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A microbial culture medium is a mixture of substances that promotes and supports the growth and differentiation of microorganisms. Culture media contain nutrients, energy sources, growth-promoting factors, minerals, metals, buffer salts, and gelling agents (for solid media). The sophisticated formulations of our culture media ensure precise, reproducible, and repeatable microbiological test results. Culture media are still the golden standard in pharmaceutical and food and beverage industry to enumerate and detect microorganisms. Microbial culture media can be prepared as a liquid (broth), a solid (agar plates), or as a semi-solid (deeps). Solid and semi-solid media contain a solidifying agent such as agar or gelatine.
Our portfolio includes a broad range of dehydrated culture media in powder or granules. Our superior granulation technology provides maximum convenience, safety and meets the highest industry performance standards. Ready-to-use media are produced under standardized production conditions and solve numerous problems in microbiology laboratories where time, equipment, and trained personnel are often in short supply. We offer ready-to-use 90- and 55-mm agar plates, liquid media bottles, tubes, or 2 mL ampoules, broths and rinse fluids for your microbial testing application.
Air sampling is a key component of effective environmental monitoring programs that ensure critical areas, such as production areas and medical facilities, meet the requirements for microbial limits.
While passive air monitoring uses settle plates for the quantitative analysis of the air, active air monitoring requires the use of a microbial air sampler. Air samplers impact microorganisms of a known volume of air onto a culture medium.
Our air samplers are based on different principles, enabling technology selection to suit your needs. We offer products specifically designed for the food and beverage industries, explosion hazard areas, cleanrooms and isolators, and compressed gas monitoring. Our easy-to-use monitoring systems are designed for many environment monitoring needs.
MICROBIAL AIR SAMPLERS FOR AMBIENT AIR
The MAS-100® series is a complete and accurate system for reliable and easy ambient air monitoring. The MAS-100® series is based on the Anderson impaction principle and uses settle plates or contact plates.
The family of MAS-100® instruments consists of dedicated instruments for different applications, such as:
MICROBIAL AIR SAMPLERS FOR AMBIENT AIR AND COMPRESSED GASES
The RCS® series is renowned for safe and reliable environmental monitoring of ambient air and compressed gases using agar strips.
Indicator organism imply the presence of spoilage organisms, pathogens, and quality indicators that can verify the overall hygienic conditions of a product.
ALTERNATIVE AND RAPID CULTURE MEDIA METHODS
Alternative and rapid culture media are efficient methods for quick indicator organism testing results.
Our MC-Media Pad® convenient culture media tests are designed for indicator organism testing and hygiene monitoring in food and beverage production. The pads are coated with growth media and chromogenic substrates for specific detection, allowing faster results and improved read-outs. This convenient method complies with international food and beverage standards (AOAC-PTM, AOAC-OMA, ISO 16140). The MC-Media Pad® improves your workflow and reduces required storage, incubation and waste capacity.
For complex matrices, testing can be simple using the SimPlate® test, which provides rapid, easy-to-interpret results, even with food and environmental matrices that are challenging for other rapid methods. SimPlate® tests have been validated by international standards (AOAC/MicroVal).
Testing for pyrogens is a critical step in ensuring parenteral pharmaceutical product and medical device safety. It is part of the mandatory release tests to avoid life-threatening fever reactions induced by pyrogenic substances. The monocyte activation test (MAT) can detect both endotoxin and non-endotoxin pyrogens in one in vitro test.
MONOCYTE ACTIVATION TEST (MAT)
Used to detect both endotoxins and non-endotoxin pyrogens in parenteral products, such as pharmaceuticals and medical devices, the MAT gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
The Rabbit Pyrogen Test and the Limulus Amebocyte Lysate (LAL) test are broadly used for pyrogen detection. Both methods use animals and show some limitations. The rabbit pyrogen test shows a lack of robustness as an animal reaction can differ greatly from a human reaction. In the LAL test, only endotoxins are detected causing a safety risk by ignoring non-endotoxin pyrogens that could be present in the tested sample.
To overcome these limitations, the Monocyte-Activation Test (MAT) was introduced in the European Pharmacopoeia in 2010 as a compendial method to replace the Rabbit Pyrogen Test (EP Chapter 2.6.30) and mentioned in FDA guidance for industry.
Please Note: The European Pharmacopoeia Commission took the decision to put an end to the rabbit pyrogen test in accordance with the 3Rs principle considering that the MAT is the best alternative option.
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PyroMAT® IN VITRO TEST TO DETECT ENDOTOXIN AND NON-ENDOTOXIN PYROGENS
The PyroMAT® system is based on the Mono-Mac-6 cell line and IL-6 read-out. It offers all the advantages of the monocyte activation test combined with the benefits of using a cell line.
