Provides enhanced operator safety and effective decontamination capabilities
Each vaccine batch is aseptically processed on fill-it using GMP-certified, single-use tubing
TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a Royston, Hertfordshire, UK-based supplier of cell culture and fermentation systems for life science applications, has developed a stainless steel version of its Fill-it system, designed for safely dispensing biohazardous materials such as vaccine stocks.
The stainless steel version was developed in response to a request from a major pharmaceutical company and is suited to the demands of working with highly potent vaccine stock, the company said. It fits into standard isolator cabinets, thus reducing the product contamination risk, as well as the operator’s exposure to this biohazardous material.
The system automatically decaps, fills and recaps a rack of 24 2ml vaccine vials every two minutes. This ensures vial-to-vial consistency and, because there is no need for any manual intervention, makes routine vial fill and finishing safer.
Each vaccine batch is aseptically processed using GMP-certified, single-use tubing that is destroyed after use. The stainless steel exterior of Fill-it can be sterilised after each batch run with high strength hydrogen peroxide vapour, further reducing product contamination risk.
Stephen Guy, Fill-it Product Manager at TAP, said the company was approached by an existing customer to produce a system capable of consistently processing batches of a highly concentrated vaccine stock in vials, while keeping staff safe from unnecessary exposure to this material.
‘The Fill-it fulfils these needs as the system is manufactured using stainless steel to prevent corrosion and potential routes of contamination such as rust spots,’ he said.
‘In addition, the electronics have been coated so that hydrogen peroxide vapour (one of the most effective sterilisation methods) can be used without affecting the Fill-it’s performance.’
Guy added: ‘The combination of containment and decontamination capabilities, as well as its routine use in a major vaccine production facility, demonstrates to any safety-conscious vaccine manufacturer that installing a stainless steel fill-it system is an excellent investment.’