Design of Containemt Isolators

Wednesday 15 th November 2006Design of isolators and glove boxes/codes and desig n guidance

Emilio Moia

2

Contents

1. Introduction

2. Development of isolator concept

3. Containment Isolator Standard

4. Containment Isolator Design Criteria

5. Testing

6. Example of isolator

3

Contents

1. Introduction




5. Testing


4

The Isolation continuum

5

Block flow diagram for development of isolator

Identify operation that

require containment

Determine worker Exposure

Limit

Review process operation

Select concept for design

Preliminary design drawing

Build Mock-upFinal Design

based on mock-up changes

Develop concepts for isolators that

perform operations

6

Contents

1. Introduction




5. Testing


7

Identification of operation that require containme nt

8

Concepts of isolator that perform operations

Extraction of material through

plastic bag

or

through the RTP port

Mater ial in

Manipulation Cleaning

9

Detail of material exhaust

10


IBC

Raw Material

FILTER

DRYER

BLENDER

IBC

IBC

Tablet packing

substanceOEL µg/m

3

H-Groupcharacteristic polverequanity >1 Kg time (Short:< 30') ----Control Strategy

MLong

CS 3

Operation description Tabletting

XXX1D

L

substanceOEL µg/m

3


MLong

CS 3


XXX1D

L

substanceOEL µg/m

3


MLong

CS 3


XXX1D

L

SubstanceOEL µg/m3

H-GroupCharacteristic polvereQuantity >1 Kg Time (Short:< 30') ----Control Strategy CS4

Operation description Filter dryer discharge

DLM

Long

XXX1

SubstanceOEL µg/m3



DLM

Long

XXX1

SubstanceOEL µg/m3



DLM

Long

XXX1

11

IBC

Raw Material

FILTER

DRYER

BLENDER

IBC

IBC

Tablet packing


Containment Isolator with RP

RABS

12

Isolator for dispensing: U.R.

Weighingscale

Chamber

Door

Interlocked doors

Full size door always open during “production”

BIN

BIN lift

ZANCHETTA ISO valve

Thermo-balance for LOD testing

Tapped density tester

Particle size distribution equipment

Double push push filter with flap

Single push push filter with flap

Exhaust fan

Battery Battery LimitsLimits

Battery LimitsBattery Limits

13

Isolator for dispensing: U.R.

Pre.chamber

Weighingscale

Chamber

Waste continuousfilm bagging andsealing system

Door

Interlocked doors Full size door always

open during “production”

Connection to BIN

Thermo-balance for LOD testing

Tappeddensity tester

Particle size distribution equipment

Electrical supply and print signal for thermo-balance

for LOD testing

Electrical supply for tapped density

tester

Electrical supply for particle size

distribution equipment

Electrical supply for weighing scale

Connection for hot/cold water

supply to spray guns

BatteryBatteryLimitsLimits

Hot water

Cold water

Distribution piping for hot/cold water

to spray guns

14

Isolator design cycle

IQ & OQFAT & SAT

Detail Design

Realization & installation

Mock-up Testing

Preliminary Design

USER USER

REQUIREMENT

REQUIREMENTIsolator Design Cycle

15

Contents

1. Introduction




5. Testing


16

Containment Isolator Standard

• ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)

• ISO 10648-1, Containment enclosures — Part 1: Design principles

• ISO 10648-2, Containment enclosures — Part 2: Classification according to leak tightness and associated checking method

• AGS-G001-1998

• EN 12469, Biotechnology — Performance criteria for microbiological safety cabinets

17

ISO 14644-7

• 1 Scope• 2 Normative references• 3 Terms and definitions• 4 Specification of requirements• 5 Design and construction• 6 Access Devices• 7 Transfer Devices• 8 Siting and Installing• 9 Testing and Approval• Annex A (informative) Separation continuum concept• Annex B (informative) Air handling and gas systems• Annex C (informative) Access devices• Annex D (informative) Transfer device examples• Annex E (informative) Leak testing• Annex F (informative) Parjo leak test method• Bibliography

18

ISO 14644-7: Terms and Definitions

• access device : device for manipulation of processes, tools or products within the separative device

• action level :level set by the user in the context of controlled environments, when exceeded immediate follow-up is required as well as investigation with subsequent corrective action

• alert level :level set by the user for controlled environments giving early warning of a potential drift from normal conditions, when exceeded an investigation is required to ensure that the process and environment are under control.

• breach velocity :velocity through an aperture sufficient to prevent movement of matter in the opposite direction to the flow

• containment :state achieved by separative devices with high degree of separation between operator and operation

• leak (of separative devices) :defect revealed by testing under a pressure differential after corrections for atmospheric conditions

• pressure integrity :capability to provide a quantifiable pressure leakage rate repeatable under test conditions

• separative device :equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume

19

ISO 14644-7: Requirements

The following information shall be defined, agreed and documented between customer and supplier:

• reliability and availability;• when appropriate, any applicable hazard analysis• if devices depend on differential pressure, the differential pressure shall be differential pressure shall be

continuously monitoredcontinuously monitoredand alarmed in some applications;• where appropriate, a specified hourly leak rate (for an example of methodology, see

Annex E);• other operational parameters, including 1) test points,2) alert and action levels to be

measured to ensure compliance,3) test methods;• required methods of measurement, sample locations, control, monitoring and

documentation;•• mode of entry or exit of mode of entry or exit of separativeseparativedevicesdevicesand related equipment, apparatus,

supplies and personnel into• the controlled environment required during 1) installation, 2) commissioning, 3)

operation, 4) maintenance;

20

ISO 14644-7: Requirements

• layout and configuration of the installation;

• critical dimensions and mass restrictions, including those related to available space;

• process requirements that affect the installationprocess requirements that affect the installation;

• process equipment list with utility requirementsprocess equipment list with utility requirements;

• maintenance requirements of the installation;

• responsibilities for the preparation, approval, execution, supervision, documentation, statement of criteria, basis of design, construction, testing, training, commissioning and qualification, including performance, witnessing, and reporting of tests;

•• identification and assessment of external environmental influencidentification and assessment of external environmental influenceses;

• compliance with local regulations.

