Aseptic packaging has to be done with special care and with the aim of eliminating microbiological and particulate contamination from the solution. Personnel is the greatest source of contamination in a parenteral production environment as they generate human dust. Particular attention must be paid, especially in the vicinity of an open container during filling, to maintain low contamination levels.
The Blow-Fill-Seal Technique has been developed so that formation of the container, filling and sealing takes place in a single machine under a controlled environment that enables the packaging of a pharmaceutical liquid in an aseptic manner, with the following advantages:
• less overall floor space requirement.
• lower personnel requirements.
• lower clean room requirements.
• better protection of product from contamination.
• lower logistic problems in the procurement and storage of the empty container.
Figures 1 – 5 show the major phases in the integrated packaging of parenteral solutions using the SYFPAC® system.
SYFPAC® is an acronym for: “System for Filling Parenterals Aseptically into Containers of plastic materials”. This system has been specifically studied to address the packaging needs of Parenteral fluids and injectables. The SYFPAC® system works on the principle of Blow Fill and Seal, and has been conceived by creative application of fantasy, engineering design and thorough knowledge of advanced materials and techniques. The SYFPAC® is designed to perform reliably and precisely throughout its long working life. The simple and robust construction does not need much maintenance.