RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007

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STAINLESS STEEL GLOVE ISOLATOR

Isolator for Toxic Product Handling

European version

SPECIFICATION

PRODUCT SPECIFICATION

The GETINGE La Calhène containment isolator is a

leaktight enclosure equipped with means of transfer and

manipulation which keep enclosed environment allowing the

introduction and removal of toxic equipment and/or

products.

APPLICATION

The containment isolator is a confined environment in which

it is possible to carry out the weighing, the dispensing and

other various handling of toxic powder.

KEY FEATURES

� 316L stainless steel isolator shell,

� One glass window on which are mounted three or four

shoulder rings allowing to operate inside the toxic

environment,

� 304 L stainless steel welded supporting frame,

� External lighting in the ventilation housing,

� Ventilation system capable of more than 3 air changes per

hour, and negative pressure of -50 ± 10 Pa (adjustable),

� Control system:

- Manual command with automatic pressure control

“PARIS 1” type,

� Double inlet and outlet HEPA filters,

� Manipulation through gloves (changeable without

breaking the containment),

� Transfer system using DPTE® double door systems.

QUALITY STATEMENT

Confidence in the Getinge group is the most important

quality criteria. This must be the hallmark of all our external

and internal commitments, activities and products. Products

and services supplied by Getinge must conform to the

agreed terms and expectations to ensure recommendations

for further business. The achievement of these quality goals

is the basis for continued competitive and successful

enterprise.

STANDARDS & CODES

The containment isolator complies with all appropriate

standards, codes and directives relevant to the region of

installation. The equipment is manufactured according to

industry requirements and standards.

Electrical regulations

� Directive n° 89/336/EEC amended 92/31/EEC,

� Directive n° 73/23/EEC.

Glove regulations

� Directive n° 89/686/EEC.

CUSTOMER:

REFERENCE:

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 2 of 9

DESCRIPTION PRODUCT DESCRIPTION

The containment isolator is composed of 5 parts:

� Containment enclosure .1.

� Ventilation / filtration .2.

� Control system .3.

� Manipulation system .4.

� Transfer system .5.

In this picture, a dispensing isolator for toxic power

OPERATION PRINCIPLE

� The isolator is equipped with a ventilation / filtration

module, which maintains a negative pressure in the toxic

volume while ensuring a minimum of air change using

filtered air (low in order to avoid powder dispersion).

� The operator can operate inside the toxic environment

using manipulation systems (3 or 4 gloves in front face)

while remaining outside this environment.

� If necessary connection to a process equipment (vessel,

reactor, filter dryer, oven).

BASIC DESIGN FEATURES

Design features and material definition conform to the

specification listed below, unless specifically mentioned as

optional.

Containment enclosure

Stainless steel isolator sheel

The shell is constructed from solid, high quality, stainless

steel (type 316 L or European equivalent).

Surfaces are polished to facilitate cleaning (Ra 0,5 µm and

Ra 0,8 µm) in accordance with ISO 1302.

The 1’’½ drain on the base makes possible to evacuate

liquids (cleaning agents).

Stainless steel welded structure

Supporting frame is constructed from solid, high quality,

stainless steel (type 304L or European equivalent).

Surfaces are polished to facilitate cleaning (Ra 0,8 µm in

accordance with ISO 1302 norm except for welding).

One glass window on which are mounted two shoulder

rings

Tailgate The front face of the isolator is equipped with an hinged

window, supported by two jacks.

Window

� The glass is made of transparent tempered securit glass

according to EN 12150.

Ventilation / filtration with ‘‘PARIS 1’’ type regulation

It comprises two modules (Air inlet and air outlet modules):

Air inlet module (inlet air) with:

� Inlet pre-filter,

� 99,99% DOP HEPA cartridge filter.

� DN 50 isolation valve in PVC (isolation valve),

� 99,99% DOP HEPA cartridge filter.

Air outlet module (extraction) with:

� 99,99% DOP HEPA cartridge.

� DN 50 isolation valve in PVC,

� 99,99% DOP HEPA cartridge.

� Leaktight extraction air blower,

Control system

Manual command with automatic pressure control PARIS 1:

� Adjustment of the set pressure,

� Display of the measure of the pressure,

� Parameters of high and low thresholds of pressure

supervision with audible and visual alarms.

Manipulation system

AD system:

AD shoulder ring is used with AD full glove. The mounting and the replacing of these AD gloves are carried out using a special ejecting device and based on “push-push” technique. This glove change-over is carried out without breaking the containment, without risk for the operator and is not operator dependant. The standard is:

� Full glove Hypalon® sleeve (9 3/4 size).

5

2

4

1

3

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 3 of 9

Principle

Transfer system (DPTE®-S)

DPTE®-S transfer system (Ø105, Ø190, Ø270, Ø350)

mounted on the side walls and / or on the working base for

the connection of a DPTE® BETA transfer system.

It comprises two parts:

� DPTE®-S transfer system .1.

� Dummy container .2.

DPTE®-S transfer system:

The DPTE®-S is totally interlocked and allows safe

connection/disconnection of the DPTE® Beta part.

