ASME BPE:2002 pdf free download.Bioprocessing Equipment.
SD-3.1.8 Design of corners and radi should meetthe foiiowing requirements:
Alil internal angles of 135 deg or less on productcontact surfaces shail have the maximum radius possiblefor case of clcanability. Whcrc possiblc,thesc surfaccsshall have radii of not less than in. (3.2 mn) exceptwhere required for functional reasons,such as thebonnet/body connection. For special cases,the radiimay be reduced to 1e in. (1.6 mm) when agreed toby the owner/user. When the ‘hi6in. (1.6 mm) radiicannot be achieved for essential functional reasons such
as fat sealing surfaces and flow control apcrtures. theproduct contact surfaces of these internai angles shaii
be readlily accessible for clearting and inspection.
sD-3.2 Sterility
sD-3.2.1While recognizing that there are variousmethods for equipment sterilization (see SD-2) thisStandard will refer only to steam sterilization.
SD-3.2.2Steam sterilizahle equipment parts andcomponents should withstand continuous flow of satu-rated steam at a minimum temperature of 266°F(130°C)for a duration of 100 hr minimun under continuoussteady-state conditions. However,at the discretion ofthe owncrluscr,conditions that are morc stringent maybe imposed. The use of elastomers!fuorelastomers(within a piece of equipment) that may thermally de-grade during sterilization will need to be thoroughlyinvestigated by the owner/user or manufacturer. Theoverall life of the equipment may be shortened significantiy if the correct elastoner is not selected.
SD-3.2.3 All product contact surfaces shall reachthe required temperatures during the steam steriliza-tion cycle.
sD-3.3 Surface Finishes
sD-3.3.1 The finishes of product contact surfacesshall be specified by the owner/user in accordance with the defnitions of Part SF in this Standard.
SD-3.4 Materiais of Construction
SD-3.4.1 Materials of construction should be capableof withstanding the temperature,pressure, and chemicalcorrosiveness assuring the purity and integrity of theproduct. Generaily.materiais such as 316.316L. stain-less steels，or higher grade naterials (AL6XN，2205,etc.) have been acceptable.Te owner/user should bercsponsiblc for the selection of the appropriate materialsof construction for the spccific proccas.
sD-3.4.2 When nonmetallic materials are used (e.g..plastics,elastoLers，oradhesives),the owner shallspccify which one of thcse materials should carry a
ccrtificate of compliancc.”The conformance of materialshould be explicity stated (e.g.,conforning to FDA,
21CFR,177, and UsP 24 Class vD.
SD-3.4.3 Materials shall be compatible with thestated bioprocessing conditions,cleaning solutions,and
sterilizing conditions,ctc.,as specified by the ownerluscr.
sD-3.4.4Cladi or electropiated surface coatings,plating,and surface preparaiory chenicals may beused provided approval from the owneruser has becnobtained. All surface coatings shall remain intact andbe tolerant to the process, SIP andCPfluids,andtemperatures,without pecling or cracking.
Surfaces exposed to bioprocessing fluids,cleaningand sterilizing conditions must be:
(a) homogeneous in nature;
(b) impervious;
(c) inert;
(d ) nonabsorbent;
(e) nontoxic;
insoluble by prncess or cleaning fluids; andigresistant to corrosion，scratching, scoring. anddistortion.
sD-3.4.5 Materials that are in contact with bio-processing fluids shall be identified by an industryrecognized standard (sec GR-9).
sD-3.4.6 Transparcnt matcrials (e.g.， glass,borosili-cate) that are used in vicwing ports should bcscratchproof，impervious,inert,and nontoxic and berated for the applicable pressure and temperature.
ASME BPE:2002 pdf free download
