Inova SV 125 User manual

OPTIMA GROUP pharma GmbH
Schwaebisch Hall / Germany
Translation of the original operating manual
Operating Manual
Fully Automatic Filling And Closing Machine
For Syringes
SV 125
Customer: AP Pharma Inc., USA
Machine no.: 4016589
Year of manufacture: 2011

OPTIMA GROUP pharma GmbH
Schwaebisch Hall / Germany
O t t o -- H a h n -- S t r a ß e 1
D -- 74523 Schwäbisch Hall
Phone.: [phone]
Fax: [phone]
Internet: www.optima--group--pharma.de
EOPTIMA GROUP pharma 03/2013
This documentation is protected by copyright. All rights reserved. No part of this
documentation may be translated, reproduced, stored in a retrieval system, or
transmitted, in any form or by any means -- graphic, electronic or mechanical, in-
cluding photocopying, recording, taping -- without the prior permission of the pub-
lishers.
The right to make technical modifications is reserved.

SV 125
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Contents
I
Contents
1 Safety regulations 1--1................................
1.1 Duties and liability 1--1............................................
1.1.1 Information and instructions given in the operating manual 1--1.................
1.1.2 Dangers in handling the machine 1--1.......................................
1.1.3 Warranty and liability 1--3.................................................
1.1.4 Behavior for safe operation 1--4............................................
1.1.5 Intended use 1--6........................................................
1.1.6 Incorrect use 1--6........................................................
1.2 Safety devices and protective equipment 1--7......................
1.2.1 Installed devices 1--7.....................................................
1.2.2 Check of safety devices 1--7...............................................
1.2.2.1 POWER supply disconnecting device 1--8........................................
1.2.2.2 Compressed air supply disconnecting device 1--8...................................
1.2.2.3 EMERGENCY STOP buttons 1--8..............................................
1.2.2.4 Guard doors 1--8...........................................................
1.2.3 Danger and information signs 1--9..........................................
1.2.3.1 Examples of danger signs 1--9.................................................
1.3 Duties of the plant operator 1--10...................................
1.3.1 Warranty and liability 1--10.................................................
1.3.2 Organizational requirements 1--10...........................................
1.3.3 Personnel requirements 1--11...............................................
1.4 Information regarding safety at work 1--11..........................
1.4.1 Information regarding operation and work practices 1--11.......................
1.4.2 First aid 1--12............................................................
1.4.2.1 Accident report 1--12.........................................................
1.4.3 Fire prevention 1--12......................................................

Contents
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1.5 Maintenance and servicing 1--13....................................
1.5.1 Constructional changes to the machine 1--14.................................
1.5.2 Cleaning 1--15............................................................
1.5.3 Disposal of the used substances and materials 1--15..........................
1.6 Information regarding electrical energy 1--16........................
1.6.1 Required qualification 1--16.................................................
1.6.2 Measures in the event of faults or defects 1--16...............................
1.6.3 Safety devices 1--16.......................................................
1.6.4 Dangers from electrical power 1--17.........................................
1.7 Residual--current--operated protective devices (RCD) 1--18...........
1.7.1 Mains connection 1--18....................................................
1.8 General information about risks 1--19...............................
1.8.1 Residual risk 1--19........................................................
1.8.2 Dangers from residual energy 1--20.........................................
1.8.3 Informal safety measures 1--20.............................................
1.8.4 Personnel training 1--20....................................................
1.8.5 Safety measures during normal operating mode 1--21..........................
1.8.6 Harmful fumes 1--22.......................................................
1.8.7 Noise emission 1--22......................................................
2 Transport, installation and connection 2--1.............
2.1 Items included in the delivery 2--1.................................
2.2 Transport 2--1....................................................
2.2.1 Type of transport 2--1.....................................................
2.2.2 Preparations for transport 2--2.............................................
2.2.3 Center of gravity mark 2--2................................................
2.2.4 Transport with pallet lifter 2--2.............................................
2.2.5 Transport drawing 2--3....................................................

