{"id":229,"date":"2026-07-10T05:28:01","date_gmt":"2026-07-10T05:28:01","guid":{"rendered":"https:\/\/industrialelectricmotor.net\/?p=229"},"modified":"2026-07-10T05:28:01","modified_gmt":"2026-07-10T05:28:01","slug":"stainless-steel-motor-for-pharmaceutical-gmp-manufacturing","status":"publish","type":"post","link":"https:\/\/industrialelectricmotor.net\/ja\/stainless-steel-motor-for-pharmaceutical-gmp-manufacturing\/","title":{"rendered":"\u533b\u85ac\u54c1GMP\u88fd\u9020\u7528\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc"},"content":{"rendered":"
\n

<\/p>\n

\n
<\/div>\n
<\/div>\n
<\/div>\n
\n
\n
<\/div>\n

\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u30fbBXG\u30b7\u30ea\u30fc\u30ba\u30fb\u533b\u85ac\u54c1GMP\u30c9\u30e9\u30a4\u30d6\u30ac\u30a4\u30c9<\/span><\/p>\n

<\/div>\n<\/div>\n

\u533b\u85ac\u54c1GMP\u88fd\u9020\u7528\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc\uff1a
\nFDA 21 CFR\u3001EU GMP\u304a\u3088\u3073EHEDG\u6e96\u62e0\u30ac\u30a4\u30c9<\/span><\/h1>\n

\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09\u898f\u5236\u306b\u57fa\u3065\u3044\u3066\u904b\u55b6\u3055\u308c\u308b\u533b\u85ac\u54c1\u88fd\u9020\u65bd\u8a2d\u3067\u306f\u3001\u88fd\u54c1\u304a\u3088\u3073\u88fd\u54c1\u63a5\u89e6\u9762\u306b\u63a5\u89e6\u3059\u308b\u3001\u307e\u305f\u306f\u88fd\u54c1\u63a5\u89e6\u9762\u306e\u4e0a\u306b\u3042\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u304c\u3001\u533b\u85ac\u54c1\u306e\u6c5a\u67d3\u3092\u9632\u6b62\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002GMP\u30be\u30fc\u30f3\u306b\u8a2d\u7f6e\u3055\u308c\u308b\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u6ed1\u3089\u304b\u3067\u8010\u8150\u98df\u6027\u304c\u3042\u308a\u3001\u6d17\u6d44\u53ef\u80fd\u306a\u8868\u9762\u3092\u6301\u3061\u3001\u7c92\u5b50\u3084\u6db2\u4f53\u304c\u6e9c\u307e\u308b\u3088\u3046\u306a\u6c34\u5e73\u306e\u7a81\u8d77\u304c\u306a\u304f\u3001\u5fae\u751f\u7269\u6c5a\u67d3\u306e\u6e29\u5e8a\u3068\u306a\u308b\u3088\u3046\u306a\u9699\u9593\u304c\u306a\u304f\u3001\u6d17\u6d44\u304a\u3088\u3073\u691c\u67fb\u624b\u9806\u304c\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fdBXG\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30b7\u30ea\u30fc\u30ba\u3092\u4f7f\u7528\u3057\u305f\u3001GMP\u533b\u85ac\u54c1\u539f\u85ac\u304a\u3088\u3073\u88fd\u5264\u88fd\u9020\u7528\u30e2\u30fc\u30bf\u30fc\u306e\u4ed5\u69d8\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n

FDA 21 CFR Part 211<\/span>
\nEU GMP\u9644\u5c5e\u66f81\/2<\/span>
\nIP69K SS316L<\/span>
\nRa \u2264 0.8 \u03bcm<\/span>
\n\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5bfe\u5fdc<\/span><\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n
316L<\/div>\n
\u3059\u3079\u3066\u306e\u5916\u90e8\u8868\u9762<\/div>\n<\/div>\n
\n
IP69K<\/div>\n
\u533b\u85ac\u54c1\u88fd\u9020\u5de5\u7a0b<\/div>\n<\/div>\n
\n
FDA<\/div>\n
21 CFR \u30d1\u30fc\u30c8 211<\/div>\n<\/div>\n
\n
EU GMP<\/div>\n
\u9644\u5c5e\u66f81\u304a\u3088\u3073\u9644\u5c5e\u66f82<\/div>\n<\/div>\n
\n
Ra 0.8<\/div>\n
\u6700\u5927\u8868\u9762\u4ed5\u4e0a\u3052\u03bcm<\/div>\n<\/div>\n
\n
H1<\/div>\n
NSF H1 \u533b\u85ac\u54c1\u7528\u30b0\u30ea\u30fc\u30b9<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\"\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc\u3001\u533b\u85ac\u54c1GMP\u88fd\u9020\u3001IP69K\u3001SS316L\u3001BXG\u3001\u97d3\u56fd\u3001\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u3001FDA\u3001EU<\/p>\n
\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fdBXG\u30b7\u30ea\u30fc\u30ba\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc \u2015 IP69K\u8a8d\u8a3c\u53d6\u5f97\u3001AISI 316L\u5916\u88c5\u3001\u8868\u9762\u7c97\u3055Ra\u22660.8\u03bcm\u306e\u4e0d\u52d5\u614b\u5316\u51e6\u7406\u6e08\u307f\u3002FDA 21 CFR Part 211\u304a\u3088\u3073EU GMP Annex 2\u306e\u533b\u85ac\u54c1\u88fd\u9020\u8a2d\u5099\u306b\u95a2\u3059\u308b\u885b\u751f\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001GMP\u88fd\u9020\u533a\u57df\u3067\u306e\u4f7f\u7528\u306b\u9069\u3057\u3066\u3044\u307e\u3059\u3002<\/div>\n<\/div>\n

<\/p>\n

\n
\u30b3\u30f3\u30c6\u30f3\u30c4<\/div>\n
1. \u30e2\u30fc\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u898f\u5236\u8981\u4ef6<\/a>
\n2. GMP\u30be\u30fc\u30f3\u306e\u5206\u985e<\/a>
\n3. \u533b\u85ac\u54c1\u88fd\u9020\u5de5\u7a0b\uff08WIP\uff09\u304a\u3088\u3073CIP\uff08\u5b9a\u7f6e\u6d17\u6d44\uff09<\/a>
\n4. GMP\u8868\u9762\u304a\u3088\u3073\u9699\u9593\u306b\u95a2\u3059\u308b\u8981\u4ef6<\/a>
\n5. IQ\/OQ\/PQ\u9069\u683c\u6027\u8a55\u4fa1\u6587\u66f8<\/a>
\n6. GMP\u30c9\u30e9\u30a4\u30d6\u306eBXG\u4ed5\u69d8<\/a>
\n7. \u533b\u85ac\u54c1GMP\u3078\u306e\u5fdc\u7528<\/a>
\n8. \u3088\u304f\u3042\u308b\u8cea\u554f<\/a><\/div>\n<\/div>\n

<\/p>\n

\n

1. \u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u30e2\u30fc\u30bf\u30fc\u306b\u95a2\u3059\u308bGMP\u898f\u5236\u8981\u4ef6<\/h2>\n

\u7c73\u56fd\u3068\u6b27\u5dde\u306e\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09\u898f\u5236\u3067\u306f\u3001\u30df\u30ad\u30b5\u30fc\u3001\u30b3\u30f3\u30d9\u30a2\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u88c5\u7f6e\u3001\u9020\u7c92\u88c5\u7f6e\u306a\u3069\u3092\u99c6\u52d5\u3059\u308b\u30e2\u30fc\u30bf\u30fc\u3092\u542b\u3081\u3001\u533b\u85ac\u54c1\u88fd\u9020\u30a8\u30ea\u30a2\u306b\u8a2d\u7f6e\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6a5f\u5668\u306b\u7279\u5b9a\u306e\u8981\u4ef6\u304c\u8ab2\u3055\u308c\u3066\u3044\u307e\u3059\u3002GMP\u30a8\u30ea\u30a2\u306e\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u96fb\u6c17\u898f\u683c\u3060\u3051\u3067\u306a\u304f\u3001\u533b\u85ac\u54c1\u6a5f\u5668\u306e\u885b\u751f\u57fa\u6e96\u306b\u3082\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\n
\n
FDA 21 CFR Part 211\uff08\u7c73\u56fd\uff09<\/div>\n

