Water for Sterile Preparation

Which type of water is used in sterile preparation?

Water for Injection(Bulk)-

Characters: A clear, colorless, odorless and tasteless liquid.

Nitrates: Not more than 0.2 ppm

Heavy metals: Not more than 0.1 ppm

Conductivity: Conductivity at 20°C not more than 1.1 µS.cm-1.

Microbial Contamination-Total viable aerobic count should less than 10 micro-organism per 100 ml. Absence of E. Coli, Salmonella, Staphylococcus aureus & Pseudomonas.

Bacterial endotoxins: Less than 0.25 IU per ml.

Pre-filter: 1.2µm, & final filter- 0.2µm.

Bubble point test- Machine Statocheck Junior.