Inova SV125 Machine Number

Transcription

1 Inova SV125 Machine Number Date of Manufacture: 2011 o Never installed or used; in original crate Configured for 10x10 nested 1.0mL Long syringe Fully automatic vacuum filling and vacuum stoppering Customized for filling of highly viscous products; capable of aqueous filling.

2 Operational Requirements Capacity The Syringe Filler must handle at a minimum syringes per hour without vacuum fill and 3500 syringes per hour with vacuum fill. The Syringe Filler must be able to handle 1 ml Long syringes Process Requirements The Syringe Filler shall automatically transfer the syringe tray (tub insert holding syringes) to load syringes into the filler. Operators must open new syringe packaging and transfer new syringes into Syringe Filler manually. The Syringe Filler must be capable of filling syringes under vacuum to minimize entraped air bubbles and oxygen exposure. The Syringe Filler shall monitor and track the Syringe Filler speed. The Syringe Filler must not damage syringes At FAT, the Syringe Filler must not crack, break, or chip syringes or syringe tip caps At SAT, syringe defects must be within AQL per specification. Rejected syringes must be NMT 1% of NLT 5,000 syringes processed. Any time the Syringe Filler stops (E-Stop & cycle stop), the current tub of syringes must be capable of being rejected and a new tub loaded at restart. Process Control There shall be 2 emergency stops. 1) At the Syringe Filler HMI, and 2) at the electrical cabinet. At a minimum, the following Faults/Alarms/Warnings are required if they are applicable to the Syringe Filler design. All alarms/warnings/messages shall be device specific. No syringes Warning - Syringe Filler is waiting for syringes. Servo(s) and VFD(s) Alarm Main drive not running Alarm Fill needle insertion fault Emergency Stop Fault Low vacuum alarm Low stopper feed alarm Low instrument Air Fault Alarm will stop the Syringe Filler and requires operator to acknowledge to resume. Warning/Messages allow the Syringe Filler to operate. Warnings will clear and self acknowledge. In maintenance screens The HMI shall display inputs and outputs. Forcing outputs will require maintenance level password for maintenance troubleshooting. The HMI shall be able to increment the Syringe Filler's functions. During the end of the production lot or production clearance, the Syringe Filler must have the ability to advance a partial tub of syringes Cleaning

3 The surface material of construction must be compatible with chemicals such as 70% IPA for routine exposure and 0.025% bleach (hypochlorite) solution, 0.39% LpH, and 0.78% Vesphene for special cleaning. Sanitization and Sterilization 70% IPA is used for equipment surface sanitization. Sodium Hypochlorite is used during mechanical interventions. Environment The unit must be capable of operation in a Class 100 aseptic environment. RH of the room is controlled within 30-60%. Constraints Mechanical Systems Stainless steel components shall conform to the following: Internal stainless steel surfaces shall be type 304 Exterior stainless steel surfaces shall be 316SS. Their exposed surfaces shall have a total surface roughness of average not more than 200 µ-in. Passivation or electropolish of welds is required. The stopper bowl and feed tray are required to be electropolished. The Syringe Filler accepts BD-Hypak tubs of 100 syringes (BD Part# and BD Part# ) Unloading station must allow a tub of syringes to be opened within the enclosure using a glove box. A counter to count the number of tubs of syringes shall be incorporated in the unloading station. Any Surface transitions need to be at the same height, or step down as the process moves a tub forward. Surface transitions need to be minimized. Every transition needs to be justified with rationale for being a necessary transition. The missing stopper sensors must detect and alert the operator of filled syringes that have not been sealed. The syringe loading platform must be at working height. All exposed surfaces must be sanitizable, and surfaces must not pool solutions. All exposed edges must be rounded or broken. Rolled edges must be welded and ground smooth (for cleanability) All fastners, when possible will be designed to be blind from the working surface. Flat head screws, button head screws will be used when blind fasteners can not be used. When possible fasteners will be used on vertical surfaces, Not horizontal. Lock washers can not be used on exterior surfaces (for cleanability). Electrical Systems Power supply for the Syringe Filler shall be 480 VAC, 30 amps A local power disconnect (with lockout tagout) shall be provided at Syringe Filler. Disconnect can be bypassed. The electrical cabinet shall be located remotely from the filler outside of the filling core area with lockout tagout power disconnect. From the electrical cabinet to the Syringe Filler machine, separate conduits/wireways will provided for 1) AC cable, 2) DC cable/ethernet, and 3) servo cable. The electrical cabinet temperature shall not operate above the maximum temperature of the lowest rated temp component.