21 CFR 211.65\u3067\u306f\u3001\u69cb\u6210\u90e8\u54c1\u3001\u533b\u85ac\u54c1\u88fd\u9020\u5de5\u7a0b\u4e2d\u306e\u6750\u6599\u3001\u307e\u305f\u306f\u533b\u85ac\u54c1\u3068\u63a5\u89e6\u3059\u308b\u6a5f\u5668\u306e\u8868\u9762\u306f\u3001\u5b89\u5168\u6027\u3001\u540c\u4e00\u6027\u3001\u5f37\u5ea6\u3001\u54c1\u8cea\u3001\u307e\u305f\u306f\u7d14\u5ea6\u3092\u898f\u5b9a\u306e\u8981\u4ef6\u3092\u8d85\u3048\u3066\u5909\u5316\u3055\u305b\u308b\u3088\u3046\u306a\u53cd\u5fdc\u6027\u3001\u6dfb\u52a0\u6027\u3001\u307e\u305f\u306f\u5438\u53ce\u6027\u304c\u3042\u3063\u3066\u306f\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u300221 CFR 211.67\u3067\u306f\u3001\u6a5f\u5668\u306f\u9069\u5207\u306a\u9593\u9694\u3067\u6d17\u6d44\u304a\u3088\u3073\u4fdd\u5b88\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u533b\u85ac\u54c1\u88fd\u9020\u5bb9\u5668\u306e\u4e0a\u90e8\u306b\u3042\u308b\u8150\u98df\u307e\u305f\u306f\u7c97\u9762\u306e\u3042\u308b\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u8868\u9762\u306e\u7c92\u5b50\u307e\u305f\u306f\u8150\u98df\u751f\u6210\u7269\u304c\u4e0b\u90e8\u306e\u533b\u85ac\u54c1\u3092\u6c5a\u67d3\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001211.65\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u307e\u305b\u3093\u3002<\/p>\n<\/div>\n

\n
EU GMP\u9644\u5c5e\u66f82\uff08\u751f\u7269\u5b66\u7684\u533b\u85ac\u54c1\uff09<\/div>\n

EU GMP Annex 2\uff082020\u5e74\u6539\u8a02\u7248\uff09\u306e\u751f\u7269\u5b66\u7684\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u898f\u5b9a\u3067\u306f\u3001\u751f\u7269\u5b66\u7684\u539f\u85ac\u304a\u3088\u3073\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u308b\u6a5f\u5668\u306f\u3001\u6d17\u6d44\u304a\u3088\u3073\u6ec5\u83cc\u3092\u5bb9\u6613\u306b\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u304a\u3088\u3073\u88fd\u9020\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u88fd\u54c1\u3068\u63a5\u89e6\u3059\u308b\u3001\u307e\u305f\u306f\u88fd\u54c1\u306b\u8fd1\u63a5\u3059\u308b\u3059\u3079\u3066\u306e\u8868\u9762\u306f\u3001\u6ed1\u3089\u304b\u3067\u3001\u9699\u9593\u3084\u89d2\u304c\u306a\u304f\u3001\u5bb9\u6613\u306b\u6d17\u6d44\u3067\u304d\u3001\u4f7f\u7528\u3055\u308c\u308b\u6d17\u6d44\u5264\u304a\u3088\u3073\u6ec5\u83cc\u5264\u306b\u5bfe\u3057\u3066\u8010\u6027\u304c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30b0\u30ec\u30fc\u30c9C\u304a\u3088\u3073\u30b0\u30ec\u30fc\u30c9D\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30a8\u30ea\u30a2\u306b\u8a2d\u7f6e\u3055\u308c\u308b\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u3053\u308c\u3089\u306e\u6750\u6599\u304a\u3088\u3073\u8868\u9762\u306b\u95a2\u3059\u308b\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<\/div>\n

\n
EU GMP\u9644\u5c5e\u66f81\uff08\u7121\u83cc\u533b\u85ac\u54c1\uff09<\/div>\n

EU GMP Annex 1\uff082022\u5e74\u6539\u8a02\u7248\uff09\u306f\u3001\u7121\u83cc\u533b\u85ac\u54c1\u306b\u95a2\u3057\u3066\u3001\u30b0\u30ec\u30fc\u30c9A\/B\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\uff08\u7121\u83cc\u5145\u586b\u30a8\u30ea\u30a2\uff09\u306b\u6700\u9ad8\u6c34\u6e96\u306e\u6a5f\u5668\u885b\u751f\u57fa\u6e96\u3092\u9069\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9A\u304a\u3088\u3073B\u30a8\u30ea\u30a2\u306e\u6a5f\u5668\u306f\u3001\u5b9a\u7f6e\u6ec5\u83cc\uff08SIP\uff09\u304a\u3088\u3073\u5b9a\u7f6e\u6d17\u6d44\uff08CIP\uff09\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3001\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u6ec5\u83cc\u6e29\u5ea6\u304a\u3088\u3073\u4f7f\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6d17\u6d44\u5264\u306b\u8010\u3048\u308b\u3001\u6ed1\u3089\u304b\u3067\u5265\u96e2\u306e\u306a\u3044\u8868\u9762\u3092\u5099\u3048\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30a8\u30ea\u30a2\u306e\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8a2d\u8a08\u306e\u4e00\u90e8\u3068\u3057\u3066\u7279\u5225\u306b\u8a8d\u5b9a\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9A\/B\u74b0\u5883\u5411\u3051\u306eBXG\u4ed5\u69d8\u306b\u3064\u3044\u3066\u306f\u3001Korea Ever-Power\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

2. GMP\u30be\u30fc\u30f3\u5206\u985e\u304a\u3088\u3073\u30e2\u30fc\u30bf\u30fc\u4ed5\u69d8<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
GMP\u30b0\u30ec\u30fc\u30c9<\/th>\n\u88fd\u54c1\u30be\u30fc\u30f3<\/th>\n\u30e2\u30fc\u30bf\u30fc\u6750\u6599\u8981\u4ef6<\/th>\nBXG\u306f\u9069\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/th>\n<\/tr>\n<\/thead>\n
\u30b0\u30ec\u30fc\u30c9A<\/td>\n\u7121\u83cc\u5145\u586b\u3001\u30d0\u30a4\u30a2\u30eb\u6813\u3001\u958b\u5c01\u5bb9\u5668\u306f\u5371\u967a<\/td>\nSIP\/CIP\u5bfe\u5fdc\u3001SS316L\u3001\u4e00\u90e8\u306e\u7528\u9014\u3067\u306fRa\u22660.4\u03bcm<\/td>\n\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u306b\u76f8\u8ac7\u3057\u3066\u304f\u3060\u3055\u3044<\/td>\n<\/tr>\n
\u30b0\u30ec\u30fc\u30c9B<\/td>\n\u30b0\u30ec\u30fc\u30c9A\u306e\u80cc\u666f\u30be\u30fc\u30f3\uff1b\u30d0\u30a4\u30a2\u30eb\u6d17\u6d44\u3001\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u6e96\u5099<\/td>\nSS316L\u3001Ra \u2264 0.8 \u03bcm\u3001CIP\u5bfe\u5fdc\u3001\u5265\u96e2\u306a\u3057<\/td>\n\u306f\u3044\u3001BXG\u898f\u683c\u3067\u3059\u3002<\/td>\n<\/tr>\n
\u30b0\u30ec\u30fc\u30c9C<\/td>\n\u30d0\u30eb\u30af\u5145\u586b\u3001\u9020\u7c92\u3001\u9320\u5264\u5727\u7e2e\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0<\/td>\nSS316L\u307e\u305f\u306f\u540c\u7b49\u54c1\u3001\u6d17\u6d44\u53ef\u80fd\u3001\u8150\u98df\u3057\u306a\u3044<\/td>\n\u306f\u3044\u3001BXG\u898f\u683c\u3067\u3059\u3002<\/td>\n<\/tr>\n
\u30b0\u30ec\u30fc\u30c9D<\/td>\n\u4e00\u822c\u7684\u306a\u88fd\u9020\u652f\u63f4\u3001\u90e8\u54c1\u306e\u53d6\u308a\u6271\u3044<\/td>\n\u8868\u9762\u304c\u6ed1\u3089\u304b\u3067\u3001\u6e05\u6383\u3057\u3084\u3059\u304f\u3001\u8010\u8150\u98df\u6027\u306b\u512a\u308c\u3066\u3044\u307e\u3059\u3002SS316L\u3092\u63a8\u5968\u3057\u307e\u3059\u3002<\/td>\n\u306f\u3044\u3001BXG\u898f\u683c\u3067\u3059\u3002<\/td>\n<\/tr>\n
\u975eGMP<\/td>\n\u5009\u5eab\u3001\u516c\u5171\u65bd\u8a2d\u3001\u975e\u6a5f\u5bc6\u533a\u57df<\/td>\n\u6a19\u6e96Y2\u30e2\u30fc\u30bf\u30fc\u5bfe\u5fdc<\/td>\nY2\u6a19\u6e96\u30e2\u30fc\u30bf\u30fc<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n

