isolator technology · maximum leg/knee clearance ... the isolator is fitted with transfer...

ENVAIR Deutschland GmbHTel. +49 7641.46 88 19-0www.envair-deutschland.de

Class

III

CytotoxicIsolator

StandardDIN 12980

EN ISO 14644-7

Width (m)

1.2 / 1.5

1.8

Isolator TechnologyENVAIR eco safe CMR (DIN 12980:2017)

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1972: Foundation ENVAIR Ltd. (GB)

1979: Development of Microbiologic Safety Cabinets/Workbenches

1986: Development of Isolators for hospitals and pharmacies

1992: Development of complex pharmaceutical Isolators for industry

2000: Honoured with „Awarded Design Council Millennium Products“, for the

development of Micro-Isolators

2006: ENVAIR Ltd. becomes subsidiary of Bassaire Ltd. www.bassaire.co.uk

2009: Foundation of ENVAIR Deutschland GmbH

2009: Re-Design Cytotoxic-Isolators CMR

2009: Expansion of optional attachments for Isolators such as vertical hatch doors

2011: Re-design Stent Line

2012: New development of Botox production line

2013: New development of Microbiological Safety Cabinet/Workbench ENVAIR eco safe Robot

2014: New development of Isolator ENVAIR eco safe Iso Compact

2015: Re-Design Cytotoxic Isolator ENVAIR eco safe CMR

2016: New development Cytotoxic Safety Cabinet/Workbench ENVAIR eco safe Robot in 3-filter system

2016: Development of ENVAIR lab Centrifuge, ENVAIR lab PCR Thermal Cycler, ENVAIR lab CO2 Incubator

High-Tech for your laboratory – Cytotoxic Isolators of latest generation 3

Cytotoxic-Isolators (CMR) 4

Optional equipment for all Isolator models 5

State of the Art for safe work and handling 6

Isolator description 7

Quality assurance concept for Cytotoxic Isolators/SOP forms 12

Technical data 14

Our service for you 16

Contents

ENVAIR GroupMuch more than just clean air

For more than 40 years the ENVAIR Group is active on the market. As specialist in Life Science/Biotechnology, Pharmacy and Chemistry we produce our units in our own factory. Since 2009 ENVAIR Deutschland GmbH takes care of the German-speaking market and is responsible for distributing ENVAIR’s complete product range. Ranging from the smallest Workbenches to most complex Isolators in clean-air and containment facilities. Cleanroom Technology of superior quality.

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High-Tech for your laboratory Cytotoxic-Isolators of latest generation

Smooth surface withoutcrevice as per GMP

Cytotoxic-Isolator (white, powder-coated) Main switch

Multi-function touch-display with PLC control, password protected.

Night mode (speed reduction)

Timer for programmable

Start/Stop

Folding front visor foroptimized cleaning

300 mm Ø glove-ports

Maximum leg/knee clearance

GMP-Cover

LED-lightingincl. 2 electric sockets

Stainless steel workzone

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Cytotoxic-Isolator (CMR)contains the following features

Electr. socket / Isokinetic sampling probe for perma-nent particle monitoring, free placement inside the work zone as far as compatible with standards in effect

• Air quality of cleanroom class A (unidirectional displacement current Laminar Flow) as per EU-GMP Guide within the com-plete work zone

• Easy cleaning of inner and outer surface

• Easy to clean multi-functional control

• Automatic pressure decay test, data are stored by the control

• Remote control function. ENVAIR service is enabled to log in the unit in case of failure messages via network, therefore cost-savings in service.

• Safe and consequent separation of operator and process due to a closed system

• Negative pressure operation (-75Pa) with laminar airflow and actively regulated blowers

• Sterile glove-changing system

• Easy surveillance, test and maintenance

• Ergonomically designed for easy operation, good visibility and high operators’ comfort

• Eligible display of internal pressure with delayed ambiv-alence time, automatic pressure decay test and pressure decay display

• Electro-polished stainless steel work surface, easy to clean.

