监管声明
查找有关产品产地、环境标准与法规符合性的声明 — 支持 GMP 及全球监管要求。
支持监管需求
Cytiva 提供文档支持，助您达成受监管环境下的产品要求 — 包括层析填料、细胞培养基、一次性耗材与过滤系统。
每项声明均依据我们合格物料供应商提供的已验证信息，或通过 Cytiva 测试结果来制定。我们通过严格的供应商资质认证与审计流程与其展开紧密合作，以确保每种材料均符合既定规格标准。
现有监管声明
查找并下载与产品质量、合规性及制造标准相关的官方文档。
产品环境声明
- REACH - Cytiva
- SVHC affected articles - Cytiva (PDF)
- SVHC affected articles - Cytiva (XLSX)
- General Information on RoHS Compliance
- Statement on Substances of concern
- PFAS statement letter
- POP statement
- California Prop 65 statement letter
- TSCA PBT statement letter
- Microplastics Reporting Guidance Datasheet
生物工艺层析填料与 ReadyToProcess™ 层析柱
细胞和基因治疗产品
- Animal origin – Sepax C-Pro and Sefia Select system single use kits and accessories
- Animal origin - Ficoll PM400 and Ficoll PM 70
- Animal origin - Ficoll-Paque PLUS and Ficoll-Paque PREMIUM
- Animal origin - Percoll, Percoll PLUS and Redigrad
- Latex - Sepax C-Pro and Sefia Select system single use kits and accessories
- Nitrosamines - Sepax C-Pro and Sefia Select system single use kits and accessories
Pall 生物工艺一次性耗材和过滤产品
- Statement of Compliance, Material safety statement for Pall single use systems
- Statement of Compliance, Use of Allergenic Substances
- Elemental Impurities Statement for Pall Pharmaceutical-Grade Filter Cartridges / Capsules and Single-Use Components
- Statement of Compliance, Use of Genetically Modified Organisms (GMOs)
- Statement of Compliance, Use of Natural Latex
- Statement of Compliance, Minimization of Transmission of Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE)
- Statement of Compliance, Shelf-Life and Recommended Customer Storage Conditions for Allegro Single-Use Systems
- Statement of Compliance, Nitrosamine Statement
- Pall Packaging Materials used with Pall Single-Use Systems, Filtration Products and Equipment
Pall 医疗产品安全数据信息
Disposable Filter Elements
- 25mm 32mm Gardian Family
- 791-08
- Acrocap with Versapor RC Family
- AEF_Family
- Aquasafe S-Series filters
- Breathing Circuits and Kits Family
- Breathing Filter Family
- Cell Therapy Product Family
- ELD96 Family
- Gas Line Filter Family
- Hydrostripe Supor Filter Family
- IGF1 Family
- IV and Acrocap Family
- Laparoshield Laparoscopic Surgical Smoke Filter Family
- NEO96 Family
- NLF Family
- Pall-Aquasafe Mini Plus Family
- Pall-Aquasafe Showerhandle Family
- PF30 Family
- PTFE Gas Filter Family
- QPoint Family
- Syringe filters w Ultipor Family
- Syringe Filters w Versapor Family
- Syringe filters with Polyscreen Family
- Syringe filters with Versapor RC Family
- TNA Family
- Ultipor 50 Family
Filter Membranes
- Asymmetric polyethersulfone membranes
- BTS membrane Family
- CytoSep Membrane
- Emflon hydrophobic membrane
- Glass Fiber A-8951 Membrane
- Hydrophilic laminated polyethersulfone membrane
- Hydrophilic Polyethersulfone Membrane
- Hydrophilic positive charged polyethersulfone membrane
- Hydrophobic Glass Fibre Media
- MM20EV asymmetric polysulfone membranes
- Nylon Membrane Family
- Polyester melt blown membranes
- Polypropylene melt blown membranes
- Positive Charged Nylon membrane
- Supor RKC membranes
- Versapor R membranes
- Versapor RC membranes
- Versapor W WA TN membranes
- Versapor WO WA membranes
- XT_028FX hydrophobic glass fibre
Cytiva 针对监管相关主题所采取的方式
- Cytiva’s Humanitarian and Compassionate Use Medical Product Policy
- EU Data Act Information
- EudraLex Annex 1 Manufacture of Sterile Medicinal Products - FAQs and Clarification of Potentially Ambiguous Statements
- Pre-Use Post Sterilization Integrity Test – PUPSIT
- PUPSIT Risk Assessment
- RNase Impurities in Single-Use Systems
常见问题解答
如何使用浏览器打开文档而不是下载到计算机上？
要在任何互联网浏览器中打开 Accelerator™ 文档中心的 PDF 文件，而不是下载它们：
- 点击"查看"按钮
适用于其他所有 PDF 文件
如需在 Firefox 中打开但不下载 PDF 文件：
- 打开右上角的菜单，然后导航至“选项”。
- 滚动至“通用”选项卡下的“文档与应用程序”部分。
- 在应用程序中搜索 PDF 内容类型，并选择“在 Firefox 中打开”操作。
如需在 Chrome 中打开但不下载 PDF 文件：
- 确保已安装并启用 “Adobe Acrobat” 或 “PDF Viewer” Chrome 浏览器扩展程序。
- 通过访问 chrome://settings/content/pdfDocuments 来进入“PDF 文档”设置。
- 选择“先下载 PDF 文件，而非在 Chrome 中自动打开”选项，并将其切换至“关闭”状态。
Acrobat® 是 Adobe 公司在美国和/或其他国家/地区的注册商标或商标。Google Chrome 是 Google Inc. 的商标。Firefox 是 Mozilla Foundation 的商标。Pall 是 Pall Corporation 的商标。任何其他第三方商标均为其各自所有者的财产。
如果我想使用新电子邮件地址接收通知，我该如何变更我的联系信息？
请创建一个新帐户。随后通过 ACMS/Accelerator™ 文档中心帐户向我们报备此变更，联系方式为：ACMS-doccontrol@cytiva.com。若需了解其他所有文档的处理方式，请联系RegulatorySupport@cytiva.com。
请注意，可以使用公司统一的电子邮件地址进行注册。
如何获得新密码？
在登录页面上点击忘记密码。