Communicate with Supplier? Supplier
Ben Liu Mr. Ben Liu
What can I do for you?
Contact Supplier

Differences between purified water systems and water for injection

2021-03-11

One of the basic considerations in the design of a system is the type of product that is to be manufactured.Water For Injection Systems For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally.
For some ophthalmic products,
Water For Injection Systems such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products.
Another design consideration is the temperature of the system. It is recognized that hot (65 – 80℃) systems are self sanitizing. While the cost of other systems may be less expensive for a company, the cost of maintenance, testing andDifferences between purified water systems and water for injection potential problems may be greater than the cost of energy saved.
Differences between purified water systems and water for injection Whether a system is circulating or one-way is also an important design consideration. Obviously, water in constant motion is less liable to have high levels of contaminant. A one-way water system is basically a "dead-leg".
Finally, and possibly the most important consideration, is the risk assessment or level of quality that is desired. It should be recognized that different products require different quality waters. Parenterals require very pure water with no endotoxins. Topical and oral products require less pure water and do not have a requirement for endotoxins. Even with topical and oral products there are factors that dictate different qualities for water. For example, preservatives in antacids are marginally effective, so more stringent microbial limits have to be set. The quality control department should assess each product manufactured with the water from their system and determine the microbial action limits based on the most microbial sensitive product. In lieu of stringent water action limits in the system the manufacturer can add a microbial reduction step in the manufacturing process for the sensitive drug product(s).

Jiangmen Leonard Industrial Machineries Co., Ltd.
Business Type:Agent , Distributor/Wholesaler , Manufacturer , Organization , Service
Product Range:Curtain Walls , Other Machine Tool Equipment , Repairs & Maintenance
Products/Service:Clean Room Design and Construction , Clean Room Sandwich Panel , Water For Injection Systems , Clean Room Construction Materials , High Purity Water System , Insdustry GMP Clean Room
Certificate:
Company Address:RM 1918, B Buliding, Wanda Plaza, Jiangmen City, Guangdong, China, Jiangmen, Guangdong, China

Previous: Made in China, Water For Injection Systems

Next: Leonard Industrial Food Industry GMP Clean Room

Related Products List

Home

Phone

Skype

Inquiry