MICROBIOLOGY AND SAMPLING / CLEAN ROOM
Microbiology is the branch of biology that studies microorganisms. The word microbiology, derives from the combination of the Greek words mikros, "small", bios and logos "study of life".
Microorganisms are living beings of small size, whose dimensions do not allow them to be observed with the naked eye by the man. Thus, they can only be viewed under the microscope.
The study of microbiology covers the identification, form, way of life, physiology and metabolism of microorganisms. In addition to its relationships with the environment and other species. The main groups of microorganisms are: viruses, bacteria, protozoa, algae and fungi. There are also pathogenic microorganisms that cause diseases in humans, animals and plants.
In the pharmaceutical industry, microbiology has a relevant role in determining the presence or species of undesirable microorganisms that may lead the user of the drug to undergo several actions by presence, such as: reduction of active substance content, pharmacological balance alterations and reactions of microorganisms.
During the manufacturing process, the product, packaging, storage, temperature and humidity conditions and the cleanliness of the professionals, contamination may occur and this will always be detrimental to the quality of the medicine as detrimental to the health of the patient.
Needs of Microbiology
Control is constant for the Pharmaceutical industries, water industry, veterinary industry, packaging industries, etc.
The T&E Analytical Center offers the following main Analyzes:
· Microbiological counting (bacteria, fungi, among others);
· Challenge test;
· Air-atmospheric and air-compressed contamination;
· Contamination of caps, bungs and packaging;
· Vitamins B12 and H;
· Analysis of antibiotics and cytotoxics;
· General analysis of drugs and surgical materials;
· Stability test follow-up;
· Water and water hemodialysis.
For sterile products it is necessary to handle the Clean Room: This special room requires positive pressure, with air insufflation by a HEPA filter. Need for sterile and single-use clothing. Laminar flow hood and segregated equipment for analysis. Materials for analysis and samples, are introduced by "past true" that are opening in the walls, one of road and another of exit, sterile and kept sterilized by ultraviolet light.
The T&E Analytical Center has a room for manipulation of cytotoxic products, such as oncology, hormone, mycotoxins, among others that protect the analyst. It is a room with two chapels, one of laminar flow where weighings or aliquots occur and another for dilutions. To enter the room it is necessary to use special clothing for single use with EPIs and pressurize the room with air passing through a HEPA filter.
The use of this room is obligatory by ANVISA for the use of the mentioned products. It is necessary in this way for the pharmaceutical industries, veterinary and chemical industry, among others.
The T&E Analytical Center offers plate collection service for:
I. Air pressurized to sterile systems such as injectables, bags, etc.
II. Analysis of contamination in laboratory ambient air.
For such sampling the Center has a specific pump that collects the air directly on a plate. Such volume is collected by time is predetermined to the search for the best concentration, after incubation.
The T&E Center maintains two calibrated autoclaves for sterilization, both equipment to be used in the analyzes, and for the disposal of post-analysis products.