21

ISO 14644-7: Design and Construction

• Separative-device design shall provide the process, the operator or third party with protection against contamination appropriate to the operation being performed.

• Consideration shall be given to malfunction, procedures and ancillary systems involved with the separative-device application (see Annex B).

• Consideration shall be given to access devices and transfer devices (see Annexes C and D).

• Separative devices shall be ergonomically designed for easy accessergonomically designed for easy accessto all internal surfaces and work: areas, and with respect to the process undertaken.

•• Access devices shall be of the minimum size and numberAccess devices shall be of the minimum size and numberconsistent with operation, cleaning and maintenance.

• Consideration shall be given to differential operating pressure, including excursionsdifferential operating pressure, including excursions.•• External influences, such as air flowExternal influences, such as air flow, vibration and pressure differences, shall be

considered to avoid adverse effects on integrity and function.• Provision for cleaning or decontamination, including possible disposal of the device

or its components, shall form part of the design criteria.

22

ISO 14644-7: Design and Construction

• Built-in test facilities and appropriate alarmsappropriate alarmsshall be included.

• Transfer device(s) shall be appropriate to process and routine operation.

•• Filtration shall be appropriate for applicationFiltration shall be appropriate for application.

• Whenever possible, items requiring maintenance shall be external to the maintenance shall be external to the separativeseparativedevice.device.

• Materials used in the construction of separative devices, including sealing materials, fans, ventilation systems, piping and associated fittings, shall be chemically and chemically and mechanically compatible with the intended processesmechanically compatible with the intended processes, process materials, application and decontamination methods. Protection against corrosion and degradation during prolonged use shall be considered. Heat and fire resistant construction materials shall be considered when appropriate (see Annex B). Where appropriate, materials used shall be checked for thermal characteristics, sorption and out gassing properties. Materials selected for viewing panels shall be tested and proven to remain transparent and resistant to changes that would prevent clear visibility.

23

ISO 14644-7 Access Devices• Gauntlets, glove systems, half-suits• When using gauntlets, glove systems and half-suits, these types of flexible-membrane

access device systems shall be designed and constructed to allow for glove change without breaching the separative device (see Annex C). These systems are unlikely to maintain molecular containment, therefore alternative systems should be considered for applications requiring molecular containment.

•• Glove ports and glove cuff rings devices shall be designed for eGlove ports and glove cuff rings devices shall be designed for ease of changease of change, integrity testing and security of operation.

• The following selection criteria shall be considered in choosing gauntlet, glove sleeve and halfsuit system materials that are vital in maintaining separation:

• a) materials and tools to be handled within the separative device;• b) temperature limitations of the glove materials;• c) acceptable permeability;• d) chemical resistance or mechanical strength, or both;• e) sorption and desorption of chemicals;• f) known shelf and service lives of glove material;• g) differential pressures, including transient excursions (operating and abnormal

pressures);• h) operations to be performed.

24

ISO 14644-7 Access Devices – Glove Materiala) Latex, natural rubber or cis-1,4-polyisoprene• Latex, natural rubber or cis-1,4-polyisoprene is suitable in cases where great flexibility and good

mechanical properties are necessary. However, latex articles are not impermeable to gas, perish in ozone, offer no resistance to flame, hydrocarbons and oxidising salts and poor resistance to esters, acids and bases. The potential of life-threatening allergic reactions should be considered.

b) Polychloroprene or 2-chloro-1,3-butadiene• Polychloroprene or 2-chloro-1,3-butadiene is especially recommended when good resistance to

oils and greases is needed. This chloroprene is self extinguishing, i.e. when the source of ignition is removed it no longer continues to burn. Polychloroprene is highly resistant to ozone, ultraviolet light, concentrated acids and bases, and strong oxidising agents. Polychloroprene articles are unsuitable for work with hydrocarbons, halogens and esters.

c) Nitrile or copolymer of butadiene and acrylonitrile• Nitrile or copolymer of butadiene and acrylonitrile is recommended when good resistance to

solvents is required. Nitrile articles stand up well to aliphatic hydrocarbons and hydroxyl compounds.

d) Polyvinyl chloride• Although plastic, polyvinyl chloride has a certain elasticity and is recommended for its good

electrical properties and resistance to chemical agents.e) Chlorosulfonated polyethylene• Chlorosulfonated polyethylene offers very good resistance to H2O2, and its white colour allows

good visual inspection. Other materials are resistant to H2O2, as well.

25

ISO 14644-7 Transfer Devices

• Transfer devices• Use:Transfer devices shall not diminish the performance of separative devices. In

specific applications, transfer devices become critical in maintaining integrity of the device or process. Some transfer devices are used as independent separative devices.

