Table of Contents
- Introduction
- What is Water for Injection?
- What is Purified Water?
- Water for Injection vs Purified Water
- Conclusion
- FAQs
Introduction
Since pure Water is an integral part of pharmaceutical processes, the water quality cannot be compromised. The violation of regulatory compliances leads to product recalls, which not only affect the company’s finances but may also cause severe harm to the reputation of the company. The Water for Injection and Purifies Water has its application purpose; they are not interchangeable.
The lack of knowledge about their specific applications, standards and production processes can significantly impact product quality and compliance. This blog highlights the key differences between WFI and PW and answers a few FAQs. Keep reading to learn more.
What is Water for Injection (WFI)?
Water for Injection (WFI) is pristine water used to manufacture parenteral drugs. Since parenteral medications are administered directly into the body via muscle, vein, or skin, bypassing the digestive system, the water used needs to be ultra-pure to ensure patient safety. Water is treated using distillation or reverse osmosis processes to meet the stringent standards set by pharmacopeial guidelines like the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP).
WFI is free from endotoxins, microorganisms, and inorganic contaminants. It is often sterilised and must be maintained under sterile conditions until used. Other than Injectable drugs, WFI is also used in processes where sterility is paramount.
TSA’s state-of-the-art technology delivers water for injections far superior to global pharmacopoeia standards. The multi-column distillation plant is highly efficient, having flow rates ranging from 80 LPH to 5000 LPH. The system is pre-passivated to ensure high flexibility with a production capacity of up to 80% without any additional modifications to the plant.
The plant features a sleek mechanical construction using SS 316L, with all contact parts electropolished to a finish of less than 0.4 RA microns. Additionally, the joints are orbitally welded and inspected with a video boroscope. It offers quick start-up with enhanced performances and maximum energy savings while in compliance with USFDA 21 CFR part 11 and GAMP 5
What is Purified Water (PW)?
Purified Water (PW) is also high-quality water like WFI. It is used extensively in manufacturing, pharma, and biotech. However, its purity requirements are slightly less stringent than those of WFI. Deionisation, reverse osmosis or a combination of the water purification processes are employed to produce Purified Water.
The purified water is not sterile and is used to manufacture non-parenteral products like tablets, capsules, topical formulations, and clean equipment and containers.
TSA offers an advanced closed-loop recirculation system for sustainable operations to align your business with sustainable development goals. The water treatment solutions are available in various models with flow rates ranging from 200 LPH (0.2m³/hr) to 20,000 LPH (20m³/hr).
As the water is recycled, the system saves water and energy. The Purified Water generation system has full or partial heat sanitising and incorporates softening, reverse osmosis and continuous electrode-ionization. All systems are skid mounted and comply with the validation of USFDA 21 CFR part 11 and GAMP 5.
Water for Injection vs Purified Water
In the pharma, biopharma and biotech industries, Water for injection and Purified water are used for different purposes. Therefore, knowing the fundamental differences helps us to make the right choice. Here’s a table of differentiation between them:
| Criteria | Water For Injection | Purified Water |
| Quality Standards | The WFI water must meet USP, EP, and JP standards for endotoxin, which is <0.25EU/mL and the microbial limits <10 CFU/100mL. | PW must meet USP and EP standards to ensure chemical purity and conductivity. The microbial limits are less stringent than WFI. |
| Regulations | Compliance with current Good Manufacturing Practices and stringent bacterial endotoxin and sterility tests are mandatory. | Regular checks for microbial contamination and chemical purity are required. Endotoxin testing is not required. |
| Production | Processes like distillation double-pass reverse osmosis followed by ultrafiltration are employed to purify water. The production equipment must be sanitised and validated regularly. | Processes like reverse osmosis, deionisation or a combination of such filtration methods are employed for water purification. |
| Storage and Distribution | It must be stored in a way that prevents any microbial growth. It requires a heated storage and recirculation system to preserve the quality. | The storage system must prevent contamination and is usually sanitised periodically. However, it requires a different level of control than for the WFI system. |
| Validation | WFI water must undergo rigorous validation procedures besides regular endotoxin and microbial testing, system validation and ongoing monitoring to ensure it complies with strict standards. | The PW validation procedures primarily focus on ensuring chemical purity and the appropriate microbial limits. The method is less rigorous than WFI validation. |
| Monitoring | The water purification system needs to be continuously or frequently monitored to check the integrity of the system and its sanitation status. | Regular monitoring of the water purification system is required but with less stringent requirements, unlike WFI. |
| Product Quality | Directly impacts the sterility and safety of injectable products, making it critical to ensure patient safety. | Although PW is not directly involved in producing sterile drugs, it is necessary to ensure non-parenteral products’ chemical and microbial quality. |
| Cost-effectiveness | WFI is more expensive than PW because of the rigorous purification processes. | PW is less costly than WFI. |
| Applications | Used to formulate drugs, reconstitute products, and final rinse for equipment and components in aseptic processes requiring the highest purity. | They are typically used to formulate non-sterile product formulations, rinse containers, clean non-critical equipment, and general laboratory use. |
TSA’s Water Purification Systems
We offer high-quality water purification systems
As we understand the critical role that high-purity water plays in pharmaceutical and biotech manufacturing, we render rigorous quality control processes to ensure that our Water for Injection and Purified Water meets and exceeds industry standards worldwide. By partnering with us, you can expect:
- Reliable Quality: We ensure consistent delivery of high-quality water to meet your needs.
- Expertise and Support: Our team of multidisciplinary experts is available around the clock to provide guidance and support to ensure your processes run smoothly.
- Customised Solutions: We understand customers need customisations. We provide tailored solutions to meet the unique needs of your production processes.
Invest in the purity of your products by choosing TSA as your trusted supplier for Water for Injection and Purified Water.
Conclusion
As we wrap up this blog, it must be clear that adherence to pharmacopeial standards is non-negotiable. Using the wrong type of water can violate regulatory standards, leading to costly delays and potential product recalls. Since the purity of water directly affects the quality of the product, WFI is suitable to minimise any risk of introducing harmful contaminants into the injectable drugs, thus safeguarding the patient’s health.
For a manufacturing business to sustain itself, consistently delivering high-quality products is quintessential as it builds trust with healthcare providers, enhancing your company’s reputation in the market.
Make an informed choice with us and elevate the quality of your pharmaceutical and biotech products. To explore advanced water purification systems, reach out to us at TSA.
FAQs
Recent FDA actions have underscored the importance of stringent quality controls and regular monitoring to prevent contamination and ensure the safety of pharmaceutical products.
Advancements include improved filtration methods, automated monitoring systems, and enhanced sanitisation technologies, ensuring higher reliability and compliance with regulatory standards.
Establish clear protocols for immediate response to water quality failures, including isolation of affected batches, detailed investigation procedures, and contingency supply plans to prevent production halts.
