When it comes to your pharmacy or facility, water isn’t just water. It’s a critical ingredient and utility that directly impacts the quality and safety of your products. That’s where USP 1231 and ANSI/AAMI ST108 come into play. Both standards provide guidance on how water is tested to maintain microbiological quality.
Why is USP 1231 Important?
Water is used widely for many pharmaceutical purposes, such as cleaning, formulation, or as finished product components. USP 1231 discusses how water systems are designed and maintained to prevent microbial contamination, how to monitor and control microbial growth, and relationships between water quality and drug product safety. There are two types of pharmaceutical water – purified water and water for injection. Purified water is used for non-parenteral formulations and cleaning. Water for injection is used for parenteral formulations, therefore meeting stricter quality standards.
Why is ANSI/AAMI ST108 Important?
ST108 discusses water for the processing of medical devices, setting a standard for water quality used in cleaning, rinsing, disinfection, and sterilization. This is a relatively new standard that regulatory bodies will begin to expect healthcare facilities to demonstrate. ST108 defines four categories of water quality (utility, critical, steam, and final rise). By compliance with this standard, facilities can protect patients’ safety, reduce risks of device damage, and improve internal infection control programs.
Do I choose USP 123 or ANSI/AAMI ST108?
This depends on what industry your facility is in.
Choose USP 1231 if:
You are in the pharmaceutical or biotech industry
You use water in manufacturing, formulation, cleaning, or testing of drugs
You are designing, validating, or maintaining a pharmaceutical water system
Choose ANSI/AAMI ST108 if:
You are in healthcare, sterile processing, or medical device testing
You use water to clean, rinse, disinfect, or sterilize reusable devices
You use sterile processing in hospitals, surgical centers, or clinics
How can LAB 797 help?
Using heterotrophic plate count methods, we can determine the amount of CFUs (colony-forming units) of bacteria present in a water sample. This allows us to help your pharmacy or facility establish a routine to monitor the bioburden in your water. Contact us for a special introductory rate today!