USP · JP · Ph. Eur. Compliant
Raw Material and Finished Product Testing
Sterility, B&F and Bacterial endotoxin Testing
Sterility testing designed for confidence, compliance, and patient safety.
Sterility testing (USP <71> and AAMI) is a critical quality control requirement for sterile pharmaceuticals, biologics, medical devices, cosmeceuticals, compounded preparations, and other products where microbial contamination may impact patient safety. PlumGXP supports sterility testing with GMP-focused execution, clear communication, and an understanding of the urgency often associated with product release, validation, stability, and investigation activities.
Bacteriostasis and fungistasis testing confirms that the product does not inhibit the recovery of microorganisms during sterility testing. This method suitability step helps ensure the sterility method is appropriate for the specific product, especially for formulations with preservatives, antimicrobial activity, or complex product characteristics that may interfere with microbial growth.
Product endotoxin testing helps evaluate whether bacterial endotoxins are present at levels that could impact patient safety or product suitability. PlumGXP supports endotoxin testing for sterile products, injectable products, biologics, medical devices, raw materials, and in-process samples, with method suitability to confirm the test can accurately detect endotoxin in the presence of the product. This testing helps clients support release decisions, investigations, validation activities, and overall confidence that products meet applicable quality and safety expectations.
Non-Sterile Testing
Supporting safe products through reliable microbiology.
Non-sterile product testing (USP <60>, <61>, <62>, AAMI bioburden) helps evaluate the microbial quality of products, raw materials, and in-process samples where bioburden control is essential to product safety and compliance. PlumGXP supports Microbial Enumeration Tests and objectional organism screening- Tests for Specified Microorganisms as detailed in USP <1111> Acceptance Criteria for Non-sterile Products.
Method Suitability Testing. The Foundation of Compliance.
Regulatory bodies require proof that your specific product matrix does not inhibit or interfere with microbial growth or recovery. PlumGXP performs the mandatory method suitability testing for both AAMI and USP protocols before routine testing begins.
Meeting numerical microbial limits is only one part of evaluating product quality. A microorganism that is not specifically listed in a compendial test may still be objectionable based on the product, manufacturing process, route of administration, patient population, or organism characteristics.
PlumGXP helps clients interpret microbial results within the broader context of product risk. When unexpected organisms are recovered, our scientists can support identification, investigation, historical trending, and evaluation of their potential significance. More information.
Antimicrobial Effectiveness Testing
PlumGXP provides USP <51> & CTFA antimicrobial effectiveness testing to evaluate whether a product’s preservative system can control specified microorganisms over time. This testing supports products where antimicrobial protection is important to product quality, patient safety, and intended use, including multi-dose, aqueous, topical, oral, and other preserved formulations. Suitability testing helps confirm that the method can accurately recover challenge organisms from the specific product, ensuring the results are scientifically valid, defensible, and appropriate for formulation development, validation, release support, or ongoing product quality evaluation.
Microbial Identification
PlumGXP provides microbial identification using MALDI-TOF mass spectrometry and biochemical identification methods to support environmental monitoring, product testing, water testing, contamination investigations, and routine quality control programs. Accurate microbial identification is essential for understanding contamination sources, evaluating trends, assessing potential product or process risk, and determining appropriate corrective actions. Reliable identification helps clients move beyond a colony count to a clearer understanding of what was recovered and what it may mean for product quality, facility control, and GMP decision-making.
AAMI Bioburden Testing- Quarterly Audit
PlumGXP provides comprehensive quarterly bioburden audit testing to support pre-sterilization evaluations, ensuring strict alignment with ANSI/AAMI/ISO 11737 regulatory expectations. This testing helps determine the microbial population present on or in a device prior to sterilization and supports sterilization validation, routine monitoring, and product quality decisions. Suitability testing or recovery efficiency, is performed to confirm that the extraction and test method can appropriately recover microorganisms from the specific device or material, helping ensure the bioburden results are scientifically sound and defensible.
Product Testing That Supports Confident Release Decisions
PlumGXP provides GMP-focused product testing, method suitability, microbial identification, endotoxin, bioburden, and antimicrobial effectiveness support to help clients understand product quality, address risk, and make confident decisions from development through release.