operating and maintenance manual non-rotating canister (nrc) - dynamic design … nrc - rev...

Revision 1.3

Date: March 2008

Operating and Maintenance Manual

Non-Rotating Canister (NRC)

Dynamic Design Pharma, Inc.

23332 Madero Road, Suite J

Mission Viejo, California 92692

Phone 949-643-1120

Fax: 949-639-0440

Operating and Maintenance Manual - Non-Rotating Canister (NRC)

Revision 1.3 Date: March 2008

1. GENERAL 3

2. TERMINOLOGY 4

3. RTP PORT MODIFICATION 5

4. SET UP OF RTP PORT/NRC CANISTER INTERFACE 7

5. BALL BEARING AND DYNAMIC SEAL REPLACEMENT 8

6. DOCKING INSTRUCTION 14

7. SHUTTLE OPERATIONS 15

8. SYSTEM SPECIFICATION 16

9. FUNCTIONAL SPECIFICATION 18

10. DESIGN SPECIFICATION 19

11. RECOMMENDED SPARE PARTS 21

12. ASSEMBLY DRAWINGS 21

13. ATTACHMENTS 21



1. GENERAL

1.1. Introduction

This document is the operating and maintenance instruction manual for the Non-Rotating

Canister (NRC) manufactured by Dynamic Design Pharma, Mission Viejo, California.

1.2. General Description

The following describes the NRC (Non-Rotating Canister). The device interfaces to a standard

DPTE transfer port manufactured by La Calhene or other RTP ports which require rotation of the

RTP canister upon docking. The purpose of the device is to transfer parts into and out of isolator

systems.

The NRC is a RTP canister which does not need to be rotated to properly dock and lock onto a

standard RTP port, including La Calhene's DPTE. The NRC features a forward flange which, by

means of a bearing system and seal, is free to rotate in relationship to the canister. As a result, the

canister can be locked onto the RTP port without requiring rotation.

The NRC also features self supporting devices which permit the canister to be reliably attached

to the RTP port during the docking process.

In addition, the NRC features a built-in shuttle mechanism which permits the secure attachment

of a tray or basket designed to handle parts specific to the application.

In summary, the advantages over the existing technology are:

1. Non-rotation of canister body

2. Self supporting design. Operator does not have to support the weight of the canister

during the docking process.

3. Optional, built in shuttle mechanism with interface to custom designed tray or part

holder.



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.



3. RTP PORT MODIFICATION

Minor modification to the RTP port permit taking full advantage of the self supporting feature of the

NRC RTP canister. In general, the modification consists in the addition of a supporting cradle to the

outer ring which clamps the RTP port onto the isolator wall.

3.1. Modification of the RTP outer ring.

3.1.1. Install the RTP port onto the isolator wall per manufacturer’s instructions.

3.1.2. When installing the outer lock ring, make sure that it is installed flush with the outer

edge of the RTP port, as shown in figure 1.0 below

ISOLATOR WALL

RTP PORT

INSTALL FLUSH

FRONT LOCK RING

Figure 1.0 - RTP Port Outer ring position.



3.1.3. Locate the two M6 mounting holes as shown in figure 2.0. Angular location of threaded

holes is not critical because the RTP outer ring can be slightly rotated at final

installation.

Figure 2.0 – Mounting holes location

3.1.4. Remove RTP outer ring and drill and tap holes as specified.

3.1.5. Reassemble the RTP outer lock ring onto the RTP port. Assure to rotate it until its front

face is flush with the RPT’s front face and the newly added mounting holes are

positioned at 12:00 o’clock.

3.1.6. Follow instructions in this manual for proper installation of the RTP port / NRC

canister interface.



4. SET UP OF RTP PORT/NRC CANISTER INTERFACE

Proper set up of the RTP port to NRC canister interface hardware permits to dock the NRC onto the RTP

without supporting the weight of the canister during the process.

Please refer to figure 3.0 below.

4.1. Attach but do not tighten the cradle onto the RTP outer ring using the M6 hardware provided.

The cradle attaches to the two M6 tapped holes that were added to the RTP port outer ring during

the modification process described in this document.

4.2. NOTE: to allow for vertical adjustment of the position of the cradle, its mounting consist of

vertically oriented slots.

4.3. Loosen the hook mounting hardware on the NRC.

4.4. Install the NRC canister onto the RTP port. Engage the hook into the cradle as shown in figure

2.0.

