Sterile Water for Injection
Sterile, non-pyrogenic Water for Injection in 5, 10, 20, 25 and 30 ml single-use vials, manufactured on Form-Fill-Seal lines from a hot WFI loop maintained at 80 °C and above.
Sizes & variants
- 5 mlTODO: confirm pack size
- 10 mlTODO: confirm pack size
- 20 mlTODO: confirm pack size
- 25 mlTODO: confirm pack size
- 30 mlTODO: confirm pack size
Description
Sterile Water for Injection (SWFI) is the diluent and solvent of choice for reconstituting powders for injection and for diluting parenteral drugs before administration. Swanya manufactures SWFI from its in-house Water For Injection system — multi-column distillation fed by Purified Water and pure steam, stored hot and circulated continuously — and fills it on Form-Fill-Seal machines so that the container is formed, filled and hermetically sealed in a single closed cycle.
Each vial carries an in-built twist-off cap. There is no glass to break, no separate stopper to contaminate and no particulate risk from ampoule opening, which makes the presentation well suited to hospital wards, emergency kits and high-throughput nursing environments.
Every batch is released only after in-house testing in Swanya's segregated wet, instrument and micro laboratories, including conductivity, pH, bacterial endotoxin (pyrogen) and microbial limit testing on the WFI loop, plus sterility and particulate matter on the finished product.
Specifications
| Attribute | Detail |
|---|---|
| Dosage form | Sterile liquid — solvent / diluent for parenteral use |
| Fill volumes | 5 ml, 10 ml, 20 ml, 25 ml, 30 ml |
| Container | Single-use FFS vial with in-built twist-off cap |
| Filling technology | Form-Fill-Seal (FFS) |
| Water source | In-house WFI, stored and circulated at ≥ 80 °C |
| Sterilisation | Filtration with online filter integrity testing; autoclaving / SIP for equipment |
| Release testing | In-house: conductivity, pH, BET, microbial limit, sterility |
| Shelf life | TODO: confirm with client |
| Storage | Store below 30 °C, protect from freezing (TODO: confirm) |
Product information is provided for healthcare professionals and trade partners. It is not a substitute for the approved product label or prescribing information.
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