ADVANTAPASS USER MANUAL REV 2 - rodem.com · 4 • Phone: 215-526-2151 • Toll Free Phone:...

www.advantapure.com • Phone: 215-526-2151 • Toll Free Phone: 888-755-4370

ADVANTAPASS™ USER MANUAL

PURITY IN FLUID FLOW SYSTEMS®

FROM

REV 2.0

3www.advantapure.com • Phone: 215-526-2151 • Toll Free Phone: 888-755-4370


INTRODUCTION

AdvantaPass™ (U.S. Patent 8,870,230) permits aseptic transfer of fluids between thewalls of pharmaceutical manufacturing suites. It supports the separation of differentclasses of clean rooms and lessens the risk to environments.

The system provides a reliable method for transferring fluids without physically movingbins and totes, thereby eliminating the risk of breakage and spillage during bin transfer.It’s a practical, safe and easy way to move large volumes of liquids from one room toanother.

This User Manual contains the basic instructions for using an installed AdvantaPasssystem to pass-through fluid transfer components from a “clean” space to a “dirty” one.

The instructions are color coded to help clarify which space the individual steps areperformed in:

Your AdvantaPass has most likely been customized to meet your specific requirements.The AdvantaPass system depicted in this manual may differ from your actualconfiguration. Depending on your application, your AdvantaPass system may or may nothave a built-in purge port. This option is used to more effectively maintain a positive airflow from the clean side to the dirty side when passing components through theAdvantaPass. Your purge port set-up may utilize end user supplied valves and 0.2 micronhydrophobic style air filters to provide additional functionality in maintaining separationbetween the different environments.

IMPORTANT: REMEMBER TO ALWAYS MOVE COMPONENTS THROUGH THEADVANTAPASS STARTING FROM THE CLEAN SIDE TO THE DIRTY SIDE.

CAUTION: THE ADVANTAPASS SYSTEM IS NOT A PRESSURE VESSEL AND IS NOTINTENDED TO HANDLE LIQUID PRESSURE.

blue for the clean side tan for the dirty side

4 www.advantapure.com • Phone: 215-526-2151 • Toll Free Phone: 888-755-4370


COMPONENTS

The AdvantaPass System consists of several stainless steel components that create theportal assembly. The Single-Use Isolator Assembly consists of AdvantaPure siliconetubing or AdvantaFlex® biopharmaceutical grade TPE (thermoplastic elastomer) tubingthat passes through two isolator flange seals. Single-Use Isolator Assemblies may alsoinclude customer supplied aseptic connectors or other types of quick-connects dependingon the particular application.

Some of your components may appear different than what is shown below:

*Sanitary clamps provided are BPE compliant. Non-BPE clamps may not work with AdvantaPass.**The Single-Use Isolator Assembly consists of one or more sections of AdvantaPure tubing and

two Isolator Flange Seals.

A - Sanitary Clamps* (2)B - Plastic Support Rings (4)C - Single-Use Isolator Assembly**D - Pipetites (2)

E - Portal (shown with optional purge port)F - Solid Isolator Seals (2)G - Solid End Caps (2)H - Split-ring Clamps (2)

A

D

C

D

B

E

F

F

G

HH



1. Install Purge Valve Assembly

If your AdvantaPass has the optional purge port,attach a valve assembly, filter and air supply line atthis time.

CAUTION: Purge port assembly is rated for 5 psig maximum.

2. Remove Clean Side EndCap & Seal

Open the sanitary clampand remove the end capand solid isolator seal.

3. Clean Interior of Pass-Through Portal

Wipe down the interior surface with alcohol oranother sanitizing agent suitable for 316Lstainless steel.

PASS-THROUGH ASSEMBLY INSTRUCTIONS

IMPORTANT: BEFORE YOU BEGIN, MAKE SURE BOTH SIDES OF THE ADVANTAPASSSYSTEM ARE CAPPED AND SEALED.

CLE

AN

SID

ECL

EA

N S

IDE

CLE

AN

SID

E



5. Attach Split-Ring Clamp

Continue to insert the assembly into the portal, positioning the second seal evenlyagainst the inside lip of the metal flange. Place the split-ring clamp over the seal andportal flange, then secure the assembly in place.

4. Insert Single-Use Isolator Assembly

The assembly includes AdvantaPure silicone or AdvantaFlex® biopharmaceutical TPEtubing and two flexible isolator flange seals. Begin passing the assembly into theAdvantaPass portal, flexing the first seal so that it fits inside.

