Sp scientific Fts systems lyo-sea User manual

SAMPLE EXTRACTOR ASSEMBLY OPERATOR’S MANUAL

FTS

YSTEMS

-SEA

FOR

ENESIS

AMPLE

XTRACTOR

SSEMBLY

Rev 002, 04/11 i

All brand or product names mentioned may be trademarks or registered trademarks of their respective

companies.

Part Number 100003254

Rev 002, 04/11

SP Scientific

815 State Route 208

3538 Main Street

Gardiner, NY 12525 USA

Stone Ridge, NY 12484 USA

(800) 431-8232

(845) 255-5000

SP Service

(877) 548-4666

SP Service Fax

(845) 687-0024

Website

http://www.spscientific.com/

This Sample Extractor Assembly Operator’s Manual contains confidential and proprietary information of

SP Scientific and may be used only by a recipient designated by and for purposes specified by SP

Scientific.

Reproduction of, dissemination of, modifications to, or the creation of derivative works from this Sample

Extractor Assembly Operator’s Manual, by any means and in any form or manner, is expressly prohibited,

except with the prior written permission of SP Scientific. Permitted copies of this document must retain all

proprietary notices contained in the original.

The information in this document is subject to change without prior notice. Always confirm with SP

Scientific that you are using the most current version of this document. SP Scientific is free to modify any

of its products and services, in any manner and at any time, notwithstanding the information contained in

this document.

THE CONTENTS OF THIS DOCUMENT SHALL NOT CONSTITUTE ANY WARRANTY OF ANY KIND,

EITHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES

OF MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE OR GIVE RISE TO ANY

LIABILITY OF SP SCIENTIFIC, ITS AFFILIATES OR ITS SUPPLIERS.

The terms and conditions governing the use of this Sample Extractor Assembly Operator’s Manual shall

consist of those set forth in written agreements with SP Scientific.

ii Rev 002, 04/11

Important Symbols

WARNING!

INJURY OR EVEN DEATH

MAY RESULT IF A

RECOMMENDATION MARKED

WITH THIS SYMBOL IS NOT

HEEDED.

CRUSH HAZARD. KEEP HANDS

CLEAR WHEN OPERATING DOOR.

ELECTRIC SHOCK DANGER!

USE APPROPRIATE CAUTION

TO AVOID INJURY OR DEATH.

CORROSIVE CHEMICAL. WEAR

SUITABLE GLOVES, SAFETY

GLASSES, AND PROTECTIVE

CLOTHING.

BURN DANGER! POTENTIALLY

HOT SURFACE. USE

APPROPRIATE CAUTION.

PROPERTY CAUTION! TO PREVENT

DAMAGE TO CHAMBER EQUIP-

MENT AND/OR LOAD, ADHERE TO

PROCEDURES MARKED BY THIS

SYMBOL.

DO NOT STORE FLAMMABLE

MATERIALS IN CHAMBER.

PRACTICAL OPERATING TIP.

THESE RECOMMENDATIONS

STREAMLINE UNIT OPERATION

AND PREVENT COMMON

OPERATOR ERRORS.

WEAR SAFETY GLASSES.

EXPLOSIVE MATERIALS HAZARD!

KEEP OBJECTS AWAY FROM HEAT.

Freeze Dryer Safety Warnings

Always assume that shelf, condenser and internal parts may be very cold or very hot. Wear protectiveequipment to avoid burns.

Always ensure that only an authorized technician services the refrigeration, heat transfer, vacuum and electricalsystems.

Always ensure that the refrigeration air intake is clear and clean.

Always ensure vacuum pump exhaust is properly ventilated and/or contained.

Always practice team lifting when moving heavy equipment.

Always use a maximum one pound regulator if backfilling from an inert gas source.

Always wear safety glasses when using glass flasks.

Be sure to carefully read the entire instruction manual before attempting to operate the freeze dryer.

Be sure to verify that the electric service and other utilities match the unit’s requirements before connecting topower.

Never allow hand or body contact with open vacuum ports.

Never clean with solvents. Use mild detergent and water only.

Never operate the unit without all covers in place.

Never pressurize a freeze-drying chamber unless it has been specially designed and coded as a pressurevessel (e.g., displays an ASME-coded certificate).

Never stopper vials unless the chamber door is tightly closed.

Never use acrylic closures if they are cracked or crazed.

Never use with toxic, corrosive, flammable or organic materials unless special precautions are in place toprevent injury to personnel or damage to equipment.

Rev 002, 04/11 iii

Warranty Information

FTS Systems Lyo-SEA for VirTis Genesis is warranted by SP Scientific to be free of defects in material and

workmanship when operated under normal conditions as specified in the instructions provided in this manual. Please

take this opportunity to locate the serial tag on your new FTS Systems Lyo-SEA for VirTis Genesis and record the

information below for future reference. SP Scientific also recommends that you complete and return your unit’s

warranty registration card.