Quality control is an essential element of a laboratory’s quality assurance system and certified reference materials (CRMs) are necessary for effective quality control. The VITROIDS™ and LENTICULE® discs from Supelco® are specially developed to provide laboratories with the ability to use suitable, ready-to-use microbiological controls for every media quality control test. The Colony forming unit (cfu)-concentrations are designed ensuring that no or only minimal dilution steps are required and are provided under license by National Collection of Type Cultures (NCTC®)/ National Collection of Pathogenic Fungi (NCPF®) and Spanish Type Culture Collection (Colección Española de Cultivos Tipo, CECT®), respectively.
The LENTICULE® and VITROIDS™ discs are manufactured under conditions compliant with ISO 17034 and ISO/IEC 17025. These discs contain defined certified cfu’s with a standard deviation and expanded uncertainty. The discs contain pure cultures of bacteria, yeasts or molds in a solid water-soluble matrix. The certified reference material for microorganisms finds its application in routine quality control for food, beverage, water and environmental testing, for method development and validations and as cultures used in research studies.
Biochemical, immunological, and molecular biological tests for microbial identification or the differentiation between groups of organisms are used regularly in microbiological quality control at production facilities and in academic research. Such microbial identification tests detect specific proteins, certain biochemical activities of the target cells (for example the activity of an enzyme), or gene sequences that are characteristic for microorganisms. Many microbial identification tests deliver important results within a short time, are very economical and user-friendly, and most do not need specific equipment or instrumentation. Some biochemical tests require only a drop of reagent to be applied on an agar plate or in a liquid medium.
When it comes to membrane filtration, accurate results are key for microbial product safety. We offer a complete portfolio to streamline your microbial limit test workflow from filtration to culturing and detection.
MEMBRANE FILTRATION SYSTEMS
We offer complete systems for membrane filtration including services. Our latest innovation, the Milliflex Oasis® system, is an all-in-one system designed for pharmaceutical and cosmetics applications and comes with a myriad of new features for increased productivity, result reliability and regulatory compliance. Our EZ product family is a range of membrane filtration products, including a manifold, vacuum pump, membrane dispenser and consumables. Used in combination, the system streamlines your water and beverages testing workflow.
MICROBIOLOGY FILTRATION FUNNEL
Our sterilized, disposable filtration funnels for microbiological testing can streamline your workflow, save time and give you highly reliable microbial enumeration results. While eliminating time-consuming steps, such as autoclaving, our funnels ensure you stay compliant to international regulations.
MEMBRANE FILTERS FOR MICROBIOLOGY
Our sterile membrane filters for microbial testing are ready-to-use and allow a good bioburden recovery. Our S-Pak® filters are individually packed and easy to use with gloved hands. For high volume applications, our EZ-Pak® membranes come in a band with 150 filters for easy loading with our EZ-Pak® Dispenser Curve. Combined with our touch-free membrane dispenser they allow high throughput for your membrane filtration.
RAPID MICROBIAL TESTING SYSTEMS
To keep pace with increasing production demands, reducing the time-to-result in microbial safety testing is key. Rapid microbial detection methods using fluorescent-based technology give you the ability to obtain microbiology test results earlier and therefore enables you to gain better control and understanding of your manufacturing process. The Milliflex® Quantum system is a non-destructive method enables reliable identification using any ID technology and comes with a service offering for training, maintenance and validation.
ON-LINE FILTRATION SYSTEM
To verify the microbial contamination limits of purified and processed water in tanks and water loops, the MicropreSure® system allows fast and easy in-process water testing. It is a closed, ready-to-use system that samples and processes in one step right at the collection site and can be used with solid or liquid culture media.
Culture media raw materials are the core ingredients used to prepare own culture media formulations. We offer an extensive portfolio of granulated and powdered biological raw materials that include dehydrated raw materials, such as peptones, agar-agar, and extracts, as well as additives. They are available in many varieties to meet a wide range of microbiology applications. Dehydrated raw materials available in granulated format facilitate safe handling and optimal performance. Granulated raw materials produce less dust contamination of the laboratory environment and dissolve quickly to ensure optimal flow properties. All our raw materials combine handling safety and optimal performance. Our strict quality control and assurance standards are the basis for their production.
Hygiene monitoring is a critical step in food production plants and other industries and markets to minimize the contamination risk of products and personnel within applicable environments. This is achieved by routinely verifying the effectiveness of cleaning and disinfection practices for equipment, personnel, and high touch surfaces.
For rapid monitoring, our tests use of established detection methods such as ATP (Adenosine Triphosphate), NAD (Nicotinamide Adenine Dinucleotide), and protein detection which are commonly known and accepted indicators of overall surface hygiene and cleaning efficacy.
For traditional monitoring, our tests use various selective media for semi-quantitative determination of hygienic conditions on surfaces or in liquid samples.