operating and maintenance manual 190 alpha nrf … - 190 alpha nrf rev. 1.0...operating and...

Revision 1.0

Date: August 2011

Operating and Maintenance Manual

190 Alpha NRF Docking System

Dynamic Design Pharma, Inc.

23332 Madero Road, Suite J

Mission Viejo, California 92691

Phone 949-643-1120

Fax: 949-639-0440

Operating and Maintenance Manual – 190 Alpha NRF Docking System

Revision 1.0 Dynamic Design Pharma, Inc. Date: August 2011

1. GENERAL 3

2. TERMINOLOGY 4

3. SYSTEM COMPONENTS 5

4. SYSTEM ASSEMBLY 7

5. DOCKING INSTRUCTION 18

6. BALL BEARING AND DYNAMIC SEAL REPLACEMENT 23

7. SYSTEM SPECIFICATION 30

8. FUNCTIONAL SPECIFICATION 32

9. DESIGN SPECIFICATION 33

10. RECOMMENDED SPARE PARTS 35

11. ASSEMBLY DRAWINGS 36

12. ATTACHMENTS 36



1. GENERAL

1.1. Introduction

This document is the operating and maintenance instruction manual for the 190 Alpha NRF

Docking System manufactured by Dynamic Design Pharma (DDP), Mission Viejo, California.

1.2. General description of the system

The Alpha NRF docking system integrates a standard DPTE Alpha/Beta transfer port system

manufactured by Getinge-La Calhene into a DDP’s proprietary NR flange. The NR flange

permits the docking process to be performed without rotation of the Beta flange relative to the

Alpha flange. For reference, the DPTE system requires a 60 degree rotation of the Beta flange

relative to the Alpha flange to complete the docking process.

The NR flange is based on DDP’s NR technology. The NR technology is adopted in DDP’s

standard NRC Canister, a transfer canister which can be docked without rotation. The NR flange

consists of a dynamic seal and a set of ball bearings that allow proper rotation while maintaining

the integrity of the joint.

The Alpha NRF system is a standard LAC Alpha flange mounted on a specially designed NR

flange. The beta flange is a standard LAC beta flange that is attached to the canister, tank, or

other system to be docked.

The Alpha NRF flange permits the docking of rigidly mounted devices featuring a beta flange to

the Alpha flange by simply rotating the alpha flange during the docking process.

The Alpha NRF Flange is mounted on a silicone rubber diaphragm that permits free float of the

Alpha NRF flange during the docking process.

1.3. Alpha NRF system – Application specific

The application specifically described in this document is one of an Alpha NRF flange used to

dock a tank filled with sterile stoppers to a filling isolator system. The tank features a rigidly

mounted beta flange on its narrow end.



2. TERMINOLOGY

2.1. Alpha NRF Flange: Alpha flange that is mounted on a proprietary DDP NR flange.

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. Alpha Flange: The half of the RTP port that is usually attached onto the isolator wall and has the

swing access door.

2.6. Beta Flange: The half of the RTP port which is part of the RTP canister, transfer isolator or other

moveable system.

2.7. LAC: Getinge-La Calhene.



3. SYSTEM COMPONENTS

Below is the Alpha NRF system components structure.

3.1. DDA-2027 System Assembly, 190 Alpha NRF Transfer System

3.1.1. DDA-2026 - 190 Alpha NRF Flange Assembly

3.1.1.1. LAC 15511 - 190 DPTE-S Alpha Flange – Getinge-La Calhene

3.1.1.2. DDA-2025 – Assembly, Alpha NRF Flange.

3.1.2. DDA-1803 Beta flange with adapter assembly

3.1.2.1. LAC 20204 – 190 DPTE-S Beta Flange – Getinge-La Calhene

3.1.2.2. DD-2028 – Adapter, 190 beta to IDF flange

Figure 1 – Alpha NRF System Viewed from the sterile side

BETA FLANGE

ALPHA NRF FLANGE



Figure 2 - Alpha NRF Components - Viewed from the non-sterile side

ALPHA NRF FLANGE

BETA FLANGE



4. SYSTEM ASSEMBLY

The following instructions describe the assembly of the components with the assumption that they are in

the disassembled state.

