Rapid sterility testing for products that cannot wait 14 days.
PlumGxP has the Celsis Advance II™ system for growth-based rapid sterility testing across suitable short-life products, compounded sterile preparations, pharmaceuticals, biologics, and advanced therapies. The platform combines shortened enrichment with ATP-bioluminescence detection to provide an objective result earlier than traditional visual growth detection.
- Celsis Advance II
- USP <73>
- 503A & 503B
- MicroSEQ identification
PlumGxP is accepting early onboarding discussions for organizations preparing to adopt rapid sterility testing for short-life and time-sensitive products.
Discuss your program →A compendial framework designed around short-life products.
USP <73>, ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products, gives manufacturers a focused framework for ATP-bioluminescence methods when the traditional 14-day timeline does not match the realities of a product’s shelf life or clinical use.
Support short-life products
Build a sterility strategy around the period in which the result is most useful for the product, the quality unit, and ultimately the patient.
Detect viable contamination earlier
Shortened enrichment allows viable microorganisms to multiply, while ATP bioluminescence provides an objective signal before growth would necessarily be visible.
Move from signal to understanding
A predefined recovery and MicroSEQ identification pathway can turn a detected signal into information that supports a meaningful investigation.
Grow enough to detect—not enough to see.
Celsis Advance II is PlumGxP’s primary ATP-bioluminescence rapid sterility platform. It retains a growth-based approach while replacing the wait for visible turbidity with sensitive, instrument-generated detection of microbial ATP.
Prepare
Establish the appropriate test quantity, media, sample preparation, neutralization, and controls for the product.
Enrich
Incubate the prepared sample for a shortened period so viable microorganisms can generate detectable growth.
Process
Apply the qualified Celsis reagent workflow to the enriched sample in preparation for ATP detection.
Detect
Measure microbial ATP through amplified bioluminescence on the Celsis Advance II system.
Act
Report the result and, when needed, move directly into recovery, identification, and investigation support.
The advantage: Celsis Advance II is not a stand-alone instrument at PlumGxP. It sits inside a connected rapid sterility program that supports product onboarding, routine testing, organism recovery, MicroSEQ identification, and investigation.
One platform. Three high-need markets.
PlumGxP can help organizations evaluate, onboard, and operationalize a rapid sterility pathway appropriate to their product and quality system.
- Early product and sample-volume assessment
- Platform onboarding and method-transfer support
- Product-specific suitability and implementation planning
- Routine GMP testing and quality review
- Positive recovery and MicroSEQ identification strategy
503B outsourcing facilities
ScalableDevelop a repeatable outsourced pathway for suitable formulations, with defined submission, testing, reporting, and investigation processes.
503A compounding
Patient-focusedExplore a rapid, growth-based option for appropriate compounded sterile preparations and time-sensitive clinical decisions.
Cell & gene therapy
Adapt-enabledSupport for short-life, limited-volume, and cell-containing products where conventional sterility timelines can extend beyond administration.
Celsis Adapt for cell and gene therapy products.
Celsis Adapt is a specialized addition to our Celsis Advance II platform used specifically for cell and gene therapy products. It addresses the challenge of testing cellular matrices that may contain high levels of non-microbial ATP.
Adapt concentrates potential microbial contamination while helping remove interfering sample components before ATP-bioluminescence detection on Celsis Advance II.
- Designed specifically for cell and gene therapy products
- Supports challenging cell-containing matrices
- Concentrates potential microbial contamination
- Helps reduce interference from non-microbial ATP
- Connects directly to Celsis Advance II detection
- Can be paired with MicroSEQ identification for recovered positives
Two connected capabilities: Celsis Advance II supports PlumGxP’s broader rapid sterility program. Celsis Adapt extends that platform specifically to cell and gene therapy products.
Results in days—when the information can still support the decision.
Celsis rapid sterility applications can deliver results in as little as four days. The established turnaround for each program will reflect the product, sample preparation, enrichment time, controls, and quality-review requirements.
Rapid, growth-based detection
An earlier objective endpoint can support more useful quality decisions for short-life and time-sensitive products.
From onboarding to identification
PlumGxP connects the sterility method, routine workflow, positive recovery plan, and microbial identification capability from the beginning.
A positive result is the beginning of the question—not the end.
Rapid detection tells you that microbial growth may be present. MicroSEQ can help answer the next essential question: what organism is it?
- Recover the organism through a predefined positive workflow
- Apply sequence-based bacterial or fungal identification as appropriate
- Compare findings with environmental, personnel, water, and product isolates
- Support root-cause analysis with more discriminating identification data
- Keep detection and identification inside one coordinated laboratory program
Why MicroSEQ matters: implementing sequence-based microbial identification alongside Celsis strengthens PlumGxP’s rapid sterility offering. Clients do not have to stop at “positive”; they can move toward organism identity and a better-informed investigation.
