ROTARY WASHING MACHINE MECHANICAL & MAINTENANCE MANUAL

ROTARY WASHING MACHINE MECHANICAL & MAINTENANCE MANUAL MACHINE TYPE: MACHINE MODEL: SERIAL NO. RA-V4 15499LV YEAR: 2016 CUSTOMER: Intarcia - USA - STERILINE S.R.L. Via Tentorio 30, 22100 -COMO- ITALY Ph. +39.031592064

Index 1 PERFORMANCES... 7 2 INSTALLATION... 8 2.1 INSPECTION AT RECEIPT... 8 2.1.1 Technical data... 8 2.1.2 Dimensions... 8 2.2 INTERNAL TRANSPORT... 9 2.2.1 Crated machine... 10 2.2.2 Uncrated machine... 10 2.3 REMOVE PACKAGING... 11 2.3.1 Pallet... 11 2.3.2 Box or crate... 11 2.4 STORAGE... 12 2.4.1 Environment... 12 2.4.2 Loads... 12 2.4.3 Change Parts... 12 2.5 POSITIONING... 13 2.6 CONNECTIONS... 14 2.6.1 Utilities Connections... 14 2.6.2 Electrical connection... 14 2.7 STEP CONTROL... 15 2.8 START UP... 15 3 MODEL RA-V4... 16 3.1 WASHER DESCRIPTION... 16 3.2 WASHING CYCLE... 17 3.2.1 Pre-flushing... 18 3.3 WASHING STATIONS... 18 3.3.1 Compressed air station... 18 3.3.2 WFI station... 18 3.4 PROTECTION HOOD... 19 3.4.1 Draining... 19 3.4.2 Drying... 19 4 FORMAT CHANGE... 20 4.1 FORMAT CHANGE PARTS... 21 4.1.1 Infeed guides... 22 4.1.2 Loading cylinder contrast... 23 4.1.3 Loading cylinder guide... 24 4.1.4 Loading position guide... 25 4.1.5 Pincers jaws... 26 4.1.6 Unloading station guides... 27 4.1.7 Outfeed guides... 28 4.1.8 Needles... 29 4.2 ADJUSTABLE PARTS... 30 4.2.1 Infeed minimum load... 31 4.2.2 Inlet lifting side guide cylinder... 32 RA-V4 1.0 (23.01.2017) MECHANICAL MAINTENANCE MANUAL Pg.3

4.2.3 External water spraying nozzles station 3... 33 4.2.4 External air blowing nozzles station 7... 34 4.2.5 Tower/Needles Height... 35 5 GENERAL INSTRUCTION... 36 5.1 USE OF DETERGENTS HAZARDOUS TO HEALTH... 36 5.2 CLEANING PRIOR TO START-UP... 36 5.3 SIZE CHANGE PARTS CLEANING... 37 5.4 GENERAL... 38 5.5 DISPOSAL... 39 5.5.1 Batteries... 39 5.5.2 Lubricants... 39 5.6 INSTRUCTIONS FOR USE OF LUBRICANTS... 40 5.6.1 Contact with skin... 40 5.6.2 Disposal... 40 5.7 VALVES ASSEMBLING - SMC VALVES... 41 5.8 GENERAL LUBRICATION INSTRUCTIONS... 42 6 RECOMMENDED LUBRICANTS... 43 6.1 IN GENERAL... 43 6.2 INSTALLED AGGREGATES OF OTHER MANUFACTURERS... 43 6.3 LUBRICATING STUFF LIST... 44 6.3.1 Oil Lubrication... 44 6.3.2 Grease Lubrication... 44 7 INSPECTION... 45 7.1 INSPECTION SCHEDULE... 45 7.2 INSPECTION PLAN... 45 7.2.1 Pneumatic cylinder... 47 7.2.2 Pneumatic valves... 48 7.2.3 Gear... 49 7.2.4 Chain... 50 7.2.5 Chain wheel... 51 7.2.6 Chain joint... 52 7.2.7 Ball bearing... 53 7.2.8 Pillow block... 54 7.2.9 Motors... 55 7.2.10 Conveyor belt... 56 7.2.11 EMERGENCY STOP Device... 57 8 MAINTENANCE... 58 8.1 MAINTENANCE INTERVAL... 58 8.1.1 Daily... 58 8.1.2 Weekly... 59 8.1.3 Monthly... 60 8.1.4 Quarterly... 61 8.1.5 Half-yearly... 62 8.1.6 Other Maintenance Hints... 63 9 SPARE PARTS... 65 9.1 COMMERCIAL COMPONENTS SPARE PARTS... 65 Pg.4 1.0 (23.01.2017) RA-V4

9.2 MECHANICAL COMPONENTS SPARE PARTS... 65 9.2.1 Infeed guide... 66 9.2.2 Loading cylinder contrast... 67 9.2.3 Loading cylinder guide... 68 9.2.4 Loading position guide... 69 9.2.5 Pincers... 70 9.2.6 Unloading station guides... 71 9.2.7 Outfeed guides... 72 9.2.8 Washing station... 73 9.2.8.1 Needles distributor... 73 9.2.8.2 Needles... 74 9.2.8.3 External nozzles... 75 9.2.9 Drying station... 76 9.3 INDICATION FOR ORDER... 77 10 ATTACHMENTS... 78 RA-V4 1.0 (23.01.2017) Pg.5

