Excellence in Sterility and Safety

Essential services for life sciences facilities aiming to ensure the highest standards of sterility and safety. Our approach targets the heart of microbial risk, offering comprehensive assessments and solutions tailored to your unique environment. By identifying critical areas prone to contamination, we lay the groundwork for a robust sterility assurance program that aligns with global regulatory expectations.

  • Risk Assessment: Pinpointing contamination risks with precision.
  • Custom Solutions: Tailored strategies that fit your specific environmental challenges.
  • Regulatory Compliance: Mastery in FDA and global standards ensures your operations are audit-ready.

Our EMPQ services go beyond basic compliance, setting a new standard in environmental monitoring. We not only identify the most effective monitoring points within your facility but also implement a strategic EM program that's both robust and representative of your operational risks. Trust Quantus, Inc. to elevate your cleanroom integrity, ensuring your manufacturing processes are safeguarded against contamination, thus protecting product safety and patient health.

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We Have Answers To Your Problems

Frequestly Asked Questions

What is Environmental Monitoring Performance Qualification (EMPQ)?

EMPQ refers to the specialized process of assessing and ensuring that a cleanroom or controlled environment meets the required standards of cleanliness and control. This involves testing for particulates and microbial contamination, ensuring that the environment is suitable for its intended use, especially in pharmaceutical or biotech production.

Why is EMPQ critical for my cleanroom operations?

EMPQ is crucial because it ensures that your cleanroom environment adheres to the necessary regulatory and compliance standards, such as those set by the FDA and other international regulatory bodies. This not only helps to prevent product contamination, ensuring product safety and effectiveness, but it also helps to protect your operations from costly downtime and liability issues.

How does your EMPQ service differ from standard environmental monitoring?

Our EMPQ services are designed to go beyond basic compliance requirements. We provide expert validation against global standards, risk assessment, cutting-edge microbial and particulate monitoring, and tailored solutions specific to your needs. Our approach is more comprehensive, targeted, and strategic, ensuring a higher level of cleanroom integrity and operational risk management.

Can your EMPQ services be customized to fit my specific industry needs?

Absolutely. We understand that each industry and facility has unique requirements. Our EMPQ services offer custom solutions that are developed to fit the specific needs of your cleanroom and manufacturing processes, whether you operate in pharmaceuticals, biotechnology, medical device manufacturing, or any other field requiring controlled environments.

How do you ensure compliance with FDA and global regulations through EMPQ?

We pride ourselves on regulatory mastery. Our team stays up-to-date with the latest FDA and global regulations to ensure that your cleanroom environment is always compliant and audit-ready. We provide comprehensive documentation and support throughout the process to make certain that your facility meets all the necessary standards for operational excellence.

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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Get in touch with us today and we can help.

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