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Home Focus Conveying & Filling, Packaging, Labeling & Storage

Small batches of single-dose PFSs

20. July 2023
in Conveying & Filling, Packaging, Labeling & Storage, Focus
Small batches of single-dose PFSs

Ster­i­line, an Ital­ian man­u­fac­tur­er of robot­ic and stan­dard fill/finish lines for the asep­tic pro­cess­ing of injectable drugs, deliv­ered to Fatro an com­pact robot­ic fill­ing machine, to pro­duce small batch­es of vet­eri­nary vac­cines in sin­gle-dose pre-filled syringes (PFSs).

Fatro devel­ops and pro­duces med­i­cines and vac­cines for ani­mals. In order to enter into the vet­eri­nary seg­ment mar­ket that requires sin­gle-dose for­mats, the com­pa­ny decid­ed to intro­duce into its fleet of machines a lean solu­tion, equipped with a few com­po­nents, that process­es small batch­es of sin­gle-dose PFSs. The machine was sup­posed to occu­py as lit­tle space as pos­si­ble, to reduce the man­age­ment costs of the grade B area the equip­ment would have to be housed in.

Ster­i­line pro­posed a com­pact and flex­i­ble fill­ing solu­tion: a Robot­ic Nest Fill­ing Machine (RNFM2) designed to man­age 0.5 ml PFSs with a pro­duc­tion capac­i­ty of up to 2,900 pieces per hour. With two man­u­al load­ing and unload­ing sta­tions, where an oper­a­tor inserts tubs pre­vi­ous­ly peeled under a Lam­i­nar Air Flow, the stand-alone solu­tion is equipped with a robot­ic arm that picks up the nest in the tub con­tain­ing the emp­ty PFSs and posi­tions it under the two fill­ing heads con­nect­ed to peri­staltic pumps. Simul­ta­ne­ous­ly to the fill­ing process, two stop­per­ing heads seal the filled PFSs. Once both process­es are com­plet­ed, the robot­ic arm repo­si­tions the nest in the tub at the exit sta­tion, ready for the oper­a­tor to with­draw and trans­fer to the sec­ondary pack­ag­ing process.

The whole process there­fore requires a small action area, which trans­lates into the lim­it­ed machine foot­print (1.250 meters x 1.250 meters) under the open Restrict­ed Access Bar­ri­er Sys­tem (oRABS). The whole project, from the order to the prod­uct set-up, took one year. The Fac­to­ry Accep­tance Test (FAT) was com­plet­ed in Sep­tem­ber 2022 with­out requir­ing any cus­tomer ser­vice intervention.

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