4.1. Assembly of the silicone diaphragm to the NRF flange

NOTE

The two handles of the Alpha NR flange must be removed to complete the next

step of the assembly. See re-assembly description below.

4.1.1. Figure 3 shows an exploded view of the Alpha NRF components of the flange that clamp

the silicone diaphragm in place.

4.1.2. Place the male mounting ring into the groove of the main ring.

4.1.3. Place the diaphragm over the main ring boss. It should fit tightly.

4.1.4. While holding the female ring in the groove of the mounting ring, place it over the

silicone diaphragm.

4.1.5. Install all clamping screws and finger tighten

4.1.6. Sequentially tighten the screws down while working around the hole pattern numerous

times. Slowly the silicone diaphragm will deform enough to allow the clamping screws

to bottom out and tighten against the main ring.

NOTE

Do not tighten or loosen the clamping screws unevenly, this might cause the

diaphragm to be improperly clamped in place or the hardware to seize in the

threaded holes.

NOTE

Tighten or loosen the hardware one quarter turn at the time while going around

the hole pattern.



Figure 3 - Diaphragm assembly onto Alpha NRF flange

MALE CLAMPING RING

FEMALE CLAMPING RING

SILICONE DIAPHRAGM

MOUNTING RING

MAIN RING

CLAMPING SCREWS



Figure 4- Section view of the diaphragm clamping features

FEMALE CLAMPING RING

MALE CLAMPING RING

SILICONE DIAPHRAGM



4.2. Assembly of the LAC Alpha flange onto the Alpha NR flange. See Figure 5 and 6.

NOTE

The two handles of the Alpha NRF flange must be removed to complete the next


4.2.1. Insert the Alpha flange into the NRF Flange assembly as shown. Assure to place the

sealing gasket provided with the alpha flange between the two assemblies.

Figure 5 – Assembly of the 190 LAC Flange onto the Alpha NRF Flange

4.2.2. Place the alpha flange contrast ring onto the threaded body of the flange.

LAC ALPHA FLANGE

SEALING GASKET

ALPHA NRF FLANGE

CONTRAST RING

LOCKING RING



4.2.3. Thread the locking ring onto the threaded portion of the alpha flange body. Rotate until

snug. Do not overtighten.

4.2.4. Tighten all M8 locking set screws to permanently lock the alpha flange ring in place.

NOTE

The relative orientation of the LAC Alpha flange and the Alpha NRF flange

depends on the application. See Figure 6.

4.2.5. The orientation shown in Figure 6 will yield a correct positioning of the LAC Flange

with a horizontal swing of the alpha door when fully docked and a desirable rotation of

the NRF handles.

Figure 6 – LAC Alpha flange to NRF Flange orientation

HANDLE ORIENTATION

LAC FLANGE ORIENTATION



4.2.6. Figure 7 shows a cut-away view of the assembly.

Figure 7 – Cross section of the NRF flange with the LAC flange installed

ALPHA NRF FLANGE

LAC ALPHA FLANGE

SILICONE DIAPHRAGM



4.3. Assembly of the Alpha NR Flange Assembly onto the isolator wall

NOTE

The two handles of the Alpha NR flange must be removed to complete the next


Figure 8 – Assembly of the Alpha NRF Flange onto the isolator wall

NOTE

Do not support the weight of the Alpha NRF flange by the silicone diaphragm

until all the clamping nuts and washers have been completely assembled and

tightened.

4.3.1. Install the sterile side clamping ring on the silicone diaphragm.

CLAMPING RING – STERILE SIDE

ALPHA NRF FLANGE

ISOLATOR WALL

CLAMPING RING – NON-STERILE SIDE

CLAMPING HARDWARE



4.3.2. Place the assembly onto the isolator wall.

4.3.3. Install the non-sterile side clamping ring over the threaded studs protruding though the

isolator wall

4.3.4. Install washer and clamping nut. Tighten sequentially around the assembly.

NOTE

The assembly clamps the diaphragm in place. Do not over-tighten the locking

nuts. It is recommended to apply a small amount of low strength thread-lock

compound over the studs of the clamping ring upon assembly.

4.3.5. Figure 9 shows a cut-away view of the NRF Flange mounted onto the isolator wall



Figure 9 - Cut away view of assembled alpha NRF flange

LAC ALPHA FLANGE

ALPHA NRF FLANGE

SILICONE DIAPHRAGM

CLAMPING HARDWARE



4.3.6. Install the two turning handles onto the Alpha NR flange assembly to complete the

installation. See Figure 10.