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2.3 Storage and conservation 2--3.....................................
2.4 Installation and connection 2--4...................................
2.5 Dismantling 2--6..................................................
2.5.1 Scrapping and disposal 2--6...............................................
3 Description of the machine 3--1.......................
3.1 Views of the machine 3--1.........................................
3.2 Workplace 3--2...................................................
3.3 Guard doors 3--3.................................................
3.4 Danger areas 3--4.................................................
3.5 EMERGENCY STOP buttons 3--6...................................
3.6 Interfaces and connections 3--7...................................
3.7 Identification of the machine 3--8..................................
3.7.1 Nameplate 3--8..........................................................
3.8 Technical specifications 3--9......................................
3.8.1 General data 3--9........................................................
3.8.2 Power supply 3--9........................................................
3.8.3 Formats 3--10............................................................
3.8.4 Output 3--10..............................................................
3.8.5 Ambient conditions 3--10...................................................
3.9 Machine accessories 3--11.........................................
4 Structure and function 4--1............................
4.1 General 4--1......................................................
4.1.1 Intended use of the machine 4--1..........................................
4.1.2 Reasonably foreseeable misuse 4--1.......................................
4.1.3 General description 4--2..................................................
4.1.4 Mode of operation 4--3....................................................

Contents
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4.2 Functional description 4--4........................................
4.2.1 Overview 4--4...........................................................
4.2.2 Infeed chute 4--5........................................................
4.2.3 Tub support 4--5........................................................
4.2.4 Transport belt 4--6.......................................................
4.2.5 Nest pick--up station 4--8.................................................
4.2.6 X--Y--table 4--9..........................................................
4.2.7 Nest centering device 4--9................................................
4.2.8 Dosing station 4--10......................................................
4.2.8.1 Functional description rotary piston pump 4--10......................................
4.2.9 Filling station 4--11.......................................................
4.2.10 Filling station with vacuum filling 4--12.......................................
4.2.10.1 Sensor Syringe too high after filling 4--13..........................................
4.2.11 Stopper sorter and stopper lanes 4--14......................................
4.2.11.1 Filling the stopper lanes with stoppers 4--15........................................
4.2.12 Stopper insertion station 4--16..............................................
4.2.12.1 Sensors of the stopper insertion station 4--17.......................................
4.2.13 Vacuum--stopper insertion station 4--18......................................
4.2.13.1 Sensor Syringe too high after stopper insertion. 4--20.................................
4.2.14 Evacuation station 4--21...................................................
4.2.15 Nest insertion position 4--23...............................................
4.2.16 Discharge 4--24..........................................................
4.2.17 Particle counting tube 4--24................................................
4.2.18 Airborne germ collectors 4--25..............................................

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5 Operation 5--1........................................
5.1 Control elements on the operator panel 5--1........................
5.2 Screens 5--3.....................................................
5.2.1 General information 5--3..................................................
5.2.1.1 Changing the values 5--3.....................................................
5.2.2 Start screen 5--4.........................................................
5.2.3 Info OPTIMA GROUP pharma 5--6.........................................
5.2.4 Clean screen 5--7........................................................
5.2.5 Software 5--8............................................................
5.2.6 Log in 5--9..............................................................
5.2.7 Security -- Menu 5--11.....................................................
5.2.8 Security -- Code screen [1/2] 5--12..........................................
5.2.9 Security -- Code screen [2/2] 5--13..........................................
5.2.10 Security -- Code function [1/2] 5--14.........................................
5.2.11 Security -- Code function [2/2] 5--16.........................................
5.2.11.1 Security -- Code [help] 5--18...................................................
5.2.12 Security -- Parameter 5--19.................................................
5.2.13 Security -- User account 5--20..............................................
5.2.14 Security -- User password 5--23.............................................
5.2.14.1 Security -- User account [help] 5--25..............................................
5.2.15 Main screen 1 5--26.......................................................
5.2.16 Main screen 2 5--29.......................................................
5.2.17 Performance [1/2] 5--31....................................................
5.2.18 Performance [2/2] 5--33....................................................
5.2.19 Alarm -- Menu 5--35.......................................................
5.2.20 Alarm -- Active 5--36.......................................................
5.2.21 Alarm -- History 5--38......................................................
5.2.22 Alarm -- Status list 5--40...................................................

