EUROLABis a leading provider of sterility assurance testing services for medical device, pharmaceutical and tissue manufacturers for sterile and non-sterile products.
Most tests follow the United States or European Pharmacopoeia (USP or EP) and similar international standards. disinfected medical device standards are also found in ISO, AAMI and ASTM guidance documents.
For ease of finding routine quality control testing services, the links below may include testing services not traditionally associated with sterile sterility assurance programs, but are compatible with routine testing services for many medical devices and pharmaceutical products.
For ease of finding routine quality control testing services, the links below may include testing services not traditionally associated with sterility assurance programs, but are compatible with routine testing services for many medical devices and pharmaceutical products.
Bioburden tests determine the total number of viable microorganisms in or on a medical device, container or component. It is usually performed on any product that requires control and / or monitoring of biological load counts as part of a sterilization program. This test acts as an early warning system for potential manufacturing problems that could lead to inadequate sterilization. It is also used to calculate the dose required for effective radiation sterilization and to monitor the product routinely as part of quarterly dose inspections.
To clarify, the bioburden of the product is intended for medical devices, containers and components. However, we also offer standard plate counts and microbial enumeration studies for powders, solutions and similar products where reconstruction and filtration may be required. Tissue products can also be evaluated in terms of biological burden.
Offering both traditional cleanroom and isolator product sterility testing EUROLABcan uniquely assist customers with the right testing facility to meet your product sterility testing needs. Clean rooms are often used for medical devices and some tissue products. Isolators are generally used for injectable and drug products that are processed aseptically and have low or no tolerance for sterility test failure.
Sterility tests should be validated by applying a Method Compliance test (Bacteriosis / Fungistasis or B / F). For products tested at the isolator facility, a package validation should also be performed to evaluate the decontamination process associated with placing the product in the isolator.
A replacement product or indicator may be used for some sterilization processes. Most commonly, the use of a biological indicator (BI) or spore strip saves both testing time and product cost. EUROLABBI sterility testing in is performed similarly to product sterility but requires a shorter incubation time and low volume of media, allowing for a more cost-effective sterility test to verify processing of the sterilization payload.
EUROLABprovides a Bacterial Endotoxin Test (BET), an in vitro assay for the detection and quantification of bacterial endotoxins, a component of the cell wall of Gram-negative bacteria. BET is performed as part of batch release testing for medical devices that have direct or indirect contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. Injectable pharmaceutical products should also be tested for bacterial endotoxins. Routine monitoring of water systems and incoming materials can ensure that the process does not contribute endotoxins to the final product.
Particle Analysis testing involves procedures to extract, count, and size particle contaminants on or in medical devices, stents, catheters, pharmaceuticals, IV bags, and contact lens solutions. This test is useful in determining the amount of particulate matter from the manufacturing environment and use of the medical device or pharmaceutical product, as well as identifying potential sources of particles. EUROLAB It applies both USP recommended methods: Light Obscuration (via HIAC ROYCO particle counter) and traditional Microscopic methods.
Sterilization processes may leave residue on the product after sterilization. For processes such as Ethylene Oxide (EO), sterilizer residuals, aeration time and safe levels need to be evaluated. EUROLABProvides non-sterile residue testing for EO, H202OXNUMX and other common sterilization process residues.
Microbial or Organism Identification tests are used to characterize product bioburden and/or environmental bioburden and identify organisms in sterility positives. For tissue products, a confirmation of the presence or absence of potentially objectionable organisms may also be made. EUROLABuses genotypic identifications using conventional Gram staining and other laboratory techniques using the MicroSeq system.
Specific to pharmaceutical manufacturers EUROLABprovides routine USP and EP comparative testing for product sterility (isolator), bacterial endotoxin, particle analysis, antibiotic potency assays (APA), antimicrobial protective efficacy studies (APE) and microbial identification services. For non-sterile pharmaceutical products such as transdermal patches, we also offer routine microbial enumeration studies for objectionable organisms (USP 61/62).
Specific to tissue processing and preservation EUROLABprovides routine USP and EP benchmark tests for microbial count studies to evaluate objectionable organisms and standard bioburden tissue tests for overall bioburden assessments. Microbial identifications can also be performed to characterize bioburden load and type. Tissue products present unique issues, particularly inhibition due to the use of antibiotics to preserve tissue material, which must be confirmed by compatibility study before some routine testing can be performed.
EUROLAB, with its highly expert team and internationally accredited laboratories, Sterility Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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