WFI 滅菌注射用水、容器入り ザルトリウス・ステディムの滅菌注射用水 (WFI)、容器入り製品は欧米の薬局方基準を上回る厳密な業界基準に従っ て製造・品質検査されています。 ・ cGMP ( 米国医薬品適正製造基準 ) 適合基準で製造 ・ バックアップ体制の強化 ( 欧米の 2 つの製造工場にて生産ラインを増強 ) ・ お客さまのご要望に合わせたカスタマイズ ( 大容量、3D バッグ ) ・ すべてのサイズについて一貫した製造方法、 ドキュメンテーション管理を実施 ・ 調液とフィルター製品の洗浄作業を効率化 特長 滅菌注射用水 ( 容器入り ) 製品には、標準品として 500 mL、1 L サイズのボトルと 20 L、100 L、200 L サイズのバッグが ございます ( ご要望に応じて容器、容量のカスタマイズも可能です )。納品後すぐにお客さまのアプリケーションに合わ せて使用可能な滅菌注射用水 ( 容器入り ) のほかに、すぐに使用可能な細胞培地、緩衝液、臓器移植用溶液としての ご提供も可能です。 納期：受注後 24 時間～ 1 週間 ( アジア地区への納品の場合は 2 週間 ) 製造施設 cGMP 21CFR820 に準拠、ISO 9001 および ISO 13485 認証取得 アプリケーション 出荷証明書に当製品品質を明記しております。 アップストリームプロセス：培地調製と調液 ダウンストリームプロセス：緩衝液の調製 両プロセス：洗浄、リンス ( フィルター、機器 ) 特長 エンドトキシンレベルの管理と滅菌 利点 コンタミネーションを最小化 cGMP 21CFR820 の環境下における製造 関連法規への準拠、 リスクの軽減 お客さまサイトでのWFI製造が不要 大幅なコスト削減 製品詳細 滅菌注射用水 ( 容器入り ) は欧米の薬局方基準に適合した条件で生産、ろ過滅菌グレードフィルターのザルトポア 2 で ろ過処理後ボトルまたはバッグに充填を行っています。 – 標準品としてボトル (500 mL、1 L)、バッグ (20 L、100 L、200 L) をご用意しています。 非経口投与の用途以外は容器入りの滅菌注射用水をご使用いただけます。 ザルトリウス・ステディムの滅菌注射用水グレードの製品は、現行の欧米薬局方の基準に適合、認可された製造シ ステムにおいて無菌処理を行っておりますが、用時調製配合剤や注射用薬剤の希釈を目的として使用される注射用 滅菌水とは性質を異にします。また、注射用滅菌水は単回投与用の容器の使用が義務付けられておりますが、この 場合の最大容量は 1 L が限度です。 この製品は cGMP 21CFR820 の条件下、バリデートされたろ過滅菌により無菌製造しており、現行の米国および欧州の 薬局方に準拠した方式で試験済です。 この製品は研究機関・製造施設用に製造されています。体外診断目的での使用については確立されておらず、お客さま の用途に適合するかどうかの確認はお客さまご自身にお願いしております。 出荷証明書 (CoA) Printed on, 30-May-2014 09:20 Page 1/ 1 ______________________________________________________________________________ Printed on, 30-May-2014 09:20 1/ 1 Printed on, 09-Jul-2014 16:56 4MB001 07-Jan-2014 07-Jan-2016 Product Code: Product: 1/ 1 Printed on, 09-Jul-2014 16:56 3MB240 29-Oct-2013 29-Oct-2015 Product Code: Product: 1/ 1 CERTIFICATE OF ANALYSIS Lot Number: Manufacture Date: Expiration Date: 08-199E Water for Injection (Bulk Pkg.-Comm. Use Elsewhere) Page ______________________________________________________________________________ CERTIFICATE OF ANALYSIS Lot Number: Manufacture Date: Expiration Date: BE02-038P200 Bulk Packaged sterile filtered WFI EP-USP Tested, 200L bag Page ______________________________________________________________________________ CERTIFICATE OF ANALYSIS Lot Number: Manufacture Date: Expiration Date: BE02-038P20 Bulk Packaged sterile filtered WFI EP-USP Tested, 20L bag Page ______________________________________________________________________________ CERTIFICATE OF ANALYSIS Product Code: Product: 0000419403 25-Jun-2014 24-Jun-2016 Product Code: Product: Lot Number: Manufacture Date: 08-199F Water for Injection (Bulk Pkg.-Comm. Use Elsewhere) 0000414848 12-May-2014 _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ TEST (Method) TEST (Method) TEST (Method) TEST (Method) SPECIFICATIONS Min. Max. Results Endotoxin E.P. Sterility (EP and USP) Tested according to current USP Particulate matter *** Negative <0.25 Negative < 0.005 Negative *** Conforme Pass Water Conductivity Oxidizable substances Tested according to current EP Acidity or alkalinity Conductivity Oxidizable substances Chlorides Nitrates *** *** Conforme Conforme Pass Pass *** *** *** *** *** Conforme Conforme Conforme Conforme Conforme Sulfates Ammonia Calcium and magnesium Residue after evaporation Particulate matter *** *** *** *** *** Conforme Conforme Conforme Conforme Conforme SPECIFICATIONS Min. Max. Results Endotoxin E.P. Sterility (EP and USP) Tested according to current USP Particulate matter *** Negative <0.25 Negative < 0.005 Negative *** Conforme Pass Water Conductivity Oxidizable substances Tested according to current EP Acidity or alkalinity