Cytiva

Explore

  • Applications
    • Bioprocessing
    • Cell and Gene Therapy
    • Cellular Analysis
    • Diagnostics
    • Emerging Biotech
    • Enterprise Solutions
    • Genomics
    • Lab Filtration
    • Protein Research
  • Products
  • Service & Support
  • Our Company
    • About Us
    • Our Brands
    • News Center
    • Careers
  • {{main.productCount}} {{main.productCount}}
    Your Cart
    Showing {{main.getNumberOfShowingResults(main.products)}} of {{main.products.length}} items

    You don't have any items in your cart yet.

    {{item.qty}} x {{item.productName}} Product Code: {{item.catalogCode}} Pack Size: {{item.packSize}} Price: {{item.price}} {{item.unitPrice}} {{item.currency}}
    Subtotal
    {{main.subtotal}} {{main.currency}}
    Checkout now
Service & Support
  • Product Documentation
    • Certificates
    • Hyclone Certificates & Documents
    • Labels Search
    • Safety Data Sheets
  • Services
    • OptiRun Service Solutions
    • Biomanufacturing Services
    • Scientific Support
    • Instrument qualification services
  • Quality
    • Regulatory Support
    • Bioprocess Regulatory Statements
    • Extractables Information
    • Quality Management Documents
  • Contact Us
  • Find a Distributor

Please change the country on your profile in order to switch to another country store.

Edit Profile

Extractables information

Extractables information
  • Bioprocess Regulatory Statements
  • Extractables information
  • FAQ
  • Quality Management
  • Regulatory Support

Extractables and bioprocess products

In bioprocessing, minimizing potential safety risk to patients is of highest priority. Part of that is ensuring that no harmful leachable compounds can find their way into the product from production equipment or storage materials.

Our expertise from the bioprocess industry tells us the value single-use technologies deliver. For this reason, we take extractables and leachables (E&L) very seriously. Our bioprocess products are meticulously designed to minimize the risk of leachables impacting drug safety and efficacy. We are also committed to standardize E&L testing for bioprocess products, improving safety and reducing confusion in the industry.

Here are a few ways we are contributing:

  • Comprehensive extractables information on our products
  • Alignment with the extractables protocol published by BioPhorum Operations Group (BPOG)
  • E&L testing service for customers

Comprehensive extractables information

In our view, bioprocess technology manufacturers should be responsible for extractables testing of their components. We therefore offer extractables information for our products.
For assistance in identifying available extractables data by product, please refer to the Extractables Data Guide below.
By logging in to the regulatory support application, you can access relevant extractables data for use in your own risk assessments.

Access extractables information

Alignment with the BPOG extractables protocol

We test new products in line with the BPOG extractables protocol and update past products in a staggered approach. To find out how we do this, download the white paper Single-use extractables and leachables: Cytiva's alignment with the BPOG protocol.

Extractables Data Guide & BioPhorum Extractables Status

  • United States
Applications
  • Bioprocessing
  • Cell and Gene Therapy
  • Cellular Analysis
  • Enterprise Solutions
  • Genomics
  • Lab Filtration
  • Protein Research
Shop
  • Find a Distributor
  • Order Status
  • Register With Us
  • Shipping Information
  • Special Offers
Our Company
  • About Us
  • Newsroom
  • Careers
  • Events
Support
  • Support
  • Certificates
  • Contact Us
  • Handbooks
  • Regulatory
  • Safety Data Sheets/SDS
  • Tools & Calculators
  • Training
© 2021 Cytiva TermsPrivacyManage CookiesTrademarksPreferences