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5.2.23 Main -- Menu 5--42........................................................
5.2.24 Counter -- Production 5--44.................................................
5.2.25 Counter -- Total 5--45......................................................
5.2.26 Timer -- Production 5--46...................................................
5.2.27 Timer -- Total 5--47........................................................
5.2.28 Date / Time 5--48.........................................................
5.2.29 Format -- Selection 5--50...................................................
5.2.30 Format selection -- Setting 5--52............................................
5.2.31 Format -- Copy 5--53......................................................
5.2.32 Format input -- Menu 5--55.................................................
5.2.33 Format input -- Format name 5--57..........................................
5.2.34 Format input -- Setting 5--58................................................
5.2.35 Format input -- Performance 5--59...........................................
5.2.36 Format input -- Stations 5--61...............................................
5.2.37 Format input -- Pick--up station [1/2] 5--63....................................
5.2.38 Format input -- Pick--up station [2/2] 5--65....................................
5.2.38.1 Format input -- Pick--up station [help] 5--67.........................................
5.2.38.2 Format input -- Pick--up station [help] 5--68.........................................
5.2.39 Format input -- Piston pumps [1/3] 5--69......................................
5.2.40 Format input -- Piston pumps [2/3] 5--71......................................
5.2.41 Format input -- Piston pumps [help] 5--74.....................................
5.2.42 Format input -- Piston pumps [3/3] 5--75......................................
5.2.43 Format input -- Filling curve (piston pumps) [1/2] 5--77.........................
5.2.44 Format input -- Filling curve (piston pumps) [2/2] 5--79.........................
5.2.44.1 Adjusting the needle stroke 5--83................................................
5.2.44.2 Format input -- Filling curve (piston pumps) [help] 5--84................................
5.2.44.3 Format input -- Filling curve (pump stroke > 1) [help] 5--85..............................
5.2.44.4 Example: Entry of step points 5--86..............................................

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5.2.45 Format input -- Filling curve vacuum (piston pumps) [1/4] 5--89..................
5.2.46 Format input -- Filling curve vacuum (piston pumps) [2/4] 5--91..................
5.2.46.1 Example: Entry of step points 5--95..............................................
5.2.46.2 Adjusting the needle stroke 5--97................................................
5.2.47 Format input -- Filling curve vacuum (piston pumps) [3/4] 5--98..................
5.2.47.1 Format input -- Filling curve vacuum (piston pumps) [help] 5--101..........................
5.2.47.2 Format input -- Filling curve vacuum (pump stroke > 1) [help] 5--102........................
5.2.48 Format input -- Filling curve vacuum (piston pumps) [4/4] 5--103..................
5.2.49 Format input -- Stopper setting normal [1/3] 5--106..............................
5.2.50 Format input -- Stopper setting normal [2/3] 5--108..............................
5.2.51 Format input -- Stopper setting normal [3/3] 5--111..............................
5.2.51.1 Format input -- Stopper setting [help] 5--113.........................................
5.2.52 Format input -- Stopper setting vacuum [1/3] 5--114.............................
5.2.53 Format input -- Stopper setting vacuum [2/3] 5--116.............................
5.2.53.1 Format input -- Stopper setting vacuum [help] 5--119...................................
5.2.54 Format input -- Stopper setting vacuum [3/3] 5--120.............................
5.2.54.1 Format input -- Stopper setting vacuum [help] 5--123...................................
5.2.55 Format input -- Tub transfer [1/4] 5--124.......................................
5.2.55.1 Format input -- Tub transfer [help] 5--127...........................................
5.2.56 Format input -- Tub transfer [2/4] 5--128.......................................
5.2.56.1 Format input -- Tub transfer [help] 5--130...........................................
5.2.57 Format input -- Tub transfer [3/4] 5--131.......................................
5.2.58 Format input -- Tub transfer [4/4] 5--133.......................................
5.2.59 Format input -- Main drive (virtual) 5--135......................................
5.2.60 Format input -- Menu teach servo axes 5--137..................................
5.2.61 Format input -- Teach servo axis pick--up station nest 5--139.....................
5.2.61.1 Teach--in servo axis 5--140.....................................................
5.2.62 Format input -- Teach servo axis plunger 5--142................................
5.2.62.1 Teach--in servo axis 5--143.....................................................