<\/p>\n

\n

3. \u533b\u85ac\u54c1\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3051\u308b\u6d17\u6d44\u5264\u304a\u3088\u3073\u5b9a\u7f6e\u6d17\u6d44\u5264<\/h2>\n

\u533b\u85ac\u54c1\u88fd\u9020\u8a2d\u5099\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6e08\u307f\u306e\u6d17\u6d44\u624b\u9806\u3092\u7528\u3044\u3066\u6d17\u6d44\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u624b\u9806\u306b\u306f\u3001\u30b9\u30d7\u30ec\u30fc\u30d8\u30c3\u30c9\u306b\u3088\u308b\u5b9a\u7f6e\u6d17\u6d44\uff08WIP\uff09\u3084\u624b\u52d5\u6d17\u6d44\u3001\u304a\u3088\u3073\u63a5\u7d9a\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u6a5f\u5668\u306e\u5b9a\u7f6e\u6d17\u6d44\uff08CIP\uff09\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u85ac\u54c1GMP\u3067\u4f7f\u7528\u3055\u308c\u308b\u6d17\u6d44\u5264\u306f\u3001\u98df\u54c1\u696d\u754c\u306eCIP\u3068\u306f\u7570\u306a\u308a\u3001\u6c34\u7cfb\u6d17\u6d44\u5264\u306b\u52a0\u3048\u3066\u3001\u6709\u6a5f\u6eb6\u5264\u30ea\u30f3\u30b9\u3001\u7279\u6b8a\u6d17\u5264\u3001\u6ec5\u83cc\u6eb6\u6db2\u306a\u3069\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\n
\n
\u6c34\u7cfb\u6d17\u6d44\uff08\u30b0\u30ec\u30fc\u30c9C\/D\uff09<\/div>\n

\u6a19\u6e96\u7684\u306a\u533b\u85ac\u54c1GMP\u6d17\u6d44\u3067\u306f\u3001\u6eb6\u5a92\u3068\u3057\u3066\u7cbe\u88fd\u6c34\uff08PW\uff09\u307e\u305f\u306f\u6ce8\u5c04\u7528\u6c34\uff08WFI\uff09\u3092\u7528\u3044\u3001\u30a2\u30eb\u30ab\u30ea\u6027\u6d17\u5264\uff08NaOH 0.5\uff5e2%\u3001pH 11\uff5e13\uff09\u3068\u9178\u6027\u30ea\u30f3\u30b9\u5264\uff08\u30ea\u30f3\u9178\u307e\u305f\u306f\u30af\u30a8\u30f3\u9178 0.5\uff5e1%\uff09\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002BXG SS316L\u306f\u3053\u308c\u3089\u306e\u85ac\u5264\u306b\u5bfe\u3057\u3066\u5b8c\u5168\u306b\u8010\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30e2\u30fc\u30bf\u30fc\u306e\u6d17\u6d44\u306f\u3001PW\/WFI\u3067\u6e7f\u3089\u305b\u305f\u6d17\u6d44\u6e08\u307f\u306e\u5e03\u3067\u624b\u62ed\u304d\u307e\u305f\u306f\u30b9\u30d7\u30ec\u30fc\u6d17\u6d44\u306b\u3088\u3063\u3066\u884c\u3044\u307e\u3059\u3002IP69K\u8a8d\u8a3c\u306f\u3001\u52a0\u5727\u30b9\u30d7\u30ec\u30fc\u6d17\u6d44\u306b\u5bfe\u3059\u308b\u8010\u6027\u3092\u8a3c\u660e\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/div>\n

\n
\u30a2\u30eb\u30b3\u30fc\u30eb\u6d88\u6bd2\uff08\u30b0\u30ec\u30fc\u30c9B\/C\uff09<\/div>\n

\u88fd\u85ac\u5de5\u5834\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306f\u3001\u88fd\u9020\u30d0\u30c3\u30c1\u9593\u306e\u8868\u9762\u6d88\u6bd2\u306b70%\u30a4\u30bd\u30d7\u30ed\u30d4\u30eb\u30a2\u30eb\u30b3\u30fc\u30eb\uff08IPA\uff09\u307e\u305f\u306f70%\u30a8\u30bf\u30ce\u30fc\u30eb\u30b9\u30d7\u30ec\u30fc\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002BXG SS316L\u30e2\u30fc\u30bf\u30fc\u306e\u8868\u9762\u306f\u3001\u3053\u308c\u3089\u306e\u6fc3\u5ea6\u306eIPA\u304a\u3088\u3073\u30a8\u30bf\u30ce\u30fc\u30eb\u306b\u5bfe\u3057\u3066\u5b8c\u5168\u306a\u8010\u6027\u304c\u3042\u308a\u307e\u3059\u3002FDA\u30b7\u30ea\u30b3\u30f3\u30b7\u30e3\u30d5\u30c8\u30b7\u30fc\u30eb\u3068NSF H1\u30d9\u30a2\u30ea\u30f3\u30b0\u30b0\u30ea\u30fc\u30b9\u3082\u3001\u533b\u85ac\u54c1\u7528\u9014\u6fc3\u5ea6\u306e\u30a2\u30eb\u30b3\u30fc\u30eb\u6d88\u6bd2\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002IPA\u30b9\u30d7\u30ec\u30fc\u6d88\u6bd2\u306f\u3001BXG IP69K\u306e\u5b8c\u5168\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<\/div>\n

\n
VHP\u6ec5\u83cc\uff08\u30b0\u30ec\u30fc\u30c9A\/B\uff09<\/div>\n

\u30b0\u30ec\u30fc\u30c9A\/B\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u5f8c\u307e\u305f\u306f\u88fd\u54c1\u5207\u308a\u66ff\u3048\u6642\u306e\u9664\u67d3\u30b5\u30a4\u30af\u30eb\u306b\u306f\u3001150\uff5e750 ppm H\u2082O\u2082\u306e\u6fc3\u5ea6\u3067\u6c17\u5316\u904e\u9178\u5316\u6c34\u7d20\uff08VHP\uff09\u304c\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002VHP\u306f\u3001\u533b\u85ac\u54c1\u6ec5\u83cc\u6fc3\u5ea6\u306b\u304a\u3044\u3066SS316L\u304a\u3088\u3073\u3059\u3079\u3066\u306eBXG\u30b7\u30fc\u30eb\u6750\u3068\u30b0\u30ea\u30fc\u30b9\u6750\u306b\u9069\u5408\u3057\u307e\u3059\u3002VHP\u66dd\u9732\u3092\u5fc5\u8981\u3068\u3059\u308b\u30b0\u30ec\u30fc\u30c9A\/B\u30e2\u30fc\u30bf\u30fc\u7528\u9014\u306b\u3064\u3044\u3066\u306f\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u6587\u66f8\u304a\u3088\u3073\u6750\u6599\u8a3c\u660e\u66f8\u3092Korea Ever-Power\u793e\u306b\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