RTP PORT

NRC CANISTER

CRADLE

HOOK

ISOLATOR WALL

Figure 3.0 – Hook and cradle interface

4.5. Simultaneously move both the cradle and the hook until they align to each other as shown in

figure 3.0 and tighten the affected four lockdown screws.

4.6. If the NRC canister is intended to dock to multiple RTP ports, it is important that all RTP’s are

set up in identical fashion. Repeat the above steps for all the RPT’s but omitting to move the

NRC canister hook at all.



CANISTER

ADAPTER

BETA FLANGE

DYNAMIC SEAL

BALL BEARINGS

COMPRESSION RING

BEARING RACE

BEARING RACE

BALL BEARINGS

5. BALL BEARING AND DYNAMIC SEAL REPLACEMENT

Replacement of the ball bearings and/or dynamic seal requires the disassembly of the beta flange of the

NRC. The activity requires handling numerous small precision parts, the ball bearings. It is

recommended to pursue this activity on a flat, clean surface that has raised edges to contain the ball

bearings.

5.1. Ball bearings removal

5.1.1. Separate the canister from the beta flange by removing 24 M4 socket head cap screws

shown in Figure 4.0.

5.1.2. Inspect and replace, if necessary, the “O” ring located in the groove at the canister to

flange interface.

Figure 4.0 – Canister body separation from beta flange



BALL BEARINGS

BETA FLANGE

COMPRESSION RING

DYNAMIC SEAL

ADAPTER

M6 FASTENER

BALL BEARINGS

BEARING RACE

5.1.3. Remove compression ring from the beta flange by removing the 12 M6 socket head cap

screws. See figure 5.0 above.

5.1.4. With a small tool, remove and discard the row of ball bearings located in the upward

facing groove.

Figure 5.0 – Compression ring removal



BALL BEARINGS

BETA FLANGE

DYNAMIC SEAL

ADAPTER

COMPRESSION "O" RING

BEARING RACE

5.1.5. Lift the adapter ring away from the beta flange. This will allow the ball bearings to fall

into the center of the beta flange. See Figure 6.0.

5.1.6. The dynamic seal and compression “O” ring may remain seated in the adapter ring that

was just removed or may be found resting on the beta flange itself. Remove and discard

either or both components, as necessary.

Figure 6.0 – Dynamic seal removal



BETA FLANGE

BALL BEARINGS ADAPTER

DYNAMIC SEAL

COMPRESSION "O" RING

BEARING RACE

5.2. Dynamic seal and ball bearings installation

Clean the ball bearing races and the dynamic seal groove using Isopropyl Alcohol. Perform a

final inspection of the ball baring races and dynamic seal groove to make sure that they are free

of dirt or lint.

5.2.1. Place the adapter ring beta flange on a flat surface and oriented as shown in Figure 7.0.

5.2.2. Place the compression “O” ring in the groove, as shown.

5.2.3. Place the dynamic seal in the groove as shown

5.2.4. Place a full row of ball bearings in the upward facing groove, as shown. Make sure to

install enough ball bearings to totally fill the groove in the adapter.

5.2.5. Place the beta flange over the adapter until it is properly seated onto the adapter, make

sure of contact between the beta flange and the dynamic seal.

5.2.6. While maintaining the beta flange and the adapter clamped together with both hands,

flip the assembly over onto the work surface.

Figure 7.0 – Dynamic seal and bearings installation



5.2.7. Place a full row of ball bearings in the upward facing groove, as shown in Figure 8.0.

Make sure to install enough ball bearings to totally fill the groove between the adapter

and the beta flange.

5.2.8. Install the compression ring onto the beta flange. Fasten with 12 M6 socket head cap

screws.

5.2.9. Test rotation of the adapter relative to the beta flange. There should be some resistance

to rotation but it should be slight enough that turning by hand can be accomplished.

Make sure rotation is smooth for a full 360 degree rotation.

Figure 8.0 –Compression ring installation

BALL BEARINGS

BETA FLANGE

BALL BEARINGS DYNAMIC SEAL

ADAPTER

BEARING RACE

COMPRESSION RING

BEARING RACE

M6 FASTENER



BALL BEARINGS

BETA FLANGE

COMPRESSION RING

CANISTER

ADAPTER

DYNAMIC SEAL

"O" RING

M4 FASTENER

BEARING RACE

BEARING RACE

5.3. Final assembly

Final assembly consists in the attachment of the canister body to the beta flange.