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5.2.63 Format input -- Teach servo axis insertion tube 5--145...........................
5.2.63.1 Teach--in servo axis 5--146.....................................................
5.2.64 Format input -- Teach servo axis stopper swivel arm 5--148......................
5.2.64.1 Teach--in servo axis 5--149.....................................................
5.2.65 Format input -- Teach vacuum chamber 5--151.................................
5.2.66 Format input -- Teach servo axis needle stroke 5--152...........................
5.2.66.1 Teach--in servo axis 5--153.....................................................
5.2.67 Format input -- Teach servo axis pump stroke 5--155............................
5.2.67.1 Teach--in servo axis 5--156.....................................................
5.2.68 Format input -- Teach servo axis pump rotation 5--158...........................
5.2.68.1 Teach--in servo axis 5--159.....................................................
5.2.69 Format input -- Teach servo axis X 5--161.....................................
5.2.69.1 Teach--in servo axis 5--162.....................................................
5.2.70 Format input -- Teach servo axis Y 5--164.....................................
5.2.70.1 Teach--in servo axis 5--165.....................................................
5.2.71 Format input -- Alarm active 5--167...........................................
5.2.72 Service -- Menu 5--169......................................................
5.2.73 Service -- General 5--170....................................................
5.2.74 Service -- Axis 5--173.......................................................
5.2.75 Service -- Vacuum 5--175....................................................
5.2.76 Operator -- Menu 5--177.....................................................
5.2.77 Operator -- General 5--178..................................................
5.2.78 Operator -- Piston pumps 5--180.............................................
5.2.79 Information -- Menu 5--182..................................................
5.2.80 Information -- Code nest [1/2] 5--183..........................................
5.2.81 Information -- Tub error code general 5--185...................................
5.2.82 Information -- Tub error code needle stroke 5--186..............................
5.2.83 Information -- Tub error code plunger 5--187...................................

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5.2.84 Information -- Tub error code insertion tube 5--188..............................
5.2.85 Information -- Tub error code piston pumps 5--189..............................
5.2.86 Information -- Code nest [2/2] 5--190..........................................
5.2.87 Information -- Code nest Pick--up station nest 5--191............................
5.2.88 Information -- Code nest Y--Axis 5--192........................................
5.2.89 Information -- Interlock infeed 5--193..........................................
5.2.90 Information -- Piston pumps [1/2] 5--194.......................................
5.2.91 Information -- Piston pumps [2/2] 5--196.......................................
5.2.92 Information -- Vacuum [1/2] 5--197............................................
5.2.93 Information -- Vacuum [2/2] 5--199............................................
5.2.94 Information -- Axis position actual and homestatus 5--200........................
5.2.95 Batch 5--202..............................................................
5.2.96 System -- Password 5--203..................................................
5.3 Control and display elements on the machine 5--204..................
5.3.1 Overview 5--204...........................................................
5.3.2 Jog cable and jog button 5--205.............................................
5.3.3 Air maintenance unit 5--206.................................................
5.3.4 Compressed air supply disconnecting device 5--207............................
5.3.5 Adjustment of vacuum tanks 5--208..........................................
5.3.6 Pressure reducer -- Ventilation vacuum chamber 5--209.........................
5.3.7 Pressure reducer -- shut--off needles 5--209...................................
5.3.8 Control elements on the control cabinet 5--210................................
6 Machine startup / stop 6--1............................
6.1 Machine startup 6--1..............................................
6.1.1 Preparing machine for operation 6--1.......................................
6.1.2 Switching machine on after EMERGENCY STOP 6--2........................

