Lift/Transport System Serial Number: 06-142L Dynamic Design Pharma, Inc. 23332 Madero Road, Suite J Mission Viejo, California 92691 Phone 949-643-1120 Fax 949-639-0440 Revision 1.0 Date:November 30, 2006 Page 1
1. GENERAL 3 2. TERMINOLOGY 4 3. INTERFACE WITH NRC CANISTER 5 4. NRC CANISTER TRANSPORT 5 5. DOCKING OF THE NRC CANISTER TO THE RTP PORT 5 6. MAINTENANCE 6 7. DOCUMENTATION DESCRIPTION 12 8. GENERAL REQUIREMENTS 13 9. FUNCTIONAL SPECIFICATION 14 10. DESIGN SPECIFICATION 15 11. RECOMMENDED SPARE PARTS 18 12. DRAWINGS 18 Page 2
1. GENERAL 1.1. Introduction This document is the operating and maintenance instruction manual for the Lift/Transport System manufactured by Dynamic Design Pharma, Mission Viejo, California. 1.2. General description The system is a transport device designed to safely and efficiently transporting the Non-Rotating Canisters (NRC) within the aseptic filling room and/or facility. Refer to the Non-Rotating Canister (NRC) manual for information related to the application, process sequences and all other non Lift/Transport System details. The Lift/Transport System provides means of docking, undocking and transporting the NRC canister without requiring the operator to support the weight of the canister during the necessary operations. 1.3. Key features Following are the key features of the Lift/Transport System. 1.3.1. Structural The system features a welded stainless steel base attached to an upright column. The column consists of two side plates held together by a number of horizontal plates. The column houses the vertical drive system and guidance system of the horizontal NRC support beam. 1.3.2. Interface to the NRC canister The system features a horizontal support beam that is moveable in the vertical direction by the drive system contained within the vertical column. The NRC interface also includes the appropriate features to assure a safe NRC attachment and the NRC s rotation in the horizontal plane to facilitate the operations required by the application. 1.3.3. Vertical drive 1.3.4. Casters A manual drive mechanism permits the operator to bring the NRC s beta flange into vertical alignment with the RTP port s alpha flange or to fit into the BSC door opening. The base of the system features four swivel casters that permit easy movement of the loaded system within the filling room and the manufacturing facility. The two rear casters also include locking brakes to avoid unwanted Lift movement during the process. 1.3.5. Maneuvering handle A rigid handle is attached to the vertical column of the system at such location that it allows the operator to maneuver the system within the filling room. Page 3
2. TERMINOLOGY 2.1. NRC: Non-Rotating RTP Canister 2.2. Isolation or Barrier Technology: Technology used to maintain containment or sterility of manufacturing processes. 2.3. RTP: Rapid Transfer Port 2.4. DPTE: Standard La Calhene RTP port 2.5. Shallow: Short RTP canister that is used to simulate the presence of an RTP canister onto a DPTE port. 2.6. Ring of Concern: Point of contact between the Alpha and the Beta Flange which raises microbiological concern because of its potential bacterial contamination. 2.7. Alpha Flange: The half of the RTP port which usually is attached on the isolator and has the swing access door. 2.8. Beta Flange: The half of the RTP port which is part of the RTP canister or transfer isolator. 2.9. Isolator: Enclosure that meets isolation technology requirements and features an Alpha port for component transfer operations. 2.10. BSC: Biological Safety Cabinet. 2.11. Fore-aft orientation: the NRC is oriented with the beta flange is facing away from the operator when he/she is standing at the maneuvering position of the lift 2.12. Side-to-side orientation: the NRC is oriented with the beta flange facing to the right of the operator when he/she is standing at the maneuvering position of the lift. 2.13. Lift or Lift/Transport: NRC transport device that is used to safely handle the NRC during docking and transport activities. Page 4
3. INTERFACE WITH NRC CANISTER See the NRC manual for instructions related to attachment of the NRC to the Lift. 4. NRC CANISTER TRANSPORT See NRC manual for instructions related to movement of the NRC and Lift within the filling room. 5. DOCKING OF THE NRC CANISTER TO THE RTP PORT See NRC manual for instructions related to docking the NRC to the alpha flange of the RTP port. Page 5