The Alpha flange is constructed from solid, high quality,

stainless steel (type 316L or European equivalent).

The Alpha door is manufactured of high molecular weight

HDPE.

A J3L I lip seal made of PVC (polyvinyl chloride) is

mounted onto the Alpha door.

Dummy container:

The DPTE®-S are supplied with a dummy container for

easier bio decontamination of the seal surface areas.

The dummy container is manufactured of high molecular

weight HDPE.

A J3L E lip seal made of PVC (polyvinyl choride) is

mounted onto the beta flange.

Transfer system (1/2“ tri-clamps and cables glands)

The tri-clamps and compression fitings are manufactured

from solid, high quality, stainless steel (type 316L or

European equivalent). The two tri-clamps and two

compression fitings are located in the side isolator (air

sampling connection and cable of the particle counter,

spray gun for exemple).

Accessories

� PTFE Spray gun

Spray gun for cleaning inside the isolator.

2

1

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 4 of 9

ORDERING

ORDERING

Description

Use the description below in combination with the capacity

table to select the appropriate models.

Example Model: ISO IX TOXIC 3 GTS A F R

Range Name

Type

Installation style

INSTALLATION STYLE SELECTION

Containment enclosure

3 Gloves (3 GTS)

4 Gloves (4 GTS)

Transfer system

DPTE®-S transfer system

TYPE

Left

hand

side

Right

hand

side

Bottom

Left hand

side

Bottom

Right hand

side

DPTE®-S

Ø 105 (A) (B) (J) (K)

DPTE®-S

Ø 190 (C) (D) (L) (M)

DPTE®-S

Ø 270 (E) (F) (N) (P)

DPTE®-S

Ø 350 (G) (H) (Q) (R)

DIMENSIONS (Detail see page 7)

OPTION LIST

Ventilation / filtration

Compressed air/nitrogen suply

Control system

Humidity display and transmitter

Paper recorder

Manipulation system

Full AD glove Hypalon®

Size 4/10

9 3/4 Standard

8 1/2

Full AD glove Butyl

Size 4/10

9 1/2 9 3/4

Full AD glove Neoprene

Size 4/10 6/10

9 9 3/4

Full AD glove Neoprene antistatic

Size 6/10

9

Hypalon ® sleeve negative pressure assembly

Hypalon glove

Size 3/10

T7 T8 T9 Neoprene glove

Size 3/10

T7

T8

T9

Transfer system

Rectangular external door - Boyer® (314x424 mm)

Rectangular external door - Boyer® (410x534 mm)

Rectangular external

door Left hand side Right hand side

Boyer® (314x424 mm) (S) (T)

Boyer® (410x534 mm) (U) (V)

PROCESS FEATURES AND OPTIONS

Ventilation / filtration

Compressed air/nitrogen supply:

� connection for compressed fluid inlet,

� flow reduction,

� regulator,

� manometer,

� solenoid valve,

� compressed air inlet valve,

Manipulation system

Manipulation inside the isolator can also be done through

glove-sleeve assemblies. Gloves are available in various

sizes. The sleeves are made of Hypalon®.

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 5 of 9

The assembly of the glove onto the sleeve is done using a

cuff ring called RAC100, which is used to test the integrity

of the glove using the GLT2 (Glove Leak Tester) and for

replacement of the glove without breaking the sterility.

Gloves supplied by GETINGE-La Calhène are EC certified.

« Standard » assembly

(enclosure under negative pressure)

Transfer system

Rectangular external door (Boyer®):

A rectangular external simple door can also be on lateral

wall (s).

The door is constructed from solid, high quality, stainless

steel (type 316 L or European equivalent) with seal gasket.

SERVICES

Check

Standard:

The containment isolator is inspected before shipment.

This operation is carried out by our Inspection Quality

Department following the inspection plan.

The inspection plan describes the manufacturing process

and Inspection. It gives the input and ouput datas of the

different phases of the product manufacturing and

inspection.

Inspections sheets are signed by the Inspection Quality

Department and the Quality Internal Validation

Department.

Option:

FAT with dedicated protocol (Factory Acceptance Test),

written according to GETINGE-La Calhène format and test

procedures.The protocol is send to the customer for

approval before test execution.

Documentation

Standard:

English language

French language

Operating file including (following general goods-in

acceptance testing procedure):

� General description (Piping Instrumentation Diagram),

� Assembly drawing(s) and parts list(s),

� Electrical file(s),

� Technical documents (component data sheet),

� User manual(s),

� Inspection notes,

� Certificates (material certificate main parts and the

calibration certificates of the equipment used during the

test),

� Acceptance reports.

Option list:

Other language:

Factory Acceptance Testing (included the standard

documentation in place of the inspection notes)

PACKING AND OPTIONS

Packaging identification

� Item reference,

� Quantity,

� Assembly.

Packing method

� The containment isolator will be packed according to the

agreed shipment.

Storage conditions

� Normal storage temperature (16°C and 24°C).

SHIPPING AND OPTIONS

Shipping by air

Shipping by sea

Shipping by road (distribution service)

Shipping by road (direct carriage)

INSTALLATIONS

Limits of use / specification

� Operating pressure (production):

-50 Pa ± 30 Pa.

