ASME BPE:2007 pdf free download

ASME BPE:2007 pdf free download.Bioprocessing Equipment.
(b) Tank plates that support bottom-mounted magnetically-driven mixers shall not interfere with drainage of the vessel.
(c) When an application mandates the use of steady/foot bearings, design features and/or procedures are required to ensure cleanability (e.g., drain holes, spray ball and/or wand additions, increased CII’ flow, operating the steady bearing immersed in CIP fluid).
(d) Shaft-steady bearings, where used, shall not interfere with the drainage of the vessel.
(e) Shaft-steady bearing pedestal support members may be of solid or hollow construction. Hollow pedestal supports, if used, shall be of sealed (welded) construction, inspected for integrit and accepted per criteria given in Part MJ after installation.
‘f) Magnetically-driven mixers require design features and/or procedures to ensure cleanability (e.g., drain holes, spray ball and/or wand additions, increased Cli’ flow, operating the agitator with the magnetically-driven impeller immersed in CIP fluid).
(g) The arrangement of wear surfaces (bushing, shaft, or shaft sleeve) shall facilitate drainage.
SD-4.8.6 Mechanical Seals
(a) Mechanical shaft seals shall incorporate design features for drainabilit’ surface finish, material of construction, etc., as outlined in Part SD, and shall be suitable for the application (e.g., Process, CIP, SIP. Passivation).
(b) Normal operation of a mechanical seal generates particulate debris. It is the responsibility of the end-user to establish complaince with applicable standards (e.g., UISP limits for particulate material in inectables) as appropriate.
(c) Seal debris wells or traps (see Fig. SD-21-6) may be used to prevent ingress of seal face wear particles that could contaminate the process fluid.
(e) Refer to Part SC of this Standard for specific seal design details.
SD-4.9 Heat Exchange Equipment
SD-4.9.1 General
(a) Straight tube heat exchangers are easier to clean and inspect. The tubes can be seamless or full-finish welded, as specified by the owner/user or manufacturer.
(b) The heat exchanger product and non-product contact surface inspection shall be possible by conventional means.
(g) Thermostatic steam traps, installed in vertical trap legs, are preferred for use in clean steam systems (see Fig. SD-22-3).
(h) Trap operation/reactivity should be improved by the installation of an uninsulated section of tubing upstream of the trap Isuggested 12 in. (30 cm) as recommended by supplierJ (see Fig. SD-22-2).
SD-4.1L4 Compendial Water Systems
(a) Compendial water systems, such as USP Grade Water-for-lnection (WFI), USI’ Grade l’urified Water, and Highly Purified Water, should be designed as looped circulatory systems, rather than noncirculating, dead-ended, branched systems.
(&) Loops shall he designed to provide fully developed turbulent flow in the circulating sections, and prevent stagnation in any branches.
SD-4.115 Point-of-Use Piping Design for Compendlal Water Systems. Point-of-use (l’OU) can be defined as a location in a compendial water loop where water is accessed for the purpose of processing and/or sampling. Typically, the point-of-use assemblies are comprised of the following elements:
(a) piping associated with a compendial water loop at the physical P013; and
(1) P013 valves, equipment, and instruments.
Additional process components and equipment may be added to satisfy application and/or system requirements and will be discussed further in this Part (see Fig. SD-23).
SD-4 11.6 Critical Design Criteria for Point-of-Use Assemblies
(a) All P013 assemblies will be designed to optimize drainahility through the P013 valve.
(b) Assemblies will be designed to promote the ability to dr. SIP, and/or purge with clean gasses.