USP <1231> Water For Pharmaceutical Purposes

Without a reliable source of pure water in your facility, you cannot safely develop or test your products destined for sale in the health care industry.

Manufacturers should know that one of the crucial USP guidelines that apply to the control of source water is <1231>, which addresses the control of microbes in pharmaceutical water systems.

Failure to meet USP <1231> guidelines could result in unsafe conditions, including:

• Compromised purification processes
• Contaminated finished water
• Risks to employee safety
• Risks to patient safety

The professionals at BA Sciences are standing by to provide you with on-site sampling and laboratory testing of your water for pharmaceutical purposes to meet USP <1231> guidelines. Doing so will enable you to focus on your core capabilities of producing safe, efficacious products for patients.

If your cleanroom facility is not up to standards for using pharmaceutical water, multiple potential failure points could lead to contamination and the formation of biofilms, including:

• Filtration
• Operations
• Sanitization practices
• Source water
• System design
• System maintenance
• Type of construction materials

If your staff is not trained and experienced in all aspects of using and maintaining a water system for pharmaceutical purposes, you risk the formation of a biofilm. Unfortunately, biofilms tend to resist chemical sanitizing agents, so an ounce of prevention is worth more than a pound of cure.

Given the risks to the patients, it’s vital that you monitor water purification processes.

You also need to engage in ongoing preventative maintenance to prevent a biofilm from growing in the system. At the same time, you will need a safe and reliable approach to control microbes in the water to meet USP <1231> guidelines.

Your responsibilities include testing water for total organic carbon and conductivity, as well as for the presence of microorganisms.

To that end, BA Sciences provides a complete line of water testing services with a rapid turnaround time. Our services include pharmaceutical water testing to precisely determine whether it meets USP <1231> guidelines.