Use the method that fits the product and decision.
PlumGxP is building traditional and rapid sterility capabilities so different formulations can remain within one coordinated laboratory program.
Traditional USP <71>
Membrane filtration or direct inoculation with defined media and 14-day incubation. Appropriate when a compendial pathway is required or the product favors traditional testing.
ScanRDI®
Non-growth-based viability labeling and solid-phase cytometry for compatible filterable products requiring an ultra-rapid alternative pathway.
Celsis Advance II™ · USP <73>
Shortened enrichment followed by ATP-bioluminescence detection for suitable short-life, 503A, 503B, and other sterile-product applications. Celsis Adapt is added specifically for cell and gene therapy products.
We help turn the platform into a working client program.
Technology adoption involves more than running a sample. We help clients define the complete path from product assessment and sample logistics through reporting and positive identification.
- Review product characteristics and sample availability
- Define the Celsis Advance II workflow
- Add Celsis Adapt only for cell and gene therapy products
- Establish submission, scheduling, and reporting expectations
- Predefine positive recovery and MicroSEQ identification
- Coordinate quality, change-control, and routine program launch
Validation is included without becoming the whole story
Every alternative method must be appropriately qualified and shown to be suitable for its intended product and use. PlumGxP incorporates that work into onboarding while keeping the program focused on the client’s larger goal: a reliable, faster, and operationally useful sterility result.
From first conversation to routine rapid sterility testing.
Discover
Understand the product, patient timeline, current method, sample constraints, and desired decision point.
Design
Select the preparation and detection workflow and define the right-sized onboarding plan.
Demonstrate
Complete the required suitability and performance work for the intended application.
Launch
Move into a controlled routine program with clear logistics, reporting, escalation, and identification pathways.
Planning for Celsis?
What is USP <73>?
USP <73> addresses ATP bioluminescence-based microbiological methods for detecting contamination in short-life products. It is particularly relevant when a conventional 14-day sterility timeline is not practical for the product’s shelf life or clinical use.
What is the difference between Celsis Advance II and Celsis Adapt?
Celsis Advance II is the ATP-bioluminescence detection system used for PlumGxP’s broader rapid sterility program. Celsis Adapt is a specialized sample-preparation technology used specifically for cell and gene therapy products before detection on the Advance II system.
Why is Celsis Adapt relevant to cell and gene therapy?
Cell-containing samples can have high background ATP. The Adapt workflow is designed to concentrate microorganisms while helping remove non-microbial sample components before Celsis Advance II detection. PlumGxP uses Adapt specifically for cell and gene therapy products.
Can PlumGxP help 503A and 503B organizations adopt Celsis Advance II?
Yes. For appropriate compounded sterile preparations, PlumGxP can support initial product assessment, onboarding strategy, product-specific work, routine outsourced testing, reporting expectations, and the investigation pathway using the Celsis Advance II platform. Celsis Adapt is reserved for cell and gene therapy applications.
How quickly can Celsis provide a result?
Some Celsis rapid sterility applications can deliver results in as little as four days. The final time to result is established for the specific product, workflow, enrichment period, controls, and quality-review process.
What happens if a sample is positive?
PlumGxP can establish a positive recovery and confirmation pathway during onboarding. When an organism is recovered, the MicroSEQ platform can provide sequence-based identification to support investigation and root-cause assessment.
Does MicroSEQ replace the sterility test?
No. Celsis detects potential microbial contamination; MicroSEQ identifies a recovered bacterial or fungal isolate. Together they provide a stronger detection-to-investigation workflow.
Is validation still required?
Yes. The method must be appropriately demonstrated for its intended use, including product-specific suitability. PlumGxP makes that work part of a practical onboarding plan rather than treating validation as the entire client story.
When should we begin onboarding?
Begin before the first time-sensitive sample is ready to ship. Early collaboration gives the product, sample strategy, workflow, quality requirements, reporting timeline, and positive-identification pathway time to come together as one program.
Celsis®, Celsis Advance II™, and Celsis Adapt™ are trademarks of Charles River Laboratories. MicroSEQ™ is a trademark of Thermo Fisher Scientific. Platform references describe the technologies; PlumGxP’s service availability and validated applications are established independently.
Bring us your rapid sterility goal. We’ll help build the program around it.
Tell us about the product, shelf life, available sample volume, current sterility approach, and target timeline. We’ll map the most practical onboarding path.