ASME BPE-2007 pdf free download.Bioprocessing Equipment.
– (c) The elevation of the pan should lake into account the clearance required for the Jumper drain valve position when a connection is made to the bottom row of nozzles. The pan should extend honzontally to accommodate the furthest connection and/or drain point from the face of the panel.
SD-4.16.6 Proximity Switches
Proiumity switches are used to detect the presence or absence of a jumper with a stem positioned between selected nozzles.
(b) The use of magnetic proximity switches, which are mounted behind the panel structure avoiding the need to penetrate the panel face, are preferred. This elimination of structural penetration will remove an unnecessary cracks, crevices, or threads at the point of attachment, thus removing the risk of product entrapment and/or sterility concerns.
(c) Jumpers will contain a magnetic stem to activate the corresponding proximity switch The use of a ferrous magnetic material is required; huwevet it must be fully encapsulated to ensure that the ferrous material does not contaminate the classified manufacturing area. Attention shall be paid to the weld between the sensor stem and the jumper.
(d) The magnet should be of sufficient gauss rating to properly activate the corresponding proximity switch. In addition, the temperature rating of the magnet should withstand the specified temperature ranges for process and sterilization without compromising the magnet perforniance.
(e) The proximity switch mounting shall be of hygienic design and structurally sound to maintain the specified design location,
All testing shall be performed using systems that avoid surface contamination of the equipment.
There are two tvpesol testing and quality assurances performed: performance/calibration and sterility cleaning. All testing and quality assurance docunwntation will he stamped with date and time. For each test documentation sheet, signatures of the test personnel and a supervisor shall be required, confirming the test results.
Thc test shall be performed by spraying a dye (e.g., riboflavin) on the entire interior of the equipment productlprocess contact walls, nozzles, and miscellaneous surfaces. The test may be performed with ambient temperature waler and before the riboflavin dye has dried, This test will confirm coverage of the sprayhalls. but may not verily cleanabilit Cleanability should be checked using the lull CIP protocol at the facility where the vessel is installed including cleansers and temperatures. Water used for the following nnse shall meet the requirements of SD-5.3:
(a) pressure
(b) flow (per spray device)
(c) burst duration and delay sequence between bursts
Acceptance shall be determined when all (100%) of the dye has been removed via the rinse. This shall be visually determined using an ultraviolet lamp, or by other verification methods as agreed to by the owner/ user and manufacturer.
SD-5.2 Sterility/Cleaning Testing
Sterility and cleanability testing (other than spray ball testing) shall be as agreed to by the owner/user and manufacturer, arid in accordance with accepted industry standards.
SD-S.3 Hydrostatic Test
Where applicable, all product contact surlaces shall be hydrostatically tested with clean purified oc deionized water filtered at (1.2 m. If purified or deionized water is not available, then the water quality for testing shall be agreed toby the owner/user and manufacturer.
SD-5.4 Dralnability Test
A drainability test for vessels shall be conducted as agreed to by all parties. As a proposed test procedure. the following shall be considered. The bottom head of the vessel shall be leveled with the outlet nozzle flange face (to within a tolerance agreed to) and shall be filled approximately to the weld seam. The outlet valve shall be opened, and the vessel allowed to drain by gravity. There shall be no puddles 04 waler lelt on the bottom of the vessel greater than 5 mm in diameter (or as agreed to by the owner/user and manufacturer).