圧縮空気・ガス 微生物 微粒子測定 - sysmex-is.jp

1 Confidential and proprietary / PMS PMS 2016 10 Confidential and proprietary FDA Guidance for Industry -Sterile Drug Products Produced by Aseptic Processing -Current Good Manufacturing Practices ISO14698-1 2003 1 fssc22000 Confidential and proprietary 5) 4) Confidential and proprietaryFDA Guidance for Industry -Sterile Drug Products Produced by Aseptic Processing -Current Good Manufacturing PracticesA compressed gasshould be of appropriate purity ( , free from oil) and its microbiological and particle qualityafter filtration should be equal to or better than that of the air in the environment into which the gas is introduced.

2 Grade A GradeA Confidential and proprietaryISO14698-1 2003 1 h) 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) 13) 14) 15) Confidential and proprietaryFSSC22000 fssc22000 PAS220 PAS223 PAS220 PAS223 fssc22000 PAS220:2008, Prerequisite programmeson food safety for food manufacturing 6 Utilities air, water, energy( ) / Confidential and proprietary MiniCaptMobile CG kit LasairIII HPD IIIC onfidential and proprietary MiniCapt MobileCG kit25L/min50 L/min100 -10 -10 -10 Bar( -145 PSI)( -145 PSI)( -145 PSI)(50 -1000 kPa)(100 -1000 kPa)(150 -1000 kPa) 90mm 6mm 25 L/min 50 L/min 100 L/min Confidential and proprietaryConfidential and proprietary Lasair III HPD III L/min 50 L/min 100 L/min 25 -100 psi ( L/min, 50 L/min)60 -100 psi (100 L/min) (h, w, d)38 x 7 x14 cm Kg 1m Male 4-VCR (Swagelok)

3 HPD III HPD III Lasair IIIC onfidential and proprietary