1 PERFORMANCES The Rotary Washing Machine model RA-V4 is designed to handle glass vials having the following dimensions: Container type Diameter [mm] Height [mm] Output [v/h] Format Mark 15ml 26,75 57,00 1500 F0 The washer has pincers to treat vials. The number of pincers is 8 and the number of vials per pincers is 3. The processing parameters for each washing cycle are included in the recipes parameters setting. RA-V4 1.0 (23.01.2017) Pg.7

2 INSTALLATION 2.1 INSPECTION AT RECEIPT Inspect the machine immediately after unloading. All damages and contamination, caused during transport, must be reported to the forwarding company, and must be stated in the forwarding papers as well. In case of shipment in a wooden box, all damages to the box must also be stated in the forwarding papers. IMPORTANT All damages should be reported to Steriline S.r.l. within 5 working days after receipt. Describe damages as accurately as possible. By means of the forwarding documents, check the presence of all parts. In the event that anything is missing, report this to Steriline S.r.l. within 5 working days after receipt. 2.1.1 Technical data Also see Control System Manual (Ref. 15499QE3MA01). 2.1.2 Dimensions Length mm 1656 Width mm 976 Height mm 2203 Production level mm 900±25 Weight approx. Kg 600 (See Layout Ref. 15499LVLY01) Pg.8 1.0 (23.01.2017) RA-V4

2.2 INTERNAL TRANSPORT Internal transport is best left to a specialized company for internal machine transport. Read carefully the instructions and the signs on the equipment shipping box/crate. (NOTE: Do not expose the equipment to significant shocks or vibrations.) CENTER OF BALANCE FRAGILE KEEP DRY OFF BALANCE SLING HERE THIS END UP DO NOT USE HOOK RA-V4 1.0 (23.01.2017) Pg.9

2.2.1 Crated machine Using a fork lift, raise the box/crate and slide it on the forks until it stops against the lift s vertical guide for stability; and then transport the equipment on an even floor without any pits or holes. 2.2.2 Uncrated machine Using a fork lift, raise the machine as little as possible and tilt the forklift beam to support the machine against it. Secure the machine against the forklift beam by means of a safety strap for safe transport. Pg.10 1.0 (23.01.2017) RA-V4

2.3 REMOVE PACKAGING 2.3.1 Pallet Keep the machine attached to its shipping pallet until it is placed at its final location. Before removing the pallet, locate the machine as close as possible to its final location; then lift the machine from the pallet using a fork-lift truck as described in section 2.3.2. 2.3.2 Box or crate Keep the box or crate closed during storage to avoid damage or loss of enclosed machine parts. Remove the box/crate only after it has been placed at its final location. Using a crowbar, remove the box panels that are nailed in place. Use a 10 mm wrench to remove the box panels that are bolted together. After uncrating the equipment, compare the actual contents of the box with the packing list or forwarding documents. RA-V4 1.0 (23.01.2017) Pg.11

2.4 STORAGE 2.4.1 Environment Machines, shipped on a pallet or crate, should be stored in a dry (relative humidity maximum 80%) and dust-free place, free of condensation of which the minimum temperature will never get below 10 C to avoid condense in e.g. control cabinets; the maximum temperature may not exceed 40 C. The storage room should also be free of vermin. Machines, shipped in seaworthy packaging, should be stored in a dry (unheated) place since protection against condense was provided during packaging. When machines must be kept in store unexpectedly for a longer period of time, consult Steriline s.r.l. for specific measures. 2.4.2 Loads Packed equipment may not be stacked. Take notice of the signs on the packing. 2.4.3 Change Parts Store in a dry (relative humidity maximum 80%) and dust-free environment, free of condensation; maximum temperature 40 C. The storage room should also be free of vermin. Store a complete set of change parts according to machine number and vial type. Pg.12 1.0 (23.01.2017) RA-V4

2.5 POSITIONING For exact location of the utilities and machine dimension refer to the layout drawing (15499LVLY01). Before installing the machine, ensure that the following actions have been carried out: - unpack the machine and all the separately packed components - make the floor free of all objects in the area where the machine must be placed - clean the floor - check if every necessary utility is available. Adjust the height of the machine by rotating the shafts of the feet. By means of a spirit level on the frame, check that the machine is in plane. Important Verify that each feet supports the frame of the machine! Important Verify by means of a spirit level that the machine is positioned horizontally! RA-V4 1.0 (23.01.2017) Pg.13

