Whenever feasible, regulatory agencies require injectable products to be terminally sterilized. Due to somewhat fragile molecules and compounds, this aseptic process may render the intended product to be adversely impacted and not endure the stress that moist-heat processes may subject them to. However, for those products that are more compatible to the heat and exposure, the terminal sterilization process effectively can be used for both open/vented or closed containers. Critical products with a residual atmosphere of air or nitrogen, such as prefilled syringes may also be sensitive to traditional terminal sterilization processes using conventional vacuum steam cycles. To maintain equilibrium between inner and outer environments within the sterilization chamber, a process that uses air and steam in tandem external to the sterilization load, may allow for this final method of asepsis to be achieved. For larger volume parenterals, whether in glass or plastic bottles and bags, the process to accomplish the same outcome can also be performed using superheated water for heat transfer. This hot water shower approach is most commonly used for closed containers and meets the demand ranging across different batch sizes as well. Notwithstanding the sterilizing approach and mediums, the consideration to allow the most effective distribution of the sterilizing source and product exposure often lies with the product placement, orientation, and the load configuration effectively considered. Regardless of sterilization process used, the temperature deviation should be at a minimum delta throughout the load and during the process, to deliver the highest throughput yield.
For over 50 years, the SBM division of Syntegon has led the market in quality and customer-centric driven solutions that meet the client’s needs. Whether vacuum/steam, air/steam mixture, or superheated water sterilizers are required, SBM exceeds performance expectations. With their extensive experience, this has led to the company’s expansion into the freeze-drying equipment space, further leveraging its core competencies in process know-how and quality of design. From standard traditional applications, to execution of complete line automation with specialized product handling, the company demonstrates is extensive GMP knowledge, refined after years of partnering with global pharma manufacturers.