4. GMP\u8868\u9762\u3001\u9699\u9593\u3001\u304a\u3088\u3073\u6392\u6c34\u53e3\u306e\u8a2d\u8a08\u8981\u4ef6<\/h2>\n
\n
\n
Ra \u2264 0.8 \u03bcm \u2014 \u5fae\u751f\u7269\u5236\u5fa1<\/div>\n

EU GMP\u304a\u3088\u3073FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3044\u305a\u308c\u3082\u3001\u52b9\u679c\u7684\u306a\u6d17\u6d44\u6027\u306e\u95be\u5024\u3068\u3057\u3066EHEDG\u8868\u9762\u7c97\u3055\u57fa\u6e96Ra \u2264 0.8 \u03bcm\u3092\u53c2\u7167\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u7c97\u3055\u4ee5\u4e0b\u3067\u3042\u308c\u3070\u3001\u7d30\u83cc\u306e\u4ed8\u7740\u3084\u30d0\u30a4\u30aa\u30d5\u30a3\u30eb\u30e0\u306e\u5f62\u6210\u304c\u5927\u5e45\u306b\u6e1b\u5c11\u3057\u3001\u6a19\u6e96\u7684\u306a\u6d17\u5264\u306b\u3088\u308b\u8868\u9762\u6d17\u6d44\u3067\u533b\u85ac\u54c1GMP\u306b\u5fc5\u8981\u306a\u5fae\u751f\u7269\u4f4e\u6e1b\u52b9\u679c\u304c\u5f97\u3089\u308c\u307e\u3059\u3002BXG\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u7d0d\u54c1\u6642\u306b\u3059\u3079\u3066\u306e\u5916\u90e8\u8868\u9762\u304cRa \u2264 0.8 \u03bcm\u306b\u4ed5\u4e0a\u3052\u3089\u308c\u3066\u304a\u308a\u3001SS316L\u6750\u6599\u306f\u901a\u5e38\u306eGMP\u6d17\u6d44\u30b5\u30a4\u30af\u30eb\u3067\u306f\u7c97\u304f\u306a\u308a\u307e\u305b\u3093\u3002IQ\u6bb5\u968e\u3067\u8868\u9762\u4ed5\u4e0a\u3052\u3092\u78ba\u8a8d\u3057\u3001\u30b5\u30a4\u30c8\u5909\u66f4\u7ba1\u7406\u624b\u9806\u3067\u5b9a\u3081\u3089\u308c\u305f\u5b9a\u671f\u7684\u306a\u518d\u9069\u683c\u6027\u78ba\u8a8d\u9593\u9694\u3067\u518d\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<\/div>\n

\n
\u30c7\u30c3\u30c9\u30ec\u30c3\u30b0\u3001\u9699\u9593\u3001\u6c34\u5e73\u65b9\u5411\u306e\u6bb5\u5dee\u304c\u306a\u3044\u3053\u3068<\/div>\n

GMP\u3067\u306f\u3001\u30e2\u30fc\u30bf\u30fc\u8868\u9762\u306b\u304a\u3044\u3066\u3001\u6d17\u6d44\u624b\u9806\u3067\u5c4a\u304b\u306a\u3044\u5834\u6240\u306b\u88fd\u54c1\u3001\u6d17\u6d44\u6db2\u3001\u307e\u305f\u306f\u5fae\u751f\u7269\u6c5a\u67d3\u7269\u8cea\u304c\u84c4\u7a4d\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7b87\u6240\u3092\u6392\u9664\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002BXG\u30d5\u30ec\u30fc\u30e0\u306f\u3001\u81ea\u7531\u306b\u6392\u6c34\u3067\u304d\u308b\u89d2\u5ea6\u4ed8\u304d\u51b7\u5374\u30d5\u30a3\u30f3\u3001\u51f8\u578b\u306e\u7aef\u5b50\u30dc\u30c3\u30af\u30b9\u84cb\uff08\u5e73\u3089\u306a\u6c34\u5e73\u9762\u304c\u306a\u3044\uff09\u3001\u6a5f\u68b0\u7684\u306b\u63a5\u5408\u3055\u308c\u305f\u30d1\u30cd\u30eb\u3067\u306f\u306a\u304f\u6ed1\u3089\u304b\u306a\u6eb6\u63a5\u69cb\u9020\u3001\u305d\u3057\u3066\u7c92\u5b50\u304c\u4ed8\u7740\u3057\u3084\u3059\u3044\u5341\u5b57\u7a74\u3084\u516d\u89d2\u7a74\u4ed8\u304d\u30d5\u30a1\u30b9\u30ca\u30fc\u3067\u306f\u306a\u304f\u6ed1\u3089\u304b\u306a\u30bd\u30b1\u30c3\u30c8\u30ad\u30e3\u30c3\u30d7\u30d5\u30a1\u30b9\u30ca\u30fc\u3092\u63a1\u7528\u3057\u3066\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8a2d\u8a08\u4e0a\u306e\u7279\u5fb4\u306f\u3001GMP\u6a5f\u5668\u9069\u683c\u6027\u8a55\u4fa1\u306b\u542b\u3081\u308b\u305f\u3081\u306eBXG\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

5. GMP\u65bd\u8a2d\u306b\u304a\u3051\u308bBXG\u306eIQ\/OQ\/PQ\u9069\u683c\u6027\u8a55\u4fa1\u6587\u66f8<\/h2>\n

FDA 21 CFR Part 211\u304a\u3088\u3073EU GMP\u3067\u306f\u3001\u533b\u85ac\u54c1\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u308b\u6a5f\u5668\u306f\u3001\u88fd\u9020\u306b\u4f7f\u7528\u3059\u308b\u524d\u306b\u9069\u683c\u6027\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u30e2\u30fc\u30bf\u30fc\u306f\u901a\u5e38\u3001\u6a5f\u5668\u30b7\u30b9\u30c6\u30e0\u9069\u683c\u6027\u8a55\u4fa1\uff08\u30e2\u30fc\u30bf\u30fc\u3092\u542b\u3080\u9020\u7c92\u6a5f\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u3001\u307e\u305f\u306f\u30b3\u30f3\u30d9\u30a2\uff09\u306e\u4e00\u90e8\u3068\u3057\u3066\u9069\u683c\u6027\u8a55\u4fa1\u3055\u308c\u307e\u3059\u304c\u3001\u5c11\u306a\u304f\u3068\u3082\u8a2d\u7f6e\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u3092\u88cf\u4ed8\u3051\u308b\u305f\u3081\u306b\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u7528\u610f\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\n
\n
IQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<\/div>\n

\u30e2\u30fc\u30bf\u30fc\u306e\u30e2\u30c7\u30eb\u3068\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3001\u88fd\u9020\u5143\u306e\u9069\u5408\u8a3c\u660e\u66f8\u3001SS316L\u30d5\u30ec\u30fc\u30e0\u306e\u6750\u6599\u8a3c\u660e\u66f8\uff08EN 10204\u30bf\u30a4\u30d73.1\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff09\u3001\u8868\u9762\u7c97\u3055\u6e2c\u5b9a\u30ec\u30dd\u30fc\u30c8\uff08Ra \u2264 0.8 \u03bcm\uff09\u3001IP69K\u8a66\u9a13\u8a3c\u660e\u66f8\u3001\u30b7\u30fc\u30eb\u3068\u30b0\u30ea\u30fc\u30b9\u306b\u95a2\u3059\u308bFDA 21 CFR\u6750\u6599\u9069\u5408\u6027\u58f0\u660e\u3001\u30d9\u30a2\u30ea\u30f3\u30b0\u30b0\u30ea\u30fc\u30b9\u306b\u95a2\u3059\u308bNSF H1\u8a3c\u660e\u66f8\u3002<\/p>\n<\/div>\n

