International Conference on
Pharmaceutics & Pharmaceutical Microbiology

Biofilm is an assemblage of the microbial cells that is irreversibly associated with a surface and usually enclosed in a matrix of polysaccharide material. Biofilm is composed primarily of microbial cells and extracellular polymeric substance. Extracellular polymeric matrix plays various roles in structure and function of different biofilm communities. Microbial cells attach to the surfaces and develop a biofilm .Biofilm associated cell is differentiated from suspended counterparts by reduced growth rate, up and down regulation of gene and generation of extracellular polymeric matrix. Biofilm formation occurs by formation of conditioning layer, bacterial adhesion, bacterial growth and biofilm expansion .They can exist on all types of surfaces such as plastic, metal, glass, soil particles, and wood,medical implant   materials tissue and food products. A biofilm contains about 15% of microbial cells and 85% EPS(Extra Polymeric substance).EPS composed of polysaccharides, proteins, and other polymers and water. Quorum sensing plays an major role in the initial stages of biofilm formation and biofilm dispersion .Biofilm cells can be dispersed by three main process they are shedding, detachment and by physical process. Dispersion of biofilm cells can have detrimental effects on a process unit operation, a piece of equipment or water system. In Pharmaceuticals the risk of systemic microbial contamination in a water system is low due to proper purification steps and routine monitoring. Microbial contamination of pharmaceutical equipment occurs primarily with equipment and materials that do not meet sanitary design standards. Biofilm control involves preventing the initial contamination of the material attempting to minimize the initial microbial adhesion to the surface ,killing of biofilm cells via chemical or heat treatment and removing the piece of equipment together and replacing with a new and clean one.

Microbiology is the biological science involved with the study of Microscopic organisms. Microbiology is made up of several sub- disciplines including bacteriology (study of bacteria), Mycology (the study of fungi), Phycology (the study of algae), Parasitology (the study of Parasites) etc. These broad areas enclosed a number of specific fields .These fields includes Immunology. Pathogenic Microbiology and Food Microbiology .The relevant part of microbiology is the pharmaceutical microbiology, an applied branch of microbiology (Part of Industrial microbiology). Pharmaceutical microbiology is concerned with the study of microorganisms associated with the manufacture of pharmaceuticals .In this they use microorganisms to help to produce microorganisms or with controlling the numbers in a process environment. This mainly concerned about the ensuring that the finished product is either sterile or free from those specific strains. The Pharmaceutical Microbiologists are mostly interested in the toxins particularly the ‘’vestiges ‘’ of microorganisms are absent from products. Microbiological Contamination mostly causes many problems in the preparation of pharmaceuticals .According to the risk assessment terminology  this topic mainly  deals with the product contamination arising  understanding the severity of such contaminations various ways have been employed to minimize the contamination and developing new methods to detect the contamination . . Microbiological Contamination of sterilie injectable products is the greatest risk of contamination which leads to death of patients. The foundation of Pharmaceutical Microbiology is the culture media these are growth factors are designed to cultivate and grow bacteria and fungi.

Antimicrobial is an agent that kills microorganisms or inhibits their growth. The Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria and antifungals are used against fungi.. Agents that kill microbes are called microbicidal, while those that merely inhibit their growth are called biostatic. The use of antimicrobial medicines to treat infection is known as antimicrobial chemotherapy, while the use of antimicrobial medicines to prevent infection is known as antimicrobial prophylaxis. The main classes of antimicrobial agents are disinfectants. Antiseptics (which are applied to living tissue and help reduce infection during surgery), and antibiotics (which destroy microorganisms within the body).  The term "antibiotic" originally described only those formulations derived from living organisms but is now also applied to synthetic antimicrobials, such as the sulphonamides, or fluoroquinolones. Antiviral drugs are a class of medication used specifically for treating viral infections. Like antibiotics, specific antivirals are used for specific viruses. Antiparasitics are a class of medications indicated for the treatment of infection by parasites, such as nematodes, trematodes, infectious protozoa, and amoebae. Like antifungals, they must kill the infecting pest without serious damage to the host.

Microbial Contamination refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins and by-products. The sources of microbial contamination includes equipment, process operations, raw materials, column resins, filter membranes, water, process gases, and personnel. All sources of microbial contamination should be considered when developing a microbial control strategy and performing an investigation for a microbial contamination deviation. Modern laboratories are busy environments with personnel sharing equipment across overlapping workstations that may be near high-traffic areas and busy instruments.  The prevention of microbial contamination can be done by Practicing good aseptic technique is critical to maintaining the purity of cell cultures as well as a safe lab environment. Some of the most basic laboratory procedures are the most important, including using proper aseptic technique, wearing clean lab coats and washing hands in order to reduce the risk of introducing microorganisms into mammalian cell cultures. Cleanrooms and associated controlled environments provide the control of contamination (inert particles and microbiological entities) to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, electronics, food and beverages, cosmetics, general healthcare, and medical devices and pharmaceutical products requiring a variety of clean environments.  Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods

