Proven Speed. Proven Compliance. Proven Confidence.
When patient safety and production timelines are on the line, every moment matters. With Celsis®, results are delivered in as little as 7 days; therefore, compounding pharmacies, biopharma, and pharmaceutical manufacturers can cut release times by 50%. In addition, faster results help safeguard supply continuity while maintaining full compliance with global regulatory standards.
Why Celsis®?
Selecting an alternative rapid sterility testing method over traditional USP <71> requires consideration of several factors. That is why Celsis® stands out: not only does it shorten testing timelines but also preserves product integrity and regulatory confidence.
Accelerated Release
Shortens microbial detection timelines from two weeks to 7 days, enabling earlier product release and faster response to contamination events.
Product flexibility
Designed to work with a variety of product types (pharmaceutical drug products, biologics, vaccines, cell and gene therapy products, raw material, etc.), including filterable and non-filterable samples.
Preserves Product Integrity
Non-destructive ATP-bioluminescence testing ensures valuable samples remain viable for further identification.
Objective Results
Positive/Negative results determined by validated instrument parameters removing the need for subjective visual determination.
Broad Detection Capability
Sensitive enough to detect environmental bacteria, yeast, and mold as low as 1 CFU Limit of Detection (equivalent to the compendial sterility test).
Regulatory Alignment
Proven method suitability in alignment with USP <73>, USP <797>, USP <1223>, Eur. Ph. 5.1.6, and PDA TR33.
Celsis® systems are trusted by leading pharmaceutical manufacturers and compounding pharmacies, providing reliable support for sterility assurance of final products as well as the release of raw materials.
Trusted Across the Industry
With decades of proven performance and global regulatory acceptance, Celsis® offers a dependable rapid microbial detection solution. It helps companies accelerate delivery of safe, high-quality products to patients while maintaining compliance at every step.
Your Faster Path to Compliance
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Got Sterility Testing Needs?
Call the Eagle Client Care Team at (800) 745-8916 to discuss your operation’s specific needs and answer any questions!