Figure 10 - Close up of turning handles installation

HANDLE

LOCKING SCREWS

DOWEL PINS



4.4. Beta Flange

4.4.1. Attach the beta flange to the canister or tank using a standard 6 inch IDF sanitary clamp

and gasket. See Figure 11.

Figure 11 - Beta flange attachment to the canister or tank

TANK SIMULATOR

IDF CLAMP

IDF GASKET

BETA FLANGE



5. DOCKING INSTRUCTION

NOTE

For instruction purposes, the following images show the beta flange attached to a

simulator of the tank.

5.1. Bring the beta flange into proximity to the alpha flange

5.2. Rotate the Alpha NRF flange to bring the receptacles of the alpha flange into alignment with the

lugs of the beta flange. See Figure 12

Figure 12 - Beta lug alignment with alpha flange

5.3. Bring the beta flange into close proximity to the alpha flange while making sure to keep the two

flanges parallel and centered to each other. See Figures 13 and 14.

ALPHA FLANGE RECEPTACLE

BETA FLANGE LUG



Figure 13 - Approximate position of handle upon docking

Figure 14 - Alpha flange orientation upon docking



5.4. Use the handles of the Alpha NRF flange to pull the flange into contact with the beta flange.

Once in contact, turn the Alpha NRF flange counterclockwise (CCW) to dock the two assemblies

together.

5.5. See Figures 15 and 16

5.6. Make sure to turn the Alpha NRF flange the full 60 degrees required for a full docking.

Figure 15 - Approximate handle orientation after docking



Figure 16 - Approximate alpha flange orientation after docking

5.7. Once the alpha and the beta flanges are docked, open the Alpha/Beta door by actuating the door

locking mechanism.

5.8. The door is now free to be opened. See Figure 17.

ALPHA DOOR LOCK



Figure 17 - Alpha/Beta door open into isolator

`



6. BALL BEARING AND DYNAMIC SEAL REPLACEMENT

Replacement of the ball bearings and/or dynamic seal requires the disassembly of the Alpha NRF flange.

To accomplish this, the flange must be removed from the isolator system.

6.1. Remove the silicone diaphragm from the Alpha NRF Flange. See appropriate section.

6.2. Remove the LAC Alpha flange from the Alpha NRF flange. See appropriate section.

6.3. Proceed with Alpha NRF flange disassembly.

NOTE

The following maintenance 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.

6.4. Alpha NRF Flange disassembly

6.4.1. Remove and set aside the two turning handles. See Figure 18.

Figure 18 - Handle removal

MOUNTING SCREWS

DOWEL PINS

HANDLE



6.4.2. While laying the assembly flat on a clean surface, remove the outer ring by unscrewing

the 12 M6 socket head caps screws that clamp the assembly together. This exposes the

ball bearings top row. See Figure 19

Figure 19 - Outer ring removal

NOTE

Each ball bearing row consists of alternating Teflon (PTFE) and stainless steel

balls. Make sure to follow the same component order during re-installation of the

components.

OUTER RING

BALL BEARING TOP ROW



6.4.3. Remove all ball bearings from the upper groove. See Figure 20.

Figure 20 - Ball Bearings removal - Top row

6.4.4. Grab the assembly at 9 o’clock and 3 o’clock and, while holding it together, flip it over

back onto the clean flat work surface. See Figure 21

Figure 21 – Flange assembly flipped over



6.4.5. Lift the outer flange to expose the ball bearing row and the dynamic seal. See Figure 22.

NOTE

Each ball bearing row consists of alternating Teflon (PTFE) and stainless steel

balls. Make sure to follow the same component order during re-installation of the

components.

Figure 22 - Outer flange removal to expose dynamic seal and ball bearings

OUTER FLANGE

BALL BEARING ROW

DYNAMIC SEAL



6.4.6. Remove the Teflon dynamic seal and the compression seal from the upward facing

groove. See Figure 23.

