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GMP Testing Laboratory · Allentown, PA | Build Your Audit Package

USP • ISO • AAMI • GMP testing

Finished Product, Medical Device & Raw Material Testing

One laboratory partner for microbiological testing—from incoming materials and presterilization bioburden through finished-product release.

Discuss your testing program Explore capabilities
Product-specific methodsIndependent verificationDirect SME accessClear, defensible data

Start with the product

What are you testing?

Select a pathway to see the microbiological testing program that fits your product and its point in the lifecycle.

Finished products

Release decisions backed by the right method.

Testing for sterile and nonsterile pharmaceuticals, biologics, compounded preparations and preserved formulations.

  • Traditional and rapid sterility testing
  • Bacterial endotoxin testing
  • USP <60>, <61> and <62> microbiology
  • USP <51> antimicrobial effectiveness
  • pH testing
  • Method suitability and alternative-method validation
  • Microbial identification

More than incubation

A scientifically appropriate sterility strategy

Compendial testing by membrane filtration or direct inoculation, selected according to the product. Programs may support routine testing, validation, stability and investigations.

Method suitability demonstrates that the product does not inhibit recovery of the challenge organisms under the conditions of the sterility test.

Support may include equivalency, limit of detection, specificity, repeatability, matrix effects, method suitability and recovery of stressed or representative organisms.

Testing is aligned to the intended use. Tests used to define, validate or maintain a sterilization process are distinguished from routine finished-product release testing.

Nonsterile microbiology

Counts, specified organisms and the risk behind the result

PlumGXP supports finished products, raw materials, components and in-process samples using applicable compendial methods and product-specific suitability.

61

USP <61> Enumeration

Total Aerobic Microbial Count (TAMC) and Total Combined Yeasts and Molds Count (TYMC) using plate count, membrane filtration or most-probable-number methods when appropriate.

62

USP <62> Specified Organisms

Applicable enrichment, selective culture, subculture and confirmation for the specified microorganisms required by the product type, route and specification.

60

USP <60> B. cepacia Complex

Method suitability and routine testing for Burkholderia cepacia complex in applicable aqueous nonsterile products and materials.

51

USP <51> Antimicrobial Effectiveness

Challenge testing of preserved drug products and applicable formulations to evaluate whether the preservative system controls specified microorganisms over time.

85

USP <85> Bacterial Endotoxin

Routine testing, investigations and product-specific inhibition/enhancement suitability for products, devices, materials and components.

ID

Objectionable Organisms

Identification and risk-based evaluation beyond the count, considering the organism, formulation, route, patient population and manufacturing process.

Explore microbial limits Explore endotoxin testing

Independent presterilization verification

Medical-device bioburden & quarterly audit testing

Bioburden testing measures the viable microbial population on or within a device after production and before sterilization. It supports sterilization-process development, validation, maintenance and routine control under ISO 11737-1 and applicable AAMI requirements.

1Device produced
2Presterilization bioburden evaluated
3Sterilization exposure conducted
4Post-exposure microbiological testing

Recovery efficiency proves the extraction works.

Device geometry, coatings, lumens, joints, absorbent materials and internal pathways can make organisms difficult to remove. A recovery-efficiency study evaluates whether the selected extraction method can sufficiently recover the population from the specific device.

Without this evidence, a low result could reflect poor extraction rather than low bioburden.

Why independence matters

Independent presterilization bioburden and post-exposure testing create separation between the sterilization service and verification of its microbiological outcomes—supporting clearer, more defensible quality decisions.

Fit for the product

Method suitability or full method validation?

Compendial method suitability

Compendial procedures are established methods, but suitability must be demonstrated in the presence of the specific product.

  • Dilution and sample preparation
  • Neutralizers and rinsing solutions
  • Membrane filtration
  • Solubility or dispersion
  • Recovery of challenge organisms
  • Bacteriostasis and fungistasis

Alternative-method validation

When a procedure is meaningfully modified or an alternative technology is used, PlumGXP can build the appropriate validation program for its intended use.

  • Accuracy and precision
  • Specificity and repeatability
  • Limit of detection and range
  • Robustness
  • Equivalency or comparability
  • Matrix effects and stressed organisms
Know what was recoveredNot only how many
Recovered isolateProduct, material, device or process
MALDI-TOFFast routine identification
Genetic IDAdditional resolution when needed
Quality insightSource, significance and next action

Connect the organism to the risk

Microbial identification completes the picture.

PlumGXP uses MALDI-TOF mass spectrometry and genetic identification when additional resolution is needed. Identification supports bioburden characterization, objectionable-organism evaluation, contamination investigations, sterilization-process assessment, trending and root-cause analysis.

Comparing product, raw-material and facility isolates can help reveal whether recovered organisms are consistent with the process or point toward a developing contamination source.

Explore microbial identification

Confidence in every result

Bring us the product. We’ll help build the right testing strategy.

Tell us about the product, material, device, specification and intended use. A PlumGXP scientist will help identify the applicable methods, suitability requirements, sample needs and testing pathway.

Let’s talk
Final scope is established against the applicable product specification, method and regulatory requirements.