Sterile Formulation 623 All product-contact equipment, especially large mixers, should be electropolished. When stability is a concern, product should be cooled as soon as possible after leaving the cyclone separator Materials that cannot be sterilized should be transferred into the sterile area through an isolated area in which an outer wrapping is removed. The object is then wiped down with a sanitizing agent such as isopropanol or hydrogen peroxide Stationary equipment such as conveyors and filling equipment must be sanitized at some specified frequency. This can be accomplished by wiping down with a sanitizing agent or fogging the sterile area with formaldehyde All product contact parts such as powder hoppers, filling wheels, and stopper bowls are removed from the sterile area, cleaned and sterilized as previously described Freeze dryers are usually steam sterilized or sterilized using VPHP (vapor phase hydrogen peroxide). Trays used in a freeze dryer are usually cleaned and sterilized separately. 10.0 VALIDATION Procedures must be developed and staffing provided for the collection of data that proves that the processes and equipment meet all parameters claimed(12) Systems should be in place for equipment qualifications, validation, changes, and replacement. The manufacturing process validation could be invalidated without proper documentation of equipment mainte nance. A minimum of three consecutive manufacturing lots should be evaluated for process validation. Parameters involved in process validation include in-process and final bulk product test, deviation analysis of the process, stability testing of final product and equipment qualification and validation. Other validation requirements are discussed by S 11.0 FILLING VIALS WITH STERILE BULK MATERIALS 11.1 Vial and Stopper Preparation Vials must be thoroughly washed, dried, sterilized, and depyrogenated They should be handled in a clean room to minimize contamination by Washing is normally done in au d vial washe using purified water, filtered oil-free air, and a final rinse of WFISterile Formulation 623 All product-contact equipment, especially large mixers, should be electropolished. When stability is a concern, product should be cooled as soon as possible after leaving the cyclone separator. Materials that cannot be sterilized should be transferred into the sterile area through an isolated area in which an outer wrapping is removed. The object is then wiped down with a sanitizing agent such as isopropanol or hydrogen peroxide. Stationary equipment such as conveyors and filling equipment must be sanitized at some specified frequency. This can be accomplished by wiping down with a sanitizing agent or fogging the sterile area with formaldehyde. All product contact parts such as powder hoppers, filling wheels, and stopper bowls are removed from the sterile area, cleaned and sterilized as previously described. Freeze dryers are usually steam sterilized or sterilized using VPHP (vapor phase hydrogen peroxide). Trays used in a freeze dryer are usually cleaned and sterilized separately. 10.0 VALIDATION Procedures must be developed and staffing provided for the collection of data that proves that the processes and equipment meet all parameters claimed.~'*] Systems should be in place for equipment qualifications, validation, changes, and replacement. The manufacturing process validation could be invalidated without proper documentation of equipment mainte￾nance. A minimum of three consecutive manufacturing lots should be evaluated for process validation. Parameters involved in process validation include in-process and final bulk product test, deviation analysis of the process, stability testing of final product and equipment qualification and validation. Other validation requirements are discussed by Sawyer and stats .[I3] 11.0 FILLING VIALS WITH STERILE BULK MATERIALS 11.1 Vial and Stopper Preparation Vials must be thoroughly washed, dried, sterilized, and depyrogenated. They should be handled in a clean room to minimize contamination by particulate matter. Washing is normally done in automated vial washers using purified water, filtered oil-free air, and a final rinse of WFI