Regulatory statements
Find statements on product origin, environmental standards and regulatory alignment — supporting GMP and global requirements.
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
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
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
Cytiva’s approach on regulatory related topics
- 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
Frequently asked questions
How can I open a document in the browser instead of downloading it to the computer?
To open Accelerator™ documentation center PDF files in any internet browser instead of downloading them:
- Click the ‘VIEW’ button.
For all other PDF Files
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 can I change my contact details in order to be notified at a new email address?
Please create a new account. Then inform us of the change at ACMS/Accelerator™ documentation center account, contact ACMS-doccontrol@cytiva.com. For all other documentation, contact RegulatorySupport@cytiva.com.
Please 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.