Conductivity Oxidizable substances Chlorides Nitrates *** *** Conforme Conforme Pass Pass Pass Pass Pass Pass Pass *** *** *** *** *** Conforme Conforme Conforme Conforme Conforme Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass Sulfates Ammonia Calcium and magnesium Residue after evaporation Particulate matter *** *** *** *** *** Conforme Conforme Conforme Conforme Conforme Pass Pass Pass Pass Pass _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Bulk packaged for commercial use elsewhere, not for parenteral administration. Our WFI Quality Water is aseptically processed from a validated Water For Injection System that meets current USP and EP specifications.Our WFI Quality Water is not to be confused with Sterile Water for Injection which is intended for use in extemporaneous prescription compounding, and as a diluent for injectable parenteral products. In addition, Sterile Water for Injection must be packaged in single dose containers not larger than 1 liter in size. This product was product was manufactured aseptically under cGMP conditions by a validated sterile filtration method and tested according to current U.S.P. and E.P. This product has been produced for laboratory/ manufacturing use. Use for in vitro diagnostic procedures has not been established. It is the end user's responsibility to ensure that the final products meets the requirements of the application for which it is. Manufactured aseptically under cGMP conditions by a validated sterile filtration method and tested according to current U.S.P. and E.P. This product has been produced for laboratory/ manufacturing use. Use for in vitro diagnostic procedures has not been established. It is the end user's responsibility to ensure that the final products meets the requirements of the application for which it is. This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's Quality System. This document was generated from a validated Part 11-compliant electronic system and thus handwritten signatures are not required. This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's Quality System. This document was generated from a validated Part 11-compliant electronic system and thus handwritten signatures are not required. For Technical Assistance, call +32 87 32 16 11 E- Mail: [email protected] Min. Max. Results SPECIFICATIONS _____________________________________________________________________________ Min. Max. Results USP Testing of Water: Sterility Endotoxin-Media (EU/ml) USP Testing of Water: Conductivity Negative *** *** < 0.250 Negative 0.014 EU/ml Pass: Meets USP Requirements Pass TOC (1) Pass: Meets USP Requirements Pass _____________________________________________________________________________ This product is processed from a validated Water for Injection (WFI) system that is tested and meets or exceeds USP and EP criteria. It is manufactured aseptically under cGMP conditions using a validated sterile filtration system. Lonza's WFI, bulk packaged, is not to be confused with Sterile WFI, which is intended for use in extemporaneous prescription compounding, and as a diluent for injectable parenteral products. In addition, Sterile WFI must be packaged in single dose containers not larger than 1 liter in size. Lonza's WFI system is monitored _____________________________________________________________________________ for microbial contamination, endotoxin, conductivity, total organic carbon, and inorganic attributes. Lonza's WFI, bulk packaged, has not