Brevetti Angela

Conventional Blow Fill and Seal technology has now been in use since last 40 years, and it is widely accepted technology proven to confer high sterility assurance levels. The advantage of this technology has been even recognized by EU GMP. Actually, in revised Annex on the manufacturing of sterile medicinal products, a separate paragraph is dedicated to the Blow/Fill/Seal technology. It states: "Blow/Fill/Seal equipment used for sterile production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/B clothing is worn". To further reduce the chances of contamination from viable and non viable particles, we have developed SYFPAC® - ULTRACLEAN, to guarantee protection against contamination which is comparable to modern isolator technology. It is well known fact that: Motors, drives, pipes and mechanisms in movement generate non viable particles. Human intervention is the biggest source of viable particles and increase chance of contamination. To address the above problems related to particle generation and contamination SYFPAC® ULTRACLEAN has been designed so that: only essential parts or assemblies remain inside the clean room. Rest of the parts are taken out of the clean room in an area adjacent to the clean room. Human intervention is reduced to almost nil, because most of the machine setting work can be performed from outside the clean room. The human intervention is required only during start up. To reduce the human intervention, most of the mechanisms and mechanical assemblies are so designed that they remain outside the clean room. Two control panels are provided so that most of the settings can be done from outside the clean room. Self contained HEPA Filter modules are installed in area below the Extruding Head The HEPA filter module protects area below extruding head, so that the transfer of the open containers from Extruding position to the filling position takes place under the protection of HEPA filtered air. So even during transit time of about 1 second the containers are protected against contamination.