KS J 0013-2006 Biotechnology-equipment-Guidance on testing procedures for leaktightness《生命工程装备的泄露试验顺序指南书》.pdf

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1、KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS 2006 12 18 http:/www.kats.go.krKS J 0013 KS J 0013: 2006 (2011 ) J 0013: 2006 : ( ) ( ) KT&G ( ) : (http:/www.standard.go.kr) : :2006 12 18 :2011 12 29 2011-0646 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . ICS 07.100.00 KS J 0013: 2006(2011 ) Biotech

2、nology-equipment Guidance on testing procedures for leaktightness 1. ( ) . , , , , . 2. . 2.1 , . 2.2 () 2.3 () / 2.4 2.5 2.6 2.7 ( ) EEC/90/679 , , , 2.8 2.9 / . 2.10 3. 3.1 , , . A . 1. 1 . , / . 2. , . . . J 0013: 2006 2 . , . / , . . , , , . 3. . . . 4. . 5. 12, 13, 14, 15 . 3.2 ( A B ). a) . b)

3、 . c) . . 3.3 . a) . b) 3.2 . c) 3.2 . d) 3.2 . e) . f) . 3.4 . . . 3.5 3.5.1 , 3.5.1.1 3.5.1.2 . 3.5.1.1 . a) ( ) b) c) d) e) 3.5.1.2 . a) . b) . c) . J 0013: 2006 3 d) . e) . Behizad et al.( 3 ) Griffiths & DeCosemo( 4 ) . 3.5.2 (swabbing contact plates ) . . . . 3.6 . . . ( B ). a) , , SF6(sulphu

4、r hexafluoride) b) c) ( ) d) e) f) 4. / . ( , ) . J 0013: 2006 4 A() A.1 A.1 A.4 . . A.1 . . BATNEEC(Best Available Technique Not Entailing Excessive Costs) . BATNEEC . . A.2 (PC, Performance Classification) (OPC, Oper ational PreCheck) . ( ). , , , . A.3 . , . A.1 (PC) A.2 (OPC) , A.3 (PC) A.4 (OPC

5、) . A.4 . , . , . A.5 . . . A.6 . . , . , . A.7 . , GMP . J 0013: 2006 5 A.1 1 ( / ) 2 ( ) 3 4 SF6/ 5 6 7 ( ) 8 ( ) 9 ( ) 10 ( ) 11 12 (NaCl) 13 14 15 16 17 ( ) J 0013: 2006 6 A.1 ( A.1)( A.1)J 0013: 2006 7 A.2 ( A.1)( A.1)J 0013: 2006 8 A.3 ( A.1)( A.1)J 0013: 2006 9 A.4 ( A.1)( A.1)J 0013: 2006 10

6、 B() B.1 , . . mmcL = L: m: cm: . , . . ( ) , . ( ) ( 6 ). . . B.2 ( ) B.2.1 . . , . . . . . . . B.2.2 . a) . b) , . c) . d) . J 0013: 2006 11 e) ( 10 30 ). 1. . f) ( pi) . g) (t) ( pf ) . 2. (t) ( 1 ) . 1 . 3. , , . , . . )(298PfPtTtVLt = Lt: (Pa m3/s) V: (m3) T: (K) t: (s) Pt: (Pa) Pf: (Pa) . )()1

7、0(2210outin PPsLtLs= Ls: (Pa m3/s) : (Pa s) s: 298 K (Pa s) Pin: (Pa) Pout: (Pa) . Ls . . )()(222outinliqliqoutinPPPPLtQ= Q: (m3/s) liq: (Pa s) (Pin Pout)liq: (Pa) Q . . Q . B.3 () ( ) . / ( ) . . J 0013: 2006 12 , , . . B.4 SF6(sulphur hexafluoride) . , . . MS(mass spectrometers) . . . ( ) . . / .

8、. (chamber) . SF6 . . . . . . . . , , , . BS3636 ( 5 ). B.5 . . . (16 KHz ) . . Piezo-ceramic . . . . . B.6 . . (365 nm) . , , . . B.7 . . . . J 0013: 2006 13 . / . . . . B.8 , . . . . . B.9 . . , . . . ( ) . , ( ) . B.10 . , . . . . . . . . . . B.11 / 2 . , , , . . . . . . J 0013: 2006 14 B.12 . .

9、B.13 , . . , . B.14 . . . J 0013: 2006 15 1 Helium leak detection in Bioprocessing applications, A.L. Stockli, Balzers Limited, Balzers, Liechtenstein 2 Non Destructive Testing Handbook, Volume One, Leak Testing, Mcmaster, R C(Ed), ASNT/AMS, 1982, ISBN 0 87170 125 1 3 Behizad M., Cunning R.H., Rowel

10、l F. J., Salusbury T.T. and stewart, I.W. Safety in Biotechnology: The Use of Biosensors for the Detection of Hazardous Biochemicals in Air. Process Biochemistry. August 1989 24(4) 126 132 4 Griffiths W.D and DeCosemo G.A.L. Problem assessment of airborne microorganisms. EAC 1992. J. Aerosol Sci., Vol 13, (S1), S655 S658. 1992 5 BS 3636: 1985 Methods for proving the gastightness of vacuum or pressurized plant 1963

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