The Microbiological testing of Non sterile products contains supplemental information for the quantitative enumeration of viable microorganisms and the determination of the absence of specified microorganisms in finished pharmaceutical products and raw materials, commonly called as Microbial Limits Testing (MLT). Methods for enumeration of microorganisms from pharmaceuticals (as described in USP) include membrane filtration, conventional plate count (including pour-plate method, surface spread method), and the Most-Probable-Number (MPN). Products which are insoluble or immiscible in water must be appropriately treated to obtain a suspension suitable for the test procedures. The sterility testing involves the method suitability test this test is used to determine the bacteriostatic and fungi static has been retained on the filter membrane. Regarding the media the cultivation of the test organisms, select agar medium that is favourable to the rigorous growth of the respective stock culture. The recommended media are Soybean Casein Digest Agar/Broth and Sabouraud’s Dextrose Agar/Broth. Add a suitable in activator (neutralizer) for the specific antimicrobial properties in the product to the broth and/or agar media used for the test procedure if required.

Waterborne pathogens and related diseases are a major public health concern worldwide, not only by the morbidity and mortality that they cause, but by the high cost that represents their prevention and treatment. These diseases are directly related to environmental deterioration and pollution Proper assessment of pathogens on water and water quality monitoring are key factors for decision-making regarding water distribution systems’. Quantitative microbial risk assessment (QMRA) is a helpful tool to evaluate the scenarios for pathogen contamination that involve surveillance, detection methods, analysis and decision-making. Waterborne pathogens have appeared in ontaminated water, increase in sensitive population, changes in drinking water treatment technology, globalization of commerce and travel, and by the development of molecular methods for detection and source tracking . The protozoa Microsporidia, as the bacteria Mycobacterium avium intracellulare, Helicobacter pylori,Tsukamurella, Cystoisospora belli and viruses such as adenoviruses, parvoviruses, coronaviruses (SARS), and polyomavirus are some examples of the emerging potential waterborne pathogens .The most importantly used methods for water borne Pathogens are Polymerase chain reaction, Oligonucleotide DNA Microarrays, pyro sequencing, Immunology based methods and biosensor based methods  

Disinfection is defined as destruction of pathogenic microorganisms or their toxins or vectors by direct exposure to chemical or physical agents. General Disinfectants used in Pharmaceutical industry include alcohols, chlorine and chlorine compounds, formaldehyde, glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, iodophors, peracetic acid, phenolic and quaternary ammonium compounds. Sterilization is the process of killing all forms of microbial life in or on the given object or preparation. Microbiologically, sterile material is one that contains no living organisms at all and the term sterile is therefore an absolute one. According to WHO, sterilization is process of complete destruction or removal of all microorganisms (including spore-forming and non-spore-forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Sterilization refers to the complete destruction or elimination of all viable organisms in or on a substance being sterilized. Types of sterilization include: Physical (Moist Heat & Dry Heat), chemical and radiation.

Antibiotics, also called antibacterials, are a type of antimicrobial drug used in the treatment and prevention of bacterial infections.They may either kill or inhibit the growth of bacteria. Antibiotics are not effective against viruses such as the common cold or influenza etc. Antibiotics are used to treat or prevent bacterial infections, and sometimes protozoan infections. (Metronidazole is effective against a number of parasitic diseases). When an infection is suspected of being responsible for an illness but the responsible pathogen has not been identified, an empiric therapy is adopted. This involves the administration of a broad-spectrum antibiotic based on the signs and symptoms presented and are initiated pending laboratory results that can take several days. Antibiotics may be given as a preventive measure (prophylactic) and this is usually limited to at-risk populations such as those with a weakened immune system (particularly in HIV cases to prevent pneumonia), those taking immunosuppressive drugs, cancer patients and those having surgery.Their use in surgical procedures is to help prevent infection of incisions made. They have an important role in dental antibiotic prophylaxis where their use may prevent bacteremia and consequent infective endocarditis. Antibiotics are also used to prevent infection in cases of neutropenia particularly cancer-related.

Environmental monitoring is a survillenance system for microbiological control of clean rooms and other controlled environments .It is a process which provides monitoring testing and feedback to the microbiological quality levels in aseptic environments .The sources of contamination due to environment is personnel ,equipment and  cleaning agents  ,containers ,water and compressed gases The main aspect in drug preparation is Environmental monitoring in which contamination is caused due to microorganisms .The materials /equipments used are for example sterile Dacron or cotton swab with a sterile transport media solution .The sample preparation can be done by sample equipment controls  and by EM sampling procedure . In the Environment monitoring sites the facility and the equipment should be sampled during a ready-to-use state as determined by the firm. The presence of disinfectant on the swab may reduce the microbial bioburden or increase inhibition during broth incubation. The information on the quality of aseptic processing environment during manufacturing and prevents the release of potentially contaminated batch if appropriate standards are not fulfilled