In the pharmaceutical sector, water is the most important raw material needed in production, cleaning, and testing procedures. The two major water systems used in this sector include Purified Water System and WFI System (water for injection). Even though both systems have similar objectives, there are notable differences between the two.
Understanding the Purified Water System
The Purified Water System is used to purify raw water by removing various forms of impurities such as dissolved solids, microorganisms, and organics. In addition to purification methods include pre-treatment, reverse osmosis, EDI (Electrodeionization), and UV sterilization among others. The resulting product should satisfy the standards set out in pharmacopoeias including USP, EP, and IP.
Applications of Purified Water
Generally, purified water is utilized in several processes within the pharmaceutical field. For instance, purified water is used for equipment cleaning purposes, preparation of non-sterile products, and laboratory testing.
Difference in Purity Level between the Purified Water System and the WFI System
The purification level achieved by the WFI system is greater than the level of purification obtained in the Purified Water system especially regarding endotoxin removal.
- Production Method: While purified water is produced using RO and EDI technologies, WFI is mainly produced using distillation.
- Application Areas: Water for injection should be used in sterile and injectable processes while the purified water system is used in non-sterile processes.
- Complexity and Cost: Compared to purified water systems, WFI systems are more complex and expensive to install and maintain.
- Regulatory Requirements: Both systems have to adhere to the regulations set forth by the pharmacopeia, though the requirements for WFI systems are stricter.
How to Choose Between the Two Systems
It depends entirely on what processes your facility needs the water for to determine which system to select between the Purified Water System and the WFI System. For example, if you have non-sterile applications or require purified water for cleaning purposes, then using a purified water system makes sense. In cases where you need sterile water for injectable applications, the WFI system is mandatory.
By working with an expert manufacturer like Micro Fine RO, you will get the best systems possible.
Conclusion
Both the Purified Water System and the WFI System play significant roles in pharmaceutical production and serve different functions. Grasping their difference will help pharmaceutical firms decide which solution to adopt. By acquiring the right solution & machine and finding a reliable partner, companies can maintain quality standards and comply with international regulations.