Lyophilization / Freeze Drying
Prior to freeze drying (FD), drug formulations are typically filter-sterilized and filled into lyophilization vials or bottles along with materials added to protect the product from the FD process, and excipients added to facilitate dissolution in the vial. These sterilizing filters must be tested to confirm their integrity. Pall’s range of Palltronic® Integrity Test Systems and Instruments are used for this vital quality function. Palltronic® Integrity Test systems and instruments are also available to equipment manufacturers to build into machinery.
The freeze dryer itself is a sterile environment, protected by air-sterilizing vent filters.
Vent filters also protect the exhaust, and prevent droplets or particles of active ingredients from being carried into the environment. Vacuum pumps have filters and may have coalescers for elimination of oil mist.
Lyophilizers are cleaned and steamed in place. Pall® filters are used in the Clean-in-Place (CIP) and Steam-in-place (SIP) systems that may be coupled with the lyophilizer, or in the plant systems supplying CIP and SIP requirements.
Pall’s Technical Services team can advise on suitable products to incorporate in your lyophilization project.