WFI Water

Cell culture performance is highly dependent on water purity. Irvine Scientific continuously monitors its Water for Injection (WFI) system for microbial levels, endotoxin, conductivity, and Total Organic Carbon (TOC). Irvine Scientific tests the final packaged product according to both USP and EP standards, and offers WFI Quality Water readily packaged in 1L bottles, 20L carboys, and 20L and 200L flexible packaging. Customized packaging and JP testing for WFI Quality Water is also available upon request.

WFI System

Our WFI system incorporates a pre-treatment system, vapor compression still and WFI distribution loop. Water treatment steps include KDF filtration for chlorine/chloramines destruction, a polisher cation exchange system for the removal of ammonia, and a MECO® vapor compression pharmaceutical distillation unit for chemical and microbial purification. The entire system is designed for high-throughput production, ensuring this critical component’s availability.

WFI System Performance

Parameter Specification IS Average Performance
Bioburden 10 cfu/100mL 0 cfu/100mL
Endotoxin ≤ 0.25 EU/mL ≤ 0.05 EU/mL
TOC < 500 ppb 50.8 ± 21.3 ppb
Conductivity ≤ 2.1 µS/cm 0.71 ± 0.13 µS/cm

Product Description

WFI Quality Water meets both EP and USP grade specifications and can be readily purchased as either a 1L bottle, 20L plastic carboy, 20L sealed BioProcessing Container (BPC) shipped in an outer container, or 200L sealed BPC shipped inside a sealed drum. All flexible packaging is 0.1µm sterile filtered at time of fill into USP Class VI qualified BPCs. All BPCs are terminally sterilized at 25-40kGy with weldable tubing for our clients' bioprocessing needs.

Water meets the testing requirements for Sterile Water for Injection as stated in current USP and EP.

Every WFI lot is tested according to USP and EP Packaged Sterile Purified Water Standards and comes with a Certificate of Analysis. WFI is tested to JP standards — available upon request

Part No. Storage Description Testing Product Uses
9309-20L 2°C to 30°C WFI Quality Water; 20L BPC sealed in a box Multi-Compendial testing in accordance with Packaged Sterile Purified Water and Sterile Water for Injection Standards
  • USP
  • EP
  • JP (available on request)
  • Media / Reagent Manufacturing
  • Process Equipment Cleaning / Rinsing
  • Pharmaceutical and Life Science Research
9309-200L 2°C to 30°C WFI Quality Water; 200L BPC sealed in a drum

Product Specifications

Assay Specification
Appearance: Clear colorless liquid
Sterility: Pass
Endotoxin: < 0.25 EU/mL
Conductivity: ≤ 5µS/cm
Oxidizable Substances: Conforms
Acidity or Alkalinity: Conforms
Chlorides: Conforms
Nitrates: NMT 0.2 ppm
Sulfates: Conforms
Aluminum: NMT 10 ppb
Ammonium: NMT 0.2 ppm
Calcium and Magnesium: Conforms
Particulate Matter: Conforms
Heavy Metals: NMT 0.1 ppm
Residue on Evaporation: NMT 0.003%

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Product Description

USP Purified Water meets USP grade specifications and can be purchased as a 20L sealed container or 200L sealed drum.

USP Purified Water is intended for use as an ingredient of official preparations and in tests and assays.  USP Purified Water is not intended for sterile dosage forms or parenteral administration. USP Purified Water is not filled in a sterile area, nor is it filled into sterilized containers. It is produced from high purity water that meets USP microbial quality requirements. It contains no added substance.

Part No. Storage Description Testing Product Uses
9308-20L 2°C to 30°C USP Purified Water
20L plastic container in a sealed box
Tested in accordance with USP standards
  • Media / Reagent Manufacturing
  • Process Equipment Cleaning / Rinsing
  • Pharmaceutical and Life Science Research
9308-200L 2°C to 30°C USP Purified Water
200L BPC sealed in a drum
Tested in accordance with USP standards
  • Media / Reagent Manufacturing
  • Process Equipment Cleaning / Rinsing
  • Pharmaceutical and Life Science Research

Product Specifications

Assay Specification
TOC: ≤ 500 ppb
Microbial Count: ≤ 100 cfu/mL
Conductivity: ≤ 5µS/cm
Oxidizable Substances: Pass

Sample Certificate of Analysis

Irvine Scientific Certificate of Analysis (PDF)

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