Traditional & Rapid Sterility Testing
Three sterility platforms. The right fit for your products.
From traditional sterility testing to Celsis and ScanRDI rapid methods, PlumGxP offers choices for different formulations, timelines and testing goals. Whether you manufacture one product or a diverse portfolio, our scientists help match each product to a suitable pathway.
- USP <71> traditional testing
- Two rapid sterility options
- Options for diverse product matrices
Three testing pathways
More choice for every product in your portfolio.
Different drugs call for different approaches. With traditional testing, Celsis and ScanRDI available, we can consider formulation, sample volume, release timing and the ability to recover an organism when recommending a method. PlumGxP will plan the appropriate method suitability and validation work with your team.
Traditional Sterility
Membrane filtration or direct inoculation selected according to the product, test requirements and method-suitability results.
- USP <71> and applicable compendial methods
- Membrane filtration or direct inoculation
- Incubated media support organism recovery
- Established option for varied product types
Celsis Rapid Sterility
Growth-based rapid detection with the ability to retain viable organisms for follow-up identification. Celsis Advanced 2 supports rapid sterility programs; Celsis Adapt provides a dedicated option for cell and gene therapy products.
- Rapid, growth-based results
- Organism recovery for investigations
- Advanced therapy option with Adapt
- Method selected for product fit
ScanRDI Rapid Sterility
Direct microbial detection can provide information in as little as four hours for suitable products, giving time-sensitive programs another route to informed decisions.
- Detection in as little as four hours
- Especially relevant to 503A and 503B needs
- Distinct detection approach
- Product suitability assessed with your team
One laboratory relationship for many product types.
Aqueous, viscous, oily, preservative-containing and cell and gene therapy products can have different testing needs. Three platforms give your team more ways to find a suitable approach across product lines, with coordinated communication and oversight.
Traditional sterility testing
Controlled execution in an ISO-classified environment.
Traditional sterility testing is performed within an ISO 7 cleanroom under ISO 5 conditions. Based on product characteristics and applicable requirements, testing is performed by membrane filtration or direct inoculation.
For filterable products, PlumGxP uses the Sartorius Sterisart closed filtration system. The closed pathway helps reduce open manipulations during filtration, rinsing and incubation, adding another layer of contamination control to the test process.
- Membrane filtration
- Direct inoculation
- Fluid thioglycollate medium
- Soybean-casein digest medium
- Organisms can be recovered from growth
- Documented observation and review
A confident start
We help make the method work for your product.
Every pathway needs the right supporting work. Our team plans suitability and, for rapid alternatives, appropriate validation around your product and intended use, then guides the transition into routine testing.
We review formulation, sample availability and release goals to identify promising testing pathways.
We assess whether the selected method can detect microorganisms in the presence of the product.
For Celsis or ScanRDI, we plan the validation needed for the technology and intended use.
Once the method is established, we coordinate sample submission, reporting and investigation support.
What to expect: Traditional testing includes method suitability; rapid alternatives also need an appropriate validation strategy. The work varies by product, method and intended use. PlumGxP will explain the plan and conduct the necessary studies with your team.
Product diversity
A sterility program built around what you manufacture.
The most appropriate method can depend on formulation, sample volume, container, filtration characteristics, antimicrobial activity, background interference, release timeline and the need to recover an organism for identification.
Aqueous Products
Often suitable for filtration, subject to product-specific rinsing and suitability considerations.
Viscous & Oily Products
Different preparation and testing options can be evaluated for challenging formulations.
Biologics & Cell and Gene Therapies
Small sample volume, short shelf life and time-sensitive decisions can guide the choice of method, including Celsis Adapt where suitable.
Medical Devices
Configuration, extraction, immersion, rinse fluid and product geometry influence the method design.
A better fit across your portfolio
When you manufacture different types of drugs, a choice of platforms lets us assess each product on its own merits while keeping your sterility program coordinated with one laboratory. Traditional testing and Celsis are growth-based methods that preserve viable organisms for follow-up; ScanRDI adds a direct-detection option when speed is a priority. This gives you two pathways that retain viable organisms for identification when growth is detected, alongside a fast direct-detection option.
When detection becomes investigation
A positive signal is the beginning of the question—not the end.
When a microorganism is recovered, identification can help assess what the result may mean and where the investigation should look next. The ability to retain or recover an organism for identification should be considered when selecting a sterility pathway.
- Evaluate potential associations with personnel, environment, water, raw materials or processing
- Compare the recovery with historical environmental or product isolates
- Support risk assessment, targeted resampling and investigation decisions
Program development
From product assessment to routine testing.
- 01 / ASSESS
Understand the product
Review the formulation, manufacturing process, container, sample availability, release needs and testing history.
- 02 / SELECT
Choose the pathway
Determine whether traditional filtration, direct inoculation or a rapid option provides the appropriate fit.
- 03 / CONFIRM
Establish the method
Complete the suitability and validation work appropriate to the product and selected pathway.
- 04 / IMPLEMENT
Begin routine testing
Establish sample submission, scheduling, reporting, investigation and change-management expectations.
Frequently asked questions
Planning a sterility program?
Does every product need the same sterility method?
No. Product matrix, antimicrobial activity, filtration characteristics, sample volume, container configuration, release timeline and intended market can affect method selection. A portfolio may appropriately use more than one testing pathway.
What is bacteriostasis and fungistasis testing?
B&F testing is the method-suitability evaluation used with traditional sterility testing to demonstrate that the product does not inhibit recovery of the required challenge microorganisms under the proposed test conditions.
What validation is needed for a rapid method?
The work depends on the product, platform and intended use. PlumGxP will develop the appropriate suitability and validation plan with your team and complete the required studies before routine testing.
Why is organism recovery important when selecting a rapid method?
If a test produces a positive result, recovery of the organism can be essential for identification and investigation. The investigation pathway—including how an organism will be recovered and identified—should be considered before selecting and validating the rapid method.
Can PlumGxP help select a method across several product lines?
Yes. We can review the portfolio and recommend traditional testing, Celsis or ScanRDI according to each formulation’s needs while keeping the program coordinated through one laboratory. Explore Celsis or explore ScanRDI.
Build a sterility strategy around your products—not one instrument.
Tell us about your formulations, timelines and current testing challenges.