Figure 23 - Dynamic seal removal

6.4.7. Inspect and replace, if necessary, the dynamic seal and compression seal.

6.4.8. This completes the disassembly of the Alpha NR flange.

COMPRESSION SEAL

DYNAMIC SEAL



6.5. Flange re-assembly

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

6.5.2. Perform a final inspection of the ball bearing races and dynamic seal groove to make

sure that they are free of dirt or lint.

NOTE

The ball bearing row consists of alternating Teflon and stainless steel ball. Make

sure to create the same alternating pattern upon re-assembly of the flange

NOTE

The silicone compression seal must be well placed in the groove upon

reassembly. Make sure that it is well centered and not twisted. The silicone seal

is easier to manipulate when wet. Place a small amount of Isopropyl Alcohol in

the groove to facilitate this process.

6.5.3. Reverse the steps outline above to reassemble the flange.

6.5.4. Refer to figure 24 for a cross sectional view of the Alpha NR flange. This view will help

the mechanic understand the assembly of the Alpha NR flange.

Figure 24 - Cross section view of the Alpha NRF flange



6.5.5. Once reassembled, test the NRF flange for proper operation.

6.5.5.1. Use the turning handles to turn the inner ring relative to the outer flange. The

rotation should be smooth and with slight resistance.

6.5.5.2. The smoothness is an indication that the ball bearings have been properly

installed.

6.5.5.3. The resistance to turning is an indication that the dynamic seal was properly

installed and is working properly.

6.5.5.4. It is recommended to run an ammonia leak test after such major overall of the

Alpha NRF flange.



7. SYSTEM SPECIFICATION

7.1. Human factor and safety

7.1.1. The Alpha NRF flange fastens securely but in a flexible manner to the isolator bulkhead.

7.1.2. The LAC 190 Alpha Port fastens securely in the Alpha NR flange.

7.1.3. The Alpha NR handles permit turning the flange with a maximum force of 4.5 Kg (10

lbs.)

7.1.4. Docking the beta flange to the Alpha NRF requires a turning force that is typical of

alpha/beta port docking operations.

7.2. Physical configuration

7.2.1. Beta flange

7.2.1.1. Standard Beta flange including door and seal

7.2.1.2. Adapter Beta flange to Canister: 6 inch IDF flange interface

7.2.2. Alpha flange

7.2.2.1. Standard Alpha flange including polyethylene door and seal

7.2.3. Alpha NRF flange

7.2.3.1. Dynamic seal system that permits turning the alpha flange relative to the

isolator wall

7.2.3.2. Docking handles 180 degrees apart allow the operator to turn the Alpha NR

flange during docking operations.

7.2.3.3. Bearing system consisting of multiple ball bearings housed inside machined

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

7.3. Mounting

7.3.1. The Alpha NRF flange can be mounted and operated at any mounting orientation

(Vertically, horizontally and at any angle in between).

7.3.2. Attachment to the isolator wall

7.3.2.1. Flexible attachment using a silicone diaphragm

7.3.2.2. Stainless steel frame to clamp the diaphragm to the isolator wall.

7.4. Physical specification

7.4.1. Nominal port size: 190mm.

7.4.2. Weight

7.4.2.1. Alpha NR flange: 27 Kg.

7.4.2.2. Alpha Flange and Door: 17.5 Kg.

7.4.2.3. Beta flange and adapter: 10 Kg.

7.4.3. Outside diameter of Alpha NRF flange: 464mm.



7.4.4. Diameter of opening in isolator wall: 550mm.

7.4.5. Swing radius of turning handles: 800mm.

7.5. Cleaning and sterilization capability

7.5.1. The Alpha NRF flange is designed to withstand and facilitate standard cleaning

procedures using cleaning agents that are commonly used in aseptic applications.

7.5.2. Materials of construction are compatible with the VHP decontamination process.

7.6. Leak Tightness

7.6.1. The Alpha NRF flange is capable of passing an ammonia leak test from either side when

pressurized to 250 PA maximum.

7.6.2. The fully assembled system (Alpha, Beta and Alpha NRF Flange) is capable of passing

ammonia leak test when pressurized to 250 PA



8. FUNCTIONAL SPECIFICATION

8.1. Docking functionality: Beta flange to Alpha flange

8.1.1. The Alpha NRF flange is such that the standard Alpha flange mounting within the Alpha

NRF flange permits unobstructed docking of the Beta flange.