4 Process Control Systems General The PLC enclosure house the controllers in an NEMA 4XSS type Cabinet with no door interlocks. UL Listing E-Stops wired in series (if more than one). All cabinet shall adhere to lockout tagout device. Fixed Equipment numbers on all panels Factory wiring verification must be documented on highlighted schematics All instruments shall be 4-20 MA analog signal type All solenoids shall be 24 VDC signal type Instruments that must be Calibrated under periodic program need to be documented. Audible alarm shall be included with the system. Audible alarm shall be silenced via the HMI. One (1) HMI shall be included and be installed at the Syringe Filler. A jog handswitch/cord shall be avaliable to select device(s) and change speeds for maintenance purposes. Sensor and device tags will follow ISA Instrumentation Symbols and Identification Standard ISA Speed of needle retraction after dispensation of product must be controlable through user controlled set point above top of syringe. Must be possible for user to create multiple set points and speeds between each set point. Timing of needle opening must be controlable by user. I.e. user must have the ability to delay needle open so that it is after initiation of pump output stroke. Input for delay setpoint should be in degrees before or after initiation of output stroke. Machine speed must be controllable throughout cycle by user input and set points. For example, 100% between 0 degrees and 90degrees; 50% between 90 degrees and 180 degrees; 100% between 180 degrees and 360 degrees. Software Development Software development shall follow GAMP-5 life cycle:function Spec., Hardware Spec., Software Design Spec. Vendors shall submit the version of programming software revision be used to program the PLC and HMI (current version from AB is 16.x) All software must be developed using revision history with revision levels having unique numbers and dated for approval Core application to have the ability to force variables to allow complete operation & testing of all steps for conditions and alarms PLC code will be Ladder Logic programming only. Fully documented code, including rung descriptions (In English) No dead code Simulation and Production mode capable (i.e. Soft switch in PLC to test functionality without turning on outputs). All raw values must be scaled into engineering units. Control Platform Allen-Bradley Control Logix PLC platform with local rack mounted Inputs and Outputs (24 VDC power) HMI- Panelview Plus " Touch (24 VDC powered) and communicate on ethernet

5 Ethernet connectivity: Hirchmann model: 1 quantity - SPIDER 5TX (5 port din rail for SCADA) & 1 quantity - 24 port switch (for HMI to PLC to servos ) I/O spares (20%) Functions Manual Overrides of all components in maintenance mode. Alarms shall be reset automatically upon elimination of the alarm condition and clearing the alarm via HMI. The machine will not automatically resume after alarms are cleared. Warning messages will automatically reset when condition is cleared, they do not need to be acknowledged, machine will not stop Data, Interface, and Security All Software and variable parameters will be securited with passwords (HMI) Will be password protected Map data in dedicated memory tags to be read remotely (SCADA). There shall be an alarm history screen for troubleshooting purposes on the HMI. Compatibility The Syringe Filler control system must interface with the existing product heating PLC. Availability The Syringe Filler shall be available for production use 24/7. Other Constraints Provide Seismic Calculations Maximum noise level is 85 db when measured 3 feet from the equipment If applicable, the vendor shall provide calibration certificates for any calibrated instruments. Maintenance and Spare Parts Detailed Spare Parts List & wear parts shall be provided as part of TOP package. At FAT, with prices and delivery schedule. Maintenance and operation manuals for all purchased equipment and software shall be provided. Refer to IRF A comprehensive recommended maintenance schedule, including regular recommended inspection intervals, PLC/HMI backup and restore procedures and maintenance tasks shall be provided. Supplier shall supply one editable format (MS Word, MS Excel, AutoCAD, or other pre approved formats) of Operation, Installation and Maintenance manuals, Design Documents, PLC/Servo/HMI/VFD configurations files and test forms on non-erasable CD/DVD.

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