� Temperature (production):

Between 18°C and 24°C.

� Climatic resistance:

20 to 70 % relative humidity without condensation.

� Environment classification at rest:

M 5.5 as per standard FS 209 E or Iso 7 as per standard

ISO 14644-1.

Glove Sleeve

RAC 100

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� Inlet air change rate:

3 minimum per hour (free extraction new filters).

� Type of flow:

Turbulent flow.

� Leaktightness specifications (value at factory test):

0.5 % vol/h at 150 Pa.

� Filtration level:

≥ 99,99 %.

� Equivalent sound pressure:

≤ 75 dBa.

� Volume of the isolator (Values given for information only):

3 glove isolator: 0,7 m3

4 glove isolator: 0,9 m3

� Isolator protection index:

IP 20.

� Weight unit:

3 glove isolator: 250Kg

4 glove isolator: 400Kg

� Maximun acceptable load:

3 glove isolator: 100 Kg/m2

4 glove isolator: 100 Kg/m2

Resistance limits

� Temperature range:

0°C / + 50°C.

� Maximun pressure tests:

- 250 Pa / + 250 Pa.

Electrical

� Power supply:

AC 170 to 264 V, 48 to 63 Hz for,

� Number of phases:

1/2.

� Amperage:

5 A.

� Power:

1150 VA.

� State of compatible neutral:

IT, TT, TN.

� Breaking power:

State of ITneutral: 10 KA .

State of TT / TN neutral: 20 kA.

� Testing voltage (standard test):

As per EN 61 010-1, 2001 issue.

Classification of II excess-voltage, degree of pollution 2.

� Electrical safety device:

As per EN 61 010-1, 2001 issue.

� Electromagnetic compatibility:

EN 50 081-2, 1992 issue

EN 50 082-2, 1995 issue

EN 61000-4-3, 1997 issue

EN 61000-4-6, 1997 issue EN 61000-4-4, 1995 issue EN 61000-4-2, 1995 issue EN 55011, 1991 issue

UTILITY REQUIREMENTS

Isolator

� Mains plug: 230 / 5A.

Compressed air (nitrogen option)

� filtered 5 µm

� 4-10 bars

� air flow rate : 3 m3/h mini.

ACCESSORIES

List of spare parts

Full AD glove Hypalon® sleeve (9 3/4

size) 22220C

HEPA cartridge filter (inside containment) 22523

HEPA cartridge filter (outside containment) 2581C

Kit for replacing the J3L lipseal including one device for replacing the J3L lipseal, procedure of replacement, particle-free cleaning paper and silicone bottle

23024C

Membrane filter 0,2 µm 6599

Prefilter 582C

R48 O’ ring (for RAC 100) 2285C

R77 O’ ring (for RAC 300) 4177C

Window gasket EPDM 18222

Depending on transfer systems

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 7 of 9

DIMENSIONS

(diagrams)

TRANSFER POWDER

3 GLOVES - 4 GLOVES

Overal 1550 / 2050

1500 / 2000

RIGID WALL GLOVE ISOLATOR – FP 105 - rev Dec - 2007 Page 8 of 9

RELATED & OTHER APPROPRIATE PRODUCTS

DESCRIPTION

GLT2

The GLT2 (Glove Leak Tester) is used to test the leak rate

of gloves and sleeves installed on an isolator.

The gloves and the sleeves are closed with a plug outside

the isolators. The glove is inflated and the pressure drop is

checked. The cycle test is directly run with a touch screen

on the GLT2 interface operator.

An internal program determines the test pressure test and

the measurement of the pressure drop is directly printed on

the GLT2 operator screen.

The GLT2 can be used to detect 100 µm holes on a glove.

One, two, three or four gloves can be tested at the same

time.

The entire test lasts 5 minutes max.

The system can be used to test gloves/sleeves of different

diameters at the same time.

In this picture, a GLT2.

GLOSSARY

DPTE® Tranfer system : Safety double door transfer

system. The safest method for introducing and removing

sterile and or for toxic material without breaking

containment.

GLT2: Glove Leak Tester.

Hypalon®: Synthetic elastomer compatible with H2O2.

Getinge Infection Control

PO Box 69, SE-310 44 Getinge, Sweden

Phone:+46 35 15 55 78

Fax:: +46 35 549 52

Info@getinge.com www.getinge.com

THE GETINGE GROUP is a leading global provider of equipment and systems that

contribute to quality enhancement and cost efficiency within healthcare and life

sciences. Equipment, services and technologies are supplied under the brands

ARJO for patient hygiene, patient handling and wound care, GETINGE for infection

control and prevention within healthcare and life science and MAQUET for surgical

workplaces, cardiopulmonary and critical care.

Getinge provides complete solutions for effective and

efficient cleaning, disinfection and sterilization in the

healthcare and life science sectors. Our know-how

comprises everything from architectural planning,

production and handling equipment, to systems for full

traceability of sterile goods. Our commitment covers

expert advice, training and long-term technical support.