Analysis of the methods for projection of spaces for good manufacturing practice

Abstract

BACKGROUND: In this Paper we will present the evolution of the best practice for biobanks, the technical and medical standards for collecting, processing and storing, as well as the socio-economic standards for biobank management. AIM: The aim of this Thesis is to analyse and to present the methods for projection of spaces for good manufacturing practice. METHODS: The European Union has adopted guidelines for good manufacturing practice which define the requirements for manufacturing of sterile products. In the following text we will describe the details for determining microbiological cleanliness and cleanliness of the particles in the air, on the surfaces, etc. RESULTS: The length of time between the collecting of blood or tissues could affect the final result. The preparation of sterile products requires special conditions, in order the risk of microbiological contamination and certain pyrogenic contaminations to be minimized. We make difference between four levels of guidelines for good manufacturing practice, which in this Paper are taken from the practice of the European Union. Level A is local zone with high-risk procedures, e.g. filling, closing of bottles, opening of ampoules and bottles and making septic connections. Level B is aseptic preparation and filling of the samples. Level C and D are the clean spaces for less critical procedures for preparation of sterile products. CONCLUSION: Technical standards, medical standards, socio-economic standards for biobank management, informatics practices for biobanks, economic recommendations for biobanks have been established, as well as a quality of biobanks has been provided.