Cytiva recognizes the importance of supplying information to support our customers in fulfilling regulatory requirements.
The statements primarily concern BioProcess chromatography resin products, cell culture products, single-use consumables and filtration products, and are applicable to products aimed for use in GMP environments. The information contained in the statements has been obtained from our material suppliers.
Cytiva assures that purchases of materials conform to specific requirements and that materials are acquired from qualified suppliers. This is achieved through working closely with our suppliers and through a robust qualification process and supplier monitoring process, including continuous supplier audits for materials essential to function.
Download statements:
- 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
- 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
- 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
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
- 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 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