been established for use in in vitro diagnostic procedures. It is the end users responsibility to ensure that this product meets the requirements of the application for which it is to be used. This product is processed from a validated Water for Injection (WFI) system that is tested and meets or exceeds USP and EP criteria. It is manufactured aseptically under cGMP conditions using a validated sterile filtration system. Lonza's WFI, bulk packaged, is not to be confused with Sterile WFI, which is intended for use in extemporaneous prescription compounding, and as a diluent for injectable parenteral products. In addition, Sterile WFI must be packaged in single dose containers not larger than 1 liter in size. Lonza's WFI system is monitored for microbial contamination, endotoxin, conductivity, total organic carbon, (1)TOC tested at source at time of production. and inorganic attributes. Lonza's WFI, bulk packaged, has not been established for use in in vitro diagnostic procedures. It is the end users responsibility to ensure that this product meets the requirements of the application for which it is to be used. (1)TOC tested at source at time of production. _____________________________________________________________________________ Bulk packaged for commercial use elsewhere, not for parenteral administration. Our WFI Quality Water is aseptically processed from a validated Water For Injection System that meets current USP and EP specifications. Our WFI Quality Water is not to be confused with Sterile Water for Injection which is intended for use in extemporaneous prescription compounding, and as a diluent for injectable parenteral products. In addition, Sterile Water for Injection must be packaged in single dose containers not larger than 1 liter in size. This _______________________________________________________________________ SPECIFICATIONS _____________________________________________________________________________ _______________________________________________________________________ For Technical Assistance, call +32 87 32 16 11 E- Mail: [email protected] This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's Quality System. This document was generated from a validated Part 11-compliant electronic system and thus handwritten signatures are not required. _______________________________________________________________________ For Technical Assistance, call 1-800-521-0390 This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's Quality System. This document was generated from a validated Part 11-compliant electronic system and thus handwritten signatures are not required. _______________________________________________________________________ For Technical Assistance, call 1-800-521-0390 出荷証明書は、販売しているすべての製品に添付されております。 出荷証明書は地域・容器サイズによって個別に発行されます。 製品番号 製品名 BE17-724F 細胞培養用水―滅菌注射用水 ( 容器入り ) 500 mL ボトル BE17-724Q 細胞培養用水―滅菌注射用水 ( 容器入り ) 1 L ボトル BE02-038P20 細胞培養用水―滅菌注射用水 ( 容器入り ) 20 L バッグ 08-199D 細胞培養用水―滅菌注射用水 ( 容器入り ) 100 L バッグ BE02-038P200 細胞培養用水―滅菌注射用水 ( 容器入り ) 200 L バッグ ザルトリウス・ステディム・ジャパン株式会社 ザルトリウス・ステディム・ジャパン株式会社 〒 140-0001 〒 140-0001 東京都品川区北品川 1-8-11 東京都品川区北品川 1-8-品川 11 North ビル 4 階 Daiwa 4 階 Daiwa 品川 North ビル TEL.(03)4331-4300 FAX.(03)4331-4301 TEL.(03)4331-4300 FAX.(03)4331-4301 http://www.sartorius.co.jp/ http://www.sartorius.co.jp/ カタログNo.BT66 ※本記載内容は予告なく変更することがあります。本カタログ内容を、弊社の承諾なしに複写・複製することは禁じられています。 ※本記載内容は予告なく変更することがあります。本カタログ内容を、弊社の承諾なしに複写・複製することは禁じられています。
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