Automatic filling and sealing machine SYFPAC® ULTACLEAN

liquidampoulefor pharmaceutical products

SYFPAC® ULTRACLEAN INDICATED FOR BIOLOGICAL PRODUCTS, CYTOTOXIC PRODUCTS, PRODUCTS WHICH CAN CONTAMINATE THE CLEAN ROOM AND ASEPTIC FILLING Conventional Blow Fill and Seal technology has now been in use since the 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 a 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. The 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.