Functional Specification For Area 3 Vial Washer · PDF fileFunctional Specification For Area 3 Vial Washer Covering Systems: PLC510004 PD510004 REV NO. DATE REVISION DESCRIPTION BY

Functional SpecificationFor

Area 3 Vial Washer

Covering Systems: PLC510004PD510004

REV NO. DATE REVISION DESCRIPTION BY REVIEW AND APPROVAL

0 04/03/07 ISSUED FOR APPROVAL WSV1 05/08/07 SEE REVISION HISTORY WSV WSV2 08/28/07 DOCUMENT RECONCILIATION MATRIX3 07/07/08 UPDATED PER CO1013878 AC

This document is the property of Genentech Inc. The information is private and confidential and is to be used only in occurrence with work directed by Genentech Inc. and no part of this is to be disclosed to others without written permission from Genentech Inc.

Functional SpecificationsFor

Area 3 Vial Washer

SO. SAN FRANCISCO, CA DOCUMENT NO.: 151-I01-005

Functional Specification – A3 Vial Washer Documentation No. 151-I01-005Genentech, Inc. Revision 3

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TABLE OF CONTENTS

1. INTRODUCTION ......................................................................................................................72. GLOSSARY ................................................................................................................................8

2.1. DEFINITIONS AND TERMINOLOGY............................................................................................82.2. ABBREVIATIONS / ACRONYMS ................................................................................................8

3. PRODUCT FUNCTIONAL SPECIFICATIONS......................................................................93.1. MAIN GOALS ..........................................................................................................................9

3.1.1. High level description....................................................................................................93.1.2. Wash cycle ..................................................................................................................11

4. MACHINE OPERATION ........................................................................................................124.1. WORK MODE........................................................................................................................12

4.1.1. Password Management................................................................................................134.1.2. Operating parameters..................................................................................................14

4.1.2.1. General parameters ..............................................................................................144.1.2.2. Size parameters....................................................................................................174.1.2.3. Unloading unit calibration parameters..................................................................18

4.1.3. Automatic operating mode...........................................................................................194.1.3.1. Description of vial washer operations in automatic mode .....................................20

4.1.3.1.1 Standby..............................................................................................................204.1.3.1.2 First Vial loading ...............................................................................................204.1.3.1.3 Tank filling ........................................................................................................204.1.3.1.4 Pump loading.....................................................................................................204.1.3.1.5 Wash vials movement ........................................................................................214.1.3.1.6 Pause .................................................................................................................214.1.3.1.7 Emptying ...........................................................................................................214.1.3.1.8 Drainage and drying...........................................................................................224.1.3.1.9 Flushing.............................................................................................................23

4.1.3.2. ‘VALIDATION’ Procedure .................................................................................234.1.3.3. Pinchart ...............................................................................................................24

4.1.4. Manual operating mode...............................................................................................254.1.4.1. Description of the functions in manual mode .......................................................25

4.2. STOP CONDITIONS AND SIGNALS ...........................................................................................264.2.1. Description of the automatic stop mode .......................................................................264.2.2. Description of the stop modes in manual mode ............................................................274.2.3. List of the alarms and warnings...................................................................................274.2.4. List of machine state messages ....................................................................................28

4.3. MACHINE FUNCTIONS ..........................................................................................................294.3.1. Group 0 – Power Supply and Common devices............................................................30

4.3.1.1. Power Supply ......................................................................................................304.3.1.2. Auxiliary Power Supply.......................................................................................30


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4.3.1.3. JOG Button..........................................................................................................304.3.1.4. Emergency Circuit ...............................................................................................314.3.1.5. Electric Cabinet Temperature...............................................................................314.3.1.6. Safety doors.........................................................................................................314.3.1.7. Supervisor communication error ..........................................................................324.3.1.8. HMI communication error ...................................................................................32

4.3.2. Group 2 – Infeed Belt ..................................................................................................334.3.2.1. Infeed Belt Motor ................................................................................................334.3.2.2. Mobile guide Motor .............................................................................................334.3.2.3. Backward Motion ................................................................................................334.3.2.4. Minimum Load....................................................................................................34

4.3.3. Group 3 – Vials Loading .............................................................................................344.3.3.1. Motorization ........................................................................................................344.3.3.2. Loading Start/Stop...............................................................................................344.3.3.3. Overload protection .............................................................................................35

4.3.4. Air extractor fan group................................................................................................354.3.4.1. Air extractor fan motor ........................................................................................354.3.4.2. Air Extractor Fan Sectioner..................................................................................35

4.3.5. Group 5 – Recycle water circuit ..................................................................................364.3.5.1. Recycle Tank .......................................................................................................364.3.5.2. Recycle Pump......................................................................................................364.3.5.3. Recycle Washing Valve .......................................................................................374.3.5.4. Recycle Water Washing Valve.............................................................................374.3.5.5. Recycle Refill Valve ............................................................................................374.3.5.6. Recycle Purge Valve............................................................................................374.3.5.7. Recycle Drain Valve ............................................................................................384.3.5.8. Pump Drainage Valve ..........................................................................................384.3.5.9. Recycle Purge Valve............................................................................................384.3.5.10. Recycle Draining Valve .......................................................................................394.3.5.11. Recycle Tank Valve.............................................................................................394.3.5.12. Recycle Water Pressure .......................................................................................394.3.5.13. Recycle Water Tank Temperature........................................................................394.3.5.14. Recycle Tank Heating..........................................................................................40

4.3.6. Group 6 – Compressed Air Circuit ..............................................................................404.3.6.1. Blowing Air Valve...............................................................................................404.3.6.2. Drying Air Valve 6Y2. ........................................................................................414.3.6.3. Drying Air Valve 6Y3 .........................................................................................414.3.6.4. Draining Valve ....................................................................................................414.3.6.5. Drying Air Valve 6Y10........................................................................................424.3.6.6. Pressure Service Air.............................................................................................424.3.6.7. Compressed Air ...................................................................................................42

4.3.7. Group 7 – W.F.I. water circuit.....................................................................................424.3.7.1. W.F.I. Supply ......................................................................................................434.3.7.2. W.F.I. Root Valve................................................................................................43


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4.3.7.3. W.F.I. Washing Valve .........................................................................................434.3.7.4. W.F.I. Draining Valve 7Y2..................................................................................434.3.7.5. W.F.I. Draining Valve 7Y7..................................................................................444.3.7.6. W.F.I. Pressure ....................................................................................................444.3.7.7. W.F.I. Temperature..............................................................................................44

4.3.8. Group 9 – Main Motorization......................................................................................454.3.8.1. Main Motor .........................................................................................................454.3.8.2. Torque Limiter.....................................................................................................454.3.8.3. Washing Carriage ................................................................................................464.3.8.4. Upside Down Vial ...............................................................................................464.3.8.5. Ejection Device ...................................................................................................464.3.8.6. Reordering Device ...............................................................................................474.3.8.7. Washing Consent .................................................................................................474.3.8.8. Consent from Tunnel ...........................................................................................47

4.3.9. Group 10 – Unloading Vials........................................................................................484.3.9.1. Unloading rotating Motor ....................................................................................484.3.9.2. Unloading Device Motor .....................................................................................484.3.9.3. Unloading Belt Motor ..........................................................................................484.3.9.4. Pusher Horizontal Motion ....................................................................................494.3.9.5. Unloading Device Rotary Motion ........................................................................494.3.9.6. Pusher Pressure....................................................................................................494.3.9.7. Vacuum Circuit Root Valve .................................................................................494.3.9.8. Vacuum Circuit Drainage Valve ..........................................................................494.3.9.9. Vacuum switch ....................................................................................................50

5. INTERFACE.............................................................................................................................515.1. INTERFACE WITH USERS........................................................................................................51

Devices on the electrical panel ............................................................................................515.1.1............................................................................................................................................51

5.1.1.1. ‘VALIDATION TEST’ SELECTOR ...................................................................515.1.1.2. WARNING LIGHT TURRET .............................................................................525.1.1.3. AUDIBLE INDICATOR .....................................................................................525.1.1.4. OPERATOR PANEL...........................................................................................525.1.1.5. START BUTTON ...............................................................................................525.1.1.6. STOP BUTTON ..................................................................................................525.1.1.7. ALARM RESET BUTTON.................................................................................525.1.1.8. EMERGENCY LIGHT........................................................................................535.1.1.9. EMERGENCY STOP BUTTON .........................................................................535.1.1.10. POWER LINE ISOLATING SWITCH................................................................53

5.1.2. Control components on-board the machine..................................................................545.1.2.1. JOG BUTTON.....................................................................................................54

5.1.3. Operator panel ............................................................................................................545.1.3.1. Operating parameters ...........................................................................................54

5.2. INTERFACE WITH OTHER SYSTEMS ........................................................................................545.2.1. Electrical interface ......................................................................................................55


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5.2.1.1. Consent from tunnel.............................................................................................555.2.1.2. Consent to tunnel .................................................................................................555.2.1.3. Infeed shutter opening enabled.............................................................................555.2.1.4. Tunnel start emptying ..........................................................................................55

5.2.2. Mechanical interface ...................................................................................................555.2.3. Batch Tracking Interface .............................................................................................56

6. ATTACHMENTS .....................................................................................................................576.1. ATTACHMENT A – ALARMS AND WARNING MESSAGES LIST.............................................586.2. ATTACHMENT B – SEQUENTIAL FUNCTION CHARTS .........................................................63

REVISION HISTORY .....................................................................................................................67


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1. INTRODUCTION

This document sets out the Functional Specifications of the HYDRA 1800-18-C/S vial washer manufactured by IMA (LIBRA Aseptic Processing Division), which is part of a Line to be installed in the modular facility (Building 51) at Genentech, Inc. in South San Francisco, CA.

Manufacturer Machine Model Serial Number

IMA HYDRA 1800-18-C/S LW9022

The Functional Specifications document defines the machine's behavior and the aim of the mechanical and electrical/electronic design.


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2. GLOSSARY

The following codes, acronyms or definitions are used, as far as terminology is concerned.

2.1. Definitions and terminology

User Interface Control and Display Items as a WholeOperator Panel Control and Display Terminal equipped with Alphanumeric Display Panel and

Function Keys.JOG Button for Manual Operations

2.2. Abbreviations / Acronyms

AI Analog InputAO Analog OutputCPU Central Process UnitDI Digital InputDO Digital OutputFD Floppy DiskHD Hard DiskI/O PLC Input/OutputISA Instrument Society of AmericaMIP Going Into Production (Italian: Messa In Produzione)MPI Standard Profibus LAN (Siemens)N.A. Not ApplicableOP Operator PanelPC Personal ComputerPLC Programmable Logic ControllerRAM Random Access MemorySOP Standard Operating ProcedureSW SoftWareTCP/IP Transmission protocol for Ethernet networksWBS Work Breakdown Structure (in-house document for the planning of the project)W_I Work InstructionsUPS Uninterruptible Power SupplyURS User Requirement Specifications


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3. PRODUCT FUNCTIONAL SPECIFICATIONS

3.1. Main goals

The linear vial washer was designed for being inserted in a production line, the process cycle of which consists of cleaning glass vials both on the inside and on the outside by washing them with distilled water. Then sterile, filtered compressed air is blown onto the vials three times: at the beginning, halfway through the process and at the end of the process.

The scope of the vial washer is to remove any impurities from the vials that, if injected, could cause undesired or toxic effects. The vial, inside which the product is distributed, could be contaminated with different types of particles such as: glass particles, cellulose fibers, oils from the glass work machines, metals, rubber, bacteria, alkaline oxides, calcium oxides, sodium oxides, etc.

These particles may be divided into two types: disposable and non-disposable. The disposable particles are those that are easily removed with a normal washing cycle by means of which the vial's purity is achieved through subsequent dilutions. The non-disposable particles are those that can be removed only by mechanical action due to their adhesiveness to glass. Usually the non-disposable particles include alkaline oxides, calcium oxides and sodium oxides that are normally contained inside tubing glass and are formed by a sublimation effect on creating the vials.

The vial washing machine has been built by separating the washing, media treatment and mechanical area, thus avoiding that whichever quality control, maintenance or other operation provokes crossed contamination effects to the process.

3.1.1. High level description

The operator places the containers to be washed onto the loading belt at the infeed of which a system is installed for manually opening the bundles, by means of tipping plates, so that the operator may free the vials from the wrapping and place them on the belt. The belt, which is made of XLG-polyacetal moves by means of a motorized roller, carries the containers to the loading zone. Here the vials are arranged into eighteen (18) rows by specific sorting units made of Delrin or stainless steel that move back and forth (the movement is achieved by a dedicated motor). When the row of vials to be loaded is ready, the belt stops and reverses a few millimeters for the purpose of eliminating any rubbing between the row of vials being loaded and the next one. When the belt stops, a lift picks up the vials that are inserted into the conveying baskets by sliding on a spoke-shaped sector. The lift stops and the main conveyor chain moves ahead one step.

The lift/inserter is fitted with a geared motor with a torque limiter that releases, and stops the machine, if it trips due to contrasts or excessive load. This system is designed to minimize load break risks.Once the vials have been inserted into the baskets they are conveyed to a first station where a system,


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consisting of an up-and-over feeler system, checks that the vials have been properly inserted into the baskets. Otherwise, if an error occurs, the system triggers an alarm and consequently the machine stops.

