Element has broad microbiological analysis and detection capabilities for both product validation & lot release protocol. Our experts undertake a wide range of projects for medical device and pharmaceutical manufacturers, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
Microbiological analysis provides the characterization of micro-organisms on or in a medical device, package, raw material or component. Testing the microbiological makeup of a product allows manufacturers to ensure that there are no bacteria or toxins that may harm the user.
Partnering with Element allows your company to mitigate risk knowing that we are working diligently to help ensure your success, and to bring a safe product to market quickly. For more information about our microbiological analysis services or to request a quote, contact us today.
Prior to final sterilization and packaging, medical devices and pharmaceuticals often must undergo bioburden testing, a quantitative determination of the population of viable micro-organisms either on or in the product. This testing relates to non-sterile medical products as well as pre-sterilization product evaluation. Results from bioburden testing can be utilized to determine proper sterilization levels and procedures.
Microbial Characterization (ISO 11737-1)
Bioburden testing per ISO 11737 may include aerobic bacteria, spores, aerobic fungi, anaerobes, or any combination of the above. Most commonly, the microbiological analysis involves product extraction followed by a membrane filtration, microbial growth on medium, and enumeration of visible colonies. Alternatively, a plate-count method can also be applied (product specific).
Bioburden Recovery Validation (ISO 11135) – Repetitive or Inoculation Method
Bioburden recovery validation is employed to develop and validate a product-specific bioburden testing procedure that will evaluate effectiveness of the procedure, assess antimicrobial properties of the product/sample, and establish a recovery factor for the procedure.
The repetitive (exhaustive) recovery method uses the naturally occurring bioburden of the product to determine the efficiency of the recovery on a test article.
The spore inoculation method determines the efficiency of recovering the naturally occurring bioburden on a test article by creating an artificial bioburden.
Testing for endotoxins helps ensure that medical devices and implants are safe for human use. Bacterial endotoxins are known to cause fevers and disease when injected into the bloodstream. It is therefore critical to ensure that these devices are endotoxin-free.
Kinetic Chromogenic & Turbidimetric Methods (USP 85)
This method is an in-vitro quantitative assay which photometrically detects endotoxins from gram-negative bacteria, using Limulus Amebocyte Lysate (LAL).This microbiological analysis is applicable to medical devices, sterile and nonpyrogenic assemblies, human and animal parenteral drugs, and other biological products as an important predictor of pyrogenic response.
Validation must be performed with each device and change to process/material. Element’s Kinetic Chromogenic detection limit is 0.005 EU/ml, while the Kinetic Turbidimetric detection limit is 0.010 EU/ml.
Cytotoxicity is the quality of being toxic to cells. Testing for cytotoxins is required for all medical devices prior to regulatory approval. The testing process is a rapid and highly standardized method that identifies any significant amounts of potentially harmful substances in biomedical materials or devices. The results are useful for screening materials because they serve as a first step to providing evidence of biocompatibility (no mammalian studies).
Cytotoxicity (ISO 10993-5, USP 87)
ISO 10993-5 and USP 87 are in-vitro qualitative assays used to determine the presence of toxins from medical devices, their components, or raw materials in relation to mammalian cellular viability.
Testing is performed on the final product, representative samples from the final product, or materials processed in the same manner as the final product (see ISO 10993-1). Specimens are prepared in accordance with ISO 10993-12.
Any device or implant that is sterilized before use should be sterilized per manufacturer recommendations prior to testing. If non-sterile test samples are used, the lab will also require that they be checked for bacterial contamination in order to avoid a false assessment of cytotoxicity.
Testing is performed in triplicate with L929 cells.
Element does not conduct animal testing.
Methods Commonly Performed:
- Direct Contact Method
- Agarose Overlay Method
- MEM Elution Method
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