\n
OQ\u6587\u66f8<\/div>\n

\u8a2d\u7f6e\u6642\u306e\u30e2\u30fc\u30bf\u30fc\u5b9a\u683c\u901f\u5ea6\u3001\u30c8\u30eb\u30af\u3001\u51fa\u529b\u3002\u8a66\u904b\u8ee2\u6642\u306e\u632f\u52d5\u7279\u6027\u3002\u30e2\u30fc\u30bf\u30fc\u4fdd\u8b77\u30ea\u30ec\u30fc\u8a2d\u5b9a\u8a18\u9332\u3002\u7279\u5b9a\u306e\u8a2d\u7f6e\u5834\u6240\u306b\u8a2d\u7f6e\u3055\u308c\u305f\u30e2\u30fc\u30bf\u30fc\u306e\u6d17\u6d44\u624b\u9806\u306e\u8a8d\u5b9a\u3002\u6d17\u6d44\u5264\u306e\u9069\u5408\u6027\u78ba\u8a8d\u3002\u8a2d\u7f6e\u5f8c\u6700\u521d\u306e\u691c\u67fb\u8a18\u9332\u3002<\/p>\n<\/div>\n

\n
PQ\u304a\u3088\u3073\u518d\u8cc7\u683c<\/div>\n

PQ\uff08\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\uff09\u306f\u3001\u5546\u696d\u751f\u7523\u306b\u304a\u3044\u3066\u30e2\u30fc\u30bf\u30fc\u304c\u751f\u7523\u8a2d\u5099\u306e\u4e00\u90e8\u3068\u3057\u3066\u6b63\u3057\u304f\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u518d\u9069\u683c\u6027\u78ba\u8a8d\u306f\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u4ea4\u63db\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u4fee\u7406\u3001\u6d17\u6d44\u5264\u306e\u5909\u66f4\u3001\u8a2d\u5099\u306e\u518d\u69cb\u6210\u3068\u3044\u3063\u305f\u5909\u66f4\u7ba1\u7406\u30a4\u30d9\u30f3\u30c8\u306b\u3088\u3063\u3066\u958b\u59cb\u3055\u308c\u307e\u3059\u3002Korea Ever-Power\u306f\u3001BXG\u306e\u3054\u6ce8\u6587\u3054\u3068\u306b\u3001\u5fc5\u8981\u306aIQ\uff08\u8a2d\u5099\u9069\u683c\u6027\u78ba\u8a8d\uff09\u6587\u66f8\u3092\u88fd\u85ac\u4f1a\u793e\u306e\u304a\u5ba2\u69d8\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n

\n

\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u306f\u3001\u533b\u85ac\u54c1GMP\u7528\u9014\u5411\u3051BXG\u30e2\u30fc\u30bf\u30fc\u3092\u3001\u88fd\u9020\u696d\u8005\u9069\u5408\u5ba3\u8a00\u66f8\u3001\u6750\u6599\u8a66\u9a13\u8a3c\u660e\u66f8\uff08EN 10204 3.1\uff09\u3001\u8868\u9762\u7c97\u3055\u8a66\u9a13\u5831\u544a\u66f8\u3001IP69K\u8a8d\u8a3c\u66f8\u30b3\u30d4\u30fc\u3001FDA 21 CFR\u6e96\u62e0\u58f0\u660e\u66f8\u3001NSF H1\u30b0\u30ea\u30fc\u30b9\u8a3c\u660e\u66f8\u3001\u5909\u66f4\u901a\u77e5\u624b\u9806\u66f8\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u6587\u66f8\u30d1\u30c3\u30b1\u30fc\u30b8\u3068\u3068\u3082\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u30d1\u30c3\u30b1\u30fc\u30b8\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u306b\u3088\u308b\u8ffd\u52a0\u8a66\u9a13\u306a\u3057\u306b\u3001\u6a5f\u5668\u9069\u683c\u6027\u8a55\u4fa1\u306eIQ\u6bb5\u968e\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n

<\/p>\n

\n

6. \u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fd\u533b\u85ac\u54c1GMP\u5bfe\u5fdc\u30c9\u30e9\u30a4\u30d6\u300cBXG\u300d<\/h2>\n
\n
\n

\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcBXG\u30b7\u30ea\u30fc\u30ba\u306f\u3001\u30b0\u30ec\u30fc\u30c9B\u3001C\u3001D\u306e\u533b\u85ac\u54c1GMP\u88fd\u9020\u30a8\u30ea\u30a2\u5411\u3051\u306e\u5b8c\u5168\u306a\u30e2\u30fc\u30bf\u30fc\u4ed5\u69d8\u3067\u3059\u3002IP69K\u306e\u9632\u6c34\u4fdd\u8b77\u3001SS316L\u8010\u9178\u6027\u30fb\u8010\u30a2\u30eb\u30ab\u30ea\u6027\u69cb\u9020\u3001Ra\u22660.8\u03bcm\u306e\u885b\u751f\u7684\u306a\u8868\u9762\u4ed5\u4e0a\u3052\u3001FDA\u30b7\u30ea\u30b3\u30f3\u30b7\u30e3\u30d5\u30c8\u30b7\u30fc\u30eb\u3001NSF H1\u533b\u85ac\u54c1\u30b0\u30ec\u30fc\u30c9\u30d9\u30a2\u30ea\u30f3\u30b0\u30b0\u30ea\u30fc\u30b9\u3001\u30af\u30e9\u30b9H\u7d76\u7e01\u3092\u517c\u306d\u5099\u3048\u3066\u3044\u307e\u3059\u3002BXG\u306e\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u533b\u85ac\u54c1\u6a5f\u5668\u306eIQ\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u5168\u88fd\u54c1\u30e9\u30a4\u30f3\u30ca\u30c3\u30d7\u306f\u3001 \u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc\u88fd\u54c1\u30bb\u30af\u30b7\u30e7\u30f3<\/a>\u30b0\u30ec\u30fc\u30c9A\/B\u306e\u7121\u83cc\u88fd\u9020\u74b0\u5883\u4ed5\u69d8\u307e\u305f\u306f\u533b\u85ac\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30b5\u30dd\u30fc\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u4e0b\u8a18\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002 \u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u6280\u8853\u30c1\u30fc\u30e0<\/a>.<\/p>\n<\/div>\n

\n
\n
BXG \u2014 \u533b\u85ac\u54c1GMP\u30c7\u30fc\u30bf<\/div>\n\n\n\n\n\n\n\n\n\n\n
\u30d5\u30ec\u30fc\u30e0\u7d20\u6750<\/td>\nAISI 316L \u5168\u5916\u88c5<\/td>\n<\/tr>\n
\u8868\u9762\u4ed5\u4e0a\u3052<\/td>\nRa \u2264 0.8 \u03bcm\uff08\u8a8d\u8a3c\u6e08\u307f\uff09<\/td>\n<\/tr>\n
IP\u30ec\u30fc\u30c6\u30a3\u30f3\u30b0<\/td>\nIP69K<\/td>\n<\/tr>\n
\u30b7\u30e3\u30d5\u30c8\u30b7\u30fc\u30eb<\/td>\nFDA 21 CFR 177.2600 \u30b7\u30ea\u30b3\u30fc\u30f3<\/td>\n<\/tr>\n
\u30b0\u30ea\u30fc\u30b9<\/td>\nNSF H1\u533b\u85ac\u54c1\u30b0\u30ec\u30fc\u30c9<\/td>\n<\/tr>\n
\u7d76\u7e01<\/td>\n\u30af\u30e9\u30b9H<\/td>\n<\/tr>\n
\u30d1\u30ef\u30fc\u30ec\u30f3\u30b8<\/td>\n0.18\uff5e11kW<\/td>\n<\/tr>\n
IQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/td>\n\u30d5\u30eb\u30d1\u30c3\u30af\u306f\u6a19\u6e96\u3067\u4ed8\u5c5e\u3057\u307e\u3059<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

