1
For the pharmaceutical, biotech, cosmetics, food and beverage industries
​
*Not suitable 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 used in disinfection and rinsing processes as well as in cleaning agents for production facilities in the biotech, pharmaceutical, cosmetics, food and beverage industries.
Pharmaceutical production water must meet strict quality specifications. The European Pharmacopoeia (EP) specifies the requirements for water of water quality for injection (WFI).
1A Clean Bulk WFI undergoes an extensive purification process in ISO-certified facilities to meet or exceed stringent European and United States Pharmacopeia (EP/USP) specifications.
Each batch of 1A Clean Bulk WFI is released based on the specifications of EP (European Pharmacopoeia) and USP (United States Pharmacopoeia). This guarantees our customers easy compliance with regulatory requirements.
1A Clean Bulk WFI is intended for research purposes or for further use in production processes. This product is NOT intended for direct therapeutic use in humans.
​
2
1A Clean Bulk WFI quality water – 3D Bags
for further processing in industry
We supply 1A Clean Bulk WFI in single-use 3D bags with a special welding process that is easy to handle even when full. The single-use bags we use are specially designed for use in the field of biotechnology and diagnostics. The film that comes into contact with the product in the single-use bags we use consists of Ultra-low Density Polyethylene (ULDPE).
3
Specifications 3D 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 200 and 500 liter bags
After sterile filling, the bag systems are securely packaged and, after successful quality control, are made available for immediate use by the customer. The 3D-Bags are suitable for larger amounts of liquid (over 200L). The delivery takes place in a special plastic container, which has optimal properties for further storage.
4
standard connections
Our 3D bag systems can be seamlessly integrated into your production process
Port 1: MPX Male + Cap, Pinch Clamp
Port 2: MPX Female + Cap, Pinch Clamp
Port 3: MPX Male + Cap, Pinch Clamp
5
Box system for the delivery of 3D Bags
1A Clean only uses selected and specially tested packaging systems for 3D bags. The type of packaging depends on the size of the bags.
The reusable container protects the liquid content and, thanks to the extremely resilient construction, ensures optimum transport conditions. For cost saving return transport, the side walls can simply be folded in and thus reduce the volume enormously.
​
Advantages
Environmentally friendly and reusable packaging systems
Hygiene - no rotting
Collection / return delivery is planned together (less storage space required)
Creating something together.....
.... safe, reliable, transparent.