Inova SV125 Machine Number 4016589

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.

Operational Requirements Capacity

The Syringe Filler must handle at a minimum 10000 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

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# 47275110 and BD Part#

47143910)

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.

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-5.1-1984.

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 1000 10.4" Touch (24 VDC powered) and communicate on ethernet

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.

Syringe Nest Transport

Stopper Sorting Bowl and Transport

Rotary Piston Dosing Pumps

Custom Closing Needles for Highly Viscous Products

Custom Closing Needles for Highly Viscous Products

Vacuum Filling and Stoppering System