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Rapid sterility testing for 503A & 503B facilities

Microbial detection in as little as four hours.

ScanRDI® brings advanced, non-growth-based detection to sterile compounding—giving pharmacies and outsourcing facilities faster information to support confident decisions and help move needed medications toward the patients waiting for them.

  • Detection in as little as 4 hours
  • Direct viable-cell detection
  • Bacteria, yeasts & molds
  • Built for time-sensitive products
Viable-cell detection field
Implementation underway

PlumGxP is building one of the most advanced rapid sterility testing programs available to sterile compounders. Early product discussions and program planning are now open.

Discuss your program →
See viable microorganisms sooner

Why wait for growth when technology can detect viability directly?

Traditional sterility testing depends on microorganisms multiplying until growth becomes visible. ScanRDI takes a more direct approach: it captures potential contaminants, labels viable cells and scans the membrane for fluorescent microbial events—in as little as four hours.

01 / CAPTURE

Filter the product

The product is filtered through a membrane that captures potential microbial contaminants for direct evaluation.

02 / LABEL

Identify viable cells

Active microbial cells generate a fluorescent signal, allowing the technology to detect viability without waiting for visible growth.

03 / DETECT

Scan the membrane

Solid-phase cytometry scans the membrane and locates fluorescent events rapidly, turning microbial detection into actionable information much sooner.

How the method works

From product to viable-cell signal.

ScanRDI combines membrane filtration, universal viability labeling and high-speed laser scanning to detect viable bacteria, yeasts and molds without relying on extended incubation.

01

Prepare

Prepare the product using the established product-specific procedure and appropriate controls.

02

Filter

Capture potential microbial contaminants directly on a membrane for rapid evaluation.

03

Label

Apply universal viability labeling so metabolically active microbial cells generate a fluorescent signal.

04

Scan & review

Scan the entire membrane, evaluate detected events and move the result through PlumGxP quality review.

Advanced by design: ScanRDI is not simply a shorter incubation. It is an alternative microbiological method that detects viable cells directly—creating an entirely different pathway to faster microbial insight.

What speed changes

More time for the medication. Less time waiting for information.

For sterile compounders, every day of a product’s shelf life matters. Earlier microbial information can support faster operational decisions, reduce avoidable holding time and help preserve more of the product’s useful life.

  • Earlier visibility into potential microbial contamination
  • Faster, better-informed quality decisions
  • More usable shelf life for time-sensitive preparations
  • Greater flexibility when patient demand changes quickly
  • Reduced dependence on prolonged growth-based incubation
  • A modern testing strategy aligned with innovative operations

For 503A compounding pharmacies

Patient focused

When a patient needs a customized sterile preparation, time can be clinically meaningful. Rapid sterility technology can support a more responsive testing strategy for suitable preparations and help pharmacies act on microbial information sooner.

For 503B outsourcing facilities

Operational impact

Faster detection can support more agile batch decisions, inventory planning and distribution of compounded medications—especially when hospitals and healthcare providers are managing urgent demand or drug shortages.

For healthcare supply continuity

Responsive

Rapid microbial insight can help manufacturers and compounders respond more effectively to changing utilization, limited inventory and the real-world needs of hospitals, clinics and patients.

For innovation-minded quality teams

Future ready

ScanRDI gives quality organizations a validated path beyond traditional incubation—bringing sophisticated detection technology into routine microbiological testing.

From weeks to hours

Detection in as little as four hours can change what is possible.

Instead of waiting through a 14-day growth-based incubation period for microbial detection, ScanRDI can detect viable microorganisms in as little as four hours. PlumGxP pairs that speed with controlled sample handling, expert review and GMP-quality reporting.

As little as 4 hr

Rapid microbial detection

Viable-cell detection without waiting for microorganisms to multiply into visible growth.

Patient impact

Faster information supports faster action

For a 503A pharmacy responding to an individual prescription or a 503B facility supplying healthcare systems, earlier information can help teams make decisions sooner and protect valuable time in the medication’s shelf life.

Validation handled by PlumGxP

We manage the scientific pathway. You focus on the patients you serve.