The positioning-check phase is followed by the washing cycle with the plunging needles. A needle-holding carriage, synchronized with the conveying system from a mechanical point of view, moves up and down. The needle-holding strips, mounted on the carriage by means of an exclusive patented system, plunge into the vials and inject various fluids inside. The fluid-injection valves open when the needles are completely inside the vials and stay open for the amount of time set for each size and each fluid.

A number of steel strips are positioned over the vials, during the washing phases, to prevent the vials from falling out of the baskets due to the effect of the high pressure of the fluids. A cam and its telescopic lever, fitted with an alarm sensor, move the washing carriage: if the carriage or a needle encounters a contrast, the telescopic part is compressed and this causes a spring to cushion the anomalous load. A sensor detects the spring's compression and stops the machine. As a result, needles and/or vials will not break.

The washing cycle is repeated every time an alarm is triggered.

After the vials have been treated at the nine (9) available stations, they reach the unloading zone where a positive extraction system moves the vials from the baskets to the rearranging comb that sets them back up to vertical position. The extraction system, which works in horizontal position, prevents any drops of untreated water from re-entering the vial. The two cams, which control the two functions, are fitted with the respective telescopic-type levers that also compress the spring and stop the machine to avoid breaking the vials. The aforementioned process takes place in the central part of the machine which is perfectly separated and sealed off from the other two parts (which are also separated): wash circuit and mechanics.

The main vial conveying chain is fitted with a torque limiter that trips when contrasts and/or excessive loads occur. The torque limiter is restored by a dedicated function that prevents breakdowns and/or operator accidents by making the machine run in reverse direction.

The clean vials at washer outfeed are inserted directly into the sterilization tunnel by means of an unloading belt.

All the alarms will be detected in the PLC.

In case of loss of electrical supply, no residual power has to remain in the equipment (electric or pneumatic). When the power supply is restored, the restart has to be gradual. When the main power supply fails, all the motors and the fans will be powered off. The valves are normally closed. When the main power supply is restored, no motors or fans will restart automatically. It will be necessary to press the reset button to restore the operative condition of the machine.


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A counter is present on the system which is used to count the machine cycles. The number of cycles is multiplied with the number of baskets in a row where vials will be placed (18 baskets in a row) in order to get the number of processed baskets. The number of the processed baskets is displayed on the operator panel (control cycle menu page).

3.1.2. Wash cycle

The washing cycle is shown schematically in the Piping & Insrumentation Diagram, 151-D02-8500. This cycle consists of fully employing the nine (9) spraying stations available on the machine, with the last two rows of vial-holding cones (used as dripping stations) fitted with standalone connections to the relevant circuits so as to avoid any contamination among fluids.

Below we will briefly examine the functions of the machine's nine stations:1. Station 1: compressed air is injected into the vial to remove any cardboard particles that, if

diluted, become more adhesive and therefore more difficult to remove. The compressed air supplied to the machine must be dehumidified and the oil separated from it. The compressed air is then filtered before use by means of a filter (6F1) installed right after the manual valve 6HY0.

2. Stations 2 and 3: the vial is rinsed on the inside (even the outside is rinsed at station 2) using the water inside the recycle tank from which it is sucked up and pumped through a filter (5F1). The machine collects the sprayed water and which taken to the outside into the drain water collection tank.

3. Station 4: the compressed air, insufflated inside the vial, is needed to decrease the amount of theoretically dirty water that is still inside the vial after the first rinse.

4. Station 5: the vial is rinsed on the inside and on the outside using W.F.I. Once the water has been sprayed (the water is not dirty) it is collected in a tray and drained into the recycle tank.

5. Station 6: even at this station the vial is rinsed on the inside using W.F.I. Once the water has been sprayed (the water is not dirty) it is collected in a tray and drained into the recycle tank.

6. Station 7: sterile compressed air is blown into the vial so as to dry it as best as possible before inserting into the sterilization tunnel.

7. Station 8: even at this station sterile compressed air is blown into the vial so as to dry it as best as possible before inserting into the sterilization tunnel.

8. Station 9: sterile compressed air is blown on the outside of the vial so as to dry it as best as possible before inserting into the sterilization tunnel.

When the vials are detected in the correct phase, the needles wash sequence will commence.


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4. MACHINE OPERATION

This section describes how the machine operates, identifying the possible work modes and describing the operating stages for each mode. Moreover, the management of the ‘passwords’ and the operating parameters, which the operator may set, are indicated.

4.1. Work mode

The vial washer may work in two modes:• Automatic• Manual

The automatic or manual operating mode is selected on the operator panel. On activating the Manual mode the operator must also plug the JOG button into the appropriate connector.

Automatic operating modeThe machine may work problem-free in a vial production line in automatic mode. When the Automaticmode is selected, the machine runs the automatic cycle. Machine start is enabled if no alarm conditions are present. Once the start command is issued the machine begins the production cycle and its condition is recognized as Running.

The machine's automatic mode halts under the following conditions:• motor alarms (overload cutout, inverter alarm-if inverter is present)• valve alarms (position sensors, feed, guards open)• emergency button pressed• other alarms (temperature, pressure, etc.)• minimum load• no go-ahead signal from the tunnel

When an alarm is triggered the machine stops. To restart the machine, clear the cause that triggered the alarm, HMI must acknowledge and delete the alarm and then issue the start command. If the cycle is interrupted due to minimum loads or because the go-ahead signal from the tunnel is missing, the machine restarts on its own once the operating condition has been restored.

The following operating procedures are foreseen in this mode, selectable on the operator panel:

• First Vial Load• Flushing• Emptying• Draining• Drying


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After having selected the automatic mode, operations may be activated by pressing the START button and deactivated by pressing the STOP button.

The emptying procedure is possible only when the machine is in automatic mode whereas the draining and drying procedures can be run regardless of the machine's automatic/manual status. All three procedures must be selected and controlled via HMI. Keep in mind that the drying is not an independent procedure since it can be run only in sequence with a draining procedure.

Furthermore, a "Validation" mode has also been designed to bypass the protections relevant to the machine's unloading zone during routine machine operations. This mode is enabled on the operator panel and activated with the key selector located on the control panel so that the validating technician may access the tunnel's infeed to insert the temperature probes for running the ‘heat penetration tests’ (see detailed information in section 4.1.3.2).

Manual operating modeDuring the manual operating mode all the vial washer's service units (valves and motors) may be selected and controlled from the HMI. The JOG button must be used to control some of these units. The draining procedure may also be controlled.

The manual operating mode permits the control of the foregoing functions even when the guards are open. In this case, the speed of the main motor (activated with the jog button) is automatically reduced and continuous operation may take place for a maximum duration of 15 seconds, after which the operator must release the jog button and press it again.

The manual operating mode halts under the following conditions:• alarm at the controlled user• emergency button pressed

4.1.1. Password Management

The user password is stored in the GNE2 active domain. However, the user groups and access levels are stored in the operator panel. In order to have valid access to the system, a user must be a member of the valid user groups. To register a new user, it must be performed under GNE2 AD. The Touch Panel writes the current level value of the password, by means of a general function, into a PLC variable. This variable will be used for enabling/disabling the display of the entry fields. As a rule, the objects protected by passwords should be displayed at the lower levels as well (when a password-protected function is requested, the panel automatically asks for the logon). The panel runs the logoff after a length of dead time settable via the HMI development software.


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The following levels are envisaged:

Level User Accessible functions0 --- Default: only navigation.

1 OSelect/Load recipe, Start/stop batch, load batch, function key, access to the alarms page and alarms acknowledge

2 T Level 1 + Change Status Automatic/Manual.3 S Level 2 + general parameter modificatio + edit recipe.4 A All access.

Further details about the functionalities of the access levels are described in the Software Design Specifications, 151-I36-002.

4.1.2. Operating parameters

The operation of the vial washer envisages the setting of a series of operating parameters on the operator panel. The parameters may be set via the operator panel at any time (see section 5.1.3) and the password is level 3.

Below is a list of the settable parameters, broken down into general, size and calibration parameters, in addition to a brief description.

4.1.2.1.General parameters

The general parameters are applicable to all sizes. You may distinguish parameters, which are associated with process phases, by functional units and by time.


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PARAMETERS OF THE FUNCTIONAL UNITSA level 3 password is required to change the parameters of the units.

Recycle UnitParameter Description Recycle circuit minimum pressure

minimum pressure value associated with the recycle water unit

Recycle circuit minimum temperature

minimum temperature value associated with the recycle water unit. If the temperature value of the recycle tank drops below this value, the machine stops and triggers an alarm.

Recycle circuit maximum temperature

maximum temperature value associated with the recycle water unit. If the temperature value of the recycle tank rises above this value, the machine stops and triggers an alarm.

Recycle tank temperature temperature at which the recycle tank must stay (setpoint).

Compressed Air UnitParameter DescriptionCompressed air minimum pressure

Minimum pressure value that must be present inside the circuit.

W.F.I. UnitParameter DescriptionW.F.I. minimum pressure minimum pressure value that must be present inside the

circuit.W.F.I. minimum temperature minimum temperature value that must be present inside

the circuit.W.F.I. maximum temperature maximum temperature value that must be present inside

the circuit.

Unloading UnitParameter DescriptionUnloading rotation speed pusher rotating speed for emptying the machine by

removing the vials present on the unloading surfaceHome position angular position of the pusher for the home positionForward position angular position of the pusher for the forward positioningBackward position angular position of the pusher for the backward

positioningRotation unloading position 1 position of the pusher's first rotation during the emptying


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phaseEmptying unloading position 1 position of the pusher for the first emptying phase

translationRotation unloading position 2 position of the pusher's second rotation during the

emptying phaseEmptying unloading position 2 position of the pusher for the second emptying phase

translation

TIME PARAMETERSBelow are indicated the time parameters to be set for certain process phases. A level 3 password is required to change the time parameters.

Draining TimesParameter DescriptionCircuits drainage valve opening time for draining the W.F.I. and recycle

circuits

Drying TimesParameter DescriptionRecycle circuit drying valve opening time for drying the recycle circuitW.F.I. circuit drying valve opening time for drying the W.F.I. circuit


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4.1.2.2.Size parameters

A level 3 password is required to set these parameters. The following values must be set for each foreseen size part.

* The minimum and maximum limit of the wash valve opening times is supplied by sensor 9ZS34 that detects the position of the wash carriage with the needles inside the vials (wash start) and the position of the wash carriage with the needles inside the vials on the outside of the vial (wash interrupt/stop). If the set wash time is longer than the time defined by the go-ahead of sensor 9ZS34, the wash cycle is interrupted in any case.

Parameter DescriptionNumber of vials at infeed number of vials that enter the washing cycle at each step,

i.e. the number of cones present on each rowPRODUCTION SPEED number of vials that are washed in one minuteLOADING BELT SPEED moving speed of the vial loading belt toward the washing

stationsMOBILE GUIDE SPEED moving speed of the sorting units located in the vial infeed

zoneEXTRACTION AIR SPEED sucking speed of the air from the washing stations to the

outsideUNLOADING DEVICE SPEED translating speed of the pusher for emptying the unloading

surfaceUNLOADING BELT SPEED moving speed of the vial unloading belt toward the

machine's outfeedRECYCLED WASHING TIME* opening time of the washing needles relative to the stations

in which the used water comes from the recycle tankCOMPRESSED AIR BLOW TIME* opening time of the blowing needles relative to the stations

in which compressed air is usedWFI WASHING TIME* opening time of the washing needles relative to the stations

in which W.F.I.MOBILE GUIDE POSITION FORW forward position of the sorters located at the bottle infeed

zone.MOBILE GUIDE POSITION BACK back position of the sorters located at the bottle infeed zone.VIALS LOADING SPEED moving speed of the vial unloading belt toward the

machine's outfeedUNLOADING BELT START washer ‘steps’ count for the step-by-step movement of the

loading belt to better arrange the bottles between the washer and the tunnel.

UNLOADING SEPARATION TIME running time of the unloading belt's motor for the step-by-step movement.


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4.1.2.3.Unloading unit calibration parameters

The calibration parameters exclusively concern the unloading unit. The sole parameter that may be changed is the "Offset" parameter, with the level 3 password. The 'Measurement' is re-calculated according to the offset parameter. The calibration parameters are to be changed only when the unit's potentiometer is replaced or if the operator notices that the positions reached by the unit do not match the set ones. They must never be changed under routine operating conditions.

The calibration values are as follows:

Unloading PusherParameter Description10ZT120 numerical (decimal) value of the incoming signal to the analog

channel converted in digitalOffset position of the pusher as compared to the mechanical zero pointMeasurement position of the pusher as compared to the zero point

Unloading RotorParameter Description10ZT21 numerical (decimal) value of the incoming signal to the analog

channel converted in digitalOffset Angular position of the rotor as compared to the mechanical zero

pointMeasurement Angular position of the rotor as compared to the zero point

Mobile guideParameter Description2ZT8 numerical (decimal) value of the incoming signal to the analog

channel converted in digitalOffset position of the mobile guides as compared to the mechanical zero

pointMeasurement position of the mobile guides as compared to the zero point


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4.1.3. Automatic operating mode

To activate the automatic mode, it must be selected on the operator panel and the operator must check that the JOG button is not plugged in otherwise the system will not allow the machine to run in automatic mode. The system also notifies the operator about the JOG being plugged in by displaying an alarm message on the operator panel. If no alarms are present and if the safety guards are closed, the machine starts running by pressing the START button on the vial washer's control panel.