6. MAINTENANCE Ite m No. 6.1. Drive system description The following is a description of the drive system and its principal components. See Figure 1.0 below for a pictorial representation of each device. Description/Function 1 Bottom plate. Serves the function of closing off the bottom of the column to prevent possible leakage of lubricant from the drivetrain. This plate also provides structural rigidity to the bottom half of the column. 2 Chain tensioner. Tension of the drive chain is adjusted by locking a clamping screw onto a swivel plate. The swivel plate has an idler chain sprocket that is free to spin on plastic flanged bushings. 3 Cross brace block. Provides a structural connection between the two halves of the base. 4 No. 40 lubrication free roller chain 5 Rear access panel. Attached with socket head cap screw fasteners. 6 Front access panel. Attached with socket head cap screw fasteners. 7 Chain to lift shaft adapter. Block that fastens onto two links of the chain and attaches to the lift shaft. 8 Lift shaft. 25mm diameter stainless steel shaft. Serves the dual function of lifting the load up and of preventing its rotation in the horizontal plane. 9 Cross plate. Provides structural rigidity and is also the mounting plate for the lift shaft lower bushing. 10 Lower bushing for the lift shaft. 11 Drive sprocket and worm gear tandem pair. Pinned together to spin freely on common shaft (with plastic bushings). 12 Hand wheel. Two spoke, plastic, with rigid hand crank. 13 Worm. Converts rotary motion from hand wheel to rotary motion of the worm wheel. Cannot be backdriven. 14 Upper bushing for the lift shaft. 15 Cross plate. Provides structural rigidity and is also the mounting plate for the lift shaft upper bushing 16 Main shaft, 40mm diameter stainless steel. Fixed in place at the top end and at the bottom end. 17 Lower bushing, main shaft drive 18 Main lift block. Supports the NRC interface assembly, it is free to ride in the vertical direction and is positioned in the horizontal and vertical planes by the lift shaft. 19 Upper bushing, main shaft drive 20 Side plate, one per side of the system. Stainless steel material. Provides structural framework for the system, the column. Page 6
Ite m No. Description/Function 21 Upper plate. Provides structural rigidity and means for upper main shaft attachment. 22 NRC interface structure. Multiple stainless steel plates in bolted construction. 23 Bearing block. Houses the ball bearings that permit the rotation of the NRC in the horizontal plane. 24 NRC interface hub. Positioned by the ball bearings, it is free to rotate freely in the horizontal plane. It includes rotation engagement slots to permit locking in position and engagement pins for correct attachment of the NRC. 25 Ball bearings. Dual, stacked and preloaded in the vertical direction. 26 NRC interface locking handle. When pushed down, the connected mechanism engages slots in the NRC interface hub to prevent its rotation. When pulled up, the NRC interface hub is free to rotate. Page 7
21 20 22 19 18 16 24 23 17 15 25 26 14 13 11 10 8 7 4 9 5 12 6 2 3 1 Figure 1.0 Lift/Transport drive system Page 8
6.2. System inspection Operating and Maintenance Manual It is possible for components and hardware to loosen during shipment or as a result of normal operation. Follow this checklist to make sure that the system is in proper operating order prior to placing it into service. Refer to the enclosed assembly drawings to identify components descriptions and locations. Note Absolute torque values are not necessary to perform this inspection. Adopt basic mechanical principles to assess whether the system s status is adequate for safe operation. 6.2.1. Remove the front and rear access covers. 6.2.2. Check all column hardware for tightness. This includes all the hardware that is accessible from the outside of the vertical column. 6.2.3. Check the casters mounting hardware for tightness. 6.2.4. Check the NRC Interface structure attachment to the Lift main block. 6.2.5. Check the tightness of the hardware of the NRC interface structure. 6.2.6. Check the chain tension. Adjust if necessary (refer to proper section in this document) 6.2.7. Check the chain to lift shaft adapter attachment and locking hardware. CAUTION Failure of this hardware could cause the NRC Interface assembly to drop suddenly thus creating an unsafe condition for the operator. 6.2.8. Check hardware of the drive system plates. Inspect for sloppiness of the vertical drive (worm to wormgear interface). 6.2.9. Inspect the lateral play of the drive worm. If found to be excessive, replace the appropriate bushings. 6.2.10. Inspect the lateral play of the worm gear/sprocket assembly. If found to be excessive, replace the appropriate bushings. 6.2.11. Check the chain links, particularly the removable link, for damage. CAUTION The failure of the drive chain could cause the horizontal beam to drop suddenly thus creating an unsafe condition for the operator. 6.2.12. Check the fit of the shafts, both the main shaft and the lift shaft, in their respective bushings. If excessive play is found, replace the appropriate bushings. Page 9