Clean the “O” ring groove on the adapter using Isopropyl Alcohol. Perform a final inspection of

the “O” ring groove to make sure that it is free of dirt or lint.

5.3.1. Refer to figure 9.0. Place “O” ring in the groove. Make sure that it is properly seated so

that it does not get “pinched” upon installation of the canister.

5.3.2. Install the canister onto the assembled beta flange. Fasten with 24 M4 socket head cap

screws.

5.3.3. An ammonia leak test should be conducted after completion of the above maintenance

activity.

Figure 9.0 – Canister body attachment



6. DOCKING INSTRUCTION

6.1. When supported by one or two operators

6.1.1. Lift the NRC canister until the supporting hook engages the supporting cradle located

on the RTP port.

6.1.2. Bring the NRC into engagement with the RTP port. If resistance to engagement is

found, rotate the NRC handle until the NRC lug align with the RTP indentations.

6.1.3. Make sure that the NRC is properly seated in the RTP port, the weight of the unit itself

will aid this action.

6.1.4. Turn the NRC handles as far as they will turn, approximately 60 degrees

6.1.5. Reach into the isolator system and open the RTP door to perform the operations

required.



7. SHUTTLE OPERATIONS

7.1. Installation

The shuttle installs into the NRC without any hardware. Gravity is used to retain the unit in place

during operation.

7.1.1. The shuttle is installed into the NRC pre-assembled as shown in the attached assembly

drawing

7.1.2. Insert the unit into the NRC until the outer rods engage the two receptacle holes located

inside the canister assembly.

7.1.3. Once inserted in the rear receptacles, the same outer rods are free to drop into two

receptacles located near the front of the unit (beta flange end)

7.1.4. If properly installed, the shuttle members will be free to slide and extend approximately

500mm beyond the front edge of the beta lange.

7.2. Usage

7.2.1. The shuttle is free to slide in and out of the NRC canister. Friction in the bushing

system prevents undesired movement.

7.2.2. To exercise the shuttle functions, simply pull or push anywhere on its components to

extend it or retract it as desired.

7.3. Tray attachment

7.3.1. The tray attaches to the shuttle mechanism to allow safe and convenient access to the

components housed inside the NRC canister.

7.3.2. The tray attachment consists of a “hook and drop” arrangement.

7.3.3. In the rear of the shuttle, two receptacles are “hooked” by two pins on the tray.

7.3.4. When “dropped” into position, the tray features a receptacle near the front that well

locates the tray to the shuttle front components.

7.3.5. When properly connected, the tray is secured to the shuttle by its own weight.



8. SYSTEM SPECIFICATION

8.1. Human factor and safety

The NRC features an interface to the lifting hook of a hoist system. Lifting capacity is 50kgs

minimum.

The NRC features dual lifting handles along its sides that the operator can use to carry and lift

the device.

The shuttle system is such that it can be installed inside the NRC body by an operator in a half

suit while the unit is located either inside or docked to an autoclave interface isolator

The NRC docking torque is such that an operator can safely perform the operation without risk of

injury. The docking torque does not exceed the torque required to dock a standard canister onto a

DPTE port.

8.2. Interface with RTP port

The front end of the NRC features a beta flange designed to interface with a standard RTP port

such as a La Calhene DPTE.

An optional support hook system between the NRC and the RTP port eliminates the need for the

operator to support the weight of the canister upon the docking process.

8.3. Physical configuration

8.3.1. Beta flange including door and seal

8.3.2. Docking handles 90 or 180 degrees apart (adjustable) that allow the operator to turn and

lock the beta flange onto the RTP.

8.3.3. Canister body - cylindrical in its standard form but it can take many shapes as required

by the application.

8.3.4. Seal system between the beta flange and the canister body to create a leak tight system

while permitting relative rotation between the two components.

8.3.5. Bearing system consisting of multiple ball bearings housed inside machined grooves

that permit rotation of the beta flange relative to the canister body.

8.3.6. Upper support system which vertically supports the NRC into alignment with the RTP

port during the docking and locking process.

8.3.7. Shuttle mechanism within the canister body

8.4. Shuttle mechanism

An optional shuttle mechanism is provided to support a tray holding machine parts inside the

NRC.

The shuttle mechanism is securely attached to the inside of the NRC body.

The shuttle is easily removable from the NRC without requiring tools.