7. \u533b\u85ac\u54c1GMP\u88fd\u9020\u3078\u306e\u5fdc\u7528<\/h2>\n\n\n\n
\"\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc\u642d\u8f09\u533b\u85ac\u54c1GMP\u5bfe\u5fdc\u9020\u7c92\u30fb\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u64b9\u62cc\u6a5f<\/p>\n
\n
\u9320\u5264\u9020\u7c92\u6a5f\u304a\u3088\u3073\u9320\u5264\u30d7\u30ec\u30b9\u6a5f<\/div>\n

\u30b0\u30ec\u30fc\u30c9 C \u9320\u5264\u88fd\u9020\u30a8\u30ea\u30a2\u306e\u9ad8\u305b\u3093\u65ad\u6e7f\u5f0f\u9020\u7c92\u6a5f\u304a\u3088\u3073\u30ed\u30fc\u30e9\u30fc\u5727\u7e2e\u9020\u7c92\u6a5f\u3002BXG 1.1 \uff5e 5.5 kW 4 \u6975\u30e2\u30fc\u30bf\u30fc\u304c\u5bc6\u9589\u30ae\u30a2\u30dc\u30c3\u30af\u30b9\u3092\u4ecb\u3057\u3066\u30a4\u30f3\u30da\u30e9\u304a\u3088\u3073\u30c1\u30e7\u30c3\u30d1\u30fc\u30b7\u30e3\u30d5\u30c8\u3092\u99c6\u52d5\u3057\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9 C \u9020\u7c92\u5ba4\u3067\u306f\u3001\u9732\u51fa\u3057\u305f\u30e2\u30fc\u30bf\u30fc\u8868\u9762\u306f\u3059\u3079\u3066 SS316L \u3067\u3001IPA \u304a\u3088\u3073\u6c34\u6027\u6d17\u6d44\u5264\u3067\u6d17\u6d44\u53ef\u80fd\u3067\u3001\u6c34\u5e73\u306e\u6bb5\u5dee\u304c\u306a\u3044\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9 C \u88fd\u9020\u5ba4\u306e\u9320\u5264\u30d7\u30ec\u30b9\u99c6\u52d5\u30e2\u30fc\u30bf\u30fc: \u30bf\u30ec\u30c3\u30c8\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u304a\u3088\u3073\u30d7\u30ec\u30b9\u529b\u99c6\u52d5\u7528\u306b BXG 0.75 \uff5e 2.2 kW\u3002<\/p>\n<\/div>\n<\/td>\n

\"\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u30e2\u30fc\u30bf\u30fc\u533b\u85ac\u54c1GMP\u30b3\u30f3\u30d9\u30a2\u5145\u586b\u30d0\u30a4\u30a2\u30eb\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0BXG<\/p>\n
\n
\u533b\u85ac\u54c1\u642c\u9001\u30b3\u30f3\u30d9\u30a2\u304a\u3088\u3073\u79fb\u9001\u30b7\u30b9\u30c6\u30e0<\/div>\n

\u30b0\u30ec\u30fc\u30c9C\u304a\u3088\u3073D\u306e\u533b\u85ac\u54c1\u88fd\u9020\u30a8\u30ea\u30a2\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d9\u30e4\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u539f\u85ac\u3001\u5b8c\u6210\u54c1\u6df7\u5408\u7269\u3001\u5145\u586b\u6e08\u307f\u4e00\u6b21\u5bb9\u5668\u3092\u5de5\u7a0b\u9593\u3067\u642c\u9001\u3057\u307e\u3059\u3002\u30b3\u30f3\u30d9\u30e4\u30bb\u30af\u30b7\u30e7\u30f3\u99c6\u52d5\u306b\u306f\u3001BXG 0.18\uff5e1.5kW 4\u6975\u30e2\u30fc\u30bf\u30fc\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002GMP\u5883\u754c\u5185\u306e\u3059\u3079\u3066\u306e\u30e2\u30fc\u30bf\u30fc\u8868\u9762\u306f\u3001Ra\u22660.8\u03bcm\u306eSS316L\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30b3\u30f3\u30d9\u30e4\u30e2\u30fc\u30bf\u30fc\u306e\u6d17\u6d44\u306f\u3001\u30b3\u30f3\u30d9\u30e4\u30b7\u30b9\u30c6\u30e0\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6e08\u307f\u6d17\u6d44\u624b\u9806\u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n
\n
\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d1\u30f3\u30c9\u30e9\u30a4\u30d6<\/div>\n

\u30b0\u30ec\u30fc\u30c9C\u306e\u90e8\u5c4b\u306b\u3042\u308b\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30d1\u30f3\u306f\u3001\u9320\u5264\u30d9\u30c3\u30c9\u306e\u30bf\u30f3\u30d6\u30ea\u30f3\u30b0\u306e\u305f\u3081\u306b3\uff5e25rpm\u3067\u56de\u8ee2\u3057\u307e\u3059\u3002BXG 0.75\uff5e2.2kW 4\u6975\u30e2\u30fc\u30bf\u30fc\u3068NMRV\u30ae\u30a2\u30dc\u30c3\u30af\u30b9\uff0840:1\uff5e100:1\uff09\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002\u30d1\u30f3\u5185\u90e8\u306f\u533b\u85ac\u54c1\u3068\u76f4\u63a5\u63a5\u89e6\u3057\u307e\u3059\u3002\u30d1\u30f3\u5916\u90e8\u306eBXG\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u30d1\u30f3\u5185\u90e8\u306e\u6d17\u6d44\u306b\u4f7f\u7528\u3059\u308b\u6d17\u6d44\u5264\u3068\u540c\u3058\u6d17\u6d44\u5264\u3067\u6d17\u6d44\u3067\u304d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div>\n

\n
\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u64b9\u62cc\u6a5f\u99c6\u52d5\u88c5\u7f6e<\/div>\n

\u30b0\u30ec\u30fc\u30c9C\u306e\u751f\u7269\u88fd\u5264\u88fd\u9020\u306b\u304a\u3051\u308b\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u304a\u3088\u3073\u767a\u9175\u69fd\u306e\u5916\u90e8\u652a\u62cc\u6a5f\u99c6\u52d5\u30e2\u30fc\u30bf\u30fc\u3002BXG\u793e\u88fd\u3001\u51fa\u529b0.37\uff5e2.2kW\u3001\u6e1b\u901f\u6bd420\uff5e60:1\u306eNMRV\u30ae\u30a2\u30e2\u30fc\u30bf\u30fc\u3002\u30e2\u30fc\u30bf\u30fc\u306f\u5bb9\u5668\u306e\u5916\u90e8\u306b\u8a2d\u7f6e\u3055\u308c\u307e\u3059\u304c\u3001\u30b0\u30ec\u30fc\u30c9C\u306e\u7bc4\u56f2\u5185\u3067\u3059\u3002IPA\u306b\u3088\u308b\u65e5\u5e38\u6d17\u6d44\u3068\u82db\u6027\u6eb6\u6db2\u306b\u3088\u308b\u90311\u56de\u306e\u6d17\u6d44\u304c\u4e00\u822c\u7684\u3067\u3059\u3002BXG\u793e\u88fd\u306eSS316L\u304a\u3088\u3073FDA\u8a8d\u5b9a\u30b7\u30ea\u30b3\u30f3\u30b7\u30fc\u30eb\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u6d17\u6d44\u6761\u4ef6\u4e0b\u3067\u3082\u52a3\u5316\u3057\u307e\u305b\u3093\u3002<\/p>\n<\/div>\n

\n
\u51cd\u7d50\u4e7e\u71e5\u6a5f\u30ed\u30fc\u30c7\u30a3\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0<\/div>\n

