What is celsis testing?

The Celsis Rapid Sterility Method is a growth-based sterility test, which detects microbial contamination based on the presence of microbial Adenosine triphosphate (ATP) in a sample. Because it is a growth-based test, it can be more readily compared to the compendial USP <71> test used for decades.

What is rapid micro testing?

Ganatra: Rapid microbial methods (RMMs), also known as alternative microbiological methods, are the technologies that allow the user to get microbiology test results faster compared with traditional culture-plate methods. Miller: “Faster” means in a matter of hours, as opposed to days or weeks in some cases.

What is rapid sterility testing?

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph. Eur. 2.6. 1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results.

What is microbial detection?

Microbial detection by PRRs activates the cells that express or bind them. Those in frontline positions for detection are the first responders of the innate immune system, such as tissue macrophages, fibrocytes, epithelial cells, and mast cells.

What is bioburden test?

Bioburden testing is a quality control process used during production to quantify microbial contamination in water, raw materials, or finished products to ensure the safety of a manufactured product.

What is direct inoculation?

Direct Inoculation is the study of how a material effects the D-value during the sterilisation process. This is normally conducted on stoppers or other materials that may increase the heat resistivity of an organism/biological indicator.

How are microorganisms detected in food?

The most important methods for detecting the microorganisms from food are:

1. Microscopic studies— morphology and staining reactions.
2. Motility studies.
3. Cultural characteristics.
4. Biochemical tests.
5. Chemical and molecular biology techniques, and.
6. Immunological techniques.

What is commercially sterile?

Commercial sterilization is defined as the destruction of all pathogenic and spoilage organisms that can grow in food under normal storage and handling conditions. This includes both vegetative (metabolically active growing and reproducing) cells and their non-vegetative (metabolically inactive) spores.

How do you detect bacteria?

Conventional methods used to detect and quantify bacteria are plate culturing, polymerase chain reaction (PCR), enzyme linked immunosorbent assay (ELISA) and chemical sensors based detection strategies. Plate culturing is the “Gold Standard” for bacteria detection.

What is the purpose of bioburden?

The purpose of bioburden testing is to enumerate the quantity of viable microorganisms on a pharmaceutical product, medical device, component, raw material, or package before sterilisation. Bioburden testing is also an important indicator of problems in the production process which could lead to product recalls later.

What is Bacteriostasis and Fungistasis test?

The bacteriostasis/fungistasis test is designed to validate the procedure used to test a product for sterility by demonstrating that microorganisms present on the product will be detected in the course of the sterility test.

What are the 3 ways bacteria are identified?

Bacteria are identified routinely by morphological and biochemical tests, supplemented as needed by specialized tests such as serotyping and antibiotic inhibition patterns. Newer molecular techniques permit species to be identified by their genetic sequences, sometimes directly from the clinical specimen.

What are 4 types of microbial food analysis?

Common test formats for microbial food testing are ELISA assays, real-time PCR tests, nutrient plates and agar plates.

What do you mean by CFU?

A CFU is defined as a single, viable propagule that produces a single colony (a population of the cells visible to the naked eye) on an appropriate semisolid growth medium.

What is the difference between sterilization and commercial sterilization?

Sterilization: Killing or removing all forms of microbial life (including endospores) in a material or an object. Heating is the most commonly used method of sterilization. Commercial Sterilization: Heat treatment that kills endospores of Clostridium botulinum the causative agent of botulism, in canned food.

What is 12D process?

12D concept refers to thermal processing requirements designed to reduce the probability of survival of the most heat resistant C. botulinum spores to 10-12. This helps to determine the time required at process temperature of 121oC to reduce spores of C.