What is microbial contamination in pharmaceutical product?
Pharmaceutical Contamination involves the introduction of microbes into pharmaceutical finished products. Factors affecting the Microbial spoilage of Pharmaceutical products include: Types and size of contaminant inoculums, Factors related to pH, Moisture content, Storage temperature, Packaging Design, etc.
What are the 4 main microbial contaminants?
Microbial contamination happens when a food has been contaminated by microorganisms, including bacteria, viruses, mould, fungi, and toxins.
What is the most common cause of microbiological contamination?
The contamination process by pathogenic bacteria in humans may be caused by poor hygiene conditions during processing involving sick people and animals or involving feces from infected agents.
What is contamination in pharmaceutical industry?
Contamination is defined as the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (Active Pharmaceutical Ingredient) during production, sampling, packaging or repackaging, storage or transport.
What is a microbial contamination?
The unnecessary or unintentional habitation of pathogenic microorganisms is termed as microbiological contamination. Contagious microbes, including bacteria, fungi, yeasts, protozoa, and even virus causes microbial contamination (Braun Melsungen, 2011).
What are the types of microbial contamination?
Microbiological Contamination
- Bacteria. Bacteria are microorganisms with a size of up to 5 µm and represent the most important group of pathogens when discussing microbiological contamination.
- Viruses. Viruses are subcellular biological objects with a size of 20-200 nm.
- Prions.
- Funghi, Yeasts and Protozoa.
What is microbial contamination in water?
The microbial contamination of water is often of faecal nature related to humans (water sewage treatment plants, combined sewage overflow (CSO), non-collective sewage systems), domesticated animals (manure spreading, pit stock overflow), or wildlife.
What is microbiological contamination of water?
What is an example of microbial contamination?
Microbial contamination, also known as biological, is the most common cause of food poisoning. It is basically the existence of harmful pathogens in food, like microorganisms, bacteria, viruses, mould, fungi, and toxins. An example of this would include the bacteria and toxins found in spoiled meat.
How are bacteria found in pharmaceutical water systems?
Most bacteria in pharmaceutical water systems exist as biofilm, populations of microorganisms that adhere to equipment surfaces. They may be found on virtually any environmental surface where sufficient moisture is present. As a result, contaminants are not likely to be uniformly distributed throughout the system.
Why is microbiological monitoring of pharmaceutical water systems important?
Weaknesses in water systems are exacerbated by microorganisms being ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, monitoring pharmaceutical-grade water systems for bioburden is important. We are concerned with two primary types of water: purified water and water for injections (WFI).
Which is a major concern for pharmaceutical water?
Microbiological contamination is a major concern for pharmaceutical water. The presence of microbes, including bacteria and their endotoxins, is inevitable. Microbes are found in any and all water systems, and they are unpredictable.
How are microbial counts used in pharmaceutical industry?
AWWA/APHA Standard Methods must be validated for use in the pharmaceutical industry. The microbial counts recommended in USP <1231> for purified water and water for injection are scientifically justified. Points of use must be sanitized with alcohol prior to sampling.
