| Part No. | Description | Testing | Product Uses |
| WF-60-200 | WFI Quality Water 200L bag sealed in a drum | Multi-Compendial testing in accordance with Packaged Sterile Purified Water and Sterile Water for Injection
Standards
|
|
| WF-60-020 | WFI Quality Water 20L bag in a sealed box | Multi-Compendial testing in accordance with Packaged Sterile Purified Water and Sterile Water for Injection
Standards
|
|
*with further processing
Other Information
Quality Assurance
An Integrated Approach to Quality
Quality cannot be tested into any product. It must be designed into the product through the development of a rigorous quality system. At Microbix, we have taken extreme care to develop and adhere to a system that governs all operations– manufacturing, packaging, testing, shipping and documentation. Since purified water is more than just a commodity, our system has been designed to meet the stringent requirements of any pharmaceutical or health industry manufacturing process.
The Microbix quality system complies with biological, pharmaceutical and medical device manufacturing requirements in all of the following areas:
- Design of packaging and processing
- Monitoring packing and processing
- Testing and releasing
- Facility and Equipment
- Qualification
- Maintenance
- Calibration
- Monitoring environmental standards
- Testing and Certification
Every WFI lot is tested according to USP and EP Packaged Sterile Purified Water Standards and comes with a Certificate of Analysis.
*WFI tested to JP standards available upon request
For more information, please visit our Quality Assurance page.
Packaging
We minimize the effort required to get our product into your clean rooms.
Bringing packaged, bulk reagents from the receiving dock into clean areas is a complexity that Microbix has lived through as a consumer. That’s why we’ve gone to great lengths to provide our purified water in user friendly packaging. Shelf-life is two years from date of manufacture.
BioProcess Bag Detail
The multi-layered bag was designed with durability, stability and inertness in mind. The inner fluid contact layer is constructed of a single layer, low density polymer film. The inner layer provides excellent compatibility, low extractable levels and strong chemical resistance. The outer layers are designed for strength and gas impermeability. All layers are tested to, and meet or exceed USP <88> Class VI requirements. A validation package includes strength, biocompatibility, extractables and sterilization testing among other things.
The contact bag is protected by a thin film bag inside the clean, containment barrel. The entire barrel is protected by another thin film bag. As you enter your clean area, the outer bag is removed exposing the clean barrel. There is no need to spend extra time cleaning the packaging. Our 20L bag is protected by a thin film bag and is shipped in a box which is removed before entering your clean area.
200L Package Diagram
20L Package Diagram
Product Images
Process loop diagram (WFI)
Related products
Product Information Sheet
Water For Injection, 20L USP Tested
Water For Injection, 20L EP Tested
Water For Injection, 200L USP Tested
Water For Injection, 200L EP Tested
Frequently Asked Questions
1. How do I remove water from the bag without contaminating it? If I don’t remove all the water at once, can I make a second withdrawal?
Please click Protocol for Sampling WFI for our suggested protocol.
Ordering Information
Ready to proceed with an order? Contact customer service for pricing and availability of all items.