• Selection:Selection of a transfer device shall be based on the level of separation required by the application. The hourly leak rate of the transfer device shall not be greater than the hourly leak rate of the separativedevice which the transfer device serves. Transfer devices shall minimize the transfer of unwanted matter. Outline diagrams and descriptions of possible types of transfer device are included in Annex D. These diagrams are only illustrative examples of possible configurations.

• Fail-safe design:In the event of power failure, transfer devices that have electrical transfer devices that have electrical interlocking mechanisms shall prevent access via the transfer deinterlocking mechanisms shall prevent access via the transfer devicevice.

26

ISO 14644-7 Testing and Approval

Glove breach test:• When appropriate, the airflow through one open glove port shall be measured by placing an

anemometer at the centre of the glove port. The velocity shall be agreed between customer and supplier (guidance value: 0,5 m/s).

Leak testing• When appropriate, a leak test shall be performed. Guidance is given in Annexes E and F.

– NOTE Integrity testing on some separative devices that operate close to atmosphere pressure (less than 1 000 Pa) requires detailed procedures and sensitive test equipment to establish a quantifiable leak rate. The resulting leak determines acceptability for the intended application (see Annex A).

• When appropriate, an induction leak test shall be performed. Guidance is given in Annex E.– NOTE Induction leaks can occur when the velocity across an orifice creates a pressure

depression and induces a reverse flow through the orifice (Venturi effect). Devices that operate at low differential pressures may be compromised by induction leakage. Similarly, devices that utilise over pressure or flow to minimise or prevent the transfer of unwanted matter may be at risk from induction leakage when operating under transient volume changes such as glove entry or withdrawal.

27

ISO 14644-7 Testing and ApprovalPeriodic testing• The tests and checks are a function of the application and instrumentation/detection systems. Routine

tests shall be established and recorded for comparison preventative maintenance requirements.• The following recommendations for testing are given:

– a) half-suit/glove testing– 1) on commissioning,– 2) prior to and after completion of work,– 3) after glove/glove sleeve changes;

– b) pressure testing– 1) on commissioning,– 2) after any airflow or filter-pressure parameter changes,– 3) after maintenance affecting the separative device envelope or pressure control devices;

– c) induction testing on commissioning;– d) instrumentation and alarm system testing

– 1) on commissioning,– 2) after maintenance affecting the control system,– 3) at the frequency dictated by the instrumentation manufacturer,– 4) at predetermined periods consistent with use and operational requirements.

28

ISO 14644-7 Annex D

A1 transfer device• When operated in accordance with a validated transfer procedure, air can flow freely through

the A1 transfer device (see Figure D.1) between the background environment and the separative-device environment when the door is open.

• EXAMPLES Doors, access panels, zips, hook and loop tape, poppers and “jam pot”covers, bag-in-bag-out.

1 separative-device environment

2 background environment

3 ingress

4 egress

5 sealed door

6 work surface of controlled workspace

Figure D.1 — A1 transfer device

29

ISO 14644-7 Annex D

A2 transfer device• When operated in accordance with a validated transfer procedure in a dynamic state, air flows

freely through the A2 transfer device (see Figure D.2) out of the separative device environment.

• EXAMPLES Dynamic holes, mouse holes.



3 ingress

4 egress

5 airflow


Figure D.2 — A2 transfer device

30

ISO 14644-7 Annex D

D.4 B1 transfer device• The B1 transfer device (see Figure D.3), when operated in accordance with a correct sequence or

interlocked transfer procedure, does not permit the direct passage of air between the background environment and separative-device environment. However, air from the background environmentcan be trapped and then released into the separative-device environment, and air from the separative-device environment can be trapped and released into the background environment.

• EXAMPLES Double-door sealed transfer chambers, bagging ports, telescopic waste ports and simple docking devices.



3 ingress

4 egress

5 sealed door


Figure D.3 — B1 transfer device

31

ISO 14644-7 Annex D

D.5 B2 transfer device• The B2 transfer device (see Figure D.4) has double sealed doors and facilities that permit the

purging and evacuation of the transfer device to ensure compatibility of environments before breaching the interconnection to the separative-device environment. Evacuation gases require safe disposal.

– NOTE Evacuation may not be possible with liquid transfer, depending on the liquid boiling point/pressure relationship.

1 separative-device environment2 background environment3 ingress4 egress5 sealed door6 work surface of controlled workspace7 valveFigure D.4 — B2 transfer device

32

ISO 14644-7 Annex DD.6 C1 transfer device• The C1 transfer device (see Figure D.5) has doors and HEPA filters which, when used in a positive-

pressure separative device and operated in the correct sequence, do not allow unfiltered air from the background environment to reach the separative-device environment but which may allow unfiltered air from the separative-device environment to reach the background environment. Such transfer devices are not suitable for negative-pressure separative devices because unfiltered air from the background environment would be allowed to reach the separative-device environment. C1 transfer devices are not recommended where operator and third-party protection is required in positive-pressure separative devices.

• EXAMPLE Single-filtered transfer chambers.

1 separative-device environment2 airflow3 background environment4 HEPA filter5 positive pressure6 ingress7 egress8 sealed door9 work surface of controlled workspaceFigure D.5 — C1 transfer device

33

ISO 14644-7 Annex DD.7 C2 transfer device• The C2 transfer device (see Figure D.6) has doors and HEPA filters which, when used in a

negative-pressure separative device and operated in the correct sequence or interlocked transfer procedure, do not allow unfiltered air from the background environment to reach the separative-device environment (such air passes straight into the space below the work surface of the separative-device environment and then exits through an exhaust) or unfiltered air from the separative-device environment to reach the background environment with the separative device in an operational state. Such transfer devices are not appropriate for use with a positivepressure separative device.