• High air-change rate within the work zone and the transfer hatches for rapid clean-up of contaminated air and rapid disposal of disinfection agents

• Hatches with transfer tablets, foot switches for doors and door interlock system

• Multi-functional touch-display (size 8")

• Stand-by circuit / night-operation mode

• Tested and documented quality (IQ/OQ)

• Reasonable price/performance ratio compared to custommade Isolators

• Standard-conformity to DIN 12980, EN ISO 14644-7, EN

• 61010 (electric installation), VDE / DIN 57789 (test), VDI

• 2083-1 and VDI 2083-3 (qualification)

• Air quality of cleanroom class A as per EU-GMP guide and DIN EN ISO 14644-1 class 3

19" cleanroom monitor in the rear wall with touch-screen function.This monitor was especially developped for cleanrooms.

Range of application:

Processing of:

• Cytotoxics (CMR)

• Virustatics

• Capsules

• Hazmat, under TRGS 525

• Any other toxic active agents

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Cytotoxic Safety Workbench ENVAIR eco safe Plus with waste disposal

Remote function (remote maintenance) by ENVAIR service

Cytotoxic Isolator connected to a Microbiological Safety Workbench (4-zone concept)

• Compressed air, vacuum and nitrogen connections

• H2O2-gassing, H2O2-hatch

• Electrically adjustable support

• 2 Isolators (double version) with central 3-way-hatch

• Isolator with 1 hatch

• Vertical inner hatch doors (electric)

• Active charcoal filter

• Suspension rod in the work chamber

• Isokinetic probe for particle monitoring

• Water-protected sockets IP 44

• Connection for air sampler

• Display of hatch pressure

• Camera for documenting the process

• Test disc with manometer for glove integrity

• 19" cleanroom monitor with touch screen

• Work surface with provision for balance operation

• Interface RJ 45 / RS 232 / USB

• Monitoring of temperatur and humidity

• Entirely made of stainless steel 1.4301 / < 0,8 μm

• 3-way hatch with connected Cytotoxic Safety Cabinet/Work-bench

• Potential-free contacts

• Further options upon request

The Cytotoxic-Isolator (CMR)Optional equipment of all Isolator models

ENVAIR ServiceCustomer

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The Isolator basically consists of powder-coated sheet steel but can be constructed entirely of stainless steel 1.4301. The work chamber is made of stainless steel 1.4404 and the work surface is removable. The unit features unidirectional displacement flow (Laminar Flow), filtered by HEPA filters (High Efficiency Particulate Air Filter H14).

The front visor offers a number of practical and tested features. It is equipped with either 2 or 4 integrated glove ports of 300 mm diameter which allow most comfortable work. For easy cleaning purposes it can be turned up, held in open position by gas pressure springs.

During operation the gasket of the visor is pressed against the Isolator by 3 knurled screws.

The Isolator is connected gas-tight to the hatches with a static gasket. The rear wall optionally holds a flush-mounted 19" touchscreen monitor. In order to avoid limitations in operation due to reflec-tions there is no additional glass screen in front of the monitor.

The Isolator can be operated in sitting or in standing position. The 100% leg/knee clearance is granted by the main filter being placed backwards.

The Isolator is fitted with transfer hatches at both sides for load-ing and unloading the material to be treated. Each hatch is fitted with inner and outer doors as well as with a sliding transfer tray from the hatch into the work chamber. Each hatch is ventilated via a prefilter G4 and 2 HEPA filters H14.

The air entering the work chamber is filtered by a H14 HEPA filter in any case, no matter if one hatch door is open or not.

For safety reasons the inner and outer hatch doors are electro-magnetically interlocked so that only one door can be opened. All other doors are locked and can not be opened at that time.

When the hatch door is closed again, a pre-settable delay program becomes active until one of the other doors can be opened. Therefore it is granted that no particles can enter the work chamber or escape to the ambient during the rinsing phase. Each hatch is fitted with a foot switch to open the inner hatch doors.

Transfer tray out of the hatch into the work chamber

ENVAIR eco safe CMR State of the art for safe work

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Foot switch

Transfer hatch doors (hinged doors):inner and outer doors of the transfer hatches are of hinged type. The outer doors open upwards. Optionally they can be opened from left to right or vice versa. The mechanism is operated by a key at the hatch and a second key at the display.

The inner hatch doors open from front to back, operated by a foot switch or a second key at the display.

Advice: You do not loose space in the work zone by the hinged doors. As soon as you use the transfer tablet there is still enough space.

Optional vertical hatch doors:The inner vertical hatch doors are operated by a foot swith, by pressing the relevant foot switch the relevant inner hatch door will open automatically. The door slides vertically up. When the door is to be closed again, the foot switch must be pressed again. The door will automatically slide down.

