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日本代购-放射線滅菌の実務と包装・滅菌バリデーションおよび安定性試験のポイント
  • ecompliance:10000018
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日本代购-講師 大塚テクノ株式会社 滅菌バリデーション責任者 長嶋 和浩(ながしま かずひろ) 氏 総収録時間 288分 納品方法 セミナー映像・資料はDVDで納品いたします。 出版社 株式会社イーコンプレス 出版年月日 2020年10月22日 内容情報 1.放射線滅菌の実務  1−1.放射線と放射能  1−2.滅菌の原理(殺滅菌のメカニズム)  1−3.滅菌法(ガス・放射線・湿熱)比較および最適な滅菌法の選択  1−4.ガス滅菌から放射線滅菌への切替  1−5.滅菌切替事例とノウハウ(直面した課題事例)  1−6.電子線滅菌とガンマ線滅菌の使い分け  1−7.滅菌コスト低減策  1−8.放射線照射施設概要(電子線およびガンマ線照射施設)  1−9.照射対象事例(放射線滅菌の実施例) 2.放射線滅菌バリデーションのポイントと実務  2−1.適用規格・薬機法および最新動向  2−2.滅菌バリデーション概要(進め方・試験ポイント)  2−3.放射線滅菌製品の滅菌実務と承認申請に関する通知にかかる対応について  2−4.滅菌線量設定方法の選択基準  2−5.製品ファミリーを代表する製品の指定(検体数低減)  2−6.プロセス有効性の維持(滅菌線量監査)  2−7.再バリデーション事例  2−8.汚染菌同定および同定結果活用の事例  2−9.QMS適合性調査の状況等  2−10.医療機器 Good Review Practice(GRP) 3.包装バリデーションのポイントと実務および放射線照射による包装材料への影響  3−1.医療機器の包装ガイドライン  3−2.JIS T 0841 の2019年3月改定のポイント       −最終段階で滅菌される医療機器の包装−  3−3.ISO11607-1:2019 新規要求事項  3−4.包装(無菌バリアシステム)バリデーションの実施例  3−5.放射線照射による揮発性物質の分析  3−6.包装材料の微生物汚染と原反へのγ線照射事例  3−7.放射線滅菌に要求される包装材とは?  3−8.耐放射線包材の開発事例・経緯 4.放射線滅菌における安定性試験のポイントと実務  4−1.安定性及び耐久性(安定性試験)  4−2.最大許容線量の確立(最大線量を踏まえた妥当な試験検体)  4−3.材質劣化の資料(添付資料と宣誓書)  4−4.長期保存試験と加速試験の取扱い(有効期間の設定に係る安定性試験の取扱い)  4−5.安定性試験の実施例  4−6.放射線照射による材質への影響と樹脂劣化対策 注意事項 納品後のキャンセルはお受けできませんので予めご了承ください。イーコンプレスVOD配信セミナー セミナー映像・資料はDVDで納品 自主学習・企業内でのグループ研修におすすめ 新人社員研修などに最適 地方や自宅(テレワーク)でも受講できる
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Process: 0.184s ( Load:0.008s Init:0.009s Exec:0.161s Template:0.006s ) | DB :23 queries 0 writes | Cache :6 gets 2 writes | UseMem:26,624 kb
页面Trace信息
当前页面 : /index.php/Rakuten/ShopView/id/ecompliance:10000018.html
请求方法 : GET
通信协议 : HTTP/1.1
请求时间 : 2025-07-25 20:46:04
用户代理 : Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)
会话ID : rigf0ut3lk8ft2on75ctm87gu5
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输出编码 :
加载类库 : 33
模板编译 : 重新编译
SQL记录 : 23条SQL
[ 25-07-25 20:46:07 ] RunTime:0.000554s SQL = SHOW COLUMNS FROM bio_yahooid
[ 25-07-25 20:46:07 ] RunTime:0.000724s SQL = SHOW COLUMNS FROM bio_agent
[ 25-07-25 20:46:07 ] RunTime:0.000274s SQL = SELECT * FROM bio_agent WHERE ( `isViews` = 1 ) AND ( `domain` LIKE '%test.ripai.com' )
[ 25-07-25 20:46:07 ] RunTime:0.000234s SQL = SELECT * FROM bio_agent WHERE ( `domain` = 'www.jp-daigou.com' )
[ 25-07-25 20:46:07 ] RunTime:0.000259s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
[ 25-07-25 20:46:07 ] RunTime:0.000287s SQL = SHOW COLUMNS FROM bio_point
[ 25-07-25 20:46:07 ] RunTime:0.000886s SQL = SHOW COLUMNS FROM bio_user
[ 25-07-25 20:46:07 ] RunTime:0.000502s SQL = SELECT * FROM bio_goods WHERE `isView` = 1 and gType<=3 ORDER BY created DESC LIMIT 15
[ 25-07-25 20:46:07 ] RunTime:0.000330s SQL = SHOW COLUMNS FROM bio_syscolumn
[ 25-07-25 20:46:07 ] RunTime:0.000269s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = 17 ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-25 20:46:07 ] RunTime:0.000318s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '19' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-25 20:46:07 ] RunTime:0.000229s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '89' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-25 20:46:07 ] RunTime:0.000283s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '20' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-25 20:46:07 ] RunTime:0.000258s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '18' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-25 20:46:07 ] RunTime:0.000654s SQL = SHOW COLUMNS FROM bio_rakutencategory
[ 25-07-25 20:46:07 ] RunTime:0.000321s SQL = SELECT * FROM bio_rakutencategory WHERE id=101379
[ 25-07-25 20:46:07 ] RunTime:0.000182s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101379
[ 25-07-25 20:46:07 ] RunTime:0.000182s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=500182
[ 25-07-25 20:46:07 ] RunTime:0.000218s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101354
[ 25-07-25 20:46:07 ] RunTime:0.000187s SQL = SELECT p.id,p.name_cn FROM bio_rakutencategory p LEFT JOIN bio_rakutencategory c on c.parentid=p.id WHERE c.id=101240
[ 25-07-25 20:46:07 ] RunTime:0.000175s SQL = SELECT * FROM bio_rakutencategory WHERE parentid=101379
[ 25-07-25 20:46:07 ] RunTime:0.000422s SQL = SHOW COLUMNS FROM bio_rate
[ 25-07-25 20:46:07 ] RunTime:0.000172s SQL = SELECT * FROM bio_rate WHERE ( `type` = 'RMB->JPY' ) ORDER BY date desc LIMIT 1
错误记录 : 100条错误
[ 25-07-25 20:46:07 ] 注意:[8] A session had already been started - ignoring session_start() App.class.php 第 115 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated apiExecuter.php 第 253 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated apiExecuter.php 第 284 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated getApiData.php 第 125 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated getApiData.php 第 134 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated getApiData.php 第 499 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Request.php 第 412 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Request.php 第 736 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Request.php 第 749 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Request.php 第 794 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Redefining already defined constructor for class Net_URL URL.php 第 122 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Unserializer.php 第 691 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Unserializer.php 第 693 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Unserializer.php 第 852 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Redefining already defined constructor for class XML_Parser Parser.php 第 206 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Parser.php 第 576 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Declaration of XML_Parser::raiseError() should be compatible with that of PEAR::raiseError() Parser.php 第 634 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: openid BaseAction.class.php 第 72 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: Debug BaseAction.class.php 第 174 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: uid BaseAction.class.php 第 209 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