• EXAMPLE Single-filtered transfer chambers.• 1 separative-device environment• 2 airflow• 3 background environment• 4 HEPA filter• 5 negative pressure• 6 ingress• 7 egress• 8 sealed door• 9 work surface in controlled workspace• 10 exhaust• Figure D.6 — C2 transfer device

34

ISO 14644-7 Annex D

D.8 D1 transfer device• The D1 transfer device (see Figure D.7) has doors and HEPA filters which, when operated in

the correct sequence or interlocked transfer procedure, do not permit unfiltered air from the background environment to reach the separative-device environment or unfiltered air from the separative-device environment to reach the background environment.

• EXAMPLES Double-filter transfer chambers, or separative devices used as a transfer device.

• 1 separative device environment• 2 valve• 3 background environment• 4 HEPA filter• 5 ingress• 6 egress• 7 sealed door• 8 work surface of controlled workspace• Figure D.7 — D1 transfer device

35

ISO 14644-7 Annex D

D.10 E transfer device• The E transfer device (see Figure D.8) is subject to sanitation together with its contents, if any,

before being opened into other areas which have been subject to sanitation. • EXAMPLES Gassable/autoclavable transfer devices, including certain transfer

separative devices and docking devices, permanently connected autoclaves and similar devices.

1 separative-device environment2 three-way valve3 quick-connect coupling4 background environment5 HEPA filter6 ingress7 egress8 sealed door9 work surface of controlled workspaceFigure D.8 — E transfer device

36

ISO 14644-7 Annex D

D.11 F transfer device

• The F transfer device (see Figure D.9) docks and seals onto a separative device. The transfer device is commonly used as a transport container. Some devices may have disconnects for air bleed.

• EXAMPLES Rapid transfer systems, standard mechanical interfaces, and split valve connections.



3 quick-connect coupling

4 double interlocked doors or valves

5 work surface or controlled workspace

Figure D.9 — F transfer device

37

ISO 14644-7 Leak Detection

Table .1 — Classification of separative devices and appropriate test methods

Class Hourly Leak Rate T f

h-1

Pressure Integrity

Test Methods

1 ≤ 5 x 10 -4 High Oxygen method, pressure change method or Parjo method

2 < 2,5 x 10 -3 Medium Oxygen method, pressure change method or Parjo method

3 < 10-2 Low Oxygen method, pressure change method or constant pressure method

4 <10-1 Constant pressure method NOTES 1 The classification and specified test methods in ISO 10648-2 were combined with pressure integrity levels to allow comparison to the separation continuum in annex A. 2 Parjo method was included where appropriate. 3 ISO 10648-2 test methods are for negative pressure separative devices and can be modified for positive pressure separative devices with the exception of the oxygen method.

E.3.1.6 Classification The classification of separative devices according to hourly leakage rate is shown in Table E.1.

38

AGS-G001-1998Example of single-sided glovebox with gloveports through window

39

AGS-G001-1998Example of double-sided glovebox with gloveports throug h window

40

AGS-G001-1998Detail of glove port attachment, glove port and workin g plane elevation

41

ISO 10648-1: Dimension

42

ISO 10648-1: Dimension

43

Access Device: Glove System

Glove port and glove cuff rings shall be designed for easy

change #6

44

ISO 14644-7 & AGS-G001-1998

Leak rate < 0,5% of the glove

box volume

% of box volume =Q/V

Q/V=(60/T)*(P2T1/ P1T2-1)

Class1 : Tf ≤ 5 x 10 -4

Class 2: Tf < 2,5 x 10 -3

Class 3: Tf < 10-2

Class 4: Tf <10-1

Tf=(60/T)*(P2T1/ P1T2-1)

Leak rate

- 0,5 < pressure < -1,5 inchesGlove box negative pressure

V= 125 ± 25 ft/min

For some facility v= 150 ft/min

The velocity should be agreed

between customer and supplier

(guidance value: 0,5 m/s).

Air velocity into open port

ASG-G001-1998ISO 14644-7Description

45

Contents

1. Introduction




5. Testing


46

Isolator for dispensing: Detail design and Mock-up

Ergonomic Study for easy access #5

47

D

A DF

3072001

3072

001

STERIL

08.10.04 SC PB

DISPENSING ISOLATOR IS-1500

FIRST ISSUE

NOTES

CLIENT

BATTERYLIMIT

D-1002

W-1003

G-1003 G-1008

CAB-1002

DOORG-1004 G-1007

I

PLC

D-1001G-1001

CAB-1001

DOORG-1002 G-1005

W-1001 W-1002

PUSH-PUSH

DN

80

DPI

0102

F-0103

F-0102

-

M

INVERTER

FAN-1001

INV-0110

THIMBLEDIAM. 200 mm

ZSL

0101

I

PLC

XY

0101

I

PLC

ZSL

0102

I

PLC

XY

0102

I

PLC

P&ID

DN

32

DN50

VFA-1003

F-0101

F-0106

L-1003

L-1001

(NOTE 2)

L-1002

VFA-1001

VFA-1002

DPI

0101 DPI

0106

DPI

0110

DPT

0110

0110

DPA

LIGHTING

DIVIDING SECTORD-1004

ZANCHETTA ISO VALVE

1) CONNECTION FOR SPRAY GUNTO EXHAUSTHVAC PLAN

2) CONNECTION FOR SPRAY BALL

(NOTE 3)