PlumGxP will conduct all necessary feasibility, validation and product-specific method suitability testing required to establish ScanRDI for its intended use. Our team manages the program from initial assessment through routine testing.

A simpler path to advanced technology: you do not need to build a ScanRDI program inside your facility. PlumGxP provides the platform, microbiology expertise, quality oversight and required testing as one coordinated service.

Innovation with options

A modern sterility strategy built around your product.

PlumGxP offers traditional and rapid sterility technologies so 503A and 503B facilities can build a program aligned with their products, timelines and patient needs.

Established foundation

Traditional USP <71>

Compendial membrane filtration or direct inoculation supported by PlumGxP microbiologists and a dedicated sterility testing environment.

Fastest detection pathway

ScanRDI®

Non-growth-based viability labeling and solid-phase cytometry with microbial detection in as little as four hours for suitable products.

Rapid growth-based detection

Celsis®

Advanced ATP-bioluminescence technology providing an additional rapid pathway for products and programs with different needs.

More than an instrument

Technology backed by microbiology expertise.

Rapid detection is most valuable when the laboratory can help interpret and act on the information. PlumGxP connects ScanRDI testing with quality review, investigation support and broader facility microbiology data.

  • Experienced microbiologists review test data and controls
  • Clear notification and quality-review pathways
  • Investigation planning established before routine testing begins
  • Traditional sterility and rapid-method expertise in one laboratory
  • Connections to environmental, personnel, water and product data
  • Microbial identification support when recoveries are available
How PlumGxP supports an unexpected detection

PlumGxP helps clients follow the predefined investigation pathway, evaluate relevant controls and connect the finding with environmental, personnel, water, raw-material and processing information. The goal is not only faster detection, but faster access to the right scientific support.

Program onboarding

A clear path to rapid sterility testing.

01

Connect

Tell us about the product, current testing approach, release needs and target timeline.

02

Assess

PlumGxP evaluates product fit and defines the most efficient development pathway.

03

Establish

We complete the necessary validation and product-specific testing.

04

Launch

Your program moves into routine testing with defined submission, reporting and support expectations.

Frequently asked questions

Planning for ScanRDI?

Is ScanRDI the same as USP <71> sterility testing?

No. USP <71> is a growth-based compendial method using defined media and incubation. ScanRDI is an advanced non-growth-based alternative method that uses viability labeling and solid-phase cytometry to detect microorganisms directly.

What does “in as little as four hours” mean?

It refers to the platform’s microbial detection time using the established ScanRDI workflow. Total client turnaround also includes sample receipt, preparation, controls, data review and PlumGxP quality release. Program-specific timing will be established during onboarding.

Can ScanRDI be used for a preservative-containing or antimicrobial product?

Potentially. The method must demonstrate that antimicrobial activity can be adequately removed or neutralized without compromising microbial recovery. Rinse strategy and product-specific suitability are central to that determination.

Who completes the required validation?

PlumGxP will conduct the necessary feasibility, validation and product-specific method suitability testing. We manage the scientific program and documentation needed to prepare the product for routine rapid sterility testing.

Does ScanRDI detect viable but non-culturable microorganisms?

The technology detects viable cells based on enzymatic activity rather than requiring visible growth. This offers the potential to detect stressed, fastidious or viable-but-non-culturable organisms under appropriate method conditions.

What should we provide for an initial product assessment?

Useful information includes formulation and ingredients, container and fill volume, available sample quantity, filtration history, preservative or antimicrobial properties, current sterility method, target turnaround, market and intended use of the result.

When will PlumGxP begin accepting routine ScanRDI samples?

Implementation is underway. Contact PlumGxP to discuss expected timing, product feasibility and validation planning. Programs can be evaluated before routine testing begins so method development does not wait until the first urgent sample arrives.

ScanRDI® is a registered trademark of its respective owner. Platform references describe the technology; PlumGxP’s service availability and validated applications are established independently.

Bring rapid detection into your program

Move faster for the patients depending on you.

Share your formulation, current sterility method and release goals. PlumGxP will build the pathway from product assessment through routine rapid sterility testing.