[ 25-07-25 20:46:07 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 228 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined offset: 11 BaseAction.class.php 第 349 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe forbidcates.php 第 108 行.
[ 25-07-25 20:46:07 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: appid getApiData.php 第 417 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe getApiData.php 第 436 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe getApiData.php 第 447 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugYourMa getApiData.php 第 450 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe getApiData.php 第 468 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe getApiData.php 第 481 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: options Unserializer.php 第 448 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 509 行.
[ 25-07-25 20:46:07 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context RakutenAction.class.php 第 595 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe RakutenAction.class.php 第 607 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: categoryPath RakutenCategoryGetter.class.php 第 55 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: isDebugMe forbidcates.php 第 108 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: showmiddleOfIndex bf17f8f5a76a9d7e9186c4c573d8f8fc.php 第 2 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: meta_keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 7 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 42 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: U 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 59 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 97 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 121 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 134 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 150 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 201 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: category 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 278 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: so 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 280 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: dr 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 281 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 286 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: shopcode 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 296 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: minPrice 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 300 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: maxPrice 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 301 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 453 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: category 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 454 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: so 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 456 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: dr 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 457 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 462 行.
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[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: Act 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 464 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: sellerID 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 476 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: store 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 486 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: store 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 489 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: store 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 492 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: item_status 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 503 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: item_status 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 506 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: item_status 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 509 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: wrappingicon 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 520 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: buynow 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 523 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: thumbnail 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 525 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: aucminprice 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 537 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined index: aucmaxprice 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 538 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: isindex 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 577 行.
[ 25-07-25 20:46:07 ] 注意:[8] Undefined variable: url 97ae39e43927d85ac9989230a15609a2.php 第 4 行.