(0)Stand -by

(1)First load (2) Tank f illing

(5)Emptying

(6)Draining

(7) Drying

Start from OP

Stop from OP

Level reached

"Stop"

Stop fromOP

Stop fromOP or End

Start fromOP“Start”

(8)Pause

Alarm

Alarm

Min. loadingor tunnel

"Start" w ithempty tank

Selectionfrom OP

(7)Allarme

Alarm

Alarm

Alarm

Alarm

Fault solvingand

Alarm Reset

“Start” w ithminimum load

(9)Alarm

(3)Pump loading

(4)Wash vialsmovement

Alarm

Alarm

Start fromOP

"Stop"

Stop fromOP or End

End

"Stop"

"Start"

(10) Flushing

Stop fromOP

Start fromOP

Start from OP

Pic. 1: Vial Washer Operation Block Diagram

The block diagram in Pic. 1 shows the vial washer running in automatic mode. The transition between one operating state and another is indicated by an arrow. It may occur via a command issued by the operator (from the operator panel or the buttons on the control panel), via an anomalous condition (alarms or warnings) or a PLC command (ending of a set time).


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4.1.3.1.Description of vial washer operations in automatic mode

4.1.3.1.1 Standby

Before beginning the production cycle, right after having switched on the machine and having pressed the ALARM RESET button, the machine is in Standby (phase 0).

4.1.3.1.2 First Vial loading

When the machine starts running, the operator may select the First Vial loading procedure (phase 1). This procedure is required at the first production cycle startup, after a size changeover or in any case when the machine is stationary and completely empty. After having loaded the vials on the infeed belt either with the upstream machine, or manually, the operator must select the First Vial Loading option on the operator terminal.

After having inserted the vials and selected the First Vial Load function, press the relevant function key to start the procedure. The 2M1 infeed belt starts running and pushes the vials into the sorting channels while the machine remains stationary. Disable the function via the operator panel (always using the relevant function key) once the vials have filled the sorting channels. The loading procedure ends, motor 2M1 stops and the machine returns to "Standby" mode. During this phase any alarms triggered by the infeed belt cause the belt to stop and exit from the phase. The procedure restarts after having cleared the alarm cause and pressed the reset button.

4.1.3.1.3 Tank filling

On terminating phase 1, the machine is waiting and ready to fill the tank. Press the START button tobegin phase 2. This phase may always be activated simultaneously with phase 1. Once the tank-filling procedure is enabled it may be aborted by pressing the ‘STOP’ button; in this case the machine returns to the “Standby” phase (phase 0). Once the tank-filling procedure is aborted, on re-pressing the START button (from phase 0), the machine returns to the tank-filling phase (phase 2).

When level sensor 5LS23 indicates that the tank is full, the machine returns to phase 0 waiting for the command to be issued and heating element 5R1 is powered. As occurs with the First Vial Loading phase, this phase is necessary only during the first production startup. The system selects the procedure automatically. If an alarm is triggered during this phase (emergency button pressed or guards open) the production cycle restarts on clearing the cause (reset not necessary).

4.1.3.1.4 Pump loading

Press the START button to initiate the operating cycle. Pump 5M1 is loaded, if need be, during the first production cycle (phase 3). Valves 5Y3 and 5Y8 open and then, according to a pre-set sequence, valves 5Y1 and 5Y6 open, too.


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4.1.3.1.5 Wash vials movement

Once this procedure is complete, valves 5Y3 and 5Y6 close and the vial washer automatically starts the wash cycle (phase 4). The machine starts running with all the functions required for carrying out the production cycle. If vials are missing at infeed or if the downstream machine is not ready, the machine stops in standby (phase 8) and restarts automatically once work conditions have been restored.During the automatic work cycle the vials located on the belt are channelled by the sorting unit and transferred to the insertion unit that inserts them into the cones. During this operation the sorting units move, by means of their own motor 2M2, to facilitate channeling the vials toward the inserter. Then, the vials inserted into the conveying cones cross the various washing stations.

4.1.3.1.6 Pause

The automatic operating cycle stops if a warning is displayed; the machine switches to the pause condition, phase 8 (see section 4.1.3.3). There are two envisaged conditions: omission of the go-ahead signal from the downstream interfaced machine via the exchange of a signal between the PLC of the downstream machine and the PLC of the vial washer or due to a minimum load at infeed 2QS10.In both cases when the condition is restored the machine restarts in phase without the operator having to do anything else. But if an alarm is triggered the machine will restart, after having reset the alarm, by pressing the start button again. The cycle ends when the operator presses the stop button.

4.1.3.1.7 Emptying

Once the wash cycle is complete, the vials are unloaded in the outfeed zone where an unloading belt motor 10M3 is installed, made of steel mesh, which is activated (in the case of larger vials) or not activated (in the case of smaller vials), to send the vials to the downstream interfaced machine (the activation or non-activation of the belt and the speed setting is carried out via the OP). A pusher unit is installed at the outfeed zone and it activates during the emptying phases (phase 5) to remove all the vials from the washer's outfeed zone and push them into the downstream machine.

The emptying procedure may be requested at the end of the production cycle. Start the procedure by pressing the relevant emptying key via the operator panel. All machine functions are operational, like in automatic mode, except for the following motors: infeed belt 2M1, vial loading 3M1, sorting units 2M2 minimum load check 2QS10. Consequently the machine unloads the vials until all the cone-holding strips are empty. The main motor drive 9M1 remains operational and unloads all the vials onto the outfeed surface.

The emptying unit consists of a moved motorized carriage, the task of which is to completely empty the vial outfeed zone by pushing the washed vials into the downstream interfaced machine (tunnel), when the emptying function is ON.

The carriage moves by means of a geared motor located inside the right-hand covering guard on the unloading side. Drive from motor 10M2 to the carriage takes place by means of a chain.


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On activating the emptying procedure, on finishing the wash cycle and on unloading the vials onto the outfeed surface, the carriage reaches its limit stop on the wash zone outfeed side. Then motor 10M1, the one on the carriage, turns to bring the rear pusher onto the vial's outfeed surface. On reaching this position, motor 10M2 that controls the carriage starts running and brings the carriage to machine outfeed and pushes the vials outwards to limit stop. On reaching the limit stop, the pusher raises and the carriage returns to the home position on the outfeed side of the wash zone.

At this point motor 10M1 turns in the opposite direction as compared to the previous direction and brings the front pusher onto the vial surface. Conveyor motor 10M2 starts running again and performs a new travel towards the outfeed and therefore completes the machine emptying procedure.

Since conveyor motor 10M2 is not synchronized with the speed of the downstream machine, a spring fitted with sensor 10ZS42 acts on the transmission. The spring compresses during the thrust action.On reaching max compression, sensor 10ZS42 deactivates motor10M2. As soon as the spring decompresses (while the downstream machine is receiving the vials), the sensor permits motor 10M2 to restart. This feature avoids breaking the vials caused by the pusher pressing them. Once the emptying procedure is over, the carriage returns to standby position.

The emptying procedure may be interrupted for various reasons: if halted by pressing the Stop button, the procedure aborts and the machine returns to Standby mode (phase 0). If halted via the operator panel, the procedure is interrupted only if the unloading unit has not yet activated otherwise the machine continues the cycle.

On finishing the emptying procedure the machine returns to Standby mode (phase 0).

4.1.3.1.8 Drainage and drying

It is advisable to drain the machine (phase 6) after having run the emptying procedure. Keep in mind that the draining cycle may be selected and carried out even if the emptying procedure was not run beforehand. The draining procedure may be activated only when the machine is stationary.

Activate the procedure by pressing the relevant draining function key. The valves, through which the fluids enter, close automatically and the drain valves discharge all fluids from the machine. The various circuits are drained in sequence The draining times are set on the relevant menu of the operator panel.If an alarm is triggered during the procedure, this procedure will be interrupted and the drain times reset automatically. Clear the alarm cause and press the ALARM RESET button to restart the procedure. The machine's circuits are empty and its valves are closed once the draining phase has finished.

Two conditions may occur: if no other procedures were selected, the machine remains in standby (phase 0) until the operator presses the START button to refill the circuits. But if the drying function was enabled (by pressing the relevant drying function key on the operator panel), (and after the draining procedure has been completed) the drying procedure will be activated automatically (phase 7) and dry every single circuit.


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At the end of the drying procedure, valves 5Y1 and 7Y1 open for 1 minute in order to remove the pressure from the circuits.

The duration of the drying procedure may be programmed on the operator panel by keying in the level 3 password. During this phase the compressed air flows freely through the pipes, valves and filters so as to dry the circuits completely before continuing with the next step.If an alarm is triggered, the procedure is interrupted but not aborted and in order to restart the machine the operator must reset the alarm. The machine returns to phase condition automatically.

4.1.3.1.9 Flushing

The flushing procedure (phase 10) can be activate with the machine in ‘Standby’ condition (phase 0). The valves 5Y1 and 7Y1 open for 5 seconds every 15 seconds until the operator deactivates the procedure by operator panel. This procedure is used to flush the water in the washing circuits.

4.1.3.2. ‘VALIDATION’ Procedure

The ‘VALIDATION’ mode permits the operator to access the vial unloading zone which is betweenthe vial washer and the downstream machine (tunnel), by disabling the safety guards of the zone (side guards interlocked). All machine functions are enabled during this procedure.

For safety reasons, the foregoing mode requires the following two types of activations to work:− software activation− hardware activation

The software activation is carried out via the operator panel by entering the level 3 password. The hardware activation is carried out via the dedicated key selector by setting it to ‘VALIDATION TEST’ mode.

The yellow lamp of the light turret turns on during the ‘VALIDATION’ mode and the following warning message appears on the operator panel:

32 BYPASS SAFETY COVERS UNLOADING ZONE

This mode must remain active as little as possible and the operator who activated it must immediately deactivate this mode as soon as the validation tests are finished. If the operator runs the hardware activation during the vial washer's automatic mode, a warning message is displayed on the operator panel. If the operator runs the software activation only, nothing happens but as soon as the operator opens the safety guard in the vial unloading zone the machine will stop in alarm status.


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4.1.3.3.Pinchart

5Y1 5Y2 5Y3 5Y4 5Y5 5Y6 5Y7 5Y8 6Y1 6Y2 6Y3 6Y9 6Y10 7Y0 7Y1 7Y2 7Y7 10Y6 10Y7(15) 2M1 2M2 3M1 4M1 5M1 9M1 10M1 10M2 10M3OFF ON(4) OFF OFF OFF OFF OFF ON(4) OFF OFF OFF OFF OFF ON(10) OFF OFF OFF OFF ON OFF OFF OFF ON OFF OFF OFF OFF OFFOFF ON(9) OFF OFF OFF OFF OFF ON(4) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON ON OFF ON OFF OFF OFF OFF OFFON(8) ON(9) OFF OFF OFF OFF OFF ON(4) OFF OFF OFF OFF OFF ON ON(8) OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFOFF ON ON OFF OFF ON OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF

STEP 0 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON ON OFF OFF OFF OFFSTEP 1 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFSTEP 2 OFF ON(9) OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFSTEP 3 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON ON OFF OFF OFF OFFSTEP 4 ON ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON ON OFF OFF OFF OFFSTEP 5 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF

ON ON(9) OFF OFF OFF OFF OFF ON ON OFF OFF ON OFF ON ON OFF OFF OFF ON OFF OFF ON ON ON ON OFF OFF OFFOFF ON(9) ON(3) OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF ON ON ON OFF ON ON ON OFF OFF OFF

EMPTYING ON ON(9) ON(3) OFF OFF OFF OFF ON ON OFF OFF ON OFF ON ON OFF OFF OFF OFF OFF OFF OFF ON ON(14) ON(14) OFF ONBW (16) ON(5)

WAIT STEP OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 14 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 0 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF ONBW OFF ONSTEP 1 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF ONFW ONSTEP 2 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 3 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF ONBW ONSTEP 4 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 5 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF ONFW OFF ONSTEP 6 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF ONFW ONSTEP 7 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF ONBW ONSTEP 8 OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF ONBW OFF ONSTEP 9(14) OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 11(14) OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ONSTEP 12(14) OFF ON(9) OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF ON

ON ON OFF ON ON ON ON ON OFF OFF OFF ON OFF OFF ON ON ON ON OFF OFF OFF OFF ON OFF OFF OFF OFF OFFSTEP 1 ON OFF OFF OFF ON(7) ON(1) ON(2) OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFSTEP 2 OFF OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF ON OFF ON ON(1) OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFSTEP 3 ON OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFF

OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF ON OFF ON OFF OFF OFF OFF OFF OFF OFF OFF ON OFF OFF OFF OFF OFFOFF OFF OFF OFF OFF OFF OFF ON(12) OFF OFF OFF OFF OFF ON(12) OFF OFF OFF OFF ON(11) OFF OFF OFF ON(6) OFF OFF OFF OFF OFF

(1): It activates for 3 seconds every 30 seconds. (10): Active only after the first tank filling. FW: Forward(2): It activates for 3 seconds every 33 seconds. (11): Stops only if an emergency stop button is pressed. BW: Backward(3): It activates for 1 second every 30 seconds. (12): Stops only if an emergency stop button is pressed or a 24 VAC power supply failure occurs.(4): It activates if the tank has already been filled and the draining has not yet started. (13): It remains active for 15 steps.(5): The ON/OFF status depends on the size being processed. (14): Step is not used.(6): Stops only if an emergency stop button is pressed, a thermal overload at 4QM1 occurs, or air extractor inverter 4SY16 failure occurs. (15) Valve 10Y7 can be enabled/disabled from the HMI.