Contents
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6.2 Operating modes 6--3.............................................
6.2.1 Setup mode 6--3.........................................................
6.2.2 Automatic mode 6--4.....................................................
6.2.3 Permanent run mode 6--5.................................................
6.2.4 Emptying mode 6--6......................................................
6.2.5 Standby mode 6--6.......................................................
6.2.6 Priming 6--7.............................................................
6.2.6.1 Priming in Automatic mode 6--7................................................
6.2.6.2 Priming in Setup mode 6--8...................................................
6.3 Machine stop 6--9................................................
6.3.1 Normal operation 6--9....................................................
6.3.2 Aborting the production process 6--9........................................
6.3.3 Transport out nest 6--9...................................................
6.3.4 Emptying mode 6--10......................................................
6.3.5 EMERGENCY STOP 6--11.................................................
6.4 Monitoring operation 6--12.........................................
7 Format change 7--1...................................
7.1 Mechanical format change 7--3....................................
7.1.1 Overview 7--3...........................................................
7.1.2 Dismounting the size parts 7--4............................................
7.1.2.1 Filling needles -- (size part 22) 7--4.............................................
7.1.2.2 Drive head with shut--off needles -- (size part 24) 7--5................................
7.1.2.3 Sorting bowl -- (size part 7) 7--7................................................
7.1.2.4 Stopper lanes -- (size part 8, 9) 7--8.............................................
7.1.2.5 Stopper turning device -- (size part 11) 7--9.......................................
7.1.2.6 Stopper holder -- (size part 10) 7--9.............................................
7.1.2.7 Stopper transfer bar -- (size part 10.2) 7--10........................................

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7.1.2.8 Insertion rod holder stoppers -- (size part 14) 7--10...................................
7.1.2.9 Filling needle holder filling -- (size part 21) 7--11.....................................
7.1.2.10 Filling needle holder vacuum filling -- (size part 24) 7--11...............................
7.1.2.11 Vacuum chamber vacuum filling -- (size part 16) 7--12.................................
7.1.2.12 Hold--down device syringes -- (size part 20) 7--13....................................
7.1.2.13 Insertion tube holder -- (size part 12) 7--13.........................................
7.1.2.14 Insertion tube holder vacuum stopper insertion -- (size part 19) 7--14......................
7.1.2.15 Centering plate -- (size part 6) 7--15.............................................
7.1.2.16 Tub stopper -- (size part 1, 2, 3) 7--15............................................
7.1.2.17 Suction frame nest pick--up station -- (size part 5, 5.1) 7--16............................
7.1.3 Mounting the new size parts 7--17...........................................
7.1.4 Format settings 7--18......................................................
7.1.4.1 Overview 7--18.............................................................
7.1.4.2 Height adjustment for hold--down device 7--19......................................
7.1.4.3 Height adjustment side guide 7--20..............................................
7.1.4.4 Installation template side guide 7--21............................................
7.1.4.5 Adjustment vacuum tanks (filling and stopper insertion) 7--22...........................
7.2 Electronic format change 7--23.....................................
8 Troubleshooting 8--1.................................
8.1 General 8--1......................................................
8.1.1 Elimination of faults 8--1..................................................
8.2 Machine reaction in case of fault 8--2..............................
8.2.1 Object shortage 8--3......................................................
8.2.2 Power failure 8--3........................................................
8.2.3 EMERGENCY STOP 8--3.................................................
8.2.4 Drop of compressed air 8--3...............................................
8.3 Alarms 8--4......................................................

