SD-3.4.7 Internally cnated glass shall only be lsed if the coating complies with FDA or other regulatory authority and approved by uhe owner/user.
SD-3.5 Fabrication
SD-3.5.1 Fabrication shall be performed in facilites where the product contact surfaces are protected from contamination. Dnuring field welding and assembly, suitface contamination shall be prevented.
SD 3.5.2 Systems, equipment, and components shall be cleaned with a suitable cleaning agent and covered for protection before shipment. The use of preservative fluids is not recommended.
Any product contact surtaces that require shipment with preservatives or coatings should be:
(a) mutually agreed to. in advance. by the owner/user and manufacturer;
(b) clearly identifed to all parties; and
(c) in compliance with FDA or other applicabie regulations, as appropriate for the process.
SD-3.5.3 The use of blind welds in piping systems shall be avoided when posible. Proper installation sequencing of the piping system, in most cases, can eliminale Imust blind welds. See MJ-7.2.3 for further dctails.
SD-3.6 Static O-Rings, Seais, and Gaskets {See Fig. SD-1)
SD-3.6.1 Static seals (in piping, tubing. and similar fitings) should be designed with O-rings as the sealing elements. O-ring grooves should be shaped in accordance with the O-ring manufacturer recomumendation for functionality.
O ring groves should be designed with cleaning in mind without diminishing their functionality.
SD-3.6.2 Gaskels and O-ing seals generally should be flush with the interior surface of the pipeline or the cquipment.
SD-3.6.3 When 0-ring seals are used, they shall be set back SO the gap between sealing surfaces is as deep as it is wide to ensure flushing of the cavity atambient tempcraturc.
SD-3.6.4 All O-rings. seals, and gaskets in the product zones shall be compatible with the CIP cleaning media and sirilization leudia andi conditions (e.g.. stcam-resistant clastomcrs/fluorelastomers).