2.6 CONNECTIONS 2.6.1 Utilities Connections In the positions indicated in the Layout Drawing (Rif. 15499LVLY01), the following utilities have to be connected: W.F.I. Pipe in ¾ Tri Clamp COMPRESSED AIR Pipe in ¾ Tri Clamp WATER DRAIN Water process drain in 1 Tri Clamp EXHAUST AIR Duct external size mm 140x140 2.6.2 Electrical connection The electric connection is made between the electrical cabinet and the electrical box on the side of the machine. For detailed information refer to the Control System Manual 15499QE3MA01. Pg.14 1.0 (23.01.2017) RA-V4

2.7 STEP CONTROL Preset the washing machine to the vial type to perform and select set-up mode on the HMI (Human Machine Interface). Insert the jog button in the relative socket on the control panel. Feed the glassware on the rotating table and by operating the machine with the jog button, control the following items: When the inlet pincer is in position and opened, the infeed belt starts to load the glassware on the inlet pincer. The pincer closes and the washer starts. There are eight stations and the washer drive is based on an intermittent motion. Each station takes up three glassware per index. The pincers close around the body of the glassware. Glassware is transported to the different washing stations by the pincers. While the washer is moving, the glassware passes through the washing and drying stations in an upside and down position. The injection of compressed air, W.F.I. into the glassware is carried out when the needles are in the raised position. After washing, the glassware is up-righted and directly discharged onto the depyrogenation tunnel conveyor belt by a pneumatic cylinder. The vials pass through the tunnel inlet chamber then enter the sterilizing chamber, where the depyrogenating process takes place. The vials never stop moving and then enter the cooling chamber to cool down to a suitable temperature before discharge. All the safeties operate correctly. 2.8 START UP Before starting the first setting up of the machine, control the following items: all the utilities are correctly connected and the fluids pressures are correctly set the filters are correctly installed run the machine with the washing cycle operating RA-V4 1.0 (23.01.2017) Pg.15

3 MODEL RA-V4 The RA-V4 washing machine is designed to perform the chemical, particulate and bacteriological cleaning of glass vials by means of series of injections of water for injection (W.F.I.) and compressed air (C.A.) on the internal and external surfaces of the vials. The tags numbers listed in the below sections refer to the P&ID (Piping and Instruments Diagram) document no.15499lvpi01. 3.1 WASHER DESCRIPTION When the automatic start cycle has been started and the green button on the operator panel blinks, the operator loads the vials on the motorized rotating table M20. The rotating table transports the glassware toward the motorized infeed belt M1 which brings the glassware to the loading system. The sensor ZS02 stops the machine in case of minimum load on the rotating table. The vials loading cylinder ZA15 (KJ15B and KJ15F actuated) guides the glassware toward the pincer. The inlet side guide cylinder ZA9 (KJ09B and KJ09F actuated) lifts the inlet side guide to keep the glassware in position avoiding that glassware falls down. The pincers are opened and load the glassware. If during these operations the synchronism of the vials loading cylinder, the inlet side guide and the pincers with the glassware is wrong, the safety sensors ZS15B (Vials loading cylinder backward sensor) or ZS09B (Inlet lifting side guide cylinder backward sensor) stops the machine with alarm. The glassware are load in the pincers in row of 3 vials. The glassware are rotating by the movement of the pincers. The vials are turned upside down and proceed into the washing and drying stations. After the glassware is loaded, the washer is moved in a stepwise motion by the M3 main servo drive motor. The main servo drive motor stops when a maximum torque condition takes place and stops the machine with alarm. During the washing the glassware is positioned by the pincers over the internal spraying needles and under the external blowing nozzles. The movement of the pincers is controlled by these cylinders: - ZA1 (KJ01O/C open/close actuated and KJ01L/R left/right actuated), - ZA2 (KJ02O/C open/close actuated and KJ02L/R left/right actuated), - ZA3 (KJ03O/C open/close actuated and KJ03L/R left/right actuated), - ZA4 (KJ04O/C open/close actuated and KJ04L/R left/right actuated), - ZA5 (KJ05O/C open/close actuated and KJ05L/R left/right actuated), - ZA6 (KJ06O/C open/close actuated and KJ06L/R left/right actuated), - ZA7 (KJ07O/C open/close actuated and KJ07L/R left/right actuated), - ZA8 (KJ08O/C open/close actuated and KJ08L/R left/right actuated). When the glassware is in position the needles are lifted by the ZA14 cylinder (KJ14B and KJ14F actuated), penetrate the glassware and spray the fluids for the set time. If there is something wrong with the movement of the lifting cylinder, it is detected by the ZS14B sensor, an alarm is activated and the machine stops. Pg.16 1.0 (23.01.2017) RA-V4

