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1A Clean WFI quality water USP/EP
Water for Cell Culture

Water for Cell Culture

for laboratories, research institutes, pharmacies and

medical fields

 

 *Not for parenteral administration

 

Water for Injection is widely used as a raw material, ingredient and solvent in the processing, formulation and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs), intermediates and analytical reagents. It is commonly used for cell suspensions, preparation of cell culture media, reconstitution of biochemical reagents, and hygiene purposes.

 

Water for Injection must meet strict quality standards. The European Pharmacopoeia (EP) specifies the requirements for water for injections (WFI).

 

1A Clean WFI – Water for Cell Culture is manufactured in ISO-certified facilities according to cGMP guidelines and filled in 2D bags. 

 

1A Clean WFI - Water for Cell Culture is subjected to an extensive cleaning process,
to meet or exceed the stringent European and United States Pharmacopeia (EP/USP) specifications. This makes our WFI-quality water suitable for a wide range of upstream and downstream applications.

Each batch of 1A Clean WFI  Water for Cell Culture is released based on EP (European Pharmacopoeia) and USP (United States Pharmacopoeia) specifications.
This guarantees our customers easy compliance with regulatory requirements.

This is how we ensure the highest level of quality and performance.

 

1A Clean WFI – Water for Cell Culture is intended for research purposes or for further use in production processes.  This product is NOT intended for direct therapeutic use in humans.

We supply 1A Clean WFI in single use 2D bags and it is used in many steps of the cell culture process. It is the main component of buffers and media, it is used to dissolve additives, as well as to rinse bioreactors, plastic and glassware.

bags and packaging

Specifications 2D Bags

 

BSE-TSE Status: Raw material according to European Directive EMA/410/01

Fluid path USP Class VI classified

Sterilized to AAMI TIR33 with 10-6 Sterility Assurance Level (SAL) Gamma

Available in 10 and 20 liter sizes - other sizes on request.

 

The 2D single use bags we use are specially designed for use in the field of biotechnology and diagnostics. The product touching layer of the single-use bags we use in the 2D area consists of ethyl vinyl acetate (EVA). For many users, the 2D single-use bags represent easier handling and a one way alternative to conventional PET/PETG/glass or stainless steel containers/bottles.

 

After sterile filling, the 2D bag systems are securely packaged and, after successful quality control, are made available for immediate use by the customer.

 

standard connections

 

Port 1: MPC Male
Port 2: MPC Female
Port 3: Injection site

 

Box system for the delivery of 2D bags

 

We only use selected and specially tested packaging systems for 2D bags. The type of packaging depends on the size of the 2D bag.
 

Advantages:

Environmentally friendly and reusable

packaging systems.

 

Collection / return delivery is planned together.

Bags Standard Anschlüsse.JPG
Boxsystem für Lieferung 2D Bags.JPG

1A Clean WFI quality water USP/EP Water for Cell Culture

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