(7): Active only for the first one minute; opens after 30 seconds (for 3 seconds) then closes. (16) 10M2 is ON BW when 10ZT120 > 3mm during emptying.(8): Active 5 seconds every 15 seconds. (17) For step transitions refer to Attachment B.(9): Active only if 5LS23 requests water.

2 - TANK FILLING

SEQUENCE0 - STANDBY1 - FIRST LOAD10 - FLUSHING

4 - WASH4 - TANK REFILLING

6 - DRAINING

3 - PUMP LOADING(17)

8 - PAUSE9 - ALARM

7 - DRYING(17)

5 - EMPTYING(17)


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4.1.4. Manual operating mode

To activate the manual operating mode, select the MANUAL mode on the operator panel (after having keyed in the level 2 password) and plug the JOG button into the specific socket. The machine's functions are operative regardless of the downstream machine's go-ahead signals and are based only on the selections made with the function keys of the operator panel.

4.1.4.1.Description of the functions in manual mode

The operator may decide to run one complete cycle in manual mode (excluding the emptying cycle) by selecting all the wash cycles and motors 2M1, 2M2, 3M1, 9M1 and 10M1. In this case, the machine carries out the entire process like in automatic mode (phase 4) but at a production speed reduced by 50%. Main motor 9M1 has another limit in manual mode that allows it to work for a maximum of 15 seconds.

The operator may activate all the valves, either in groups or individually, at any time except if the draining phase has already been activated in manual. In this case, the valves do not open.Furthermore, valve 5Y2 is not activated on opening if the tank level sensor indicates that the maximum liquid level has been attained inside the tank.

As far as the motors are concerned (except motor 4M1 and motor 10M1), once the desired user has been selected via the operator panel, the chosen functions or movements are activated with the JOG button. The operation of the JOG is the held type. As stated above, the main motor's control is active for 15 seconds at the most and then the operator must release the button and press it again.

The pump 5M1 may always be controlled in manual mode but if there isn't any water inside the tank it will stop automatically after 5 seconds even if the operator keeps holding down the JOG button. The exhausted air extraction motor (4M1), which is always active during the automatic cycle, must be controlled individually.

The draining phase may be controlled at any time in manual mode.

The safety devices of the guards are disabled whereas the emergency buttons remain active in manual mode. All the alarms remain active in the manual mode therefore the operator may never control a valve or a movement that could damage the machine.

In manual mode, it's also possible to control each valve to drain the circuit with compressed air.


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4.2. Stop conditions and signals

4.2.1. Description of the automatic stop mode

The machine may stop for a number of reasons while running in automatic mode. Below is a list of the types of machine stops:

NORMAL STOP (A1)The operator stops the machine by pressing the stop button on board the machine or on the electric control panel. The machine stops in phase, with controlled stop, and power is supplied to the actuators. The normal stop makes the machine enter phase 0 (Standby).

PAUSE STOP (A2)This type of stop is determined either by a minimum vial load condition on the feeding belt or because the downstream machine is not ready. In both cases the main motor drive stops but the feeding belt and the suction fan keep running. The pump works for 15 seconds and then stops. As soon as vials are loaded or the downstream machine is ready, the cycle restarts automatically. The pause stop makes the machine enter phase 8 (Pause).

STOP WITH EMPTYING (A3)This type of stop occurs only when the machine is performing the emptying function. The washer stops automatically in phase after having unloaded all the vials still inside. The stop with emptying makes the machine enter phase 0 (Standby).

ALARM STOP (A4)This type of stop is triggered by alarms that do not entail operator hazards. All the motor drives stop when a faulty condition is detected. The stop is in phase if the type of alarm that tripped permits it. In particular, alarms triggered by the sensors on the valves (XS) determine a stop in phase whereas all the other alarms determine an immediate stop. The complete list of alarms is outlined in the attachment ‘A’ of this document.

Before restarting the machine in automatic mode the operator must clear the alarm cause, acknowledge the alarm by operator panel and press the ALARM RESET button; then press the START button. The alarm stop makes the machine enter phase 9 (Alarm).

EMERGENCY STOP (A5)The system is equipped with 3 mushroom-head red buttons for the emergency stops, located as follows:— one on the electric panel;— two on the machine.Use these buttons:— in case of imminent danger or mechanical accident;— when the machine is already stationary and must be subjected to brief interventions to ensure it

definitely remains stopped.


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The pressing of an emergency button makes the machine halt at once because power is cut-off to all motors. When a mobile safety guard is opened during operations this causes an emergency stop.

Before restarting the machine in automatic mode, the operator must release the pressed emergency button, acknowledge the alarm by operator panel, and press the ALARM RESET button; then press the START button. The emergency stop makes the machine enter phase 9 (Alarm).

MACHINE SHUTDOWN (A6)The stop due to work shift end is actuated when the operator wishes to disconnect the machine from the power supply source. This condition is achieved, with the machine stationary, by opening the electric energy disconnecting switches located on the electric power cabinet.

4.2.2. Description of the stop modes in manual mode

The only stops that may be configured during the manual operating mode are as follows:

— Stop due to alarm (A3) and (A4)— Emergency stop (A5)— Machine shutdown (A6)

The modes associated with the individual stops are the same ones described for the automatic operating modes (section 4.1.3). The only exception is the stop due to alarm for which the opening of a safety panel disappears as a possible cause (in fact in manual mode the machine can work with the guards open).

4.2.3. List of the alarms and warnings

Attachment A lists the foreseen alarms. The relevant stop mode is indicated for each alarm, conforming to what is outlined in section 4.2.1. Even the foreseen warnings are listed, i.e. those messages that indicate a stop condition with automatic restart.


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4.2.4. List of machine state messages

The table below lists the foreseen messages (machine states) with reference to the operating condition during which the message appears.

MESSAGE MACHINE STATUSS0 S1 S2 S3 S4 S5 S6 S7 S8 S10 S11 S12

MACHINE RUNNING XMINIMUM LOAD VIALS INLET 2QS10 XWAIT FOR REFILL RECYCLE TANK XEMPTYING ACTIVE XFIRST LOADING PROCEDURE ACTIVE XDRAINAGE RECYCLE / W.F.I.CIRCUITS ACTIVE XDRYING RECYCLE CIRCUIT ACTIVE XDRYING W.F.I. CIRCUIT ACTIVE XBATCH NOT ACTIVE X XWAITING FOR TUNNEL XPUSH "START" BUTTON TO REFILL TANK XFINAL PROCEDURE EMPTYING ACTIVE XLOW BATTERY PLC X X X X X X X X X X X XPROCEDURE LOADING PUMP ACTIVE XWAITING FOR COMMAND XFLUSHING PROCEDURE ACTIVE XWASHING CIRCUIT ENABLE IN MANUAL MODE XUNLOADING RESET RUNNING XPUSH "START" TO CONTINUE UNLOADING HYDRA X XELECTRIC CABINET HIGH TEMPERATURE - 0BT1 X X X X X X X X X X XUNLOADING PUSHER PRESSURE CONTROL ACTIVE -10ZS42 XWARNING UNLOADING IN MANUAL MODE XSAFETY DOORS UNLOADING EXCLUSION X

S0 = Machine in waiting for command S1 = Vial loading procedure enabledS2 = First refill recycle tank procedure S3 = Pump loading procedureS4 = Machine running S5 = Emptying procedure enabledS6 = Drainage procedure enabled S7 = Bypass safety doors procedure enabledS8 = Machine in standby, automatic restarts S10 = Flushing procedure activeS11 = Machine in manual with washing enabled S12 = Drying procedure enabled


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4.3. Machine Functions

This chapter illustrates the list of the functional units of the HYDRA 1800-18-C/S vial washer.These units include functional units for immediately identifying the elements making up the system and the individual machines. The process is broken down into control loops that make it easier to understand the operation of the entire system or the process itself.

FUNCTIONAL UNITS

Group 0 Power Supply and Common DevicesGroup 2 Infeed Belt Group

Group 3 Vials Loading GroupGroup 4 Air Extractor Fan Group

Group 5 Recycle Water Circuit GroupGroup 6 Compressed Air Circuit Group

Group 7 W.F.I. Water Circuit GroupGroup 9 Main Motorization GroupGroup 10 Vials Unloading Group

The alarm conditions and any machine malfunctions are indicated by the turning on of the red light on the light warning column and by the relevant messages on the operator interface panel.

The functional units that make up the machine are shown in the Piping & Instrumentation Diagram, 151-D02-8500. The method for identifying the instruments is taken from the INSTRUMENT SOCIETY of AMERICA Standards no. ISA-S5.1.


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4.3.1. Group 0 – Power Supply and Common devices

4.3.1.1.Power Supply

When the main power supply switch 0S1 is switched off during the production an Emergency Stopoccurs.

When in automatic mode the main power supply has a failure the anomaly is detected from the electrical device 0KF1, located inside the electrical cabinet, an Alarm stop occurs and the following message is displayed:

MAIN POWER SUPPLY FAILURE - 0KF1

To re-establish the working condition, restore the electrical lines, acknowledge the alarm message and press the Alarm reset button.

In the PLC of the machine is an input for checking of the status of the machine’s power supply. This entry is provided for future use. The closed contact indicates that the machine is powered through the distribution network and the open contact indicates that the machine is not powered or powered through an insufficient generator group.

4.3.1.2.Auxiliary Power Supply

When the 24VAC power supply switches 0QF3/4 are switched off during the production an Alarm Stop occurs and the following message is displayed:

ALARM POWER SUPPLY 24Vac FAILURE - 0QF3/0QF4

When the PLC battery’s charge level is low a warning message is displayed. The operator must inform the maintenance personnel to replace the battery following the instructions provided by the manufacturer. the warning message displayed on the Operator Panel will be the following:

LOW BATTERY PLC

4.3.1.3. JOG Button

When the JOG button is inserted during the automatic machine running, an Alarm Stop occurs and the following message is displayed:

JOG INSERTED IN AUTOMATIC MODE

The JOG button is disabled during the automatic mode.


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4.3.1.4.Emergency Circuit

In case of an emergency (Emergency Push Buttons 0SB5, 0SB6, or 0SB8 is pressed), the power supply to the electric and pneumatic actuators is interrupted. In this case an Emergency stop occurs and the appropriate message is displayed:

or:COMMAND PANEL EMERGENCY PUSHED - 0SB5

or:UNLOADING ZONE EMERGENCY PUSHED - 0SB6

or:LOADING ZONE EMERGENCY PUSHED - 0SB8

To re-establish the working condition, reset the emergency stop button, acknowledge the alarm message and press the alarm reset button.

The Emergency stop is activated while an anomaly is detected on the 0K2 device, immediately an Emergency stop is activated and the following message is displayed:

EMERGENCY RELAY - 0K2

4.3.1.5.Electric Cabinet Temperature

Inside the cabinet there are fans that provide the circulation of air and maintain the temperature inside the cabinet. When the filters are full (dirty), the amount of air flow is not enough, and the temperature increases. In this case a message is displayed on the operator panel, without any influence on the production process:

“ELECTRIC CABINET HIGH TEMPERATURE – 0BT1”

To restore the correct function, it is necessary to change the filters blocks, and check the temperature set alarm on 0BT1 device (located inside the electrical cabinet), otherwise after 5 minutes of high temperature inside the electric cabinet an Alarm Stop occurs and the following message is displayed:

ELECTRIC CABINET HIGH TEMPERATURE - 0BT1

4.3.1.6.Safety doors

A safety guard with eight doors encloses the machine. Each door is fitted with a micro-switch that detects its position ( 0SF5, 0SF6, 0SF7, 0SF8, 0SF9, 0SF10, 0SF11, 0SF12, 0SF13). The safety devices of the doors 0SF11 and 0SF12 can be disabled for VALIDATION. If any door is opened when


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the safety devices are enabled, an Emergency Stop occurs and the appropriate message is displayed:

SAFETY DOOR OPEN LOADING LEFT ZONE - 0SF5or:

SAFETY DOOR OPEN LOADING RIGHT ZONE - 0SF6or:

SAFETY DOOR OPEN LOADING ZONE - 0SF7or:

SAFETY DOOR OPEN WASHING RIGHT ZONE - 0SF8or:

SAFETY DOOR OPEN WASHING ZONE - 0SF9or:

SAFETY DOOR OPEN CAMS ZONE - 0SF10or:

SAFETY DOOR OPEN UNLOADING RIGHT - 0SF11or:

SAFETY DOOR OPEN UNLOADING LEFT- 0SF12or:

SAFETY DOOR OPEN WASHING LEFT - 0SF13

If all the safety covers are closed but a failure is present in the safety covers emergency relay circuit, an Emergency Stop occurs and the following message is displayed:

SAFETY CIRCUIT FAULT

If the machine is stopped and any one of the doors is open, the machine will not start if the START pushbutton is pressed.