8.1.2. The Alpha NRF flange is such that the beta flange can be docked without any rotation of

the beta flange.

8.2. Alpha Flange rotation

8.2.1. The Alpha NRF rotation is smooth through its 60 degrees of travel.

8.2.2. Rotation of the Alpha NRF flange is accomplished by using two handles provided.

8.2.3. Torque required to lock the beta flange onto the Alpha NRF assembly is 4.5Kg

maximum.

8.3. Beta door removal.

8.3.1. Removal of the beta door from the beta flange can be easily accomplished with the aid of

the beta door removal tool P/N DD-1825.



9. DESIGN SPECIFICATION

9.1. Alpha Flange

9.1.1. The Alpha flange is a standard Getinge-La Calhene 190 size Alpha Flange.

9.2. Beta flange

9.2.1. The Beta flange is a standard Getinge-La Calhene 190 size Beta Flange.

9.3. Alpha NRF Flange

9.3.1. The Alpha NRF flange is a proprietary Dynamic Design Pharma assembly.

9.3.2. The Alpha NRF flange features a bearing system which allows smooth and accurate

rotation of the Alpha flange relative to the beta flange.

9.3.3. The Alpha NRF flange features a dynamic seal which creates a seal between opposite

sides of the flange while permitting free rotation of flange components relative to each

other.

9.3.4. The Alpha NRF flange features two handles 180 degrees apart that allow the operator to

turn and lock the Alpha NR flange relative to the beta flange.

9.4. Dynamic seal

9.4.1. The dynamic seal creates an airtight interface between opposite sides of the Alpha NRF

flange.

9.4.2. The dynamic seal is a face seal. This seal requires a preload force applied by a molded

silicone compression seal.

9.4.3. The dynamic seal material is PTFE. Because of the low friction property of the PTFE

material, the dynamic seal requires low force to actuate.

9.5. Ball Bearing system

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

grooves machined in the Alpha NR flange.

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

positioning.

9.5.3. Ball bearing material is stainless steel and PTFE.

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

9.6. Mounting to the isolator wall

9.6.1. The Alpha NRF is mounted to the isolator wall with a 6.35mm thick silicone rubber

diaphragm.

9.6.2. The diaphragm attaches to the Alpha NRF flange by two stainless steel compression

rings under load by a number of radially located M6 screws.



9.6.3. The diaphragm attaches to the isolator wall by means of two stainless steel clamping

rings compressed together by a series of radially located clamping studs and acorn nuts.

9.7. Materials of construction and surface treatment

9.7.1. Alpha NRF flange: 316L Stainless Steel.

9.7.2. Dynamic Seal: PTFE and Silicone.

9.7.3. Alpha Flange: 316L Stainless Steel and silicone.

9.7.4. Beta Flange: 316L Stainless Steel and silicone.

9.7.5. Ball bearings: 316L Stainless Steel and PTFE.

9.7.6. Hardware: 18-8 stainless steel, metric socket head and button head cap screws.



10. RECOMMENDED SPARE PARTS

Following are recommended spare parts for the system

Item Qty/unit Part number Description Manufacturer

1 1 LAC 20161 190mm Beta Gasket Seal Getinge-La Calhene

3 1 LAC 373 190mm Alpha Gasket Seal Getinge-La Calhene

4 1 DD-1805 Dynamic Seal DDP

5 1 DD-2199 Dynamic Seal, Compression DDP

6 1 DD-2160 Diaphragm DDP

7 200 96415K75 Ball Bearing – Stainless Steel McMaster

8 200 9660K37 Ball Bearing – PTFE McMaster



11. ASSEMBLY DRAWINGS

The following assembly drawings are included in this document.

11.1. DD-2084 System Outline, 190 Alpha NRF

11.2. DD-2189 Outline, beta flange with IDF Adapter

11.3. DDA-2027 System Assembly, 190 Alpha NRF

11.4. DDA-2026 Assembly, Alpha Flange to NRF Flange.

11.5. DDA-2025 Assembly, 190 Alpha NRF Flange.

11.6. DDA-2028 Assembly, Beta Flange to Canister.

12. ATTACHMENTS

12.1. Certifications

12.1.1. Materials

12.1.2. Surface Treatment

12.2. Factory Acceptance Test (executed)

12.3. Leak test reports

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