Microbiology Lab Testing
Cambrex’s microbiological testing labs are all FDA-registered and fully compliant with all GMP and GLP testing services and standards within our Microbiology Laboratories, Cleanroom and Isolator.
Cambrex’s experienced analysts are on board in each of our labs to make sure the microbiological testing is of a high quality for our customers and delivered with a quick and reliable turnaround.
A controlled manufacturing environment requires a thorough disinfectant qualification program, and for this we are the partner you can rely on.
We use two methods of disinfectant testing – tube dilution and swab recovery. Tube dilution is best suited for clients with new facilities with little or no environmental programs, while swab recovery is for more established factories with an environmental history.
Microbial immersion testing
The microbial immersion test involves performing a vacuum and pressure challenge on media-filled samples while they are submerged in a microbial broth. Then, the samples are incubated and observed for growth. If there is growth, then a leak is confirmed.
Filter Integrity Testing
We offer filter integrity testing, where we test filters and their ability to retain bacteria. Filters are challenged with ≥ 1.0 x 107 cfu/cm2 of the effective filtration area at a specified pressure. The filtrate obtained is then filtered through an appropriate assay filter which is plated onto agar. After incubation, the assay filters are observed for the presence of bacteria.
We also offer bacterial filter retention studies that test the ability of a filter to retain bacteria after being exposed to product during process conditions.
In addition to our environmental monitoring of microbiology labs, Cambrex provides expert, compliant microbial testing and identification services to identify bacteria, fungi and yeasts for the pharmaceutical, medical device, cosmetics, personal care, food and beverage manufacturers and other industries that require identification of microbial isolates.
We are experts in both fungi and environmental contaminants. Genetic analysis of the ribosomal RNA and analysis of proteins through MALDI-TOF mass spectrometry are accurate and validated. Libraries are maintained and periodically updated by the manufacturers for quick and accurate Microbial ID analyses. Determining the correct genus and species is essential for developing a robust product and environmental surveillance program.
Testing for Mycoplasma is a necessary quality control requirement to assure reliably pure biotechnological products and allied materials used to generate these products. Cambrex’s mycoplasma testing services meet regulatory requirements for USP and FDA.
Mycoplasma, a common cell/ tissue culture contaminant, represents a group of minute bacteria, which have no cell walls. The presence of Mycoplasma does not always result in turbid growth in cultures or visible alteration of cells, and a cell culture infection may persist for an extended period without causing apparent cell damage. This is why it’s important to test materials and products for its presence.
Sterilization Validation Testing
Properly designed and executed sterilization validations are critical to ensuring the sterilization process is capable of achieving the intended sterility assurance level (SAL).
Cambrex offers superior expertise and high-quality testing to support radiation (gamma/e-beam) and gaseous (Ethylene Oxide) sterilization validations and monitoring. Cambrex’s experts have years of experience in Bioburden and Sterility testing.
Our testing services include:
- Bioburden recovery factor testing
- Bioburden testing
- Bacteriostasis/Fungistasis testing
- Sterility testing
- Ethylene Oxide Residuals testing
Bacterial Endotoxins are pyrogens that are produced in bacteria which cause fever in humans and other animals. The most common pyrogen is Lipopolysaccharide (LPS), which is a component of the cell membrane of many gram-negative organisms.
Cambrex offers the ability to test and detect the amount of endotoxins in parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection, and active pharmaceutical ingredients (API) to ensure patient safety for the medical devices or drug product that will come into direct contact with the blood or cerebrospinal fluid (CSF).
We provide a courier service available to clients located in the New England area within a 150 mile radius of the Agawam facility (located at 104 Gold Street, Agawam MA). Our experts will pick up and deliver your samples to our laboratory for analyses. Please click here for the Courier Request Form.
Find out more
To find out more about Cambrex’s microbiology services, please contact us.