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
4016589
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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4016589
II
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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4016589
Contents
III
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
SV 125
4016589
IV
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..............................................

SV 125
4016589
Contents
V
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...................................................

Contents
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VI
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..............................................

SV 125
4016589
Contents
VII
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.....................................................

Contents
SV 125
4016589
VIII
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...................................