Contents
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9 Cleaning and maintenance 9--1........................
9.1 Cleaning 9--1.....................................................
9.1.1 General 9--1.............................................................
9.1.2 Instructions for cleaning 9--2...............................................
9.1.3 Daily cleaning 9--2.......................................................
9.2 Cleaning dosing pump and filling needle 9--3.......................
9.2.1 Dismounting the dosing pumps 9--3........................................
9.2.2 Disassembling a dosing pump 9--4.........................................
9.2.3 Assembling a dosing pump 9--5............................................
9.2.4 Mounting the dosing pumps 9--8...........................................
9.2.5 Cleaning the filling needle 9--9.............................................
9.2.6 Priming 9--10.............................................................
9.2.6.1 Priming in Automatic mode 9--10................................................
9.2.6.2 Priming in Setup mode 9--11...................................................
9.3 Maintenance and care 9--12........................................
9.3.1 General 9--12.............................................................
9.3.2 Instructions for procedure 9--13.............................................
9.4 Lubrication plan 9--14..............................................
9.4.1 Overview of maintenance points 9--15.......................................
9.4.2 Maintenance plan interval 8 operating hours 9--16.............................
9.4.2.1 Check compressed air supply 9--16..............................................
9.4.3 Maintenance plan interval 40 operating hours 9--17............................
9.4.3.1 Compressed air supply drain condensate 9--17......................................
9.4.4 Maintenance plan interval 500 operating hours 9--18...........................
9.4.4.1 Grease gear wheels 9--18.....................................................
9.4.4.2 Grease guides 9--19.........................................................
9.4.4.3 Check toothed belts 9--20.....................................................

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9.4.5 Maintenance plan interval 1000 operating hours 9--21..........................
9.4.5.1 Lubricate pump drive 9--21....................................................
9.4.6 Maintenance plan interval ”As required” 9--22.................................
9.4.6.1 Nest pick--up station -- replace vacuum cups 9--22...................................
9.4.6.2 Replace battery Panel view 9--25...............................................
10 Appendix 10--1........................................

Contents
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Notes
Version 1.0
Page 1
Notes
This operating manual is designed to familiarize the operator with
Sthe mode of function
Sthe operation
Sthe safety instructions and
Sthe maintenance
of the machine.
Storage
Keep the operating manual next to the machine at all times!
The manual must be ready to hand at all times!
Danger symbols
Symbols identify safety instructions in the operating manual. They indicate special
dangers for persons, property or environment. Please observe these instructions.
Pass on all safety instructions to other users. The danger symbols that are used
in this operating manual are listed in chapter 1.1.4, page 1--4.
General danger Electrical
voltage / current
Crushing-hand
Examples of danger symbols

Notes
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Version 1.0
Page 2
Danger classes
The table below indicates the symbols and signal words as well as the dangers and
possible effects to which they refer.
Symbol Signal word Signal color Definition Effects
DANGER! Red Imminent danger Death or severe in-
jury
WARNING! Orange Potentially dange-
rous situation
Potential death or
severe injury
CAUTION! Amber Potentially dange-
rous situation
Slight or minor injury.
Material damage to
the machine.
Information symbols
Symbol Signal word Signal color Definition
NOTE Blue User tips and other important/useful in-
formation and instructions.
1
Next to this symbol you will find an action sequence, the order of which must
be maintained without fail.
1 Numbers next to photos and drawings refer to machine assemblies and ma-
chine components mentioned in the text. These are identified by the number
in brackets (1).
A Letters next to photos and drawings refer to machine assemblies and ma-
chine components mentioned in the text. These are identified by the letter in
brackets (A).
SEnumeration symbol.

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Notes
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Explanation of terms
Te r m Explanation
Safety
devices
Devices that indirectly protect from danger areas (e.g. light grids,
door contact switches).
Protection
devices
Devices that protect from intervention into the danger areas (e.g.
guard doors, casings).
Protective
measures
Measures that must be applied for the protection of persons,
equipment or environment.
Machine In this operating manual the term machine is identical with plant
(several machines/stations that are combined to one function unit).
Plant operator Liable person or organisation responsible for machine operation.
Operator,
operating
personnel
Persons who operate the machine or perform operations on the
machine.
Manufacturer Liable person or organisation responsible for the manufacture of
the machine.
Supplier Liable person or organisation selling or distributing the machine or
placing it on the market.
Intended use Permissible application area or permissible use of the machine.

Notes
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Page 4