4.3.1.7. Supervisor communication error

If the communication between PLC and SUPERVISOR is interrupted, an Alarm stop occurs and the following message appears on the display:

SUPERVISOR COMMUNICATION ERROR

4.3.1.8. HMI communication error

If the communication between PLC and HMI is interrupted, an Alarm stop occurs and the following message appears on the display:

HMI COMMUNICATION ERROR


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4.3.2. Group 2 – Infeed Belt

The feeding belt group consists of a conveyor belt and a sorter for a correct loading function. The motor drives the belt by means of a chain. The belt speed is not variable since an incorrect speed setting could lead to infeed problems. The belt speed is set per vial size.

4.3.2.1.Infeed Belt Motor

The above mentioned motor drive is fitted with a thermal relay, the activation of which causes an Alarm stop, the following message is displayed:

FEEDING BELT THERMAL RELAY - 2QM1

The inverter alarm intervention causes an Alarm stop, and the following message is displayed:

FEEDING BELT INVERTER ALARM - 2SY4

4.3.2.2.Mobile guide Motor

The motor 2M2 transmits motion to the mobile guides. If inverter 2SY6 is faulty, the machine is subjected to an Alarm stop and the following message is displayed:

MOBILE GUIDE INVERTER ALARM - 2SY6

The aforesaid motor drive (2M2) is equipped with a thermal relay 2QM2 the tripping of which triggers an Alarm stop and the following message is displayed:

MOBILE GUIDE THERMAL RELAY - 2QM2

The sensor 2ZT8 checks the mobile guides position and enables the backward/forward motion. In the event of a sensor failure, an Alarm stop occurs and the following message is displayed:

MOBILE GUIDE POSITION - 2ZT8

4.3.2.3.Backward Motion

The belt feeds the bottles into the sorter and then stops and moves back a short distance before the tip-up (loading) unit starts its stroke to insert the bottles. The distance that the belt moves back is not adjustable; this is also set during the final testing at LIBRA (one distance for all vials size). It is only possible to adjust the time when it actually stops and, as a consequence, the time it remains at astandstill, by means of the cam-sensor 2ZS5. When the sensor lights up, the belt and the sorter stop, after which the belt moves back the distance programmed inside the PLC. The belt must stop an instant before the tip-up unit begins its stroke so as to free the first row of bottles from the pressure of the


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others on the belt.

In the event of sensor failure the following message is displayed:

START FEEDING BELT SENSOR ALARM - 2ZS5

4.3.2.4. Minimum Load

During the automatic running mode the machine stops when no bottles are detected by the photocell 2QS10 on the infeed belt, and this is signaled on the supervisor unit, which causes a Pause stop and the following message is displayed:

MINIMUM LOAD VIALS INLET 2QS10

The minimum load control can be cut-out only during the manual running mode using the operator interface, so as to avoid any anomalous operations that could lead to mechanical problems. When the machine is running in manual mode, the feeding belt is running only if the function is enabled on the Operator panel.

4.3.3. Group 3 – Vials Loading

The vial loading group consists of a shaft connected, by means of a chain transmission, to the torque limiter and to the motor. Two series of steel plates are fitted at 180° on this shaft. The plates pass through the slots in the plate at the end of the belt, and when this stops they begin their stroke, picking up the containers and placing them in the baskets. The alternate movement is guaranteed by a jog device that drives the torque limiter through a chain.

4.3.3.1.Motorization

The above mentioned motor drive is fitted with a thermal relay, the triggering of which causes an Alarm stop coming on in the supervisor and the following message is displayed:

LOADING GROUP THERMAL RELAY - 3QM1

In case of an anomaly condition detected on the inverter the following message is displayed:

VIALS LOADING INVERTER ALARM - 3SY8

4.3.3.2.Loading Start/Stop

The input for the start of the stroke is given to the tip-up unit by the pointed cam-sensor 3ZS5A. Another cam-sensor 3ZS5B is fitted on the jog control which stops the jog device, such stop being


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enabled when the sensor reads the cam. In the event of sensors failure the following message is displayed:

START LOADING SENSOR ALARM - 3ZS5A OFFor

STOP LOADING SENSOR ALARM - 3ZS5B OFF

This sensor system guarantees a maximum machine speed of 20 strokes/minute.

4.3.3.3. Overload protection

When the tip-up unit is blocked by jamming, the torque limiter is activated; this moves the steel surface away from the sensor, thus causing an Alarm stop and the following message is displayed:

LOADING GROUP TORQUE LIMITER - 3WS7

4.3.4. Air extractor fan group

This unit consists of a motor 4M1 and a fan placed on the technical floor. A duct connects the washing-side of the machine to the fan. An inverter 4SY16 adjusts the quantity of the sucked air. During the automatic running mode the fan runs continuously, while during the manual running mode the fan runs when selected on the Operator panel.

4.3.4.1.Air extractor fan motor

The above mentioned motor drive is fitted with a thermal switch 4QM1 the triggering of which causes an Alarm stop, and the following message is displayed:

EXTRACTOR FAN THERMAL RELAY - 4QM1

In case of an anomaly condition detected on the inverter the following message is displayed:

EXTRACTOR FAN INVERTER ALARM - 4SY16

4.3.4.2.Air Extractor Fan Sectioner

On the exhaust fan power supply line, near the motor, is installed a disconnecting device 4S1. When this device is switched off an Alarm stop occurs and the following message appear on the display:

SECTIONER EXTRACTOR MOTOR OFF - 4S1


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4.3.5. Group 5 – Recycle water circuit

This washing group consists of a water refill valve, a recycling tank, a tank outlet valve, a recycling pump, a purge valve, one water filter, a purge valve, a recycled water pressure gauge with transmitter, a washing valve and three drainage valves. Each automatically driven valve has a feedback switch.

The recycling tank is in stainless steel. The tank collects the water which drains into it from the trays under the washing station. The stations from which water is recovered are identified in the section on the washing circuit.

4.3.5.1.Recycle Tank

The tank is fitted with a sensor 5LS23 to check the level at which the refill-stop valve 5Y2 opening is enabled. The level control has a connection check of the tank 5E1. Without this consent, the refill-valve is closed. A software timer is also mounted for its intervention at about 5 seconds. In the event of connection failure the following message is displayed:

RECYCLE TANK CONNECTION ALARM/SENSOR BROKEN

After 30 seconds with low water level inside the tank, an Alarm stop occurs, and the following message is displayed:

RECYCLE TANK LOW WATER LEVEL - 5LS23

4.3.5.2.Recycle Pump

The pump motor stops after 15 seconds (after the alarm intervention and before the circuit emptying). Water is collected by the pump from a hole in the bottom of the tank and recycled or drained. The hole is protected by a perforated sheet-metal cage to prevent accidental blockage. The tank is fitted on wheels and inserted inside the machine from the right-hand side. Two chutes guide the tank under the machine and, since they are fitted at an angle, ensure complete drainage.

The aforementioned motor drive is fitted with a thermal relay whose intervention causes an Alarm stop, and the following message is displayed:

RECYCLE PUMP THERMAL RELAY - 5QM1

During the automatic running mode the pump operates as long as the machine is running and stops automatically 10 seconds after the machine has stopped. The function 5M1 RECYCLE PUMP controls the pump only during manual running. The pump only starts running when it is enabled by the electric level gauge inside the recycling tank.


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4.3.5.3.Recycle Washing Valve

A software timer located inside the PLC and adjustable by means of the Operator panel (password access only) controls the opening time of the valve 5Y1 connected to the washing stations. This time can vary between 0.1 and 9.0 seconds. The timer is enabled by means of the appropriate function “Manual washing” located on the Operator panel when the machine is in manual running mode; during automatic running, it is automatically enabled by the machine regardless of the function activation. The timer is enabled by means of sensor 9ZS34 near the washing carriage to start counting. A cam fitted on the shaft that drives the carriage is read by the sensor when the needles are aligned with the mouth of the container to be washed. This cam can be adjusted by means of the set screw which secures it to the shaft.

If the time set is greater than the maximum time that the carriage is in its raised position, enabling is automatically cut-out when the sensor no longer detects the cam.

4.3.5.4.Recycle Water Washing Valve

The position of the washing valve 5Y1 is checked by means of feedback switch 5XS28 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE WASHING VALVE NOT OPEN ALARM - 5Y1 - 5XS28or

RECYCLE WASHING VALVE NOT CLOSE ALARM - 5Y1 - 5XS28

4.3.5.5.Recycle Refill Valve

The position of the refill valve 5Y2, is checked by means of feedback switch 5XS30 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE REFILL VALVE NOT OPEN ALARM - 5Y2 - 5XS30or

RECYCLE REFILL VALVE NOT CLOSE ALARM - 5Y2 - 5XS30

4.3.5.6.Recycle Purge Valve

The position of the pump purge valve 5Y3, is checked by means of feedback switch 5XS37 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE PURGE VALVE NOT OPEN ALARM - 5Y3 - 5XS37or

RECYCLE PURGE VALVE NOT CLOSE ALARM - 5Y3 - 5XS37


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If an anomaly of position of the valve is detected, the function of drainage and/or drying is alsostopped.

4.3.5.7.Recycle Drain Valve

The position of the tank drainage valve 5Y4, is checked by means of feedback switch 5XS32 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE DRAINING VALVE NOT OPEN ALARM - 5Y4 - 5XS32or

RECYCLE DRAINING VALVE NOT CLOSE ALARM - 5Y4 - 5XS32

If an anomaly of position of the valve is detected, the function of drainage and/or drying is also stopped.

4.3.5.8.Pump Drainage Valve

The position of the pump drainage valve 5Y5, is checked by means of feedback switch 5XS33 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:




4.3.5.9.Recycle Purge Valve

The position of the filter purge valve 5Y6, is checked by means of feedback switch 5XS45 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE PURGE VALVE NOT OPEN ALARM - 5Y6 - 5XS45or

RECYCLE PURGE VALVE NOT CLOSE ALARM - 5Y6 - 5XS45



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4.3.5.10. Recycle Draining Valve

The position of the filter drainage valve 5Y7, is checked by means of feedback switch 5XS31 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:




4.3.5.11. Recycle Tank Valve

The position of the tank outlet valve 5Y8, is checked by means of feedback switch 5XS63 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

RECYCLE TANK VALVE NOT OPEN ALARM - 5Y8 - 5XS63or

RECYCLE TANK VALVE NOT CLOSE ALARM - 5Y8 - 5XS63


4.3.5.12. Recycle Water Pressure

The pressure gauge 5PT14 fitted to the washing circuit measures the pressure value and transmits it to the PLC. The minimum value accepted in the circuit can be adjusted through the Operator panel.

Lack of pressure in the line that may be caused by closed infeed valves or by a high consumption for the infeed rate or by clogged filters will cause an Alarm stop and the following message is displayed:

RECYCLE WATER LOW PRESSURE - 5PT14

4.3.5.13. Recycle Water Tank Temperature

The temperature probe 5TE24 is fitted to the recycle tank checks the water temperature. The probe is connected with a temperature transmitter to adjust the zero and span value for calibration. When a low temperature is detected in the circuit, there is an Alarm stop and the following message is displayed:

RECYCLE WATER TANK LOW TEMPERATURE - 5TT24L

When a high temperature is detected in the circuit, there is an Alarm stop and the following message is


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displayed:

RECYCLE WATER TANK HIGH TEMPERATURE - 5TT24H

The minimum and maximum values accepted in the circuit can be adjusted by using Operator panel.

4.3.5.14. Recycle Tank Heating

The heating resistor of the recycle tank water, 5R1, is fitted with a thermal relay 5QM2, the tripping of which causes an Alarm Stop, and the following message is displayed:

RECYCLE TANK HEATING THERMAL RELAY - 5QM2

4.3.6. Group 6 – Compressed Air Circuit

This cam can be adjusted by means of the set screw which secures it to the shaft. (This is not a part change operation). If the time set is greater than the maximum time that the carriage is in its raised position, enabling is automatically cut-out when the sensor no longer detects the cam.

This drying group consists of two compressed air reducers, a pressure switch, a compressed air filter, a pressure indicator, a compressed air pressure gauge with transmitter, a drainage valve, three drying valves, two manual purge valves, a manual valve and a spraying valve. Each automatically driven valve has a feedback switch.

4.3.6.1.Blowing Air Valve

A software timer inside the PLC and adjustable by the Operator panel control the opening time of the valve 6Y1 connected to the washing stations. This opening time may range between 0.1 and 9.0 seconds. The timer is enabled by means of the appropriate function “Manual washing” located on the Operator panel when the machine is in manual running mode. During automatic running, it is automatically enabled by the machine regardless of the function activation. The timer is enabled by means of sensor 9ZS34 near the washing carriage to start counting. A cam fitted on the shaft that drives the carriage is read by the sensor when the needles are aligned with the mouth of the container to be washed.

