Sterile Water for Injection (SWFI) is sterile water that has been made free of harmful microorganisms so it can be used as an injection. SWFI is used in both hospitals and doctors’ offices to give injections to patients or to prepare and clean an area before giving an injection. Sterile Water for Injection is sterile, non-pyrogenic water for injection, USP. The pH range is 3.5–7.0 and the osmolality range is 50–300 mOsm/kg (calc).
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Uses
Sterile Water for Injection is indicated for use only as a solvent or diluents vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced to avoid tonicity of the blood.
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In some cases, it may be used as a lavage or rinsing agent, but isotonic solutions suitable to the area of exposure are preferred if available. Administered intravenously as a vehicle for drugs, Sterile Water for Injection provides a source of water for parenteral fluid replenishment after proper osmolarity has been achieved.
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Manufacturing process
Water, Fillers-Vitamin B2, Glycerol, and Thiamine hydrochloride (Vitamin B1), and other chemicals are utilised in its preparation to produce a more stable product and consistent pharmaceutical grades from batch to batch. It will then be filtered one more using a 0.22m syringe filter before being filled into sterile bottles or bags. It takes around an hour and a half to complete the process.
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After being autoclaved at 121°C for 15 minutes, this water becomes sterile. The sterile solution is suitable for usage in hospitals, as well as the food, chemical, and research industries. It can also be used to clear blood samples of pollutants before analysing them with a spectrometer or detecting them with test tubes at dialysis centres and blood testing institutes.
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Market Outlook:
The global market for sterile water products is forecast to reach US$ 738.9 million by 2022, growing awareness of sterility and safety in injections will propel market growth over next six years.
The rising incidence of infectious diseases and growing geriatric population base globally has resulted in increasing demand for sterile water solutions that can protect patients from unwanted infections and other related ailments post-injections.
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India’s biotechnology industry comprising biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics is expected grow at an average growth rate of around 30 per cent a y-o-y to reach US$ 100 billion by 2025.
The increase of lifestyle diseases in India such as diabetes and heart disease has heightened the demand for medicines. There is a large pool of scientific and research expertise in India, and an enormous population with high incidences of cancer and chronic disease. The shorter recruitment time-frames and lower costs make India an ideal setting for drug development and clinical trials.
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Indian pharmaceutical sector is expected to grow to US$ 100 billion, while medical device market is expected to grow US$ 25 billion by 2025. Pharmaceuticals export from India stood at US$ 20.70 billion in FY20. Pharmaceutical export include bulk drugs, intermediates, drug formulations, biologicals, Ayush and herbal products and surgical.
Key Players:
- Albert David Ltd.
- Amanta Healthcare Ltd.
- Chandra Bhagat Pharma Ltd.
- Denis Chem Lab Ltd.
- Health Biotech Ltd.
- Ivy Health & Life Sciences Pvt. Ltd.
- Kopran Ltd.
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