\u30b0\u30ec\u30fc\u30c9A\u306e\u7121\u83cc\u5145\u586b\u30a8\u30ea\u30a2\u306b\u96a3\u63a5\u3059\u308b\u30b0\u30ec\u30fc\u30c9B\u30a8\u30ea\u30a2\u306e\u51cd\u7d50\u4e7e\u71e5\u6a5f\uff08\u51cd\u7d50\u4e7e\u71e5\u88c5\u7f6e\uff09\u7528\u81ea\u52d5\u30d0\u30a4\u30a2\u30eb\u88c5\u586b\u30fb\u6392\u51fa\u30b7\u30b9\u30c6\u30e0\u3002\u30d0\u30a4\u30a2\u30eb\u642c\u9001\u30b3\u30f3\u30d9\u30a2\u99c6\u52d5\u88c5\u7f6e\u306b\u306fBXG 0.18\uff5e0.75kW\u3092\u4f7f\u7528\u3002\u51cd\u7d50\u4e7e\u71e5\u6a5f\u306e\u88c5\u586b\u30a8\u30ea\u30a2\u306f\u88c5\u586b\u4f5c\u696d\u4e2d\u306f\u30b0\u30ec\u30fc\u30c9B\u3002GMP\u9664\u67d3\u30b5\u30a4\u30af\u30eb\u306b\u304a\u3051\u308bBXG VHP\u9069\u5408\u6027\u3092\u78ba\u8a8d\u6e08\u307f\u3002<\/p>\n<\/div>\n

\n
WFI\u30eb\u30fc\u30d7\u30dd\u30f3\u30d7<\/div>\n

\u533b\u85ac\u54c1\u7528\u6c34\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u6ce8\u5c04\u7528\u6c34\uff08WFI\uff09\u5206\u914d\u30eb\u30fc\u30d7\u30dd\u30f3\u30d7\u99c6\u52d5\u88c5\u7f6e\u3002\u30e2\u30fc\u30bf\u30fc\u306f\u901a\u5e38\u3001GMP\u5ba4\u306e\u5916\u306e\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u30a8\u30ea\u30a2\u306b\u8a2d\u7f6e\u3055\u308c\u307e\u3059\u304c\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u4e2d\u306bWFI\u306e\u5674\u9727\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002BXG 0.75\uff5e3.0kW\u30012\u6975\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u9ad8\u7d14\u5ea6\u6c34\u306b\u5bfe\u3059\u308b\u8010\u8150\u98df\u6027\u3068\u30dd\u30f3\u30d7\u5ba4\u306e\u84b8\u6c17\u6d17\u6d44\u3078\u306e\u8010\u6027\u304c\u6c42\u3081\u3089\u308c\u308bWFI\u30dd\u30f3\u30d7\u99c6\u52d5\u88c5\u7f6e\u3067\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n

\"\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcBXG\u88fd\u85ac\u30e2\u30fc\u30bf\u30fc\u88fd\u9020\"<\/p>\n

GMP\u30e2\u30fc\u30bf\u30fc\u88fd\u9020<\/div>\n<\/div>\n
\n

\"\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcBXG\u8868\u9762\u4ed5\u4e0a\u3052\u6e2c\u5b9a\"<\/p>\n

Ra\u6e2c\u5b9a<\/div>\n<\/div>\n
\n

\"\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcCE<\/p>\n

CE\u304a\u3088\u3073ISO<\/div>\n<\/div>\n
\n

\"\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcBXG\u533b\u85ac\u54c1GMP\u8f38\u51fa\"<\/p>\n

\u8f38\u51fa\u7528\u68b1\u5305<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

8. \u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n
\n
\n
\n
BXG\u30e2\u30fc\u30bf\u30fc\u3092\u540c\u3058\u578b\u756a\u306e\u65b0\u3057\u3044BXG\u30e2\u30fc\u30bf\u30fc\u306b\u4ea4\u63db\u3059\u308b\u5834\u5408\u3001\u518d\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/div>\n<\/div>\n
\n

\u8a8d\u5b9a\u6e08\u307f\u306e\u533b\u85ac\u54c1\u88fd\u9020\u88c5\u7f6e\u306e\u30e2\u30fc\u30bf\u30fc\u4ea4\u63db\u306f\u5909\u66f4\u7ba1\u7406\u30a4\u30d9\u30f3\u30c8\u3067\u3042\u308a\u3001\u901a\u5e38\u306f\u6700\u4f4e\u3067\u3082IQ\u518d\u691c\u8a3c\uff08\u65b0\u3057\u3044\u30e2\u30fc\u30bf\u30fc\u304c\u5143\u306e\u8a8d\u5b9a\u6e08\u307f\u30e2\u30fc\u30bf\u30fc\u3068\u540c\u3058\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\uff09\u3068OQ\u518d\u691c\u8a3c\uff08\u65b0\u3057\u3044\u30e2\u30fc\u30bf\u30fc\u3092\u53d6\u308a\u4ed8\u3051\u305f\u72b6\u614b\u3067\u88c5\u7f6e\u304c\u4ed5\u69d8\u3069\u304a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\uff09\u304c\u5fc5\u8981\u3067\u3059\u3002\u4ea4\u63db\u7528\u30e2\u30fc\u30bf\u30fc\u304c\u540c\u3058BXG\u30e2\u30c7\u30eb\u304a\u3088\u3073\u5b9a\u683c\u96fb\u529b\u3067\u3001\u540c\u7b49\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u4ed8\u5c5e\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u5909\u66f4\u7ba1\u7406\u306f\u540c\u7b49\u54c1\u4ea4\u63db\u3068\u3057\u3066\u5206\u985e\u3055\u308c\u3001\u5b8c\u5168\u306a\u518d\u8a8d\u5b9a\u3067\u306f\u306a\u304f\u3001IQ\u691c\u8a3c\u3068\u7c21\u5358\u306aOQ\u6a5f\u80fd\u30c6\u30b9\u30c8\u306e\u307f\u3067\u6e08\u307f\u307e\u3059\u3002\u8a8d\u5b9a\u6e08\u307f\u306e\u533b\u85ac\u54c1\u88fd\u9020\u88c5\u7f6e\u306e\u30e2\u30fc\u30bf\u30fc\u3092\u4ea4\u63db\u3059\u308b\u524d\u306b\u3001\u30b5\u30a4\u30c8\u306e\u5909\u66f4\u7ba1\u7406\u624b\u9806\u3092\u78ba\u8a8d\u3057\u3001\u54c1\u8cea\u30c1\u30fc\u30e0\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002Korea Ever-Power\u306f\u3001\u4ea4\u63db\u7528BXG\u304c\u5143\u306e\u8a8d\u5b9a\u6e08\u307f\u30e2\u30fc\u30bf\u30fc\u3068\u540c\u4e00\u306e\u4ed5\u69d8\u304a\u3088\u3073\u6750\u6599\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5909\u66f4\u7ba1\u7406\u30b5\u30dd\u30fc\u30c8\u30ec\u30bf\u30fc\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u540c\u7b49\u54c1\u4ea4\u63db\u306e\u5834\u5408\u306e\u8a8d\u5b9a\u4f5c\u696d\u3092\u8efd\u6e1b\u3067\u304d\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n

\n
\n
\u533b\u85ac\u54c1GMP\u30a8\u30ea\u30a2\u306b\u304a\u3051\u308bBXG\u30e2\u30fc\u30bf\u30fc\u306e\u6700\u5c0f\u6d17\u6d44\u983b\u5ea6\u306f\u3069\u308c\u304f\u3089\u3044\u3067\u3059\u304b\uff1f<\/div>\n<\/div>\n
\n