Model Number

Serial Number

Part Number

Limited Warranty

SP Scientific (the “Company”) shall warrant each of its products against defects in material or workmanship for a period

of 12 months from the date of installation or 15 months from the date of shipment (whichever comes first) provided that

the product is used in a reasonable manner under appropriate conditions and consistent with the applicable operating

instructions.

The obligation of the Company shall be, at its option, to repair or replace, without charge any parts that prove to be

defective within the warranty period, if the purchaser notifies the Company promptly in writing of such defect. No

product shall be returned to the Company without prior approval of the Company.

This limited warranty shall cover the costs of parts and labor to repair or replace all defective product(s) at the Seller’s

factory. For all products installed by the Company and located within the Company service travel areas, this warranty

shall cover transportation charges to ship the product to and from the Company’s factory and/or the costs of travel,

room and board if the Company’s employees conduct repair at the Buyer’s location. In lieu of repair or replacement at

the Company’s factory, the Company may, in its discretion, authorize a third party to perform the repair or replacement

at the Buyer’s location, and at the Company’s sole expense.

The Company shall not be responsible for labor charges payable with respect to persons other than Company

employees. Replacement or repair of parts pursuant to this warranty shall not in any way extend the original warranty

period. The Company shall not be responsible for any unauthorized repairs, replacements or product modifications, nor

will it be responsible for any product failures resulting from such unauthorized repairs, replacements or product

modifications negligently or otherwise made by persons other than Company employees or authorized representatives

of the Company. The buyer shall assume transportation charges to ship the product to and from the Company’s factory

and the costs of travel, room and board if the Company’s employees conduct repair at the Buyer’s location within the

warranty period if the product was not installed by the Company’s and/or is not located within the Company’s service

travel areas.

THE COMPANY DOES NOT MAKE AND EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR

FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, WITH

RESPECT TO THE SALE, INSTALLATION, DESIGN OR USE OF ITS PRODUCTS. ADDITIONALLY, THE

COMPANY SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF OR

ANY DEFECTS IN ITS PRODUCTS.

The Company’s employees are available to provide general advice to customers concerning the use of the Company’s

products; however, oral representations are not warranties with respect to particular products or their uses and may not

be relied upon if they are inconsistent with the relevant product specifications for the items set forth herein.

Notwithstanding the above, the terms and conditions set forth in the Company’s formal sales contracts shall be

controlling and supersede any inconsistent terms contained herein, and any changes to such contracts must be made

in writing and signed by an authorized executive of the Company.

WARNING! THE DISPOSAL AND/OR EMISSION OF SUBSTANCES USED IN

CONNECTION WITH THIS EQUIPMENT MAY BE GOVERNED BY VARIOUS FEDERAL,

STATE OR LOCAL REGULATIONS. ALL USERS OF THIS EQUIPMENT ARE URGED TO

BECOME FAMILIAR WITH ANY REGULATIONS THAT APPLY IN THE USERS AREA

CONCERNING THE DUMPING OF WASTE MATERIALS IN OR UPON WATER, LAND OR

AIR AND TO COMPLY WITH SUCH REGULATIONS.

iv Rev 002, 04/11

Rev 002, 04/11 v

Contents

Important Symbols...............................................................................................................................................ii

Freeze Dryer Safety Warnings.............................................................................................................................ii

Warranty Information .......................................................................................................................................... iii

Introduction .................................................................................................................1

Extractor Components .........................................................................................................................................1

Installation...................................................................................................................3

Standard Door Removal ......................................................................................................................................3

Operation ....................................................................................................................5

Operation.............................................................................................................................................................5

Shelf Spacing.......................................................................................................................................................9

Contents

FTS Systems Lyo-SEA for VirTis Genesis

vi Rev 002, 04/11

Rev 002, 04/11 1

Chapter

Introduction

The optional Lyo-SEA Sample Extractor allows you to select and remove a serum

bottle or vial from the product chamber at any time during a freeze-dry run. The

selection and removal process is achieved with virtually no interruption to the drying

process. The simplicity of the design and ease of use provides a cost effective

methodology for periodic removal of product for sample analysis. The Sample

Extractor is often pivotal in product development or stability studies.

Note: The Lyo-SEA Sample Extractor requires the use of an auxiliary vacuum pump to

depressurize the antechamber.

Extractor Components

The Lyo-SEA Sample Extractor is comprised of a modified acrylic door with the

following components:

Stoppering Ram

Acrylic Door

Vacuum Antechamber

Vacuum Gauge

Jaw Controls

Selector Arm

Thumbscrews

Inert Gas Backfill / Vacuum Break

Vacuum Pump

Inlet

Filter

Isolation Door Lock / Handle

Antechamber Isolation Door

Introduction

FTS Systems Lyo-SEA for VirTis Genesis

2 Rev 002, 04/11

Rev 002, 04/11 3

Chapter

Installation

Standard Door Removal

Before installing the Lyo-SEA Sample Extractor, the standard acrylic door must be

removed from the freeze-dryer.

To remove the door:

Ensure that the unit is not in operation and that the product chamber is not1. under vacuum.

