Regulatory statements
Find statements on product origin, environmental standards and regulatory alignment — supporting GMP and global requirem
Supporting your regulatory needs
Cytiva provides documentation to help you meet requirements for product in regulated environment — including chromatography resins, cell-culture media, single-use consumables, and filtration systems.
Each statement is based on verified information from our qualified material suppliers or through testing performed by Cytiva. We work closely with them through a rigorous qualification and auditing process to ensure every material meets defined specifications.
Find the relevant documents below.
Available regulatory statements
Find and download official documents related to product quality, compliance, and manufacturing standards.
Product environmental statements
- REACH - Cytiva
- SVHC affected articles - Cytiva (PDF)
- SVHC affected articles - Cytiva (XLSX)
- RoHS statement letter
- Statement on Substances of concern
- PFAS statement letter
- POP statement letter
- California Prop 65 statement letter
- TSCA PBT statement letter
- Microplastics Reporting Guidance Datasheet
- Recycling of WEEE and batteries
Bioprocess chromatography resins and ReadyToProcess™ columns
Cell and gene therapy products
- 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
Cytiva bioprocess single-use consumables and filtration products
Pall bioprocess single-use consumables and filtration products
- 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
- CERTIFICATE OF CONFORMITY FOR (K) OR ()()()()-()()()() O-RING KITS
Pall medical product safety data information
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
Cybersecurity Statements
Cytiva’s approach on regulatory related topics
Explore our regulatory documentation centers
Cytiva offers two platforms:
Go to the regulatory support documentation portal for RSFs, VGs, CCNs and extractables data.
Use the Accelerator™ documentation center for Allegro™ compliance documents and drawings.
Frequently asked questions
How can I open a document in the browser instead of downloading it to the computer?
To open PDF files in Firefox instead of downloading it:
- Open the menu on top right corner, and navigate to “Options”.
- Scroll to “Files and Applications” section of the “General” tab.
- In applications search for PDF Content Type, and select “Open in Firefox” action.
To open PDF files in Chrome instead of downloading it:
- Ensure that “Adobe Acrobat®” or “PDF Viewer” Chrome extension is installed and enabled.
- Go by pass chrome://settings/content/pdfDocuments to “PDF documents” settings.
- Select “Download PDF files instead of automatically opening them in Chrome” then switch it to "Off".
Acrobat is a registered trademark or trademark of Adobe in the United States and/or other countries. Google Chrome is a trademark of Google Inc. Firefox is a trademark of Mozilla Foundation. Pall is a trademark of Pall Corporation. Any other third-party trademarks are the property of their respective owners.
How do I change the contact person for a RSF/VSF/VG/Accelerator™ documentation center or CCN?
Please send us an email to let us know who will be replacing whom. For ACMS/Accelerator™ documentation center accounts, email acms-doccontrol@cytiva.com. For all other subscriptions, email regulatorysupport@cytiva.com. The new contact person must be registered for a Cytiva account before the subscriptions can be transferred. Note that it is possible to register a generic company email address.
How do I get a new password?
Click Forgot password? on the login page.