The position of the blowing valve 6Y1 is checked by means of feedback switch 6XS27 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

BLOWING AIR VALVE NOT OPEN ALARM - 6Y1 - 6XS27or

BLOWING AIR VALVE NOT CLOSE ALARM - 6Y1 - 6XS27


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4.3.6.2.Drying Air Valve 6Y2.

During the W.F.I. drying cycle the 6Y2 valve opens to dry the circuit of the W.F.I. The position of the drying valve 6Y2, is checked by means of feedback switch 6XS70 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

DRYING AIR VALVE NOT OPEN ALARM - 6Y2 - 6XS70or

DRYING AIR VALVE NOT CLOSE ALARM - 6Y2 - 6XS70”


4.3.6.3.Drying Air Valve 6Y3

During the recycle drying cycle the 6Y3 valve opens to dry the circuit of the recycled water. The position of the drying valve 6Y3, is checked by means of feedback switch 6XS67 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

BLOWING AIR VALVE NOT OPEN ALARM - 6Y3 - 6XS67or

BLOWING AIR VALVE NOT CLOSE ALARM - 6Y3 - 6XS67


4.3.6.4.Draining Valve

The 6Y9 valve completely opens to drain the pipes during the operating drainage pipe between the valves 6Y2 and 6Y10. During the drying cycle the 6Y9 valve closes to dry the circuit of the W.F.I..The position of the drainage valve 6Y9, is checked by means of feedback switch 6XS112 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

DRAINING VALVE NOT OPEN ALARM - 6Y9 - 6XS112or

DRAINING VALVE NOT CLOSE ALARM - 6Y9 - 6XS112



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4.3.6.5.Drying Air Valve 6Y10

This valve is installed to avoid, in case of failure of the 6Y2 valve, introducing W.F.I. water in the W.F.I. compressed air circuit. During the drying cycle the 6Y10 valve opens to dry the circuit of the W.F.I. The position of the drying valve 6Y10, is checked by means of feedback switch 6XS111 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

DRYING AIR VALVE NOT OPEN ALARM - 6Y10 - 6XS111or

DRYING AIR VALVE NOT CLOSE ALARM - 6Y10 - 6XS111


4.3.6.6.Pressure Service Air

The activation of the valves air pressure switch 6PS62 causes an Alarm stop and the following message is displayed:

LOW PRESSURE AIR SERVICE VALVES - 6PS62

4.3.6.7.Compressed Air

The pressure gauge 6PT13 fitted to the washing circuit measures the pressure value and transmits it to the PLC. The minimum value accepted in the circuit can be adjusted through the Operator panel. Lack of pressure in the line that may be caused by closed infeed valves or by a high consumption for the infeed rate, or by clogged filters will cause an Alarm stop, and the following message will be displayed:

COMPRESSED BLOWING AIR LOW PRESSURE - 6PT13

4.3.7. Group 7 – W.F.I. water circuit

This washing group consists of a root valve, two drainage valves, a W.F.I. pressure gauge with transmitter, a temperature probe to measure water temperature and a washing valve. Each valve has a feedback switch.


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4.3.7.1.W.F.I. Supply

The system sends a signal to the customer to enable the opening of the W.F.I. loop water. The position of the customer root valve is returned to the system from the customer. When an incorrect condition is detected, an Alarm stop occurs and one of the following messages is displayed:

ROOT VALVE W.F.I. NOT OPEN ALARMor

ROOT VALVE W.F.I. NOT CLOSE ALARM

4.3.7.2.W.F.I. Root Valve

The position of the inlet valve 7Y0, is checked by means of feedback switch 7XS69 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

W.F.I. ROOT VALVE NOT OPEN ALARM - 7Y0 - 7XS69or

W.F.I. ROOT VALVE NOT CLOSE ALARM - 7Y0 - 7XS69

4.3.7.3.W.F.I. Washing Valve

A software timer located inside the PLC, and adjustable by means of the Operator panel, controls the opening time of the valve 7Y1 connected to the washing stations. This time can vary between 0.1 and 9.0 seconds. The timer is enabled by means of the appropriate function “Manual washing” located on the Operator panel when the machine is in the manual running mode. During automatic running it is automatically enabled by the machine regardless of function activation. The timer is enabled by means of sensor 9ZS34 near the washing carriage to start counting. A cam fitted on the shaft that drives the carriage is read by the sensor when the needles are aligned with the mouth of the container to be washed. This cam can be adjusted by means of the set screw which secures it to the shaft.

If the time set is greater than the maximum time that the carriage is in its raised position, enabling is automatically cut-out when the sensor no longer detects the cam. The position of the washing valve 7Y1 is checked by means of feedback switch 7XS29 installed on the valve. When an incorrectmovement of the valve is detected, an Alarm stop occurs and the following message is displayed:

W.F.I. WASHING VALVE NOT OPEN ALARM - 7Y1 - 7XS29or

W.F.I. WASHING VALVE NOT CLOSE ALARM - 7Y1 - 7XS29

4.3.7.4.W.F.I. Draining Valve 7Y2

During the drainage cycle the inlet valve 7Y0 closes automatically while the draining valve 7Y2 opens to drain the pipes, valve 7Y7 is open to drain the water between W.F.I. loop and washer. In case of any position problems being detected by the feedback switch 7XS35, an Alarm stop occurs and the


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following message is displayed:

W.F.I. DRAINING VALVE NOT OPEN ALARM - 7Y2 - 7XS35or

W.F.I. DRAINING VALVE NOT CLOSE ALARM - 7Y2 - 7XS35


4.3.7.5. W.F.I. Draining Valve 7Y7

Drainage valve 7Y7 is open during drainage. The position of the drainage valve 7Y7 is checked by means of feedback switch 7XS113 installed on the valve. When an incorrect movement of the valve is detected, an Alarm stop occurs and the following message is displayed:

W.F.I. VALVE NOT OPEN ALARM - 7Y7 - 7XS113or

W.F.I. VALVE NOT CLOSE ALARM - 7Y7 - 7XS113


4.3.7.6.W.F.I. Pressure

The pressure gauge 7PT15 fitted to the washing circuit visualizes the pressure value and transmits it to the PLC. The minimum value accepted in the circuit can be adjusted through the Operator panel. Lack of pressure in the line that may be caused by closed infeed valves or by a high consumption for the infeed rate, causes an Alarm stop and the following message is displayed:

W.F.I. LOW PRESSURE - 7PT15

4.3.7.7.W.F.I. Temperature

A temperature sensor 7TE24, installed in the water pipe near the washing needles, measures the W.F.I. temperature. The sensor 7TE24 is connected to a transmitter, 7TT24, which sends temperature value to the PLC and from this to the operator panel.

When the washer is running, after 30 seconds of low or high water temperature, with respect to the setpoint, an Alarm Stop occurs and one of the following messages is displayed:

W.F.I. WASHING WATER LOW TEMPERATURE - 7TT24Lor


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W.F.I. WASHING WATER HIGH TEMPERATURE - 7TT24H

4.3.8. Group 9 – Main Motorization

The machine motor drive group consists of four rollers with guides for the chains, two chains, a series of cones for bottles to be handled, a jog control device, a torque limiter, a geared motor and a motor. The system transfers the bottles automatically inserted upside down through all the washing stations to the discharge where they are turned upright again.

One of the two top rollers, the one on the discharge side, is the pulling roller which is linked by a chain to the jog device. The roller at the bottom on the discharge side is fitted with a chain-stretcher. The pinions that link the pulling roller to the jog device are fitted on a keying element and a torque limiter.

4.3.8.1.Main Motor

The entered production speed value changes the output frequency at inverter 9SY2 installed in the electrical cabinet, which transmits the power to the main motor 9M1. Electric motor 9M1 is mounted on a slide and transmits the movement to the gearbox by means of two V-belts.

The inverter alarm intervention causes an Alarm stop and the following message is displayed:

MAIN MOTOR INVERTER ALARM - 9SY1

The thermal alarm intervention causes an Alarm stop and the following message is displayed:

MAIN MOTOR THERMAL RELAY - 9QM1

4.3.8.2.Torque Limiter

The torque limiter is located on the jog control shaft and is activated when the conveyor chain encounters resistance during its rotation. A proximity switch 9WS6 is fitted close to the torque limiter. if the chain encounters infeed resistance, the outer ring of the torque limiter moves away, the sensor does not read the ring and the machine stops immediately. An Alarm stop signals the event and the following message is displayed:

MAIN MOTOR TORQUE LIMITER - 9WS6

To reset, the cause of the resistance must be removed before pressing the alarm reset on the Operator panel. Upon resetting the alarm, the main motor turns in the reverse direction until the torque limiter returns to its housing.


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4.3.8.3.Washing Carriage

The main motor drives the needle unit and the discharge unit through the above mentioned chains. The needle unit consists of a manifold support carriage, a counter-bar carriage, a telescopic lever and a cam. The manifold support carriage and the counter-bar carriage slide on two rods located at the sides of the machine, inside the washing area. The manifold support carriage is moved by a telescopic lever linked to the lever controlled by the cam inside the jog device. A stainless steel lever is connected to a telescopic lever and to the carriage linkage. The telescopic lever is fitted with a spring which is compressed between two sleeves. The sensor 9ZS19 monitors the presence of a steel block located at one end of the spring. If the spring is compressed, the block moves away from the sensor and the machine goes in Alarm stop and the following message is displayed:

WASHING CARRIAGE OVERLOAD ALARM - 9ZS19

4.3.8.4.Upside Down Vial

The counter-bar carriage is also inside the washing area and is moved by a handle on the upper part of the machine. This counter-bar carriage is fitted with a series of rods, the number of which varies according to the number of cones on the stick, and these can be adjusted so that they can be lowered inside the slots on the cones. The two screws that move the counter-bar carriage are linked by two pinions and a chain. When the handle is turned, both the screws turn and the carriage is raised or lowered to the required level. The counter-bar carriage is also fitted with the overturned bottle safety system. This system consists of a stainless steel comb with steel strips fitted at the same height as the rods so that they are integral with the carriage.The comb is hinged to the carriage and a sensor detects its presence. If a vial does not enter a cone correctly, the comb is raised by the vial and the sensor 9ZS12 does not detect it. The machine goes in Alarm stop and the following message is displayed:

UPSIDE DOWN VIALS SENSOR ALARM - 9ZS12

4.3.8.5.Ejection Device

The discharge unit consists of an extractor, a sorting comb, a retaining guide plate and an outfeed belt. The vials transferred inside the cones arrive in the discharge area held in the spokes by a stainless steel guide plate which is held by two plastic supports fixed to the side of the machine. After passing beyond the guide plate, the cones stop in front of the extractor which enters the cones and transfers the vials to a sorting comb where they are held in a vertical position by the mobile plate guide. When the vials are deposited on the sorting comb, the latter begins its stroke towards the outfeed belt while the mobile guide plate rises and the vials are released onto the outfeed belt where they arrive in a vertical position.The discharge device and the sorting comb are fitted on a carriage and connected to the lever by means of a telescopic rod with spring, the resistance of which can be adjusted by means of two ring nuts. The telescopic lever is designed so that the spring provides resistance to the sliding of the two sleeves. A sensor 9ZS20 reads the presence of a steel block located at an end of the spring. If this spring


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compresses, due to the foregoing resistance, the block moves away from the sensor, the machine goes into an Alarm Stop and the following message is displayed:

EJECTION DEVICE OVERLOAD ALARM - 9ZS20

4.3.8.6.Reordering Device

Once the reordering comb has received the vials, it begins its travel toward the outlet conveyor belt, the shield moves up and the vials are released onto the outlet conveyor belt, arriving in vertical position.The discharge device is fitted on a carriage and connected to the lever by means of a telescopic rod with spring, the resistance of which can be adjusted by means of two ring nuts. The telescopic lever is designed so that the spring provides resistance to the sliding of the two sleeves.

A sensor 9ZS21 reads the presence of a steel block located at an end of the spring. If this spring compresses, due to the foregoing resistance, the block moves away from the sensor, the machine goes into an Alarm Stop and the following message is displayed:

REORDERING DEVICE OVERLOAD ALARM - 9ZS21

4.3.8.7.Washing Consent

The change in transport speed is connected to the washing cycle as the lever connected to the shaft which moves the washing carriage is fitted with a cam which is read by the sensor 9ZS34 when the carriage is in its topmost position, thus enabling the opening of the washing valves. The sensor disables the washing valves as soon as the carriage begins to move down, that is when it no longer detects the cam. The functionality of this sensor, which is very important for the process, is automatically checked during the automatic running mode. If any anomalous operation of the sensor is detected, an Alarm stop occurs and the following message is displayed:

WASHING SENSOR ALARM - 9ZS34

4.3.8.8.Consent from Tunnel

If the contact I:3/27, that signals the consent from the tunnel, is de-energized when the line is working, the washer should stop in standby status and the following warning message is displayed:

WAITING FOR TUNNEL


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4.3.9. Group 10 – Unloading Vials

The vial unloading and emptying unit is made up of a conveyor belt, which helps to send the vials to the downstream machine during the automatic cycle, and a motor driven carriage that clears the vial outfeed area during the emptying stage by pushing the washed vials toward the downstream machine.The movement of the unloading devices is obtained by means of electric motor 10M1 (rotating motion) and 10M2 (translation motion).