During the operation, while the control valves are open, the PLC checks the pressure of fluids before the needles. If the pressure is below the limit the machine stops with alarm. Once the operator has removed the cause, the operation may continue. (See also Operation Manual) During the washing process, if the operator opens a washer door the machine stops with alarm by means of the proximity switch ZS10A and ZS10B. The process parameters are defined for all of the glassware formats foreseen in the contract. They are saved in the PLC recipes and listed in the Recipes parameters setting tables (Ref.15499QE3SP27 attached to the Operation ). After washing and drying, the glassware are up-righted and directly discharged onto the tunnel conveyor belt. The glassware keeps its position by means of the exit lifting side guide, which is moved by cylinder ZA11 (KJ09B and KJ09F actuated) and the vials unloading cylinder ZA12 (KJ12B and KJ12F actuated) helps the discharge of the glassware to the tunnel conveyor belt. If there is an obstruction in the cylinders motion, the safety sensors ZS11B (Outfeed lifting side guide cylinder backward sensor) and ZS12B/F (Vials unloading cylinder backward/forward sensors) stop the machine with alarm. 3.2 WASHING CYCLE In the next chapters the process fluids will be abbreviated as follow: - C.A. (Compressed Air) - W.F.I. (Water for Injection) The washing cycle is designed as following: Station 1: Station 2: Station 3: Station 4: Station 5: Station 6: Station 7: Station 8: Loading of glassware on the pincers Injection of W.F.I. Injection of C.A. / Spraying of W.F.I. over the vials Injection of W.F.I. Injection of C.A. Injection of W.F.I. Injection of C.A. / Blowing of C.A. over the vials Unloading of vials from the pincers RA-V4 1.0 (23.01.2017) Pg.17

3.2.1 Pre-flushing The washer pre-flushing consists of water spraying in the fluids piping lasting a set time. This function automatically starts when the production starts and after a machine stop. When the machine stops, a countdown set time begins. If the countdown ends, the pre-flushing is automatically activated when the user re-starts the machine. 3.3 WASHING STATIONS The vials are washed by special needles, which are designed to prevent clog during operation and not stagnant water, to be dismantled, easily installed and ready for maintenance. 3.3.1 Compressed air station Dry (oil free) compressed air is used to dry the glassware. The blowing time is a settable data and can vary according to the vials size. The Compressed Air station consists of a pipeline on which are fitted: - Process C.A. pressure reducer PJ40 with manometer PI40-4 hydrophobic OPTICAP capsule 0.22 micron filtration capacity DF40 - Membrane valve for the internal air blowing control KV40 (KJ40 actuated) - Pressure transmitter for internal air flow control PT40 - Membrane valve for the external air blowing control KV41 (KJ41 actuated) - Service C.A. pressure reducer PJ42 with manometer PI42 - Service compressed air switch PSL42 - Pressure reducer for open/close pincers actuators PJ43 with manometer PI43 - Pressure reducer for left/right pincers actuators PJ44 with manometer PI44 Pipe fittings are tri-clamp type. 3.3.2 WFI station New water is used in the rinsing/washing steps: this water is collected in basins under the needles and sent to the drain. The spraying time is a settable data and can vary according to the vials size. The WFI station consists of a pipeline on which are fitted: - Pneumatic membrane valve for internal water spraying control KV50 (KJ50 actuated) - Pressure transmitter for internal water spraying flow control PT55 - Pneumatic membrane valve KVA50 (KJA50 actuated) for drying the pipes - W.F.I. sampling valve KVD50 Pipe fittings are tri-clamp type and designed respecting the 3D rule. Pg.18 1.0 (23.01.2017) RA-V4

3.4 PROTECTION HOOD The washer protection hood, made of transparent polycarbonate, separates the wet process area of the machine from the environment. At the washer outfeed the hood is connected to the Depyrogenating tunnel. The transfer line is completely encased and protected by the air backflow from the tunnel. On the doors, safety switches (ZS10A and ZS10B) are installed to stop the machine in case of door/cover opening. Over the room ceiling the exhaust fan V1 with motor MV1 are installed in order to exhaust the vapors during operation. On the washer a duct connection is foreseen. A low basin is installed on the machine to avoid that the condensed water coming from the duct flows back into the process area. 3.4.1 Draining To avoid water to remain for a long time in the idle machine, the draining is carried out at the end of the production. Membrane valves are installed on the RW pipelines to empty them (refer above to valves listed as KVDnn. The valves are automatically actuated (KJDnn). 3.4.2 Drying Membrane valves feed compressed sterile air into the RW and WFI pipelines in order to dry them (refer above to valves listed as KVAnn. The valves are automatically actuated (KJAnn). RA-V4 1.0 (23.01.2017) Pg.19

4 FORMAT CHANGE The washing machine is set to operate the following vials: GLASSWARE Container type 15ml Format Mark F0 NO FORMAT CHANGE PARTS ARE FORESEEN Important FOR THIS MACHINE. In case of future implementation of different vial sizes, the Format Change Parts listed in chapter 4.1 must be Important equipped and the Washer Adjustable Parts listed in chapter 4.2 must be regulated accordingly. Pg.20 1.0 (23.01.2017) RA-V4

4.1 FORMAT CHANGE PARTS To perform the different vials sizes, the machine has to be equipped with different size changes parts. The parts to be changed are: Infeed guides Loading cylinder contrast Loading cylinder guide Loading station guide Pincers jaws Unloading station guide Outfeed guides All size change parts are marked to be identified. For the Mechanical size change refer to the Size Change Table (ref. 15499LVSP19). RA-V4 1.0 (23.01.2017) Pg.21

