water for injection WFI - ppt Quality standards

Water for injection is water of extra high quality without significant contamination.
 A sterile version is used for making solutions that will be given by injection.
 before such use other substances generally must be added to make the solution isotonic.
 isotonic solutions containing water for injection can be given by injection into a vein, muscle, or under the skin.
A non-sterile version may be used in manufacturing with sterilization occurring later in the production process.

1. Water For Injection Presented By Guided By Ms. Nikita K. Gadekar Dr. Deepak Lokwani M. Pharm

2. Contents importance of water for injection Quality standards and regulations for water for injection Manufacturing process of water for injection Introduction to water for injection Packaging and storage of water for injection Applications and uses of water for injection Potential risks and challenges associated with water for injection Conclusion References

3. Introduction Water for injection is  water  of extra high quality without significant contamination.  A  sterile  version is used for making solutions that will be given by  injection .  before such use other substances generally must be added to make the solution  isotonic .  isotonic solutions containing water for injection can be given by  injection into a vein ,  muscle , or  under the skin . A non-sterile version may be used in manufacturing with  sterilization  occurring later in the production process.

4. Introduction N-Nitrosamines are a class of organic impurities that includes highly potent mutagenic substances which are classified as probable human carcinogens . . 1 organic compounds with the general structure R 2 N–N–– O. facile in formation and are often formed by the reaction of secondary and tertiary amines, amides,carbamates , and urea derivatives with nitrites or nitrogenous groups. . 2 exist five common types of nitrosamines . . 3 RISK FACTORS FOR N-NITROSAMINE FORMATION 2 Presence of a nitrosatable amine. Presence of a nitrosating agent. Conditions conducive to N-nitrosamine formation .

5. WFI Production Methods WFI is produced through methods such as distillation, reverse osmosis, and ultra-filtration. These processes effectively remove impurities and ensure the water meets pharmaceutical standards for purity and quality . Distillation Heat-based process for water purification. Reverse Osmosis Removes impurities using a semi-permeable membrane. Ultrafiltration Filters water through a membrane with fine pores.

6. Quality Standards and Regulations for WFI WFI must meet rigorous quality standards set by pharmacopoeias like USP, EP, and JP. Regulatory bodies, including the FDA and EMA, enforce these standards to ensure the safety and efficacy of pharmaceutical products. Pharmacopoeial Compliance Strict adherence to USP, EP, and JP standards. 2 Regulatory Oversight monitoring by FDA, EMA, and other authorities. 3 Consistent Testing Regular quality control and validation processes. 1

7. Packaging and Storage of WFI WFI is packaged in specially designed containers to maintain its purity and sterility. Storage in controlled environments, alongside proper handling and distribution, is critical to preserving its quality. Specialized Containers Materials designed to prevent contamination. Controlled Storage Stored in tightly controlled environments. Handling and Distribution Strict protocols for transportation and delivery.

8. Common Uses of WFI in Pharmaceuticals WFI is used for formulation, reconstitution of drugs, medical devices, cleaning, and rinsing equipment. It is an essential component in various pharmaceutical processes to ensure product safety and efficacy. Formulation Ingredient dissolution and drug preparation. Device Cleaning Rinsing and sterilization of medical equipment. Reconstitution Dissolving or mixing dried pharmaceuticals. Pharmaceutical Processes Various production and quality control activities.

9. Advantages and Disadvantages of Using WFI Advantages include superior purity and safety while disadvantages may involve high production costs and energy consumption. The benefits and drawbacks must be carefully weighed in pharmaceutical operations. Advantages High purity, essential for pharmaceutical safety. Disadvantages High production costs and energy-intensive methods.

10. Efficiency Optimizing production processes for resource efficiency. Sustainability Developing eco-friendly purification and storage solutions. Innovations Advancements in water purification and packaging.

11. References Lachman 1. Lieberman A. Herbert "the theory and practice of industrial pharmacy", special indian edition 2009, CBS publishers & distributors PVT. Ltd., Page no 639-677. • Florence t. Alexander, sieperman jurgen " modernpharmaceutics ", vol. I "basic principles and systems" fifthedition , published by informa health care; page no. 665-607. • Alfonso r. Gennaro " remington : the science and practice of pharmacy" 20th edition, published by pheladelphia college of science and pharmacy; page no. 780-806.

12. THANK YOU