The shuttle mechanism includes a bushing system that allows free sliding of its components in

and out of the NRC body.

The shuttle mechanism extends 500mm from its fully retracted position.

The shuttle mechanism is capable of withstanding steam sterilization temperatures.



The attachment of the tray to the shuttle mechanism is a hardware free interlock interface.

8.5. Operational/Facility Interface

NRC features a hoist interface which, by design, permits balanced lifting of unbalanced loads.

NRC features two lifting handles along the two sides of its main canister body to facilitate lifting

and handling of the device during docking operations.

The NRC canister body is similar in configuration to a standard RTP canister. The NRC will then

interface with canister transport carts that are typically used within manufacturing facilities.

The NRC also interfaces with the Lift/Transport system manufactured by Dynamic Design

Pharma for a totally hands free and safe handling of the device within the facility.

8.6. Physical specification

Nominal canister size: 350mm

Weight without internal parts: 10Kg (standard configuration)

Maximum weight of parts that can be handled within unit: 40Kg

Internal length of standard NRC body: 550mm

Outside diameter of standard NRC body: 358mm.

Clear opening diameter: 332mm.

8.7. Cleaning and sterilization capability

NRC body and beta flange are designed to withstand standard cleaning procedures. The internal

surfaces are smooth, free of crevices and hard to reach places.

All materials of construction are such that both steam sterilization and VHP decontamination are

possible.

The shuttle mechanism is removable from the NRC without locking fasteners. The shuttle sliding

components are easily separable for cleaning and sterilization processes.

Leak tightness: The assembled and closed NRC is capable of passing an ammonia leak test when

pressured at 50 Pascals internal pressure.



9. FUNCTIONAL SPECIFICATION

9.1. Interface with standard DPTE port

The interface of the NRC with the standard La Calhene DPTE is such that the mechanical and

functional fit requirements are met.

The Beta flange lugs properly engage the DPTE receptacles and lock onto them when the NRC is

rotated.

The Beta flange door remains attached to the DPTE door when the DPTE door is opened.

The beta flange rotation is smooth throughout its 60 degree stroke.

Rotation of the Beta flange is accomplished by using two handles provided. Torque required to

lock the beta flange onto the DPTE is such that a small operator is capable of performing the task

without risk of injury.

Upper support system and hoist interface are capable of supporting the NRC weight when fully

loaded with components.

9.2. Shuttle Functions

The shuttle system is such that it can be installed inside the NRC canister body by an operator in

a half suit while inside an autoclave interface isolator.

Shuttle mechanism securely attaches to the inside of the canister assembly. It will not dislodge

from its attachment features as long as the NRC is handled per manufacturer's instructions.

Shuttle mechanism is easily removed from the canister without need for any tools.

Shuttle mechanism requires less than a 5 kgs force to be pulled out of the NRC body.

Shuttle mechanism resists free movement within the NRC body during normal handling of the

unit.

Shuttle mechanism extends out of the canister mechanism a minimum of 500mm.

Shuttle mechanism is capable of withstanding steam sterilization temperatures.

Attachment of the tray to the shuttle is secure and does not require tools.



10. DESIGN SPECIFICATION

10.1. Canister Body

The NRC canister body consists of a formed and welded aluminum spinning.

It features attachment means for the beta flange, the shuttle assembly, lifting handles, hoist bar

interface.

Hook like device fastened to the upper side of the canister body. Aluminum body with stainless

steel interface pin.

10.2. Beta flange

Beta flange features multiple locking lugs which interface with a standard La Calhene DPTE

port.

Beta flange features multiple radial and axial rollers mounted on the locking lugs which serve the

function of minimizing the friction and therefore the torque required to lock the beta flange onto

the DPTE port.

Beta flange features a bearing system which allows smooth and accurate rotation of the beta

flange relative to the canister body

Beta flange features a dynamic seal which permits the seal to be leak tight while allowing

rotation of the beta flange relative to the canister body.

The beta flange features two handles 90 or 180 degrees apart (adjustable) that allow the operator

to turn and lock the flange onto the RTP port.

Beta flange provides mounting of a beta seal which interfaces with the standard DPTE.

10.3. Beta door

The beta flange features a door that locks onto the alpha flange door during the NRC canister to

DPTE docking process.

10.4. Dynamic seal

The dynamic seal creates an airtight interface between the beta flange and the canister body.

The dynamic seal is a face seal. It creates a low preload force and very low friction.