CLE

AN

SID

ECL

EA

N S

IDE




7. Remove Dirty Side End Cap & Solid Isolator Seal

CAUTION: If your system has the optional purge port, check for air flow from theexhaust port. If the port is blocked or closed, the portal will be pressurized.

6. Purge AdvantaPass Portal

If your system has the optional purge port, openthe air valve at this time.

CLE

AN

SID

ED

IRTY

SID

E

YOU ARE NOW READY TO CONTINUE THE PROCESS FROM THE DIRTY SIDE




YOUR ADVANTAPASS SYSTEM IS NOW READY FOR USE

9. Attach Split-Ring Clamp

Position the seal evenly against the inside lip of the metal flange. Place the split-ringclamp over the seal and portal flange, then secure the assembly in place.

DIR

TY S

IDE


8. Pull Isolator AssemblyThrough

Pull the single-use isolatorassembly through theopening until the first flangeseal is outside of the portal. D

IRTY

SID

E



1. Disconnect or Heat Seal Clean Side Assembly

If you are using aseptic connectors or other typesof quick-connects, disconnect them now.AdvantaFlex® biopharmaceutical grade TPE tubingcan be heat sealed and then cut to disconnect. IfAdvantaPure silicone tubing is provided with theassembly, it can be crimp sealed.

3. Insert Isolator Assembly

Push the entire assemblyinto the AdvantaPass portal,flexing the flange seal sothat it fits inside.

PASS-THROUGH DISASSEMBLY INSTRUCTIONS

CLE

AN

SID

ECL

EA

N S

IDE

2. Remove Clean Side Split-Ring Clamp

Open the split-ring clamp and remove.

CLE

AN

SID

E



5. Open Dirty Side

Remove the split-ring clamp and pull the entire single-use isolator assembly throughthe opening until completely outside of the portal.

DIR

TY S

IDE

CONTINUE THE PROCESS FROM THE DIRTY SIDE

4. Attach Solid Isolator Seal & End Cap

Position the solid isolator seal evenly against the inside lip of the metal flange. Placethe end cap on top to seal the opening and secure with the sanitary clamp.

CLE

AN

SID

E




6. Attach Solid Isolator Seal & End Cap

Position the solid isolator seal evenly against the inside lip of the metal flange. Placethe end cap on top to seal the opening and secure with the sanitary clamp.

DIR

TY S

IDE

7. Turn Off Clean Air Supply

If your system has the optional purge port, close theair valve at this time.

NOTE: Periodically check purge filters per your SOP.

CLE

AN

SID

E

FINISH THE PROCESS FROM THE CLEAN SIDE

YOUR ADVANTAPASS SYSTEM IS NOW CAPPED AND SEALED



Address: NewAge Industries AdvantaPure®

145 James Way Southampton, PA 18966 U.S.A.

Toll Free Phone: 888-755-4370Phone: 215-526-2151Toll Free Fax: 888-258-4293Fax: 215-526-2167Web Site: www.advantapure.comE-mail: [email protected]

©2014-2015 NewAge® Industries, Inc.AdvantaPass™, NewAge Industries AdvantaPure®, NewAge®, the "N" logo, and Purity in Fluid Flow Systems® are trademarks of NewAge® Industries, Inc.All other trademarks are the property of their respective owners.

09-30-15

WARRANTY: NewAge Industries AdvantaPure products are warranted to be free from defects in material and workmanship. Any product found to carry such defects will be replaced without charge. This warranty is limited only to the replacement ofNewAge Industries AdvantaPure products, item for item, which after examination by NewAge Industries AdvantaPure are deemed defective. NewAge Industries AdvantaPure specifically disclaims any other liability. The data supplied is provided as ahelpful guideline and is believed to be reliable; however, nothing stated shall constitute a guarantee, recommendation, or warranty for any application.NOTICE: NewAge Industries, Inc. has been a privately owned corporation since 1954. Neither the corporation nor its principals are affiliated, in any way, with any other group or entity either representing themselves as or being referred to by the term New-Age.

DISTRIBUTED BY:

Purity in Fluid Flow Systems®

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NOTES

ADVANTAPASS USER MANUAL REV 2 - rodem.com · 4 • Phone: 215-526-2151 • Toll Free Phone:...

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