vented and drained, neutralized and/or purged of hazardous material to avoid personal injury.
7.4 Gasket Replacement
Gaskets and gasket surfaces should be thoroughly cleaned and should be free of scratches and other defects. Gaskets should be properly positioned before attempting to retighten clamps or bolts.
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Tank Manual a. Composition gaskets can become dried out and brittle so that they do not always provide an effective seal when reused. b. Metal or metal-jacketed gaskets, when compressed initially, flow to match their contact surfaces. In so doing they are work hardened and, if reused, may provide an imperfect seal or result in deformation and damage to the gasket contact surfaces.
Replacement gaskets or O-rings should be purchased in the material originally
provided. Please refer to your vessel drawings and Bill of Materials for required size and elastomer composition. The sizes indicated are generally a standard part number that can be purchased through a local gasket distributor.
8.0 WARRANTY
Allegheny Bradford Corporation warrants the products manufactured by it against defects in
materials and workmanship when used in accordance with the applicable instructions for a period of one year from the date of shipment of the products. Allegheny Bradford Corporation makes no other warranty, expressed or implied. There is no warranty of merchantability or fitness for a particular purpose. The warranty provided herein and the data, specifications, and descriptions of ABC products appearing in ABC’s published catalogs and product literature may not be altered except by express written agreement signed by an officer of ABC. Representations, oral or written, which are inconsistent with this warranty or such publications are not authorized and if given, should not be relied upon.
In the event of a breach of the foregoing warranty, ABC’s sole obligation shall be to repair or replace, at its option, any product or part thereof that proves defective in materials or workmanship within the warranty period, provided the Customer notifies Allegheny Bradford Corporation promptly of any such defect. The exclusive remedy provided herein shall not be deemed to have failed of its essential purpose so long as ABC s willing and able to repair or replace, F.O.B. our plant, any nonconforming ABC product or part. ABC shall not be liable for consequential damages resulting from economic loss or property damages sustained by any Customer from the use of its products.
