Confidence
in Every
Result.

PlumGXP provides sterility testing (USP <71> & AAMI) to support sterile pharmaceuticals, biologics, medical devices, compounded preparations, and other products where microbial contamination control is essential. Our testing helps clients evaluate product sterility with a focus on patient safety, regulatory expectations, and confident release decisions.

Bacterostasis and fungistasis testing confirms that the product does not inhibit the recovery of microorganisms during sterility testing. This method suitability step is especially important for products with preservatives, antimicrobial activity, complex formulations, or characteristics that may interfere with microbial growth.

With GMP-focused execution and responsive scientific support, PlumGXP helps clients understand not only the result, but also the suitability and meaning behind the test. Read More

PlumGXP provides endotoxin testing to support injectable products, biologics, medical devices, pharmaceutical water systems, raw materials, and in-process samples. Because endotoxins can present a patient safety risk even when viable organisms are not detected, this testing is an important part of product release, validation, and contamination control programs.

Endotoxin Validation confirms that the sample does not interfere with endotoxin detection or amplify it. PlumGXP works with clients to evaluate product-specific considerations, appropriate dilutions, and testing requirements so results are reliable, meaningful, and aligned with GMP expectations.

PlumGXP provides microbial limits testing to support non-sterile pharmaceuticals, raw materials, in-process samples, and other products where microbial quality must be evaluated. MLT helps determine total microbial burden and assess for specified microorganisms that may impact product quality, safety, or compliance.

Testing may include method suitability, total aerobic microbial count, total yeast and mold count, and specified organism screening based on product type and regulatory expectations.

Relevant USP Chapters: USP <61>, USP <62>, USP <1111>, and USP <60> when Burkholderia cepacia complex testing is applicable. Read More.

PlumGXP provides microbial identification using MALDI-TOF mass spectrometry to support environmental monitoring, contamination investigations, microbial limits testing, water testing, and routine quality control programs. Rapid and accurate identification helps clients better understand contamination sources, evaluate trends, and make informed GMP decisions.

MALDI-TOF can be used to identify bacteria, yeast, and mold isolates recovered from product, process, utility, or environmental samples, supporting both routine monitoring and deeper investigation into recurring or unusual microorganisms.

PlumGXP provides antimicrobial effectiveness testing to support products formulated with preservatives or antimicrobial systems. USP <51> evaluates whether a product’s preservative system can control microbial challenge organisms over time, helping demonstrate that the formulation remains protected during its intended use.

This testing is commonly used for multi-dose products, aqueous formulations, topical products, oral products, and other non-sterile products where preservative performance is an important part of product quality and patient safety.

PlumGXP provides flexible routine environmental monitoring services. Whether you need complete onsite support, laboratory analysis, or additional capacity for your existing program, we can function as an extension of your quality control team. Read More.

PlumGXP supports pharmaceutical water system qualifications in accordance with applicable USP, Japanese Pharmacopoeia (JP), and European Pharmacopoeia (Ph. Eur.) requirements. Testing capabilities include microbial enumeration, Total Organic Carbon (TOC), conductivity, pH, and bacterial endotoxins, as applicable to the water grade and client requirements. Read More.

PlumGXP supports clean steam condensate testing for critical quality attributes, including dryness, superheat, non-condensable Gases, total organic carbon (TOC), conductivity, bacterial endotoxins, microbial enumeration, and other specified chemical tests. Sampling and testing programs can be developed for clean steam generators, distribution loops, autoclave supplies, SIP systems, and individual clean steam points of use.

Disinfectant manufacturers perform testing to support the labeled efficacy and intended use of their products, but that information alone does not demonstrate that an agent will be effective in every pharmaceutical facility. Each site remains responsible for establishing and maintaining written cleaning and disinfection procedures appropriate for its operations and for demonstrating that its selected agents, concentrations, contact times, application methods, cleaning tools, and surface materials are suitable for maintaining the manufacturing environment in a state of control.

PlumGXP develops disinfectant efficacy studies using applicable compendial challenge organisms and facility-specific resident isolates recovered through environmental monitoring. Testing can evaluate disinfectants and sporicides against representative cleanroom surfaces, such as stainless steel, glass, plastics, wall panels, flooring, and other equipment materials, using the concentrations, preparation methods, application techniques, and contact times employed at the facility. Appropriate neutralization, recovery controls, and log-reduction analysis provide documented evidence that the program is effective against a meaningful range of vegetative bacteria, bacterial spores, yeast, and mold. Including resident organisms helps confirm that the facility’s actual microbial population is adequately addressed—not only the standard organisms evaluated by the disinfectant supplier. FDA inspection guidance notes that facility assessments typically include laboratory studies using representative production-surface coupons and the same disinfecting agents and contact times defined in written procedures. Read more. FDA sterile-drug inspection guidance

Compressed air and process gases can directly or indirectly contact pharmaceutical products, primary packaging, equipment, and other critical surfaces. Compressed air testing and compressed gas quality testing help confirm that these utility systems are not introducing viable microorganisms, particles, water, oil, or other contaminants into controlled manufacturing environments.

PlumGXP provides onsite pharmaceutical compressed air testing and compressed gas sampling for air, nitrogen, carbon dioxide, oxygen, and other process gases. Testing programs may include microbial testing, nonviable particle testing, dew point, moisture, oil aerosol, oil vapor, and other specified contaminants. ISO 8573 identifies compressed-air purity classes.

PlumGXP provides onsite sampling support for water systems, environmental monitoring, EMPQ studies, clean steam, compressed gas, cleaning verification, TOC, endotoxin, and related GMP testing programs. Our team can come to your facility to collect samples, support study execution, and help ensure sampling is performed consistently and appropriately.

We also provide the necessary sampling supplies, including containers, labels, instructions, and submission materials, so clients have what they need for accurate collection, transport, and laboratory testing. Read More.

PlumGXP provides TOC testing to support pharmaceutical water systems, cleaning validation, and routine cleaning verification programs. TOC testing helps evaluate organic residue, system cleanliness, and process control where low-level organic contamination may impact product quality or compliance.

Testing can support water system qualification and monitoring, equipment cleaning studies, rinse samples, swab samples, and ongoing verification activities. PlumGXP can also provide the appropriate sampling supplies to help ensure samples are collected and submitted correctly. Read More.