6.3. System lubrication Operating and Maintenance Manual The system is designed to be operated lubrication free except for the point of contact between the worm and the worm wheel of the vertical drive system. Follow these steps to lubricate the drive system s worm gearing. 6.3.1. Remove the rear access cover to gain access to the vertical drive mechanism. 6.3.2. Apply a small amount of food grade grease to either the worm or the worm wheel. 6.3.3. Actuate the mechanism to spread the grease over the surface of the components. 6.3.4. Wipe all excess grease from the two components. 6.4. Bushing replacement The system uses Igus bushings throughout. These bushings offer the benefits of long life without the need for lubrication and preventive maintenance, they work well in applications such as the Lift/Transport system. It may become necessary to replace one or more of these bushings. The following steps describe the general approach to the replacement of any of the bushings of the system. 6.4.1. Remove the part that houses the bushings to be replaced from the system. 6.4.2. Using an arbor press, remove the existing bushing(s) from the part. Discard removed bushing(s). 6.4.3. Inspect the bore(s) of the part to make sure that it is free of burrs, deformations and is clean. 6.4.4. Press the new bushing(s) in place. 6.4.5. Inspect the mating parts for proper sliding fit. 6.5. Angular adjustment of NRC to the alpha port The NRC/Lift system is designed to position the NRC s centerline parallel to the filling room floor. This is true in both NRC orientations, side-to-side and fore-aft. This angular position is not adjustable. It is important that the beta flange and the alpha flange be parallel to each other during docking. It may be needed to fine tune the angular position of the NRC upon docking. Note For best results, it is recommended to make this adjustment with the NRC loaded with the components to be transported. This pre-loads the system into a worse case condition. There are numerous ways to accomplish this angular adjustment, examples are given below. 6.5.1. Loosen the base weldments mounting hardware and skew the column in the desired direction while re-tightening the hardware. Page 10
6.5.2. If the needed angular correction is more than what can be corrected with the previous action, it may be best to place precision shims under the mounting pads of either the front or the rear caster, as necessary. 6.5.3. Another possibility is to add precision shims between the NRC canister body and NRC to Lift interface plate or machining the required angle in the NRC interface plate itself. 6.6. Vertical travel hard stops The Lift is designed without vertical travel hard stops. The travel capability in both directions exceeds the needs of the application by some distance. It may be desirable to limit the vertical travel in either the up or down direction to facilitate docking to the alpha port or NRC placement into the BSC. Refer to Figure 1.0 and follow these steps. 6.6.1. To stop the travel in the UP position: 6.6.1.1. Raise the NRC to the desired height for docking to the alpha port. 6.6.1.2. Precisely measure the gap between the lift block and the upper plate. 6.6.1.3. Fabricate a plastic spacer to fit over the shaft (40mm ID) and of the measured length. 6.6.1.4. Remove the upper plate and place the spacer over the shaft in the space between the lift block and the upper plate. 6.6.2. To stop travel in the Down position: 6.7. Chain tensioning 6.6.2.1. Lower the NRC to the point of a good fit into the BSC. 6.6.2.2. Precisely measure the distance between the lift block and the cross plate. 6.6.2.3. Fabricate a plastic spacer to fit over the shaft (40mm ID) and of the measured length. 6.6.2.4. Remove the upper plate and lift block and place the spacer over the shaft in the space between the lift block and the cross plate. Tensioning of the drive chain is accomplished by tightening a tensioner block located at the bottom of the system column. Refer to the enclosed assembly drawings. Follow these steps. 6.7.1. Gain access to the internal components of the column by removing the front and rear access covers. 6.7.2. Loosen the tensioner block pivot screws to allow the tensioner block to swing. 6.7.3. Adjust the tensioner locking socket head screw until the desired tension is achieved. 6.7.4. Tighten all hardware and test the vertical drive system over its full travel. Page 11
7. DOCUMENTATION DESCRIPTION Following are documentation sections that are useful for validation of the system. Each section addresses a specific documentation purpose, as described below. 7.1. System specification This section covers all the requirements applicable to the system. It includes application requirements such as safety, usage information, functional and design specification and performance requirements. This section describes all the requirements of the system from the user standpoint. 7.2. Functional specification This section defines the system specification related to the functional requirements set for the system. This section describes how the functional requirements defined in the general specification were addressed in the design of the system. 7.3. Design specification This section describes the details of the system design and how the requirements defined in the general requirements and the functional specification are met. Page 12
