Lyophilization / Freeze Drying

Proteins and many other products are presented as a freeze-dried powder in vials for reconstitution by the administering doctor or pharmacy.

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.

Formulation and Filling Introduction
Formulation and Filling Systems, Components and Services
Formulation and Filling Applications / Products

Lyophilization / Freeze Drying
Form, Fill, Seal
Vial, Bottle, Pouch (Bag) and Syringe Filling
Formulation and Filling: Capsules
Solid Dosage Forms
Formulation and Filling: Excipients and Buffers
Stopper and Vial Washing

Single-Use Systems

Links to tangential flow filtration technologies