4.1.1 Infeed guides The rotating table, located on the left side of the washer, drives the vials on the infeed belt and the washer loading cylinder in a continuous motion. The infeed guide drives the vials one by one towards the washer loading station and it is univocally marked with the vials format to be identified. The picture below shows where the operator has to unscrew and fasten the handles to replace the infeed guide: Pg.22 1.0 (23.01.2017) RA-V4

4.1.2 Loading cylinder contrast The loading cylinder is univocally marked with the vials format to be identified. The picture below shows where the operator has to unscrew and fasten the handles to remove the loading cylinder contrast: RA-V4 1.0 (23.01.2017) Pg.23

4.1.3 Loading cylinder guide The loading cylinder guide is univocally marked with the vials format to be identified. The picture below shows where the operator has to unscrew and fasten the handles to remove the loading cylinder guide: Pg.24 1.0 (23.01.2017) RA-V4

4.1.4 Loading position guide The loading position guide is univocally marked with the vials format to be identified. The picture below shows the guide to be raised to remove it from its position: RA-V4 1.0 (23.01.2017) Pg.25

4.1.5 Pincers jaws The pincers jaws are moved by the pincers and they grip four of two vials and keep it till the vials are discharged onto the tunnel conveyor belt. The pincers jaws are identified with the vials format name. The picture below shows where the operator has to unscrew and fasten the handles to remove the pincers jaws: Pg.26 1.0 (23.01.2017) RA-V4

4.1.6 Unloading station guides At the washer unloading station, two guides keep the glassware in the correct position avoiding glassware falling: - a lifting guide, raised/lowered by a cylinder, - a fixed guide. Both guides have to be changed according to the glassware size to be performed. The picture below shows the guides, raise the guides to remove them from their position: RA-V4 1.0 (23.01.2017) Pg.27

4.1.7 Outfeed guides The left and right guides drive the vials through tunnel conveyor belt. The pictures below show where the operator has to unscrew and fasten the handles to replace the outfeed guides: Pg.28 1.0 (23.01.2017) RA-V4

4.1.8 Needles The needles have to be replaced according to the vials size and they are identified with the vials format name. The needles are identified with the vials format name. The refer for the needles position is the grain: The picture below shows where the operator has to unscrew and fasten the handles to remove the needles: RA-V4 1.0 (23.01.2017) Pg.29

4.2 ADJUSTABLE PARTS On the washing machine the parts to be adjusted are: Infeed minimum load photocell Inlet lifting side guide cylinder External water spraying nozzles External air blowing nozzles Tower/Needles height Pg.30 1.0 (23.01.2017) RA-V4

4.2.1 Infeed minimum load At the machine infeed, the minimum load photocell has to be ly adjusted. To adjust the photocell position the operator has to unscrew and fasten the handles indicated in the following picture. RA-V4 1.0 (23.01.2017) Pg.31

4.2.2 Inlet lifting side guide cylinder The inlet lifting side guide keeps the vials the correct position till they are kept by the pincer avoiding vials falling. The cylinder position has to be adjusted according to the vials size to be performed. The picture below shows where the operator has to unscrew and fasten the handles to adjust the bar position or to remove the bars: Pg.32 1.0 (23.01.2017) RA-V4

4.2.3 External water spraying nozzles station 3 The external spraying water nozzles position has to be changed according to the glassware size to improve the external vials washing. The picture below shows where the operator has to unscrew and fasten the handles to adjust the external spraying water nozzles position: RA-V4 1.0 (23.01.2017) Pg.33

4.2.4 External air blowing nozzles station 7 The external air blowing nozzles position has to be adjusted according to the different glassware size to improve the vials drying. For external blowing air nozzles height refer to the Size Change Table (Document no. 15499LVSP19). The picture below shows where the operator has to unscrew and fasten the handles to adjust the external blowing air nozzles position: Pg.34 1.0 (23.01.2017) RA-V4

4.2.5 Tower/Needles Height On the bottom side of the washer there are two hand wheel used to adjust the height of tower and needles height. The correct value for the vials performed are stored in the respective recipe (Ref to the Size Change Table 15499LVSP19). The picture below shows where the operator has to work to modify the turret and needles height: RA-V4 1.0 (23.01.2017) Pg.35

5 GENERAL INSTRUCTION 5.1 USE OF DETERGENTS HAZARDOUS TO HEALTH When using detergents hazardous to health: - Wear the corresponding personal safety equipment - Do not store or take any food in the vicinity of the plant - Do not smoke 5.2 CLEANING PRIOR TO START-UP Before starting up the machine, it must be thoroughly cleaned to meet pharmaceutical aseptic standards. Pg.36 1.0 (23.01.2017) RA-V4