4.3.9.1.Unloading rotating Motor

The rotating motor for the unloading device is fitted with a thermal relay 10QM1, the triggering of which causes an Alarm stop and the following message is displayed:

UNLOADING ROTATING THERMAL RELAY - 10QM1

The inverter alarm intervention of rotating motor causes an Alarm stop and the following message is displayed:

UNLOADING ROTATING INVERTER ALARM - 10SY10

4.3.9.2.Unloading Device Motor

The motorization of the unloading pusher is fitted with a thermal relay 10QM2, the triggering of which causes an Alarm stop and the following message is displayed:

UNLOADING DEVICE THERMAL RELAY - 10QM2

The inverter alarm intervention of unloading pusher causes an Alarm stop and the following message is displayed:

UNLOADING DEVICE INVERTER ALARM - 10SY20

4.3.9.3.Unloading Belt Motor

The motorization of the unloading belt is fitted with a thermal relay 10QM3, the triggering of which causes an Alarm stop and the following message is displayed:

UNLOADING BELT THERMAL RELAY - 10QM3

The inverter alarm intervention of unloading belt causes an Alarm stop and the following message is displayed:

UNLOADING BELT INVERTER ALARM - 10SY30


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4.3.9.4.Pusher Horizontal Motion

The position of the pusher (concerning the horizontal motion) is checked by a position transducer, 10ZT120. If an anomalous position is detected, the machine goes into Alarm stop and the following message is displayed:

UNLOADING DEVICE POSITION - 10ZT120

4.3.9.5.Unloading Device Rotary Motion

The position of the unloading device (concerning the rotation motion) is checked by the sensor 10R21 connected to the position transducer 10ZT21. If an anomalous position is detected, the machine goes into Alarm stop and the following message is displayed:

UNLOADING DEVICE ROTARY MOTION POSITION - 10ZT21

4.3.9.6.Pusher Pressure

The pressure pushing of the unloading pusher during operation is checked by sensor 10ZS42, and willstart/stop the pusher motor. If the pressure is too high or a mechanical block is present the following message is displayed:

UNLOADING PUSHER PRESSURE CONTROL ACTIVE – 10ZS42

After a delay time, if the critical situation remains active, the machine goes into Alarm stop and the following message is displayed:

UNLOADING PUSHER OVERLOAD - 10ZS42

4.3.9.7.Vacuum Circuit Root Valve

The suction circuit is controlled by means of valve 10Y7, check by feedback microswitch 10XS54, the tripping of which causes an Alarm Stop and the following message is displayed:

VACUUM ROOT VALVE NOT OPEN ALARM - 10Y7 - 10XS54or

VACUUM ROOT VALVE NOT CLOSE ALARM - 10Y7 - 10XS54

4.3.9.8.Vacuum Circuit Drainage Valve

The valve 10Y6 is used to drain the water collected in the vacuum zone. The position of the drainage valve 10Y6 is checked by feedback microswitch 10XS53, the tripping of which causes an Alarm Stop and the following message is displayed:

VACUUM VALVE NOT OPEN ALARM - 10Y6 - 10XS53


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orVACUUM VALVE NOT CLOSE ALARM - 10Y6 - 10XS53


4.3.9.9.Vacuum switch

The vacuum efficiency is checked by means of a pressure switch 10PS17 which its intervention causes an Alarm stop and the following message is displayed:

VACUUM SWITCH ALARM -10PS17


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5. INTERFACE

This section describes the system's interfaces. The following sub-sections are present:

• Interface with users• Interface with other systems

5.1. Interface with users

This section describes the user interface of the HYDRA 1800-18-C/S vial washer.

The user interface is fitted with the following components:

• Devices on the electrical panel• Control components on-board the machine• Operator Interface panel

The location of the control panel and the operator interface is shown in the Wiring Diagrams, 151-I03-032.

5.1.1. Devices on the electrical panel

The control and warning components installed on the control panel are as follows:

1. ‘VALIDATION TEST’ selector2. Warning light turret3. Audible indicator4. Operator interface panel5. START button6. STOP button7. ALARM RESET button8. EMERGENCY red light9. EMERGENCY stop button10. Power line isolating switch11. Process parameters recorder

5.1.1.1.‘VALIDATION TEST’ SELECTOR

This selector allows the operator to activate the hardware of the ‘VALIDATION’ operating mode.


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5.1.1.2.WARNING LIGHT TURRET

The warning light turret is made up of four light sectors for remotely identifying the machine's operating status. These signals are from top to bottom on the turret:

Fixed Red light: machine stopped due to an alarm.Fixed Yellow light: machine in manual mode, or the ‘VALIDATION’ operating mode is

activated, or the machine is in standby due to a maximum load, or the tunnel is stationary, machine in standby due to minimum load.

Fixed Green light: machine producing.Flashing Blue light: machine in minimum load.Flashing Green light: machine stationary and ready to produce.

5.1.1.3.AUDIBLE INDICATOR

The audible indicator starts ringing if the machine stops due to an alarm.

5.1.1.4.OPERATOR PANEL

The operator interface panel is made up of an Allen-Bradley touch screen and permits the operator to view alarm messages, machine operating states and menu pages. It is also to be used for setting the machine's work parameters.

5.1.1.5.START BUTTON

The green START button should be pressed every time the operator wishes to start running the machine in automatic mode. If any alarm signals were triggered the operator must first acknowledge them, press the ALARM RESET button and then the START button.

5.1.1.6.STOP BUTTON

The red STOP button should be pressed to stop the machine in phase when running in automatic mode. A second STOP button is installed on-board the machine with the same function.

5.1.1.7.ALARM RESET BUTTON

The blue ALARM RESET button should be pressed to restore operating conditions when alarm/emergency signals have been triggered. In order to reset the tripped alarm, the operator must first clear the problem, acknowledge the message on the operator panel and then press the ALARM RESET button (the button resets only the acknowledged messages).


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5.1.1.8.EMERGENCY LIGHT

When the red light turns on, this means that the EMERGENCY button was pressed or that an interlocked guard was opened. In order to restore operating conditions, reset the EMERGENCY button, acknowledge the message and then press the ALARM RESET button.

5.1.1.9.EMERGENCY STOP BUTTON

The control electric panel is fitted with a button for the EMERGENCY stop. When the EMERGENCY stop button is pressed, the machine stops all its functions immediately since power is cut off. In order to restart the machine after an emergency stop the operator must reset the EMERGENCY button, acknowledge the message and then press the ALARM RESET button.

5.1.1.10. POWER LINE ISOLATING SWITCH

This switch is located on the vial washer's main power supply that feeds all the heating elements and all the motors. During maintenance the operator may lock this switch with a safety padlock to block the switch in the OFF position. During the vial washer's routine operating conditions, this switch must always be in the ON position.


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5.1.2. Control components on-board the machine

A set of control devices (especially machine-stopping devices) are installed on-board the machine and are arranged so that the operator may access them easily and quickly.

A STOP button, in particular, is installed on the operator's side in the unloading zone. Furthermore, two EMERGENCY buttons are installed: one is on the operator's side in the vial-unloading zone and the other is on side opposite the operator in the vial loading zone. The function of the aforementioned buttons is the same as those located on the electric cabinet.

The socket for the JOG button, for running the machine in manual mode, is also installed on-board the machine on the operator's side in the vial.

5.1.2.1. JOG BUTTON

The connector of the JOG device must be plugged into the specific socket on the operator's side of the machine. The JOG device is to be used only for maintenance operations, after having selected the manual mode. Motor movements take place at normal speed except for the main motor that runs at reduced speed by holding down the button on the device. Furthermore, the main motor stops automatically after 15 seconds – then the button must be released and pressed again. In automatic, the machine may work only if the JOG device is disconnected. The JOG button may be plugged in exclusively when the machine is stationary because if the machine is running it will stop and display the relevant alarm.

5.1.3. Operator panel

The operator interface panel displays the machine's operating status, the alarm messages and the various menu pages dedicated to the setting of the operating parameters and to the manual movements. The installed panel shall be the touch screen type (Allen-Bradley PanelView Plus 1000). For details see the Software Design Specification, 151-I36-002.

5.1.3.1.Operating parameters

The settable parameters are listed and described in section 4.1.2. The parameters may be changed with password level 3.

5.2. Interface with other systems

The vial washer was designed for being connected to a sterilization tunnel already installed.


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5.2.1. Electrical interface

The connection between the two machines, from an electrical point of view, envisages the exchange of three clean contacts (clear from potential) that supply the mutual consent signals for operating the line:

Inputsconsent from tunnelOutputsconsent to tunnel infeed shutter opening enabled tunnel start emptyingreference speed to tunnelBit “1-2-3-4-5” format size selected

5.2.1.1.Consent from tunnel

The operating logic must be structured as follows:The tunnel must attain the work temperature. Once it has attained said temperature, it issues the consent signal to the vial washer.

5.2.1.2.Consent to tunnel

After having washed the vials, they are placed onto the outfeed belt moving toward the tunnel. In order to improve the correct filling of the tunnel infeed zone, upon starting the washer emptying procedure, the washer steps will be counted while the outfeed belt stays off (parameter settable to size). Once the counter reaches the set parameter size, outfeed belt will start running step by step.

If the contact, that signals the consent from the tunnel, is de-energized when the line is working, the washer should stop in standby status.

5.2.1.3.Infeed shutter opening enabled

During the emptying phase, when the unloading pusher is activated, a signal is sent to the tunnel to open the tunnel entry shutter to a certain height, to allow the entry of the pusher inside the tunnel.

5.2.1.4. Tunnel start emptying

At the end of the ‘washing machine emptying’ a signal is sent to the tunnel to enable the ‘tunnel emptying’.

5.2.2. Mechanical interface

The machine's mechanical connections with any other line components are indicated in the mechanical drawings supplied with the machine.


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5.2.3. Batch Tracking Interface

The PLC will send some information about the machine status, phase, and alarms by Ethernet protocolto the supervisor system.

The PLC and the supervisory system will exchange data following an excel table that will contain all the data (tags, areas, etc.) that will be used in this communication.


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6. ATTACHMENTS

This document contains the following attachments:


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6.1. ATTACHMENT A – Alarms and Warning Messages list

ALARM MESSAGESNote: F = Fixed

B = Blinking

Signalization on Display Warning lights turret and Acoustic Signal STOP conditions Delay RESET

Alarm # ALARM MESSAGE

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1 ALARM POWER SUPPLY 24Vac FAILURE - 0QF3/0QF4 F F X Instant X2 EMERGENCY RELAY - 0K2 F F X Instant X3 SAFETY CIRCUIT FAULT F F X Instant X4 COMMAND PANEL EMERGENCY PUSHED - 0SB5 F F X Instant X5 SAFETY DOOR OPEN LOADING LEFT ZONE - 0SF5 F F X Instant X6 SAFETY DOOR OPEN LOADING RIGHT ZONE - 0SF6 F F X Instant X7 SAFETY DOOR OPEN LOADING ZONE - 0SF7 F F X Instant X8 SAFETY DOOR OPEN WASHING RIGHT ZONE - 0SF8 F F X Instant X9 SAFETY DOOR OPEN WASHING ZONE - 0SF9 F F X Instant X10 SAFETY DOOR OPEN CAMS ZONE - 0SF10 F F X Instant X11 SAFETY DOOR OPEN UNLOADING RIGHT - 0SF11 F F X Instant X12 SAFETY DOOR OPEN UNLOADING LEFT - 0SF12 F F X Instant X13 SAFETY DOOR OPEN WASHING LEFT - 0SF13 F F X Instant X14 UNLOADING ZONE EMERGENCY PUSHED - 0SB6 F F X Instant X17 MOBILE GUIDE POSITION - 2ZT8 F F X Instant X18 MOBILE GUIDE THERMAL RELAY - 2QM2 F F X Instant X19 MOBILE GUIDE INVERTER ALARM - 2SY6 F F X 5 X21 LOADING ZONE EMERGENCY PUSHED - 0SB8 F F X Instant X33 FEEDING BELT THERMAL RELAY - 2QM1 F F X Instant X34 FEEDING BELT INVERTER ALARM - 2SY4 F F X 5 X35 START FEEDING BELT SENSOR ALARM 2ZS5 F F X 15 X37 JOG INSERTED IN AUTOMATIC MODE F F X Instant X38 LOADING GROUP THERMAL RELAY - 3QM1 F F X Instant X39 LOADING GROUP TORQUE LIMITER - 3WS7 F F X Instant X


