The freeze drying production of many pharmaceuticals and biological materials requires sterile conditions. Traditionally freeze dryers have used steam for sterilisation. Unfortunately, working with steam means that the freeze dryers are exposed to many different stresses and strains. SP Scientific, in conjunction with Bioquell, have developed an equally effective and less expensive solution to perform surface sterilisation/decontamination of freeze dryers using hydrogen peroxide vapour (HPV).
HPV is well established as a bio-decontamination agent due to its broad spectrum efficacy and its ability to inactivate rapidly the most resilient microorganisms. The residue-free nature of HPV (breaks down to oxygen and water vapour) and low temperature, vapour-phase application increases the practicality of the process. Bioquell’s HPV technology has been tested and proven effective against many organisms including bacteria, bacterial endospores, viruses, bacteriophage, fungi, nematodes and protozoa.
Surface sterilisation/decontamination using the HPV system is remarkably quick, enabling fast turnaround of the user's freeze dryer for further work. Typically lab scale freeze dryers can be sterilized in just 1-2 hours, pilot scale freeze dryers in 2-3 hours and production scale freeze dryers in less than 4 hours. The HPV system is easy-to-use and simply integrated with the user's SP Scientific freeze dryer without need for excessive external piping or critical utilities that are commonly required to support steam sterilisers.
Configurable to the user's freeze drying needs the HPV surface sterilisation/decontamination system is highly economical to use and easy to maintain. Operating with automated gasing cycles ensures excellent process repeatability and consistency.