5.3 SIZE CHANGE PARTS CLEANING Important Please when it is foreseen to sterilize the size change parts, take care to lay them horizontally without place them one above the other. That way will avoid parts distortion. Important In case of sterilization made by autoclave: -the Polystone PE500 crystalline grain melting temperature range is 130-135 C; -the Delrin/Pom C melting temperature is 167 C. The autoclave has an acceptable range from the set point of the sterilization temperature: take care that the sterilization temperature plus this range does not exceed the melting temperature indicated above! RA-V4 1.0 (23.01.2017) Pg.37

5.4 GENERAL Thanks to the newest state of art methods, our machines are designed to be almost entirely maintenance free. This helps to avoid short-term maintenance intervals. All visible parts are made of non-corrosive material (anodized aluminum, non-corrosive steel, plastic materials). FOR MAINTENANCE AND REPARATION, DANGER MAIN SWITCH HAS TO BE SWITCHED OFF! NOTICE MAINTENANCE MAY ONLY BE EFFECTED BY SKILLED AND TRAINED PERSONNEL. Regular maintenance and care is absolutely necessary for a trouble free processing. Important Please use vacuum for cleaning. Avoid using compressed air; that way that no contamination is blown into guides, etc. In the event that compressed air is used, ensure that nobody can be injured by splinters of glass lying around (i.e. if there are broken vials). Pg.38 1.0 (23.01.2017) RA-V4

5.5 DISPOSAL Protect the environment! 5.5.1 Batteries Used batteries may not be thrown to the usual dustbin. Please bring these one to the special waste disposals. Before you throw away devices which cannot be repaired, please remove batteries. 5.5.2 Lubricants Lubricants which cannot be used any more should not be thrown into the dustbin or waste water. Please bring these to the special waste disposal points. RA-V4 1.0 (23.01.2017) Pg.39

5.6 INSTRUCTIONS FOR USE OF LUBRICANTS 5.6.1 Contact with skin Avoid long and repeated contact. Clean affected skin with soap and water. 5.6.2 Disposal Use skin protecting media when working and afterwards apply protective cream. Lubricants normally contain contaminating ingredients. Therefore they should not be allowed to get into the ground, water or drain channels. Pg.40 1.0 (23.01.2017) RA-V4

5.7 VALVES ASSEMBLING - SMC VALVES To operate on the SMC Valves, placed inside the washer machine turret: - Ensure to not have connection inside the washer machine with Compressed Air and Electricity; - Remove the below red indicated clamp and then the below green indicated labor cover. - Detach the below profibus cable and the C.A. tube. - Remove the turret cover and then act on the SMC valves placed inside the turret. RA-V4 1.0 (23.01.2017) Pg.41

5.8 GENERAL LUBRICATION INSTRUCTIONS - Before the machine start-up there should be always a control, if there is enough oil on the whole machine. - The machine is delivered with complete grease filling. - All filler necks are accessible after removal of protection hoods or coverings. - Bearings require additional lubrication during the machine life. - Gearboxes are filled by permanent type lubricant. Gearboxes do not require additional lubrication during the machine life. - The oil quantity has to be always sufficient to guarantee an adequate lubrication of the machine. - It was to be guaranteed that all lubricant have a high aging stability. Please observe absolutely that in case of further filling brands, oil brand and quality are kept. If it is not possible. Please avoid that the different oil get mixed. - Not additional devices, installed on the machine, are filled by lubricant. Not additional devices require lubrication during the machine life. Pg.42 1.0 (23.01.2017) RA-V4

6 RECOMMENDED LUBRICANTS 6.1 IN GENERAL USE ONLY QUALITY MACHINE OIL OR QUALITY Important ROLLER BEARING GREASE 6.2 INSTALLED AGGREGATES OF OTHER MANUFACTURERS Bought assemblies from other suppliers (for example motors, indexer etc.) have to be maintained according to their regulations. You will find the corresponding operating instructions or data sheets in a separate file (Ref. 15499LVMA10). RA-V4 1.0 (23.01.2017) Pg.43

6.3 LUBRICATING STUFF LIST In the following tables are indicated the lubricants recommended by us. 6.3.1 Oil Lubrication APPLICATION MANUFACTURER TYPE OF OIL INTERNAL REDUCTION GEAR INTERNAL INTERMITTER Shell OMALA S4 WE320 TIVELA S320 6.3.2 Grease Lubrication APPLICATION MANUFACTURER TYPE OF GREASE INTERMITTER Molikote Longterm W2 APPLICATION MANUFACTURER TYPE OF GREASE PINCER Klüber Klüberpaste UH1 96-402 Pg.44 1.0 (23.01.2017) RA-V4

7 INSPECTION 7.1 INSPECTION SCHEDULE The inspection is intended for the early recognition of necessary repair works in order to be able to prepare and execute them. By means of the early recognition and evaluation of the state of components and aggregates following shall be ensured: -that machine will be repaired in good time -that downtime will be limited to a minimum (as e.g. preparatory works for repair can be started when machine is operated) -that machine will be repaired at a time when production won't be affected The recommended inspection intervals in the following inspection plan are valid for single-shift operation 7.2 INSPECTION PLAN The inspection protocol following hereafter can be used to document inspections carried out by the customer s maintenance staff. The parts of the machines to be inspected are listed in the following chapters. RA-V4 1.0 (23.01.2017) Pg.45