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40 START LOADING SENSOR ALARM - 3ZS5A OFF F F X 15 X41 STOP LOADING SENSOR ALARM - 3ZS5B OFF F F X 5 X44 EXTRACTOR FAN THERMAL RELAY - 4QM1 F F X Instant X45 EXTRACTOR FAN INVERTER ALARM - 4SY16 F F X 5 X46 SECTIONER EXTRACTOR MOTOR OFF - 4S1 F F X Instant X47 VIALS LOADING INVERTER ALARM - 3SY8 F F X 5 X48 RECYCLE PUMP THERMAL RELAY - 5QM1 F F X Instant X49 RECYCLE TANK HEATING THERMAL RELAY - 5QM2 F F X Instant X50 RECYCLE TANK LOW WATER LEVEL - 5LS23 F F X 30 X52 RECYCLE TANK CONNECTION ALARM/SENSOR BROKEN F F X Instant X53 RECYCLE WASHING VALVE NOT OPEN ALARM - 5Y1 - 5XS28 F F X Instant X54 RECYCLE WASHING VALVE NOT CLOSE ALARM - 5Y1 - 5XS28 F F X 1 X55 RECYCLE REFILL VALVE NOT OPEN ALARM - 5Y2 - 5XS30 F F X Instant X56 RECYCLE REFILL VALVE NOT CLOSE ALARM - 5Y2 - 5XS30 F F X 1 X57 RECYCLE DRAINING VALVE NOT OPEN ALARM - 5Y7 - 5XS31 F F X 2 X58 RECYCLE DRAINING VALVE NOT CLOSE ALARM - 5Y7 - 5XS31 F F X 2 X59 RECYCLE DRAINING VALVE NOT OPEN ALARM - 5Y4 - 5XS32 F F X 2 X60 RECYCLE DRAINING VALVE NOT CLOSE ALARM - 5Y4 - 5XS32 F F X 2 X61 RECYCLE DRAINING VALVE NOT OPEN ALARM - 5Y5 - 5XS33 F F X 2 X62 RECYCLE DRAINING VALVE NOT CLOSE ALARM - 5Y5 - 5XS33 F F X 2 X63 RECYCLE PURGE VALVE NOT OPEN ALARM - 5Y3 - 5XS37 F F X 0.5 X64 RECYCLE PURGE VALVE NOT CLOSE ALARM - 5Y3 - 5XS37 F F X 0.5 X65 RECYCLE PURGE VALVE NOT OPEN ALARM - 5Y6 - 5XS45 F F X 2 X66 RECYCLE PURGE VALVE NOT CLOSE ALARM - 5Y6 - 5XS45 F F X 1 X67 RECYCLE WATER LOW PRESSURE - 5PT14 F F X 3 X68 RECYCLE WATER TANK HIGH TEMPERATURE - 5TT24H F F X 10 X69 RECYCLE WATER TANK LOW TEMPERATURE - 5TT24L F F X 10 X70 RECYCLE TANK VALVE NOT OPEN ALARM - 5Y8 - 5XS63 F F X 1 X71 RECYCLE TANK VALVE NOT CLOSE ALARM - 5Y8 - 5XS63 F F X 2 X73 COMPRESSED BLOWING AIR LOW PRESSURE - 6PT13 F F X 1 X74 BLOWING AIR VALVE NOT OPEN ALARM - 6Y1 - 6XS27 F F X Instant X75 BLOWING AIR VALVE NOT CLOSE ALARM - 6Y1 - 6XS27 F F X 1 X


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76 LOW PRESSURE AIR SERVICE VALVES - 6PS62 F F X Instant X77 DRYING AIR VALVE NOT OPEN ALARM - 6Y2 - 6XS70 F F X 2 X78 DRYING AIR VALVE NOT CLOSE ALARM - 6Y2 - 6XS70 F F X 2 X79 BLOWING AIR VALVE NOT OPEN ALARM - 6Y3 - 6XS67 F F X 2 X80 BLOWING AIR VALVE NOT CLOSE ALARM - 6Y3 - 6XS67 F F X 2 X81 W.F.I. WASHING VALVE NOT OPEN ALARM - 7Y1 - 7XS29 F F X Instant X82 W.F.I. WASHING VALVE NOT CLOSE ALARM - 7Y1 - 7XS29 F F X 1 X83 W.F.I. DRAINING VALVE NOT OPEN ALARM - 7Y2 - 7XS35 F F X 2 X84 W.F.I. DRAINING VALVE NOT CLOSE ALARM - 7Y2 - 7XS35 F F X 2 X85 W.F.I. LOW PRESSURE - 7PT15 F F X 3 X86 W.F.I. ROOT VALVE NOT OPEN ALARM - 7Y0 - 7XS69 F F X 2 X87 W.F.I. ROOT VALVE NOT CLOSE ALARM - 7Y0 - 7XS69 F F X 2 X94 W.F.I. VALVE NOT OPEN ALARM - 7Y7 - 7XS113 F F X 2 X95 W.F.I. VALVE NOT CLOSE ALARM - 7Y7 - 7XS113 F F X 2 X97 MAIN MOTOR THERMAL RELAY - 9QM1 F F X Instant X99 MAIN MOTOR TORQUE LIMITER - 9WS6 F F X Instant X

100 MAIN MOTOR INVERTER ALARM - 9SY1 F F X 5 X101 UPSIDE DOWN VIALS SENSOR ALARM - 9ZS12 F F X Instant X102 WASHING CARRIAGE OVERLOAD ALARM - 9ZS19 F F X Instant X103 EJECTION DEVICE OVERLOAD ALARM - 9ZS20 F F X Instant X104 REORDERING DEVICE OVERLOAD ALARM - 9ZS21 F F X 5 X105 WASHING SENSOR ALARM - 9ZS34 F F X 10 X108 UNLOADING BELT THERMAL RELAY - 10QM3 F F X Instant X109 UNLOADING BELT INVERTER ALARM - 10SY30 F F X 5 X110 UNLOADING DEVICE ROTARY MOTION POSITION - 10ZT21 F F X Instant X111 UNLOADING ROTATING INVERTER ALARM - 10SY10 F F X 5 X112 UNLOADING ROTATING THERMAL RELAY - 10QM1 F F X Instant X113 UNLOADING DEVICE INVERTER ALARM - 10SY20 F F X 5 X114 UNLOADING DEVICE THERMAL RELAY - 10QM2 F F X Instant X118 UNLOADING PUSHER OVERLOAD - 10ZS42 F F X Instant X121 UNLOADING DEVICE POSITION - 10ZT120 F F X Instant X124 DRAINING VALVE NOT OPEN ALARM - 6Y9 - 6XS112 F F X 2 X


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125 DRAINING VALVE NOT CLOSE ALARM - 6Y9 - 6XS112 F F X 2 X126 DRYING AIR VALVE NOT OPEN ALARM - 6Y10 - 6XS111 F F X 2 X127 DRYING AIR VALVE NOT CLOSE ALARM - 6Y10 - 6XS111 F F X 2 X131 ELECTRIC CABINET HIGH TEMPERATURE - 0BT1 F F X Instant X132 MAIN POWER SUPPLY FAILURE - 0KF1 F F X Instant X144 HMI COMMUNICATION ERROR F F X 60 X145 SUPERVISOR COMMUNICATION ERROR F F X 20 X146 VACUUM VALVE NOT OPEN ALARM - 10Y6 - 10XS53 F F X 1 X147 VACUUM VALVE NOT CLOSE ALARM - 10Y6 - 10XS53 F F X 1 X148 VACUUM ROOT VALVE NOT OPEN ALARM - 10Y7 - 10XS54 F F X 1 X149 VACUUM ROOT VALVE NOT CLOSE ALARM - 10Y7 - 10XS54 F F X 2 X150 VACUUM SWITCH ALARM - 10PS17 F F X 5 X151 ROOT VALVE W.F.I. NOT OPEN ALARM F F X 30 X152 ROOT VALVE W.F.I. NOT CLOSEALARM F F X 30 X185 W.F.I. WASHING WATER LOW TEMPERATURE - 7TT24L F F X 10 X186 W.F.I. WASHING WATER HIGH TEMPERATURE - 7TT24H F F X 10 X


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WARNING MESSAGESNote: F = Fixed

B = Blinking


Alarm # WARNING MESSAGE

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1 MACHINE RUNNING F - - - - - - Instant - -

2 MINIMUM LOAD VIALS INLET 2QS10 F B X 3 X

3 WAIT REFILL RECYCLE TANK B - - - - - - Instant - -

4 EMPTYING ACTIVE F - - - - - - Instant - -

6 FIRST LOADING PROCEDURE ACTIVE F - - - - - - Instant X

7 DRAINAGE RECYCLE / W.F.I.CIRCUITS ACTIVE F - - - - - - Instant - -

10 DRYING RECYCLE CIRCUIT ACTIVE F - - - - - - Instant - -

12 DRYING W.F.I. CIRCUIT ACTIVE F - - - - - - Instant - -

13 BATCH NOT ACTIVE - - - - - - - - - - - Instant - -

14 WAITING FOR TUNNEL F X Instant X

15 PUSH "START" BUTTON TO REFILL TANK B X - - - - - Instant X

16 FINAL PROCEDURE EMPTYING ACTIVE F X Instant X

17 LOW BATTERY PLC F - - - - - - - - - Instant X

18 PROCEDURE LOADING PUMP ACTIVE B - - - - - - Instant - -

20 FLUSHING PROCEDURE ACTIVE - - - - - - Instant - -

19 WAITING FOR COMMAND B X - - - - - Instant - -

21 WASHING CIRCUIT ENABLE IN MANUAL MODE F - - - - - - Instant X

22 UNLOADING RESET RUNNING F - - - - - - Instant - -

23 PUSH "START" TO CONTINUE UNLOADING HYDRA B - - - - - - Instant X

24 ELECTRIC CABINET HIGH TEMPERATURE - 0BT1 - - - - - - - - - - - Instant X

29 UNLOADING PUSHER PRESSURE CONTROL ACTIVE - 10ZS42 F - - - - - - Instant - -

30 WARNING UNLOADING IN MANUAL MODE F * - - - - - - Instant X

32 SAFETY DOORS UNLOADING EXCLUSION F - - - - - - Instant X


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6.2. ATTACHMENT B – Sequential Function Charts

Pump Loading Procedure Step Transition Diagram:


2964113_2964112.doc Page 64 of 67

Step 0

Step 1

Step 2

Step 3

Step 4

Step 5

5 second timer (T4[103])



Recycle Water Pressure (5PT14) ≥ 28 Pa

10 second timer (T4[104]) + Recycle Water Pressure (5PT14) ≥ min. recycle pressure setpoint (F8[44])

(displayed at the Operator Panel)

Enter Washing

Procedure

Start Pump Loading

Procedure


2964113_2964112.doc Page 65 of 67

Emptying Procedure Step Transition Diagram:

Emptied

Remaining Steps displayed at the Operator Panel equals zero (0).

Start Emptying Procedure

EndEmptying Procedure(Machine in Standby)

Wait Step

Unloading Device (10M2) is in Automatic mode

Step 14

Unloading Device Position (10ZT120) ≤ 3mm

Step 0

Unloading Rotating Device Position (10ZT21) < High Rotation Setpoint (F8[77])

Step 1

Unloading Device Position (10ZT120) ≥ Low Position Setpoint (F8[55]) + 15 second timer (T4[62]) expires

Step 2

Unloading Rotating Device Position (10ZT21) > Low Rotation Setpoint (F8[76])

Step 3

Unloading Device Position (10ZT120) ≤ High Position Setpoint (F8[54])

Step 4


Step 5

Unloading Rotating Device Position (10ZT21) > Low Rotation Setpoint (F8[76])

Step 6

Unloading Device Position (10ZT120) ≥ Low Position Setpoint (F8[55]) + 15 second timer (T4[62]) expires

Step 7


Step 8

Unloading Rotating Device Position (10ZT21) < High Rotation Setpoint (F8[76])


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Drying Procedure Step Transition Diagram:

Step 1

Step 2

Step 3

Step 4

5 minute step timer(displayed at the Operator Panel)

5 minute step timer (displayed at the Operator Panel)

EndDrying Procedure

(Machine in Standby)

Start Drying Procedure

Step 2 to transitions immediately to Step 3.

1 minute step timer(displayed at the Operator Panel)


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Revision History

VENDOR REVISION HISTORY

Revision Modification Request N. Modified by Date Pages Involved / Description of

Modification1.0 - - First Issue

1.1 057-2005 M. Russo 06/20/2005 See Change request



1.4 N/A D. Kelly 07/25/06 Revised per Control Qualification results.

GENENTECH REVISION HISTORY

Date Revision Section By Description04/03/07 0 All WSV Issue for approval.05/08/07 1 All WSV Updated content from tunnel to washer.

08/28/07 2 All MATRIX

Document reconciliation: Changed document title to “Functional Specification” from “Automation Functional Requirements”; Removed the Distribution List table; Moved the vendor Table of Modifications to the Revision History section; Added description of automatic and manual modes from SDS to Section 4.1; Removed “GMP” and “Test Doc. Ref.” columns from Alarms and Warnings Messages tables; Updated formatting, spelling, and grammatical issues throughout document; Where possible, replaced references to vendor document numbers with Genentech document numbers.

07/07/08 3 4.1.1 AC Modified section 4.1.1 per CO1013878.

UserName: William Vaughn (wsvaughn) Title: Automation, Tech Date: Friday, 08 August 2008, 09:22 AM US/Pacific Meaning: Approval ================================================

Documents

Functional Specification For Area 3 Vial Washer · PDF fileFunctional Specification For Area 3 Vial Washer Covering Systems: PLC510004 PD510004 REV NO. DATE REVISION DESCRIPTION BY