3) CONNECTION FOR WASTE DRAIN

VME-1001

DN20

4) CONNECTION FOR ELECTRICAL SUPPLY

DN20

DPI

0103

(NOTE 7)

(NOTE 4)

VME-1005

(NOTE 5)

5) CONNECTION FOR LINE DRAIN

SLOPESLOPE

SLOPE SLOPE

(0.3 m3/h)

LOCALPRESSURE+/- 0 Pa

B DF08.11.04 SC PB

LIGHTINGLIGHTING

D-1003

XY

0103

I

PLC

CANISTERBAG-IN BAG-OUT

CANISTERBAG-IN BAG-OUT

H

L

PUSH-PUSH

DPI

0105

DPI

0104

(85 m

3/h

)

DN

80

F-0104

F-0105

(NOTE 6)

6) FLEXIBLE FLOOR SECTION FOR WEIGH-SCALE

UPDATED AFTER CLIENT VISIT ON 18.10.04 AND 28.10.04

G-1006(NOTE 4)(NOTE 4)

SLOPE SLOPE

7) CONNECTION FOR CLEANING VACUUM

(NOTE 1)

GLOVE PORT

250

167

GUIDANCE VALUE: 0,7 m/s

GLOVE BREACH TEST

AREA PORT= 0.033 m2

Q = 0.033x0.7x3600 = 83.16 m3/h

ZSL

0103

PLC

DN20

VME-1003

DN20

DN80

DN80

DN20

DN25

DN20

DN50

DN20

(NOTE 2)DN20

VME-1002DN20

VME-1004

(NOTE 2)DN20

(NOTE 1)DN50

S

I

PLC

KY

XY

CLEANING WATER

TYPICAL 1

COMPRESSAIR

(5-7 bar)

TO ATMOSPHERE

(SEE TYP 1)

C DF10.01.05 SCUPDATED ACCORDING TO CONSTRUCTION PB

(SEE TYP 1)

(SE

E T

YP

1)

CB-0101CONTROL BOARD

CO

MP

RE

SS

AIR

(5-7

bar)

ELE

CT

RIC

AL S

UP

PLY

400V

3P

H+

N+

PE

1 K

w

d.

4/6

mm

D DF08.02.05 SC PBAS BUILT

NEGATIVEPRESSURE

-75 Pa

TO SERVICES INSTRUM COMPR AIR

(TYPICALS 1)

LETTER DATE DESCRIPTION APP.CHDBY

REV.DWG.N

APPROVED FOR CONSTRUCTION

SIGNATURE

DWG. REV. DATE

SCALE

REVISIONS

THIS DWG.SUPERSEDED BY

THIS DWG. SUPERSEDES

DWG N

THIS DRAWING IS THE PROPERTY OF STERIL AND IS LENT WITHOUT CONSIDERATION

THE APPARATUS SHOWN IN THE DRAWING IS COVERED BY PATENTS .

OTHER THAN THE BORROWER 'S AGREEMENT THAT IT SHALL NOT BE REPRODUCED

PURPOSE OTHER THAN THAT FOR WHICH IT IS SPECIFICALLY FURNISHED.

COPIED LENT OR DISPOSED OF DIRECTLY OR INDIRECTLY , NOR USED FOR ANY

cod.=

rif. SP.TEC. TOLL-001

rif. SP.TEC. PAINT-001

NOT SPECIFIED TOLLERANCE :

PAINTING:

Isolator for dispensing: P&ID

Transfer Device: Mode of entry/exit #4

Air-break: identification of

external influences #4

DP: continuous monitoring and Alarm #4

Interlocking system that prevent access via transfer device in the event of power

