SYRINGES PROCESSING OF PRE-STERILIZED SYRINGES

Transcription

1 SYRINGES PROCESSING OF PRE-STERILIZED SYRINGES

2 STERIFILL RS SERIES STERIFILL RS is a filling and stoppering machine for ready-to-fill, disposable syringes in nests. The use of such kind of drug delivery systems has become increasingly popular over the last few years, thanks to the considerable advantages over other more traditional methods of administering injections as far as helping reduce the risk of medication errors. The safety of the patient and the dosing accuracy being the major issues. IMA LIFE offers a very flexible and reliable small-batch machine, specifically designed according to cgmp and FDA regulations to work in conventional clean rooms or to be even equipped with crabs or isolator. STERIFILL RS compact design allows it to be part of a complete processing line or also serve as a stand-alone filler. STERIFILL RS-P2 with manual nest loading All product contact parts are made out of AISI 316 L st.st. STERIFILL RS is fully equipped with servo motors to drive all machine mechanisms in order to reach maximum flexibility in handling and in filling accuracy. The ready-to-fill, pre-sterilized syringes are supplied and handled in a special type of packaging, i.e. plastic tubs, wrapped in protective bags to protect their sterility during transport and storage. The syringe barrels, already provided with tip cap or needle shield, are inserted into nests. The operator will manually remove the bags and the lids over the tubs, and then take the syringes nest and place them on a central plateu placed outside the machine working area. As an option, the machine can be equipped with automatic extraction and positioning of the nest on the plateau and with the automatic re-insertion station to place the nest back in the tub.

3 STERIFILL RS-P5 with automatic nest loading Once the nests have been positioned under the filling station, the syringes will be filled, (2 or 5 at a time). The dosing station is equipped with 2 or 5 rotary piston pumps either in st.st. or in ceramic, driven by servomotor. Other types of filling systems, typical of the aseptic operations such as, for example, Peristaltic Pumps, are also available. The filling volume to be dispensed is automatically defined by the machine, according to the recipe and the sizes stored in the HMI.

4 FILLING & STOPPERING STATION FILLING STATION The filling needles enter the syringe barrels without any contact with the container. Nitrogen gas purging can be achieved during the filling and stoppering operations (optional). CIP/SIP system is available on request. In this case, all product contact parts can be cleaned and sterilized without removing them from the machine. In case of viscous product filling or, where air buxbbles can be possibly formed during dosing, the machine can be equipped with a special vacuum filling system (optional). Before filling, the air inside the barrels is vacuum sucked to allow the product to reach the bottom of the container, avoiding in this way air bubbles. In order to meet pharmaceutical industry s constantly evolving requirements, the machine is also able to process a range of ready-to-fill sterile glass vials/cartridges in a standard format consisting of a pre-sealed nest & tub or tray package, overwrapped by a plastic steribag. This solution can ensure the easy handling of the glass components, preserving sterility requirements.

5 STOPPERING STATION The stoppers are fed to the insertion station by means of a vibratory bowl and a linear chute; a pick & place arm picks the stoppers up (2 or 5 at a time) transferring them in position, over the barrels; the stoppers are then fed inside the syringe barrels to a depth which is automatically defined by the machine, according to the recipe and the sizes stored in the HMI. All stopper contact parts are made out of AISI 316L st.st. Also in this case, when air bubbles can be a problem, the stoppering operation can be carried out after air has been extracted by vacuum suction. Once these two operations have been carried out, the filled and stoppered syringes in the nests will be manually reinserted into the tubs by the operator and taken to the next step in the secondary packaging process.

6 IPC SYSTEM A pushing unit extracts the empty syringes from the nest, then a mechanical arm, driven by two servo motors, places them on to individual weigh cells to resolve the tare weight of each syringe. The syringes are reinserted into the nest for filling and stoppering. They are then weighed again in the same way. Electronically controlled scales determine the tare and gross weights and calculate the effective net weight by difference. The IPC system controls the automatic selfadjustment of the dose within the pre-set tolerance limits. FULLY AUTOMATED 100% AND STATISTICAL CHECK WEIGHING SYSTEM

7 TECHNICAL DATA STERIFILL RS-P ,5 898,5 898, STERIFILL RS-P2 646, Automatic nest loading Manual nest loading Automatic nest loading SYRINGE FILLING & STOPPERING MACHINE OPTIONAL UNITS Syringe Syringes in Nest Output (2 pumps) Output (5 pumps) 0,5 ml ml ml ml ml ml Syringe diameter 1000 kg Voltage 400 V - 50 Hz - G Siemens PLC Automatic extraction and re-insertion of nest from and into the tub Nitrogen Gas Purging Unit Vacuum Filling System for viscous products to avoid air bubbles Statistical & 100% IPC CIP/SIP systems UAF and crabs integration Pre-arranged for Isolator 21CFR Part 11 compliance 8-22 mm Weight Installed power 646,5 646,5 15 kw

8 May SRS IMA S.p.A. reserves the right to make any changes to the described machine characteristics. IMA S.p.A. IMA LIFE division Via Emilia Ozzano dell Emilia (Bologna) - Italy Tel Fax mktg.life@ima.it -