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BIOCIENCIA BIOSECURITY PROCESS
In order to learn about the biosecurity process of companies related with the development of our proyect, we visited BioCiencia S.A de C.V, a private company formed by molecular biologists and agronomists Paracitologos engineers with extensive experience theory and practice in the problems of national agriculture. They have a traditional diagnostic laboratory and a molecular plant to detect pathogens (caused by fungi, bacteria, viruses, viroids, nematodes and Mycoplasmas), using the most advanced technologies at national and international level such as ELISA, PCR (Polymerase Chain Reaction), RT-PCR (reverse transcription-PCR), Immuno-capture RT-PCR and hybridization of nucleic acids with no radioactive probes, among others. Their laboratory is approved by the SAGARPA, the secretary of agriculture, livestock, rural development, fisheries and food, (Key approval no. 98-719 -001-F) by what their diagnosis have official status.
It was a pleasant surprise to discover that a company that uses molecular biology in the detection of plant diseases was placed in our community. Their function is closely related to our project because while we develop a bioinseticide to control the plague Premnotrypes vorax, that attack the potatoe corp, they are part of the 13 plant pathology and entomology industries in México that check and approve the quality of the fruits, vegetables and legumes that end into supermarkets.
Biociencia was very accessible when we visited their laboratories. They were very disposed to show us their laboratories and process; they also explained the security standards that their installations need to satisfy in order to be approved as an official SAGARPA laboratory. Talking about the process of diagnostic, first they receive phytosanitary samples that fulfilled the necessary requirements to enter in the laboratory, without mattering they are sick or healthy. Then, the samples are passed to the third part of the laboratory, which is divided in tree parts, and stayed there until they are processed, liquefied or macerated. The samples are passed to ISO format for a better organization. After that they make the diagnostic to see the kind ok plague, bacteria or virus that affect the healty of the plant by different process being the most common the PCR, for bacteria and viruses cultures, and ISA, for the detection of proteins. All the culture media is sterilized.
The biosecurity is defined as the set of preventive measures designed to maintain control of occupational risk factors from biological, physical or chemical, obtaining preventing harmful impacts. The importance of security in the laboratory goes farer, because a failure in the process can cause the loss of the material and the whole work. Preventing this and in case of the client wants a review, the laboratory has to keep the samples for 30 days.
The impact of this area of work is big in the sense that they do not let new plagues enter in the national territory. In order to be certificated by the SAGARPA and EMA, Mexican Accreditation Entity, the installations are cheeked each year in a 40% and each four years in a 100%. Besides fulfilling the basic requirements of every laboratory, as the using of the appropriate safety equipment and following the binnacles’ registry on each instrument, it has to satisfy the requirements of the ISO/IEC 1725, the Mexican Institute of Standardization and Certification A.C., and the general requirements for the competence of testing and calibration laboratories, that is the main ISO/CASCO standard used by testing and calibration laboratories. The contents of ISO/IEC 17025 standard itself comprising five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. In the case of BioCiencia, they have to put their work and results of one month in a DVD, also they have a common server and a hard disk drive, on which depending the importance off the document is the amount of people that as access to it. Noteworthy that all the staff working in BioCiencia has at least a level of mastery. Also the information resulting of the diagnostic of the plants is confidential of the payer. The material they use is obtained from AGDIA, the World Leader In Plant Pathogen Test Kits, and NEOGEN.
The visit to BioCiencia made us realize of the importance of the security process, as well as the fulfillment of its normativity, as an essential part of the general process. If both are not satisfied, we cannot consider any kind of process complete. The security optimize the process, time, material, human resource, and reduce the margin of error in the laboratory. We realized that for our own project we will need to follow the learned in this visit in order to continue improving in this area.
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