8. SYSTEM SPECIFICATION 8.1. Human factor and safety 8.1.1. The attachment of the NRC to the Lift system is such that accidental separation cannot take place. 8.1.2. The Lift is capable of safely transport and handle the NRC canister weighing up to 50Kg. 8.1.3. The Lift has casters that permit safe movement of a loaded (50Kg) NRC canister within the filling room or the manufacturing facility. 8.1.4. The Lift has lockable casters to prevent accidental movement of the unit during normal operations. 8.2. Physical and functional requirements 8.2.1. Base and column 8.2.1.1. Structural base consisting of welded stainless tubing construction. 8.2.1.2. Four non-marking swivel casters. 8.2.1.3. Column attached to the base, constructed of stainless steel, that houses a manual vertical drive system. 8.2.1.4. Vertical drive system, manually actuated by the operator, that permits fine vertical positioning of the supported NRC canister into alignment with the RTP port. 8.2.1.5. Ergonomically located handle that permits movement of the system by the operator. 8.2.2. NRC canister interface assembly 8.3. System requirements 8.2.2.1. NRC canister support assembly that attaches to the Lift column and supports the NRC in the horizontal orientation. 8.2.2.2. Bolted construction that includes the appropriate means for attachment of the NRC. 8.2.2.3. A bearing system that permits rotation of the NRC in the horizontal plane. Manually lockable in its angular position at 90 degrees increments. 8.2.2.4. Beta door removal tool support member. 8.3.1. NRC centerline in the DOWN position: 1136 mm (44.7 inch). 8.3.2. NRC centerline in the UP position: 1175 mm (46.3 inch). 8.3.3. NRC orientation lockable in the side-to-side and the fore-aft orientation. 8.3.4. Maximum system width (at base): 488 mm (19.2 inch). 8.3.5. System geometry is such that tipping the system while transporting a loaded NRC canister is not possible given normal system usage methods. Page 13
8.3.6. Hard stops at the end of vertical travel in both directions. 8.3.7. Front casters: Non marking, polyurethane rubber, swivel type. 8.3.8. Rear casters: Non marking, polyurethane rubber, swivel type, lockable. 9. FUNCTIONAL SPECIFICATION 9.1. Interface with NRC canister 9.1.1. NRC to Lift interface: Accurate placement of the NRC onto the interface 9.1.2. Attachment of NRC to Lift: 9.1.2.1. Attachment does not require fastening tools. 9.1.2.2. Attachment is secure 9.2. Lifting and transporting capacity 9.2.1. The system is capable of safely lift a loaded NRC canister (50Kg). 9.2.2. System geometry is such that tipping the system while transporting a loaded NRC Canister is not possible given normal system usage methods. 9.2.3. Moving handle is capable of handling the 100kg load (Lift and NRC). 9.3. Vertical drive system and motion 9.3.1. Vertical positioning of the NRC centerline is possible by actuating a handwheel located in the rear of the unit. 9.3.2. Vertical movement resolution is such that docking elevation of the NRC to the RTP port can be achieved. 9.3.3. The vertical drive system includes hard stops that clearly show the operator that end of travel in either direction has been reached. No system damage will occur if end of travel is reached. 9.4. NRC canister orientation 9.4.1. NRC interface plate to the Lift has positioning features that result in correct orientation of the NRC after installation onto the Lift. The correct orientation is either in the sideto-side or fore-aft direction. 9.4.2. The orientation of the NRC can be changed by actuating a locking mechanism and requires no tools. 9.4.3. The NRC can be oriented as follows: 9.5. Beta door removal tool 9.4.3.1. Fore-aft direction 9.4.3.2. Side-to-side orientation with the beta flange either facing to the right or the left of the Lift column. 9.5.1. A beta door removal tool engages a support bar attached to the side of the Lift to Page 14