Inspection protocol MACHINE TYPE MACHINE MODEL SERIAL NO. YEAR Inspection carried out on... according to general inspection plan. Remarks Inspected by Company/Dept. Date Signature Pg.46 1.0 (23.01.2017) RA-V4

7.2.1 Pneumatic cylinder State to be checked Adjustment Bearing play Completeness Consistency Corrosion Damage Damage Deformation Fixing device Functioning Noise (smoothness of running) Pollution Pressure Striae / scratches Temperature Wear Inspection interval Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly RA-V4 1.0 (23.01.2017) Pg.47

7.2.2 Pneumatic valves State to be checked Adjustment Completeness Consistency Damage Fixing device Functioning Pollution Pressure Rupture Temperature Inspection interval Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Pg.48 1.0 (23.01.2017) RA-V4

7.2.3 Gear State to be checked Adjustment Consistency Function Noise (smoothness of running) Temperature Torque transmission Volume and state Balance error Corrosion Cracks Damage Fixing device Non-smooth running Pollution Slippage Vibrations Wear Inspection interval Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly Yearly RA-V4 1.0 (23.01.2017) Pg.49

7.2.4 Chain State to be checked Adjustment Cracks Damage Extension Functioning Noise (smoothness of running) Non-smooth running Vibrations Wear Corrosion Pollution Inspection interval Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Quarterly Yearly Yearly Pg.50 1.0 (23.01.2017) RA-V4

7.2.5 Chain wheel. State to be checked Corrosion Deformation Pollution Inspection interval Yearly Yearly Yearly RA-V4 1.0 (23.01.2017) Pg.51

7.2.6 Chain joint State to be checked Completeness Deformation Extension Rupture Corrosion Pollution Inspection interval Quarterly Quarterly Quarterly Quarterly Yearly Yearly Pg.52 1.0 (23.01.2017) RA-V4

7.2.7 Ball bearing State to be checked Balance error Function Noise (smoothness of running) Non-smooth running Inspection interval Yearly Yearly Yearly Yearly RA-V4 1.0 (23.01.2017) Pg.53

7.2.8 Pillow block State to be checked Cracks Noise (smoothness of running) Play Rupture Corrosion Damage Fixing device Pollution Wear Inspection interval Half-yearly Half-yearly Half-yearly Half-yearly Yearly Yearly Yearly Yearly Yearly Pg.54 1.0 (23.01.2017) RA-V4

7.2.9 Motors State to be checked Noise (smoothness of running) Temperature Balance error Fixing device Pollution Vibrations Inspection interval Half-yearly Half-yearly Yearly Yearly Yearly Yearly RA-V4 1.0 (23.01.2017) Pg.55

7.2.10 Conveyor belt Pollution State to be controlled Inspection interval Daily Adjustment Completeness Cracks Damage Deformation Functioning Noise (smoothness of running) Rupture Wear Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Half-yearly Pg.56 1.0 (23.01.2017) RA-V4

7.2.11 EMERGENCY STOP Device state to be checked adjustment function whether the switch can be pressed without any problems and is not jammed at all fixing device pollution inspection interval weekly weekly weekly quarterly quarterly RA-V4 1.0 (23.01.2017) Pg.57

8 MAINTENANCE 8.1 MAINTENANCE INTERVAL All indications apply to single-shift operation. 8.1.1 Daily Group Maintenance Cleaning Cleaning of whole machine (particularly of object guiding parts). When using cleansing agents, it has to make sure that components made of metal, rubber or plastic material are not attacked. Caution: Do not wash down the machine with a water hose! Pg.58 1.0 (23.01.2017) RA-V4

8.1.2 Weekly Group Maintenance Sensors Remove dust from sensors with a soft and dry cloth RA-V4 1.0 (23.01.2017) Pg.59

8.1.3 Monthly Group Electrical cabinet Maintenance Cleaning the filter of the electrical cabinet ventilator - remove the covering outside - remove the filter mat and clean it dry or clean it in soap water then dry the mat Pg.60 1.0 (23.01.2017) RA-V4

8.1.4 Quarterly Group Maintenance Roller chain(s) Grease the roller chain(s). ------------------------------------- Lubricants Adhesive lubricants, for example - Castrol (Spheerol AP 2) - Mobil (Mobiltac A / Mobiltac B / Mobiltac E) - Shell (Alvania grease R 2) RA-V4 1.0 (23.01.2017) Pg.61

8.1.5 Half-yearly Group Maintenance Detachable connections Electrical Junction Boxes Control all detachable connections and connecting elements. Tighten released screw connections. Tighten the screws located on the Electrical Junction Boxes, if the screws are loosen, communication failures can happened between the PLC the machine. The screw must be tighten in the Electrical Junction Boxes located in the Electrical Cabinet. Conveyor belt Check the tension of the conveyor belt. If the belt is too loose, increase their tension by means of the tension adjustment system. Pg.62 1.0 (23.01.2017) RA-V4

