USP 1231 Water Testing

Transform your water system compliance with Quantus's comprehensive testing services. We specialize in USP 1231-compliant testing for purified water and Water for Injection (WFI) systems, helping pharmaceutical and biotech manufacturers maintain the highest standards of water quality.

Our ISO-certified laboratory provides comprehensive testing services including:

Microbial Testing & Analysis
  • Total aerobic microbial count
  • Bacterial endotoxin testing
  • Bioburden analysis
  • Fungal contamination screening
Chemical & Physical Analysis
  • Total Organic Carbon (TOC) testing
  • Conductivity measurements
  • pH analysis
  • Particulate matter evaluation

These tests guarantee the highest level of water purity and compliance, safeguarding your manufacturing processes and product integrity.

Industry-Leading Equipment Compatibility

We support testing for all major water purification systems:

  • Milli-Q® water systems
  • Pall filtration systems
  • GE water purification systems
  • Sartorius water systems
  • Siemens pure water systems
  • Veolia water treatment systems

Why Choose Quantus for Your Water Testing?

Regulatory Compliance Focus
  • Full USP 1231 compliance
  • FDA-aligned testing protocols
  • cGMP-compliant documentation
  • Detailed Preliminary & Final Lab Reports
Industry-Specific Expertise
  • Specialized in pharmaceutical-grade water testing
  • Experience with cleanroom-grade water requirements
  • Understanding of biotech production needs
  • Validation support services
Comprehensive Testing Protocols
  • Custom sampling schedules
  • Rapid turnaround times
  • Emergency testing available
  • Trending analysis and reporting

Our Process

  1. Onsite Sampling: Our EM field service team collects samples onsite, packages and transports them, ensuring proper chain of custody.
  2. Sample Receipt: We log and inspect all water samples upon receipt, ensuring they are intact and free from contamination.
  3. Testing: Samples undergo various tests, including membrane filtration and incubation, to identify and count microbial colonies. We also perform chemical analysis for Total Organic Carbon (TOC) and Conductivity, as well as additional biological testing for Endotoxins.
  4. Analysis: After incubation, samples are meticulously analyzed for microbial growth, with results documented and communicated promptly.
  5. Control Testing: We perform negative and positive control tests to validate the accuracy and reliability of the microbial analysis.
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We Have Answers To Your Problems

Frequestly Asked Questions

What types of water and related systems does Quantus test?

Quantus provides comprehensive testing services for various water types and systems, ensuring compliance with stringent FDA and USP standards. We test USP Purified Water (PW), USP Water for Injection (WFI), Reverse Osmosis (RO) water, Deionized (DI) water, potable water, European Pharmacopeia water, and clean steam. Our services extend across several industries, covering:

1. Pharmaceutical and Biotechnology Water Systems:
  • Purified Water (PW)
  • Water for Injection (WFI)
  • Reverse Osmosis (RO) Water
  • Deionized (DI) Water
  • Clean Steam
  • Media and buffer preparation systems
2. Food, Beverage, and Personal Care Water Systems:
  • Ingredient water
  • Product formulation water
3. Medical Device Manufacturing Water Systems:
  • Sterilization systems
4. Healthcare and Hospital Water Systems:
  • Laboratory water systems
What parameters are included in your water testing services?

Our water testing services include Total Organic Carbon (TOC) analysis, endotoxin testing, bioburden testing, and conductivity testing. These tests help ensure the highest level of water purity and compliance with regulatory standards.

How do you ensure the accuracy and reliability of your water testing results?

We ensure accuracy and reliability through a rigorous process that includes onsite sampling by our EM field service team. However, using our field team is not mandatory. Customers can also perform sampling on their own and ship us their samples with their chain of custody for our lab to complete the testing and analysis.

Our process includes thorough inspection upon sample receipt, precise testing using advanced technologies, meticulous analysis, and control testing with both negative and positive controls.

What industries do you serve with your water testing services?

We serve a wide range of industries, including pharmaceuticals, biotechnology, medical devices, and more. Our specialized testing services are designed to meet the unique needs of each industry, ensuring compliance and product safety.

What are the benefits of microbial water testing?

Microbial water testing ensures the safety and quality of your water supply, preventing contamination that could impact product integrity and patient safety. It helps in maintaining compliance with regulatory standards, avoiding costly recalls, and ensuring the reliability of your manufacturing processes. This testing is essential for identifying potential microbial contamination and implementing corrective actions promptly.

Quantus can provide you with guidance and resource to help you setup your sampling plan to meet industry standards. Contact us at service@goquantus.com and we can help you get started.

What clients are saying

  • I am very pleased with the services provided. The technicians are exceptional to work with, and the customer support team is incredibly responsive and accommodating. The pricing offers excellent value for the services provided.

    Century Therapeutics Drew

  • The technicians here do an outstanding job. I truly appreciate the responsiveness of the customer support team and their proactive approach to scheduling.

    Ellume Ken

  • Everything is going great with the services. The technicians are top-notch – professional, honest, and very solid in their work. They provide excellent communication and feedback.

    RegenXBio Blake

  • Working with Quantus to resolve the disorganization of previous 3rd party reports. I have received positive feedback on the work Quantus is doing. We're looking forward to a meeting with the top management and business development teams to gain more feedback and develop additional controls.

    Christiana Care James

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