\u6d17\u6d44\u983b\u5ea6\u306f\u3001\u7279\u5b9a\u306e\u30e2\u30fc\u30bf\u30fc\u8a2d\u7f6e\u5834\u6240\u306e\u6c5a\u67d3\u30ea\u30b9\u30af\u3001\u88fd\u9020\u3055\u308c\u308b\u88fd\u54c1\u3001\u304a\u3088\u3073\u6d17\u6d44\u5264\u306e\u6709\u52b9\u6027\u306b\u57fa\u3065\u3044\u3066\u3001\u691c\u8a3c\u6e08\u307f\u306e\u6d17\u6d44\u624b\u9806\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002Korea Ever-Power\u306f\u6d17\u6d44\u983b\u5ea6\u3092\u6307\u5b9a\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u88fd\u85ac\u4f1a\u793e\u306e\u54c1\u8cea\u304a\u3088\u3073\u691c\u8a3c\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u4e8b\u9805\u3067\u3059\u3002\u6700\u4f4e\u9650\u3001\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308bGMP\u30a8\u30ea\u30a2\u306b\u9069\u7528\u3055\u308c\u308b\u90e8\u5c4b\u306e\u6d17\u6d44\u624b\u9806\u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9C\u30a8\u30ea\u30a2\u3067\u306f\u3001\u901a\u5e38\u3001\u5404\u88fd\u9020\u30d0\u30c3\u30c1\u306e\u524d\u5f8c\u306bIPA\u3067\u6d17\u6d44\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b0\u30ec\u30fc\u30c9D\u30a8\u30ea\u30a2\u3067\u306f\u3001\u6c34\u6027\u6d17\u5264\u6eb6\u6db2\u306b\u3088\u308b\u6bce\u65e5\u306e\u6d17\u6d44\u304c\u691c\u8a3c\u6e08\u307f\u306e\u624b\u9806\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u6d17\u6d44\u624b\u9806\u306f\u3001\u6307\u5b9a\u3055\u308c\u305f\u6d17\u6d44\u5264\u3001\u91cf\u3001\u304a\u3088\u3073\u65b9\u6cd5\u3092\u4f7f\u7528\u3057\u3066\u3001\u8a2d\u7f6e\u4f4d\u7f6e\u306b\u3042\u308bBXG\u30e2\u30fc\u30bf\u30fc\u306e\u8868\u9762\u3092\u5fc5\u8981\u306a\u5fae\u751f\u7269\u304a\u3088\u3073\u5316\u5b66\u7269\u8cea\u6b8b\u7559\u9650\u5ea6\u307e\u3067\u6d17\u6d44\u3067\u304d\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306b\u691c\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n

\n
\n
BXG\u30e2\u30fc\u30bf\u30fc\u306f\u3001\u7d30\u80de\u6bd2\u6027\uff08OEB 4\/5\uff09\u306e\u3042\u308b\u533b\u85ac\u54c1\u88fd\u9020\u30a8\u30ea\u30a2\u3067\u4f7f\u7528\u3067\u304d\u307e\u3059\u304b\uff1f<\/div>\n<\/div>\n
\n

\u7d30\u80de\u6bd2\u6027\u7269\u8cea\u304a\u3088\u3073\u9ad8\u6d3b\u6027\u533b\u85ac\u54c1\u6709\u52b9\u6210\u5206\uff08HPAPI\uff09\u306e\u88fd\u9020\u30a8\u30ea\u30a2\u3067\u3001\u4f5c\u696d\u8005\u66dd\u9732\u30ec\u30d9\u30eb\u304c\u30d0\u30f3\u30c94\u4ee5\u4e0a\u306e\u5834\u5408\u3001\u4f5c\u696d\u8005\u3092\u88fd\u54c1\u66dd\u9732\u304b\u3089\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306b\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u307e\u305f\u306f\u30d0\u30ea\u30a2\u6280\u8853\u304c\u5fc5\u8981\u3067\u3059\u3002\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u307e\u305f\u306fRABS\uff08\u5236\u9650\u30a2\u30af\u30bb\u30b9\u30d0\u30ea\u30a2\u30b7\u30b9\u30c6\u30e0\uff09\u5185\u3067\u306f\u3001\u53ef\u80fd\u306a\u9650\u308a\u30d0\u30ea\u30a2\u58c1\u3092\u8cab\u901a\u3059\u308b\u6a5f\u68b0\u7684\u8cab\u901a\u90e8\u3092\u8a2d\u3051\u3066\u3001\u30e2\u30fc\u30bf\u30fc\u3092\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u5883\u754c\u306e\u5916\u5074\u306b\u8a2d\u7f6e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30e2\u30fc\u30bf\u30fc\u3092\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u5185\u306b\u8a2d\u7f6e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u901a\u5e38\u3001\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u5185\u90e8\u3078\u306e\u6c5a\u67d3\u5236\u5fa1\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u304c\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u7279\u6ce8\u30cf\u30a6\u30b8\u30f3\u30b0\u5185\u306b\u5bc6\u9589\u3055\u308c\u307e\u3059\u3002BXG\u30e2\u30fc\u30bf\u30fc\u672c\u4f53\u3068IP69K\u8a8d\u8a3c\u306f\u3001VHP\u9664\u67d3\u3092\u4f7f\u7528\u3059\u308b\u9664\u67d3\u53ef\u80fd\u306a\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u5185\u90e8\u3078\u306e\u8a2d\u7f6e\u306b\u9069\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u30e2\u30fc\u30bf\u30fc\u3092\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u306b\u7d71\u5408\u3059\u308b\u306b\u306f\u3001\u5c01\u3058\u8fbc\u3081\u5883\u754c\u3001\u9664\u67d3\u30d7\u30ed\u30c8\u30b3\u30eb\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u691c\u67fb\u304a\u3088\u3073\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u30a2\u30af\u30bb\u30b9\u624b\u9806\u3092\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u306b\u3001\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u8a2d\u8a08\u8005\u304a\u3088\u3073\u533b\u85ac\u54c1\u54c1\u8cea\u30c1\u30fc\u30e0\u3068\u7dca\u5bc6\u306b\u9023\u643a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002BXG\u30a2\u30a4\u30bd\u30ec\u30fc\u30bf\u30fc\u7d71\u5408\u30b5\u30dd\u30fc\u30c8\u8cc7\u6599\u306b\u3064\u3044\u3066\u306f\u3001Korea Ever-Power\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
<\/div>\n

 <\/p>\n

\n
\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fd BXG\u30b7\u30ea\u30fc\u30ba IP69K SS316L \u533b\u85ac\u54c1GMP\u5bfe\u5fdc\u30e2\u30fc\u30bf\u30fc<\/div>\n

\u88fd\u85ac\u5de5\u5834\u5411\u3051\u306b\u3001GMP\u6e96\u62e0\u306e\u30e2\u30fc\u30bf\u30fc\u3068IQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h2>\n

\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fcBXG\uff1a\u6750\u8cea\uff1aAISI 316L\u3001IP69K\u3001\u8868\u9762\u7c97\u3055\uff1aRa \u2264 0.8 \u03bcm\u3001FDA 21 CFR\u30b7\u30fc\u30eb\u3001NSF H1\u30b0\u30ea\u30fc\u30b9\u3001\u30af\u30e9\u30b9H\u3001\u51fa\u529b\uff1a0.18\uff5e11 kW\u3002\u6a19\u6e96\u3067\u5b8c\u5168\u306aIQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u4ed8\u5c5e\u3057\u307e\u3059\u3002<\/p>\n

BXG\u30b9\u30c6\u30f3\u30ec\u30b9\u88fd\u54c1\u3092\u898b\u308b<\/a><\/p>\n<\/div>\n<\/div>\n

Cxm\u306b\u3088\u308b\u7de8\u96c6<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

Korea Ever-Power \u00b7 BXG Series \u00b7 Pharmaceutical GMP Drive Guide Stainless Steel Motor for Pharmaceutical GMP Manufacturing: FDA 21 CFR, EU GMP and EHEDG Compliance Guide Pharmaceutical manufacturing facilities operating under Good Manufacturing Practice (GMP) regulations must ensure that all equipment in contact with or above product and product-contact surfaces is constructed to prevent contamination of the pharmaceutical product. Motors installed in GMP zones are required to have smooth, corrosion-resistant, cleanable surfaces, no horizontal ledges that retain particulate or liquid, no crevices that harbour microbial contamination, and documented cleaning and inspection procedures. This guide covers the motor specification for GMP drug substance and drug product manufacturing using the Korea Ever-Power […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[28],"tags":[],"class_list":["post-229","post","type-post","status-publish","format-standard","hentry","category-industrial-electric-motor"],"_links":{"self":[{"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/posts\/229","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/comments?post=229"}],"version-history":[{"count":1,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/posts\/229\/revisions"}],"predecessor-version":[{"id":230,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/posts\/229\/revisions\/230"}],"wp:attachment":[{"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/media?parent=229"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/categories?post=229"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/ja\/wp-json\/wp\/v2\/tags?post=229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}