8.1.6 Other Maintenance Hints for example: Maintenance hints which cannot be allocated to above mentioned intervals. Maintenance recommendations regarding installed parts by subsuppliers Notice Parts by sub-suppliers: The following listing is not by all means complete! Please absolutely read as well the corresponding descriptions of the manufacturers in the Other Suppliers Technical Data included in separated file. RA-V4 1.0 (23.01.2017) Pg.63

Group Maintenance Guarding All guarding panes made of plastic may be cleaned only with a soft cloth, since other means can produce scratches. Please do not use any acid detergents! Cleansing medium The panels of the guarding are made of alcohol resistant material. Gearboxes (general) During operation, carry out regular checks. Pay particular attention to: - unusual noises - leakage or falling oil level - over-elevated temperatures - loose securing elements Should problems occur, switch the machine or plant off immediately and rectify the fault. Pg.64 1.0 (23.01.2017) RA-V4

9 SPARE PARTS 9.1 COMMERCIAL COMPONENTS SPARE PARTS The most important commercial components are listed in the components list: Washer Components List: RA-V4 (Ref.: 15499LVSP14) 9.2 MECHANICAL COMPONENTS SPARE PARTS To identify the individual mechanical components refer to picture and table listed in the chapters below. RA-V4 1.0 (23.01.2017) Pg.65

9.2.1 Infeed guide Part-no Description Quantity 49817 Infeed guide for vials size F0 No. 01 Material: Polystone Pg.66 1.0 (23.01.2017) RA-V4

9.2.2 Loading cylinder contrast Part-no Description Quantity 34586 Loading cylinder contrast for vials size F0 No. 01 Material: Polystone 22198 M5 White Hand screw Lenght 32mm for vials size F0 Material: Polystone No. 01 RA-V4 1.0 (23.01.2017) Pg.67

9.2.3 Loading cylinder guide Part-no Description Quantity 49815 Loading cylinder guide for vials size F0 No. 01 Material: Polystone Pg.68 1.0 (23.01.2017) RA-V4

9.2.4 Loading position guide Part-no Description Quantity 49818 Loading position guide for vials size F0 No. 01 Material: Polystone RA-V4 1.0 (23.01.2017) Pg.69

9.2.5 Pincers Part-no Description Quantity 1006144 Pincers for vials size F0 No. 16 Material: Pom C Pg.70 1.0 (23.01.2017) RA-V4

9.2.6 Unloading station guides Part-no Description Quantity 49819 Unloading station guides for vials size F0 No. 01 Set Material: Polystone RA-V4 1.0 (23.01.2017) Pg.71

9.2.7 Outfeed guides Part-no Description Quantity 1006133 Outfeed guides for vials size F0 No. 01 Set Material: Polystone Pg.72 1.0 (23.01.2017) RA-V4

9.2.8 Washing station 9.2.8.1 Needles distributor Part-no Description Quantity 49742 Spraying/blowing needles main distributor for vials size F0 No. 02 Material: Stainless steel 49841 Internal spraying/blowing needles distributor with top entry for vials size F0 Material: Stainless steel No. 06 RA-V4 1.0 (23.01.2017) Pg.73

9.2.8.2 Needles Part-no Description Quantity 37568 Internal spraying needles for water, for vials size F0 Ltot=70 Øe=3mm Øi=2mm. Material: Stainless steel No. 09 18825 Internal blowing needles for air, for vials size F0 Ltot=70 Øe=2,5mm Øi=1,5mm. Material: Stainless steel No. 09 Pg.74 1.0 (23.01.2017) RA-V4

9.2.8.3 External nozzles Part-no Description Quantity 5311 External spraying nozzles for vials size F0 No. 03 Material: Stainless steel 61604 External spraying nozzles distributor dim.170x47mm - th.20mm for vials size F0 Material: Polystone No. 01 RA-V4 1.0 (23.01.2017) Pg.75

9.2.9 Drying station Part-no Description Quantity 22118 External blowing nozzles for vials size F0. Composed by no. 09 needles Ltot=46mm Øe=2,5mm Øi=1,5mm, part no. 17621 Material: Stainless steel No. 01 Pg.76 1.0 (23.01.2017) RA-V4

9.3 INDICATION FOR ORDER When ordering spare parts the following details have to be given additionally: Machines Type Machines Model Serial Number Year Part No. Tag. No. Quantity Please refer the cover page Please refer the cover page Please refer the cover page Please refer the cover page Please refer to RA-V4 Rotary Washing Machine Components List and Chapter 9.2 Please refer to RA-V4 Rotary Washing Machine Components List and P&ID drawings Please specify the required quantity RA-V4 1.0 (23.01.2017) Pg.77

10 ATTACHMENTS PRESSURE REDUCERS PARAMETERS SETTING (Ref. 15499LVSP26) CE - CONFORMITY DECLARATION (Ref. MOD0023) OTHER SUPPLIERS TECHNICAL DATA (Separate folder Ref. 15499LVMA10) RA-V4 1.0 (23.01.2017) Pg.78