SANITARY AND HYGIENIC ASSESSMENT OF THE ARRANGEMENT OF «CLEAN ROOMS» IN THE PROJECTS OF SURGICAL, OBSTETRIC HOSPITALS AND PHARMACEUTICAL COMPANIES

Abstract

Introduction. The designers and the administration of health care institutions face the urgent need to adapt the regulatory and technological documentation of Ukraine to the requirements of ISO 14644-1:1999 IDT «Clean rooms and related controlled environments. Part 1. Classification of cleanliness «for the construction of» clean rooms «in the reconstruction projects of surgical and obstetric hospitals, and modern pharmaceutical companies cannot produce competitive products without the introduction of» clean rooms "in the process of ISO, GMP, GLP – the best production and laboratory practices. Material and methods. The object of research were the projects of reconstruction and overhaul of operating surgical units and maternity wards of the Children’s Cardiac Surgery of the Lviv Regional Clinical Hospital, Lviv Regional Perinatal Center and the project of bringing TFC JSC Halychpharm to GMP requirements. During the examination of projects on the basis of the Lviv branch of Ukrderzhbudexpertiza, the project documentation complied with the requirements of DSTU ISO 14644-1: 2009 (ISO 14644-1: 1999 ID) and other regulatory and technical documents. Results. Hygienic and sanitary-epidemiological examination of projects for reconstruction and overhaul of surgical and obstetric hospitals, as well as technological regulations of the pharmaceutical company revealed shortcomings that could lead to increased levels of nosocomial infections and the production of substandard pharmaceuticals. The following additional project proposals for the construction of «clean rooms» were developed for comment: use of ceiling and wall sandwich panels, single- and double-leaf door units, air distributors with fine air filters in maternity and operating rooms and in the technological process of Halychpharm JSC, luminaires in sealed housing and other equipment.