Remove the left side panel from the unit.2.

Open the product chamber door. Have an assistant in position to support the3. door.

Remove the existing product chamber door and hinge bracket by removing4. the four hex nuts and two spacers. Slide the assembly outward through the

frame in an upright position.

Install the door of the Lyo-SEA with hinge stands into the frame. Reuse the5. tube spacers and hardware from the original assembly.

Close the door.6.

Adjust the hinge stands so that the chamber gasket presses evenly when the7. door is in the closed position. This is accomplished by tightening the nuts on

the hinge. When proper contact is achieved, a dark black surface should be

visible between the acrylic door and the chamber gasket surface.

Re-install the left side panel.8.

Hex Nut

Spacer

Hinge Bracket

Frame

Hinge Bracket Assembly (Top View)

Lyophilizer

Front Panel

Hex Nut

Acrylic Lyo-SEA Door

Hinge Stand

(Top)

Installation

FTS Systems Lyo-SEA for VirTis Genesis

4 Rev 002, 04/11

Rev 002, 04/11 5

Chapter

Operation

Before beginning operation of the Lyo-SEA Sample Extractor, ensure that the front

plate is closed and that the inert gas/vacuum break valve is closed.

Operation To operate the Lyo-SEA Sample Extractor:

Activate the auxiliary vacuum pump to depressurize the antechamber.1.

After the gauge stabilizes at the maximum position, allow the vacuum pump to2. operate for an additional 15 minutes.

Open the antechamber isolation door. With locking handle in the up position3. (unlocked), slide the antechamber door open.

When the antechamber isolation door is fully open, you may lower the handle4. to lock the isolation door in position.

Antechamber Isolation Door

Raise handle to

unlock door.

Operation

FTS Systems Lyo-SEA for VirTis Genesis

6 Rev 002, 04/11

Manipulate the selector arm to select and extract vial(s).5.

Vials are held securely in spring-loaded jaws. Push the button on the selector6. arm to open the jaws. Release the button to close the jaws.

Place a sample in the antechamber directly beneath the stoppering ram.7.

Push button on selector

arm to open jaw.

Vial held in spring-loaded

jaws. Push button on

selector arm to open jaws

and release vial.

Vial placed beneath

stoppering ram.

Stoppering Ram

FTS Systems Lyo-SEA for VirTis Genesis

Operation

Rev 002, 04/11 7

Slide the isolation door closed and lower the handle to lock it into position.8.

Prior to stoppering the sample, you may backfill the antechamber with an inert9. gas, such as nitrogen (N2(gas)) via the vacuum break valve. Connect your inert

gas source to the vacuum break valve via the filter attachment.

Remove the plastic shroud from the stoppering ram. Press down on the10. stoppering ram to manually stopper the vial.

Handle lowered to

lock isolation door

into position.

Isolation Door

Vacuum Break Valve

Plastic Shroud

(Stoppering Ram)

Stoppering Ram

Vial Sample

Stopper

Connect an inert gas source

to the vacuum break valve via

the filter attachment.

Vacuum Break Valve

Operation

FTS Systems Lyo-SEA for VirTis Genesis

8 Rev 002, 04/11

Before the sample can be removed from the antechamber, the antechamber11. pressure must be returned to atmospheric pressure. If you have connected an

inert gas source for backfilling, remove it now. Open the vacuum brake valve

to release vacuum from the antechamber. Allow the antechamber to return to

atmospheric pressure.

Loosen the thumbscrews on each side of the antechamber and push down on12. the front plate until it can be opened.

Note: Vacuum pressure in the chamber will cause the antechamber front plate gasket

to seal. In order to break the seal, you may need to apply force initially when sliding

down the front plate.

Flip down the front plate.13.

Remove the vial(s).14.

Close the front plate to reseal the antechamber.15.

Thumbscrews

Antechamber

Front Plate

Push down on the

front plate until it can

be opened. You may

need to apply force

initially.

Antechamber

Front Plate

Vial Sample

FTS Systems Lyo-SEA for VirTis Genesis

Operation

Rev 002, 04/11 9

Shelf Spacing

Certain applications of the Lyo-SEA sample thief may require shelf spacing

adjustments.

To adjust shelf spacing:

Ensure that all shelves are empty before continuing.1.

Press and hold the stoppering switch in the Down position to allow the shelf2. stack to compress fully.

Remove the four (4) upper shoulder screws and install latching rod3. extensions. Remove only the upper shoulder screws installed in the four

corners of the top shelf.

Replace and secure the four (4) upper shoulder screws.4.

Press and hold the stoppering switch in the Up position to allow the shelf5. stack to extend and return to its original position. The second product shelf

(now located near the bottom of the chamber) may be loaded with product.

Insert a corrugated shelf spacer on the first product shelf to ensure sufficient6. cylinder stroke to stopper the vials.

To return the shelves to their original configuration, repeat the process and7. remove the latching rod extensions. Ensure that the shoulder screws are

secured before extending the shelf stack.