A closed cell silicone foam "O" ring, 6.35 mm (0.25 inch) cross section fitting also loosely in the

same groove as the Teflon ring.

The two rings are stacked in the groove with the Teflon ring providing the low friction sliding

medium to the mating surface and the silicone "O" ring providing a slight preload to the Teflon

ring.

10.5. Bearing system

The bearing system consists of a multitude of ball bearings which are housed in grooves

machined in the beta flange ring and corresponding surfaces in the canister body forward ring.

The ball bearings ride in stainless steel races in the axial direction.

The bearing system consists of two rows of ball bearings that provide radial and axial

positioning.

Ball bearings are 6.35mm (0.250inch) in diameter.



Ball bearing material is stainless steel.

The dynamic seal design is such that ball bearing preload is not necessary.

10.6. Shuttle mechanism

The shuttle mechanism consists of dual telescoping slides onto which a cradle or tray can be

attached.

The shuttle system is comprised of an attachment structure, the outer slide, the outer rails, the

inner slide and the inner rails.

The attachment structure is permanently attached to internal features of the canister. It provides

mounting means for the outer rails.

The outer rails are mounted to the attachment structure by locating the rear of the two shafts into

receptacles located in the rear of the canister. The front end of the two shafts is dropped into a

receptacle located in the front of the canister.

The outer slide slides onto the outer rails and provides mounting means for the inner rails. The

stroke is limited by the mechanical configuration of the device itself.

The inner rails are mounted to the outer slide by means of two pull pins.

The inner slide slides onto the inner rails and provides attachment means for the tray or canister.

Each slide of the system, the inner and outer, features four Igus T-500 series bushings. These

bushings are rated for high temperature exposure and will therefore withstand steam sterilization.

Tray design is dependent on the components to be handled and can be custom constructed to the

application

Attachment of the tray to the shuttle system is hardware free. The tray has features which allow a

hook-and-drop type interface to the shuttle system.

10.7. Hoist interface

The upper surface of the NRC canister body features a hook interface plate with multiple 20mm

diameter hoist interface holes spaced 25mm apart from each other. These attachment holes

function as hoist and transport system interface.

The multiple hook up points allow the operator to lift the canister in a horizontally balanced

fashion. The center of gravity of the loaded NRC may vary depending on the components stored

inside.

The same hook up bar serves as an attachment point to DDP’s Lift/Transport system.

10.8. Materials of construction and surface finishes

Canister body - aluminum alloy, clear anodized

Beta flange - 6061-T6 aluminum alloy

Beta flange lugs- 304 stainless steel

Beta flange door - 6061-T6 aluminum alloy

Beta seal - Silicone or viton (La Calhene)

Dynamic Seal - Teflon and silicone

Ball bearings – 316 stainless steel.



Hardware - stainless steel, metric socket head cap screws

Shuttle mechanism - 6061-T6 aluminum, clear anodized.

11. RECOMMENDED SPARE PARTS

The following are recommended spare parts for the NRC canister

Item Qty/unit Part number Description Manufacturer

1 1 9464K576 “O” ring, viton McMaster Carr

2 1 DD-1316 Seal, Teflon

3 1 DD-1344 “O” ring, custom

4 4 DD-1723 External lug

5 8 DD-1731-1 Roller, axial

6 8 DD-1731-2 Roller, radial

7 8 DD-1731-3 Pin, axial roller

8 4 DD-1731-4 Pin, lug positioning

9 8 DD-1731-5 Pin, radial roller

10 360 96415K75 Ball bearing McMaster Carr

11 1 #8008 Beta Seal, gray silicone La Calhene

12 2 DD-1292 Pin, shuttle lockdown

13 8 TSM-1517-15 Bushing Igus

14 1 DD-1305 Gasket, shuttle attach

15 1 DD-1307 Gasket, front attach

16 2 9464K105 “O” ring, viton McMaster Carr

17 1 DD-1728 Bearing race, outer

18 1 DD-1730 Bearing race, inner

12. ASSEMBLY DRAWINGS

The following assembly drawings are included in this document.

12.1. DDA-1365 Top assembly, NRC canister

12.2. DDA-1362 Beta Flange assembly

12.3. DDA-1363 Canister assembly, dual ports.

12.4. DDA-1364 Shuttle assembly

12.5. DDA-1724 Assembly, external lug

13. ATTACHMENTS

13.1. Leak Test Certification

13.2. Materials Certifications

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