The doors are fitted with a pressure sensor to avoid that fingers can be caught. Due to this new function the inner doors must no longer be opened manually, avoiding cross contamination via the doors. Even the complete work flow will be more economic.

You can watch the hatch doorfunction under: http://www.youtube.com/watch?v=FpnV2TkK3JM

Hatch door Switch to open the outerhatch door

Signal indication of doorcontrol at the rear wall

Advice:Fail safe due to compressed air function, no use of electric motors.Outer transfer hatch doors: Opens via Siemens control or switch at the hatchInner hatch doors: Opens via Siemens control or foot switch

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Air flow pattern:The fresh air enters the work zone after double-filtration. Firstly via prefilter and HEPA H14 hatch filter from the top of the hatch and secondly via a second HEPA H14 filter installed at the rear wall. Then the air is guided through the main HEPA H14 filter, installed in the work chamber. Approx. 30% of the air is exhausted through the exhaust HEPA H14 filter. The remaining 70% air portion is guided into the work chamber as laminar air flow from above through the circulation HEPA H14 filter or main HEPA H14 filter at the bottom.

Due to the main HEPA H14 filter being installed underneath the work surface only the work chamber and the area under-neath the work surface will be contaminated. Otherwise no contamination of air guidance ways is possible which simplifies maintenance and increases safety.

Exhaust – Escape Air:The exhaust air is guided via a gas-tight valve to an exhaust flange. The delivered exhaust piping must be connected to an on-site exhaust system.

Regulation / Control:Multi-function Touch-DisplayOptional free contacts for on-site exhaust system and alarms

Password protection of the control:Changes of hatch-lock time or alarm limits are only possible after entering a password.

Power breakdown:In the event of a power breakdown an acoustic alarm is released. This alarm is powered by a separate battery. Optionally a UPS is available which holds the work conditions for 10 – 20 mins.

Separat switch:• Left foot switch to open the left inner hatch door

• Right foot switch to open the right inner hatch door

Support:Fixed metal support, 800 mm highOption: entirely of stainless steel 1.4301

Initial display (size 8")

Segmented main HEPA filter for contamination-free filter exchange, suitable for all 60 liter waste bins.

Exhaust air piping for on-site fixed connection.(without covering)

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Pressure-controlles blowers(Display blower capacity exhaust)

HMI Touch PanelThe Isolator is fitted with a digital HMI-Touch-Panel with scroll-down function, which indicates all measuring values. The Isola-tor has no analogue differential pressure indications.

The menu has various features:• Operation hours counter (hours, minutes)

• Last service (date, time, password-protected)

• Last pressure test (date, time, pass or fail)

• Measured values of pressure test (value 1, value 2, etc.)

• Remaining filter lifetime

• Exhaust air blower capacity (percent)

• Circulating air blower capacity (percent)

• Inner temperature

• Outer temperature

• etc.

Alarms of the PLC-control, visible at the display:• Air change rate

• Work zone pressure

• Main filter differential pressure monitoring

All alarms are free adjustable.

Automatic Pressure Decay Test:The Isolator independently performs a pressure test to make sure that Isolator and hatches are completely tight.

Automatic negative pressure build-up of approx. -250 Pa, then holding time.

Automatic start of measuring when the negative pressure reaches -150 Pa.

Measuring is performed every 60 seconds, the values are stored from the PLC. 3 measurings in total, all values can be read from the display after the test is finished.

Criteria: maximum 25 Pa pressure decay/minIn case the pressure decay is more than 25 Pa per minute the display will show „Pressure Test Fail“.In case the pressure decay is less than 25 Pa per minute the display will show „Pressure Test Pass“.

ENVAIR criteria: 25 Pa in 90 sec. measuring time.

Parameter display Pressure decay test

TÜV certified pressure test

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Filter:

All listed filters (not prefilters) are HEPA filter (High Efficiency Particulate Air Filter) with nominal separating rate 99,995% and comply to DIN EN 1822 as filter class H14.

The prefilters on top of the hatch filters are coarse dust filters of class G4 as per DIN EN 779 and serve crucially for longer lifetime of the H14 hatch filters.

Exchanging the prefilters is simply done by taking out the filters from the filter frame and inserting a new filter. No need of tools, the filters are not contaminated.

DEHS-test – Filter-test:The Isolator is fitted with a number of test ports allowing the HEPA filters to be tested in place on separating rate and leakage.

