User requirements template
Vial Size Neck Finish
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PS2001-5-1101-001-URS, URS
Performance The vial filler is expected to properly fill and stopper vials at production speeds up to and including 300 vials per minute as identified in commodity table 3.1.1.1. The machine shall not experience more than 5.0% downtime at the production speeds defined in commodity table 3.1.1.1, during a defined one hour FAT/SAT production run. The vial filler machine shall operate at an efficiency rate of 95.0%. For the purpose of this specification, the efficiency rate is defined as the actual number of good vials filled, stoppered and output during a one hour test run, divided by the expected number of vials output. Machine efficiency rate excludes downtime due to faulty commodities or supply issues. The vial filler shall be operable by one person. Safety related faults shall stop the machine immediately. The machine shall not be allowed to restart without operator intervention. The machine changeover between vial sizes by a single operator is expected to take no longer than 60 minutes from the last vial out of the prior run to the first vial out of the next run. Functions Vial Handling Depyrogenated vials fed from the tunnel will be unscrambled, singulated and fed into the filler. Tipped vials on the unscrambler disk will be removed before being fed into the filler transport system. Depyrogenated vials are to be run through the vial filler without becoming contaminated, disoriented, marred, scratched, broken or otherwise damaged in the process. Vial Filling Properly filled vials are defined as those possessing the desired dose as defined in the commodity table (± 0.5 % by weight). The vial filler shall fill vials with water based product that has a specific gravity of 1.0 to an accuracy of ± 0.5%. The product has no foaming tendencies. Vials will be filled without dripping onto the external surfaces of the vial or transport system. Empty pockets in the transport system will not be filled. Checkweigh The wide range filler shall sample checkweigh vials prior to filling (tare) and after filling (gross). The same vial that is tare weighed will be gross weighed, and the nozzle that is displayed will be the one that fills the vial. The checkweigh accuracy shall be ± 0.05 grams total for net weight of the product (gross – tare = net weight). The percentage of vials checkweighed shall be 0.3% or greater of total vials filled. Oxygen Reduction The oxygen content in the headspace of the vial after filling will be 3.0% or less, as measured using sparged WFI for a product. The Oxygen Reduction System must be selectable to allow flow of nitrogen to the vial only for products that are oxygen sensitive. Vial Stoppering Each filled vial will have a stopper placed on it. Properly stoppered vials will be no more than 0.060 inches higher than a fully seated stopper. The rejection rate caused by missing or high stoppers must not exceed 0.05% during the defined one hour FAT/SAT production run. The vial filler shall stopper vials with the stoppers listed and at the rates defined in commodity table 3.1.1.1. The stoppers are treated with a minimal amount of silicone to aid in handling and stopper placement. Vial Eject The vial filler shall eject all vials that are faulty due to missing stoppers or high stoppers. The vial eject system must be 100% reliable. It must eject all rejected vials, and pass acceptable vials to the outfeed. The vial filler shall eject vials for manual sampling. The sampled vials shall be in order by nozzle used for filling, starting with nozzle #1. Sampled vials shall not be mixed with faulty vials without alarming. Cleaning The filler shall be capable of being cleaned by a CIP/SIP process. All necessary equipment for CIP/SIP will be provided by the Supplier. This includes all required nozzle receptacles, drains, and associated plumbing. The Supplier will provide CIP/SIP instructions to the User. Equipment will be cleaned by the Supplier prior to being transported to the User. Power Failure and Recovery On power failure, the system shall fail into a “safe state”. All motion stopped on the machine. Reset required before machine can be restarted. No damage to machine will occur as a result of going to the safe state. On power restoration, the system shall not restart without operator or communication-link input. All equipment shall be designed to retain the PLC program in case of power loss, and be recoverable with minimal operator actions. Emergency Stop Emergency-stop buttons shall be supplied within the reach of the operator at normal operator stations. When activated, the emergency stop shall shut the system down immediately in accordance with the following requirements: All motion on the machine shall stop in a safe manner. No damage to the machine will occur as a result of an emergency stop. Emergency stop will seal product path or take actions to prevent product contamination if so equipped. The machine shall not be allowed to restart without operator intervention. It shall be necessary to restore the emergency stop button to the original state, and reset the system before restarting. All Emergency stops shall be hard wired to disconnect the device power. Alarms and Warnings The wide range filler shall be equipped with the following alarms and warnings at a minimum:
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