failure #7

Pre-chamber @ -45 PaMain Chamber @ - 75 Pa

Consideration shall be given to differential operating pressure,

including excursions : #5

48

3072

.000

3072.000

A 08-10-04 DF

F

750 2250

1000

1884

3379

245 380 380 280 220

493

350

1250 1000

SI131530720

OVERALL DIMENSION

FIRST ISSUE

LIGHTING

DOUBLE PUSH-PUSH

FILTER

DISPENSING ISOLATOR IS-1500

ASSEMBLY

ELETTRICAL BOX

STAINLESS STEEL

CONNECTION FOR

SPRY BALL

DIVIDING SECTOR

CLOSE

DIVIDING SECTOR

OPEN

CONNECTION FOR

SPRY GUN

VALVE DN20

VALVE DN15

CONNECTION FOR

SPRY GUN

VALVE DN20

FLAP DN80

FLAP

DN80

PB

SLOPE

SLOPE SLOPE

B 12-10-04 DF PBCHANGING SUPPORT TYPE

1834

630

327

200

1884

FLOOR

EXHAUST FAN

FLOOR

750

600

BIN ZANCHETTA

900

80

201

167

250

450

80SLOPE

OVAL GLOVE

PORT

CANISTER FILTERBAGIN-BAGOUT

SLOPE

DOUBLE PUSH-PUSHFILTER

250

FLEXIBLE FLOOR

SECTION FORWEIGH-SCALE

INDEPENDENT SUPPORT FOR

WEIGH-SCALE

WALL STABILITYSUPPORT

WALL STABILITY

SUPPORT

FLAPDN80

WALL STABILITY

SUPPORT

CANISTER FILTER

BAG-IN/BAG-OUT

LIFTING TABLE

4590

INTERLOCKED DOOR

DIM. HOLE 350x450mm

INTERLOCKED DOOR

DIM. HOLE D.280mm

C 26-10-04 DF PB

REMOVABLE

COARSE GRID 5mm

UPDATED AFTER CLIENT VISIT ON 18.10.04

D 02-11-04 DF PBISSUED FOR APPOVAL - WHITH CLIENT COMMENT ON 28.10.04

280

400

470600

INTERLOCKED DOOR

DIM. HOLE 350x450mm

LIGHTING

220 220

2250

300

750

630

1450

1350

45

594

600

1350

3379

350

WASTE MATERIALSY STEM

VALVE DN20

327

200

1200

1350

450

EXHAUST FAN

FLOOR

857

BIN ZANCHETTA

900

1027

80

280

380

450

340

1780

1100

DOUBLE PUSH-PUSH

FILTER

LIFTING TABLE

470 600

600

220 310 220

627 576

CONNECTION TO BINZANCHETTA ISOVALVE

ELECTRIC DEVICE FOR ISOVALVE

(BY ZANCHETTA)

TO BE FIXED ON ISOLATOR

NOTES1) CONNECTION FOR SPRAY GUN

2) CONNECTION FOR SPRAY BALL

3) CONNECTION FOR WASTE DRAIN

4) CONNECTION FOR ELECTRICAL SUPPLY

5) CONNECTION FOR LINE DRAIN

6) FLEXIBLE FLOOR SECTION FOR WEIGH-SCALE

7) CONNECTION FOR CLEANING VACUUM

(NOTE 7)

(NOTE 4)

650

600

(NOTE 1, 2)

OPERATORCONTROL PANEL

OPERATORCONTROL PANEL

WALL STABILITY

SUPPORT

ELETTRICAL BOX

STAINLESS STEEL

ELECTRIC DEVICE FOR ISOVALVE

(BY ZANCHETTA)TO BE FIXED ON ISOLATOR

1700

594

SUPPORT TO BE FIXED

ON THE FLOOR

SUPPORT TO BE FIXEDON THE FLOOR

(NOTE 3)

BUTTERFLY VALVE

CLAMP 1 1/2 "

(NOTE 3)

BIN ZANCHETTA

LIFTING TABLE

TAPPED DENSITY

TESTERDIM. 330x450 h700

PARTICLE SIZE

DISTRIBUTIONEQUIPMENT

DIM. 300x350 h750

WEIGHING SCALE

DIM. 350x350 h150

INTERLOCKED DOOR

DIM. HOLE 350x450mm INTERLOCKED DOOR

DIM. HOLE 350x450mm

INTERLOCKED DOOR

DIM. HOLE D.280mm

DIVIDING SECTOR

OPEN

DIVIDING SECTORCLOSE

200

300

REMOVABLECOARSE GRID 5mm

(NOTE 6)

600

1040

(NOTE 5)

(NOTE 1, 2)

(NOTE 5)

CANISTER FILTER

BAG-IN/BAG-OUT

CONNECTION FOR

HOT WATER

VALVE DN15 VALVE DN15

VALVE DN20

LIGHTING LIGHTINGLIGHTING

OVAL GLOVE

PORT

EXHAUST FAN

400

MINIMUN FOR

MAINTENANCE

200150250150

(NOTE 4)

250

DOUBLE PUSH-PUSHFILTER

780

WASTE MATERIAL

SY STEM

SLIDING SUPPORT

FOR VISUAL WEIGHING SCALE

WALL FAN

SUPPORT

FLAP

DN80

A

A

SECTION A-A FRONT VIEW SIDE VIEW

PLANT

VIEW H2300

PLATFORM

(BY OTHERS)

PLATFORM

(BY OTHERS)

SLIDING TABLEFOR DISPLAY WEIGHING SCALE

SLIDING TABLEFOR DISLAY WEIGHING SCALE

E 19-11-04 DF PB

SC

SC

SC

SC

SC ISSUED FOR CONSTRUCTION

300 150

DISPLAY WEIGHING SCALE

DIM. 345x190 h145

F 08-02-05 DF PBSC AS BUILT

350

SLOPE

(NOTE 1, 2) (NOTE 1, 2)

VALVE DN20VALVE DN20

(NOTE 1, 2)

320

575220 220575

200

INT ERRUT T ORE GENERAL E

F IL T RO CANIST ER F - 0 1 0 6F IL T RO EXP F - 0 1 0 3 F IL T RO EXP F - 0 1 0 5

F IL T RO EXP F - 0 1 0 4F IL T RO EXP F - 0 1 0 2 F IL T RO CANIST ER F - 0 1 0 1

AL L ARM E ACUST I CO AL L ARM E VI SI VO O F F O N O F F O N

CO M ANDO L UCE CABI NAT ENSI O NE EQ UI PM ENTRESET PRO G RAM M A

CAMERA CAB- 1 0 0 2

PRESENZ A T ENSI O NE

653


REV.DWG. N


SIGNATURE

DWG. REV. DATE

SCALE

REVISIONS



DWG N






1:10

cod.=

rif. SP.TEC. TOLL-001

rif. SP.TEC. PAINT-001

NOT SPECIFIED T OLLERANCE :

PAINT ING:

Alarms

Process equipment list with utility

requirements (piping connection,

electrical sockest, bin charging.. ) #4

Isolator for dispensing: Equipment Lay-out

Balance with independent support: process requirements

that affect the installation #4

Operational ergonomics: glove port position # 8

maintenance requirements of

the installation #4

Access devices shall be of the minimum size and number consistent with

operation, cleaning and maintenance #4

Access devices shall be of the minimum size and number consistent with

operation, cleaning and maintenance #4

49

Isolator for Compounding: Equipment lay-ou30

80.0

00

240 460 460 460 220

9002273

450

10%%d

974

770

3080.000

A

1350

240 460 460 460 220

900

1116

1350

1116

450

450

450

900

2300

250

322

R-911

250

250

300

250

300

2240

2076

26.01.05 S.C.

DISPENSING COMPOUNDINGREPARTO SCHF - GSK (PARMA)

VISTA ALTO

VISTA LATO DX VISTA LATO SXVISTA FRONTE

VISTA H=1200

974

770

495

2239

656.4

VENTILATORE

RTP PORT

DPTE-S 270

CONNECTION FOR

SPRY GUN

250

339

260

1300

167

EMESSO PER COMMENTI D.F. P.B.

MIN

190

0 M

AX

200

0

1300

460

RTP PORT

DPTE-S 270

BAGNO

TERMOSTATICO

dim.240X330 h220

CORPO

BILANCIA

dim.120x330 h110

PH-METRO

dim.230x390 h100

LAMPADA LAMPADA

CARTER COPRI CAVI

PEDANA

HOUSING PUSH-PUSH

FILTER

VISIVA FRONTALE APRIBILE

CON VETRI STRATIFICATI

DI SICUREZZA

TERMINALE OPERATORE

SEZIONE FLESSIBILE

TANK

R-911

TANK

FILTER AIR

DISPOSABLE

CARTER COPRI CAVI

TERMINALE OPERATORE

CB-0102

RTP PORT

DPTE-S 270

132

CORRIPIEDE200 CORRIPIEDE

840

SX

SX DX

DX

1790

ISOLATORE IS-1400-DFDIMENSIONI D'INGOMBRO

SI131430802

+924

+3000

CB-0101

I N TE R R U TTO R E G E N E R A LE

P R E S E N ZA TE N S I O N EAL L ARME ACUST ICO AL L ARME VISIVO

OF F ON

COMANDO L UCE CABINARESET PROGRAMMA

C A B I N A D I S P E N S I N G I S - 1400

OF F ON

T ENSIONE EQUIPMENT

240460460460220

322

250

339167

FI LTR O E X P F- 0102FI LTR O E X P F- 0104

FI LTR O E X P F- 0103 FI LTR O E X P F- 0101

1000

VISTA RETRO

600

2240

1240

460

60 60 60

6060

6080

60

250

CONNECTION FOR

ELECTRICAL SUPPLY

(FORO D.22mm)

CONNECTION FOR

ELECTRICAL SUPPLY

(FORO D.22mm)

B S.C.D.F. P.B.18.02.05 EMESSO PER APPROVAZIONE

B

561

STAFFA DI SUPPORTO

CELLE DI CARICO

STAFFA DI SUPPORTO

CELLE DI CARICO

300

300

1/2" T.C.1" T.C.

1"1/2 T.C.

1/2" T.C.

3/4" T.C.

3/4" T.C.

200

465

900

540

126

256

140

50

1" T.C.AIR INLET

2" T.C.SPRY BALL

1255050

576

50

540

650

715

1/4" GMANICOTTO

SPRY BALL

2" T.C.

SCARICO

1"1/2 T.C.

MIN.

3/4" T.C.

3/4" T.C.1/2" T.C.

1/4" G1/4" G1/4" G

SPRY GUN3/4" T.C.

SPRY GUN

1/2" T.C.

1" T.C.

1"1/2 T.C.

3/4" T.C.

3/4" T.C.1/2" T.C.

1"1/2 T.C.1" T.C.1/2" T.C.

3/4" T.C.

1" T.C.

3/4" T.C.

1"1/2 T.C.1" T.C.

1/2" T.C.

1/4" G1/4" G

1050 1250

I N TE R R U TTO R E G E N E R A LE

QUADRO ELETTRICO

dim.450x600x300

RTP PORT

DPTE-S 270

(FORO D.350mm)

RTP PORT

DPTE-S 270

(FORO D.350mm)

CONTROSOFFITTO PEDONABILE

1500

VA

NO

TE

CN

ICO

CO

NT

RO

SO

FF

ITT

O

VISTA LATO DX

CONNECTION FOR

COMPRESS AIR

CONNECTION FOR

COMPRESS AIR

3/4" T.C.

CARTER COPRI CAVI

CA

RT

ERCB-0102

DISLAY PH-METRO

dim. HOLD

DISLAY BILANCIA

dim. HOLD

1240 1000CARTER

CB-0102

GOLFARE

CA

RT

ER

CA

RT

ER

600

CA

RT

ER

CARTER

1400 900

SPRY GUN


REV.DWG. N


SIGNATURE

DWG. REV. DATE

SCALE

REVISIONS



DWG

N






1:10

cod.=

ref. TEC.SP. TOLL-001

ref. TEC.SP. PAINT-001

NOT SPECIFIED TOLLERANCE :

PAINTING:

Vessel supported on weighing device:

Process requirements #4

Transfer device appropriate for

operation #5

50

Types of Containment Isolator

N2

P

I P

I P

I

CA

P PDT

2 v/h 18 v/h

Kg±±±±10g

P

I P

I P

I P PDT

P

I P

I

P

I P PDT

Variable Airflow rate:

N2 inertization system

•Supply cartridge filter

•Push-Push exhaust hepa filter

Variable Airflow rate:

• Supply cartridge filter


Constant Airflow rate:

• Supply Bag-in/Bag-out Hepa filter


51

Variable exhaust airflow: reaction to glove break

Glove break

Dp= -75 Pa

Dp= 0 Pa

breach velocity =0,7 m/s

Time

Pre

ssur

e /

Vel

ocity

~ 30 seconds

52

Constant exhaust airflow: reaction to glove break

Dp= -75 Pa

Dp= 0 Pa

breach velocity =0,7 m/s

Time (min)

Pre

ssur

e /

Vel

ocity

Glove break

Instantaneous

53

Contents

1. Introduction




5. Testing


54

Isolator testing

Operator Panel CheckForm 9

AlarmsForm 8

Noise Pressure LevelForm 7

Light Intensity TestForm 6

Smoke TestForm 5

Response Time To glove breakForm 4

Pressure Gauges ControlForm 3

Isolator Leak Pressure testForm 2

Push-Push Integrity TestForm 1

DescriptionForms List

55

Example: Response Time To glove break

Test description - Record the test instrument Manufacturer, Model, serial/number, calibration Date and due Date.

- During the normal isolator working, remove a glove and measure the time to reach a minimum velocity value of 0.7 m/s in the center of the glove port. The time should be less than 30 s.

- Once the airflow is stable, record the air velocity in the center of the glove port. - Record the value on the following table. - Verify also the alarms turn on and that the instruments work correctly. (see Form N.11 “Alarms”)

Acceptance Criteria

- Minimum air velocity value 0.7m/s in the glove port center (CIRCULAR d=167 mm) - Response time < 30 sec

Test instrument

Anemometer DESCRIPTION

ITEM

RESPONSE

TIME sec

FINAL VELOCITY

m/s

NOTE

Result

Working Chamber

Attachments

Test Result is acceptable � YES � NO Notes / Deviation N°

56

Control System and Alarms• Control System and Alarms• Negative pressure value control by means of PLC regulation of the revolution

velocity of the motor blower. The control system modifies the motorfan speed in such way to maintain the set pressure value (-75 Pa) inside the working chamber..

• Alarm device optical (red signal light visible from working position) and acoustic (buzzer) type, activated with indication of type of alarm activate, showed on the digital display.

• Monitoring with alarms/indications of the following parameters: � • Negative pressure value inside the isolator;� • Doors opening;� • Chamber bonification;• Operator terminal/control panel showing:� • Working chamber negative pressure� • Cycle steps� • Error messages� • Indication of soft key to be pushed for proceeding to the next step� • Inlet filter clogging� • Exhaust push-push filters clogging� • Voltage presence

57

Leak Pressure Test

PI

Verifica della tenuta dell’isolatore

•Predisposizione dell’isolatore per la prova

•Misura della temperatura della camera

•Misura della pressione iniziale e finale della camera

Risultato finale:

�Tf< 2,5 x 10-3 (h-3)(Tf: Hourly Leak Rate)

(ref.: ISO 19648 –2

TI

58

Placebo Containment Performance test

1,7 m

1,0 m

Verifica della concentrazione di placebo nell’aria :

•Segregazione della zona di campionamento

•Posizionamento della sonda di campionamento

•Simulazione delle operazioni utilizzando un placebo (Lattosio)

•Validazione del metodo di analisi

•Presentazione dei risultati

Risultato finale:

�#ambiente< 1µg/m3

�#Superficie< 10µg/100cm2

100 cm2

59

Check of isolator performance

Set-point - 75 Pa

alarm – 100 Pa

Alarm - 35 Pa

Check of High Pressure Alarm

Normal running and check of

pressure stability

Check of Low Pressure Alarm

Normal running and check of

pressure stability

Check of air velocity into glove

port

Start and check of isolator function

60

Contents

1. Introduction




5. Testing


61

Isolator for Compounding of Cytotoxic compound

RTP door: La Calhene DPTE 270 S

Vessel placed over the Cell Weighing

and connected to the isolator throu a

membrane

62

Isolator for dispensing and Bin Charging

Isolator to bin Connection

Independent Balance support

Bag-outsytem

63

Isolator for Quality Control

64

Isolator for Filter Dryer Discharge

65

Isolator for containment:technical characteristics

• Housing in AISI 316, thick 3 mm, continuos

welding, bend radius 30 mm(AA)

• extraction of material through barrier bag (BB)

• exhaust system through double Hepa filter,

Push-Push type (CC)

• supply system completed of 2 Hepa cartridge

filter

• DP measurements of supply and exhaust filter

• hinged front window (DD)

• predisposition for WIP

AA

DD

CCBB

CC

66

• PLC control system (AA)

• Mirror finishing (BB)

• exhaust system able to

increase the fan speed in case

of serious damage on the glove

(break of the glove): the safety

inflow velocity throught the

glove-hole is 0,7 m/s (CC)

• pressure control of the cabinet

@ -75 Pa regulating the fan

speed (DD)

0,7 m/s

AA CC

-75 Pa

Isolator for containment: technical characteristics

BB

DD

67

Exhaust filtration: push-push system

68

Some construction datails

Plastic Bag connection

69

Some construction datails

Pass-box

Electrical socket

Gloves

70

Isolator for movable lab

71

Isolator for Dispensing

Isolator with Nitrogen inertisation system

72

Isolator for dispensing and bin charging: ATEX execution

Date post:	26-Dec-2014
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Design of Containemt Isolators

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