accomplish the following: 9.5.1.1. Two handed rotation of the beta door while the system is inside the BSC 9.5.1.2. Support of the beta door while open inside the BSC. 9.5.2. The beta door removal tool easily disconnects from the Lift, without requiring any tools. 10. DESIGN SPECIFICATION 10.1. Base and column 10.1.1. The base consists of two welded square tube structures to which four casters are mounted. The two base weldments are attached to the column. 10.1.2. The column consists of two stainless steel side plates and five cross plates in bolted assembly. The five cross plates function as structural components as well as mounting means for bushings, shafts, and other components. 10.1.3. A moving handle permits movement of the system by the operator. 10.2. Vertical drive 10.2.1. The vertical drive system is embedded within the column. 10.2.2. An external drive handwheel turns a worm that engages a wormwheel. 10.2.3. The wormwheel is coupled to a roller chain sprocket that converts the rotary motion to vertical, linear motion. 10.2.4. A lubrication free roller chain drives a vertical lift shaft that is connected to a lift block. 10.2.5. The NRC interface assembly attaches to the lift block. 10.2.6. All rotary and linear motions occur within plastic bushings pressed into aluminum structural plates. 10.2.7. A tensioner assembly keeps the chain under the necessary tension. 10.3. NRC canister support assembly 10.3.1. The NRC support structure consists of a number of stainless steel plates in bolted assembly. The structure is basically shaped as an L and attaches to the main lift block of the column. 10.3.2. The structure holds a bearing block, ball bearing and spindle assembly to which the NRC is attached. 10.3.3. The spindle has radially oriented slots every 90 degrees. A separate mechanism, manually actuated from outside the Lift structure, engages one of the slots to lock the NRC at its desired orientation. 10.4. Beta door removal tool. 10.4.1. A beta tool support bar is attached to the side of the Lift s NRC support structure. Page 15
10.4.2. The beta tool support bar features a slot that permits the tool free, twist-on engagement of the beta tool. 10.4.3. When engaged, the beta tool connects to the beta door and facilitates its hands free removal. 10.4.4. When the beta door is unlocked from the beta flange, the tool, with the beta door attached, can be manually rotated down onto the floor of the BSC. 10.5. Physical design specification 10.5.1. Weight: Maximum system weight without NRC: 50 Kg (110lbs) 10.5.2. NRC centerline in the DOWN position: 1036 mm (40.8 inch) 10.5.3. NRC centerline in the UP position: 1236 mm (48.7 inch) 10.5.4. Resulting vertical travel: 200 mm (7.9 inch) 10.5.5. Distance from vertical drive handle centerline and the floor: 813mm (32.0 inch ). 10.5.6. Distance from transport handle to floor: 1036 mm (40.8 inch). 10.5.7. Maximum system width (at base): 488 mm (19.2 inch) 10.5.8. System geometry is such that tipping the system while transporting a loaded NRC canister is not possible given normal system usage methods. 10.5.9. Drive resolution: 5.1 mm / turn (0.200 inch/turn). 10.5.10. Hard stops at the end of travel in both directions. 10.5.11. Front casters: Non marking, polyurethane rubber, swivel type. 10.5.12. Rear casters: Non marking, polyurethane rubber, swivel type, lockable. 10.5.13. Lubrication: Minor lubrication required, internal vertical drive components. 10.6. Materials of construction 10.6.1. Upright section: 10.6.1.1. Side plates: 303 Stainless steel, electropolished 10.6.1.2. Front and rear covers: Stainless steel, electropolished 10.6.1.3. Internal and external structural components such as closure plates, brackets, tensioner, bearing blocks: 6061-T6 aluminum, clear anodize plated. 10.6.1.4. Vertical guide rods: 303 stainless steel, electropolished 10.6.1.5. Base: 303 stainless steel square tubing, welded and ground smooth, electropolished. 10.6.2. NRC canister support assembly: 10.6.2.1. Main bearing block: 6061-T6 aluminum, clear anodize plated. 10.6.2.2. NRC support structure: 303 stainless steel, electropolished. 10.6.2.3. NRC canister interface components: 303 stainless steel, electropolished. Page 16
10.6.3. General: 10.6.3.1. Drive chain: Lubrication free roller chain 10.6.3.2. Hand wheel: Hard plastic 10.6.3.3. Moving handle: 304 stainless steel with rubber grips. 10.6.3.4. Bushings: Igus M series plastic bushings. 10.6.4. Casters: 10.6.4.1. Front: Polyurethane rubber, non-marking, swivel type 10.6.4.2. Rear: Polyurethane rubber, non-marking, swivel type, lockable. Page 17
11. RECOMMENDED SPARE PARTS The following are recommended spare parts for the Lift/Transport System. Item Qty/unit Part number Description Manufacturer 1 8 GFI-1011-08 Bushing, flanged Igus 2 2 GSM-2528-20 Bushing, sleeve Igus 3 2 GSM-4044-30 Bushing, sleeve Igus 4 4 TFM-1012-08 Bushing, flanged Igus 5 2 97065K42 Vinyl grips McMaster Carr 6 2 8359T43 Stainless steel caster- swivel McMaster Carr 7 2 8359T431 Stainless Steel caster- swivel with lock McMaster Carr 8 6 ft. 2336K1 Chain, #40 McMaster Carr 9 1 2336K11 Chain connecting links McMaster Carr 10 2 6153K79 Ball bearing 6205 size McMaster Carr 11 1 DD-1327 Worm/Sprocket assembly DDP 12 1 DD-1380 Sprocket, tensioner DDP 13 1 DD-1487 Shaft, upper drive DDP 14 1 DD-1650 Tee Screw DDP 15 1 DD-1657 Locking tool DDP 12. DRAWINGS The following drawings are included in this document. 12.1. DDA-1664 Assembly, column and base 12.2. DDA-1665 Assembly, NRC Interface 12.3. DDA-1666 Top assembly, Lift/Transport 12.4. DDA-1669 Assembly, NRC and Lift Page 18