All test ports are accessible from the front. All HEPA filters are tested (main filter H14, circulation air filter H14, exhaust air filter H14 and hatch filter(s) H14).

Air classification:Air classifications within the complete work zone are standardised:

• EU GMP, Grade A

• BS 5295 (1989) class F

• ISO class 3 as per DIN EN ISO 14644-1

Air pressure:On drop or increase of the preset alarm values optical and acoustic alarm will be released.

Air speed:

Vertical, unidirectional displacement flow (laminar flow) in the work zone is approx. 0,45 m/s. Inflow into the chamber in case of unintended sleeve opening is ≥0,7 m/s (0,7 m/s is regulation as per DIN EN 14644-7).The air speed inside the work chamber is adjustable in certain limits by adjusting the vertical airflow blower.

Particle monitoring inside the Isolator:User-friendly, versatile to be linked in terms of data, portable and with immense capacity: These are the features of particle counter of PZG-series.

The compact particle counters in elegant stainless steel ousing with large color touch-screen display are preferred tools of experts in filter tests, semiconductor and pharmaceutical industry, for hospitals and pharmacies as well as in various other production processes

Precision and flexibility are outstanding on PZG-serie. The particle counters measure at a flow rate of 28,3 l/min from 0,2 μm and at a flow rate of 100 l/min particle size from 0,3 μm. The two model variants can display up to eight particle sizes simultaneously.

The units of PZG-series are fitted with two interface (USB and ETHERNET) and generate data reports as per all importants standards: DIN EN ISO 14644-1, DIN 1946-4, CFM, GMP at rest and GMP in operation. The particle counters are not only usable as independent measuring systems but also as component of entire particle monitoring.

PZG-Series

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Gloves/Sleeves:Separately changeable glove/sleeve combination. The gloves can be exchanged without breaking the clean atmosphere inside the work chamber.

The advantage of a large sleeve opening is a better mobility. The unit can be operated by persons of different body size without problems.

Double-glove systemBiogel Eclipse Indicator – the ultimative solution in protection and safety. The innovative Biogel Eclipse™ Indicator consists of two gloves: one green inner glove and one outer glove.

The inner glove is half a number bigger than the outer glove. The advantage is that the pressure to the hand is reduced so that less fatigue can occur. In case the outer glove will be erforated, the liquid from the operation field distributes between the two gloves. A green spot on the outer glove indicates the perforation. Beside this quick perforation indication the Biogel Eclipse™ convinces of its optimal fit and the clearly better wearing comfort and the excellent sense of touch. Biogel Eclipse™ gloves are thinner and clearly smoother than other gloves. The special Biogel inner lining allows to put it on easy even with moist hands.

Why double-glove system?Perforation of normal gloves remain undetected during handling but perforations are detected with the patented Biogel Eclipse Indicator system.• 97% of the perforation will be detected with the patent

Biogel Eclipse Indicator System

• Double-glove systems reduce the perforation risks from 34,7% to 3,8%.

• Double-glove systems reduce the contamination of hands from 13% to 2%.

Easy-Change Cuff Ring System (push/push)The easy to exchange ENVAIR Easy-Change cuff ring system was especially designed for sterile change of gloves. In case of changing a glove Easy-Change guarantees person and product protection. If you need to do a routine glove change, change a defective glove or just put on another glove size, the system allows easy and quick change without breaking the integrity of the surrounding area. The cuff ring has a double lip seal system which ensures that the containment never will be broken.

You can change a glove by putting a new sterile glove onto one inner blue cuff ring, inside the Isolator, and then push the old glove together with the other inner cuff ring into the sleeve or a bag.

Biogel Eclipse™ Indicator

Certified sleeves for CMR

You can watch the glove changeprocedure under:http://www.youtube.com/watch?v=3UNsJ7SFCqI

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Ergonomic and relaxed work

Iso-Chair evolution Iso-AssistentIso-Footrest

Quality Assurance Concept for Cytotoxic Isolators / SOP-Pattern

We have established a number of SOPs which you may adopt to your needs with minimum effort.

SOP-pattern

Cleanroom• Cleanroom and Air Condition

• Isolators and Workbenches

• Monitoring

Personnel• Basics

• Instructions, Trainings,

• Advanced Education

• Validation of Personnel

• Personal PPE

Cleaning• Cleaning Person

• Handling Items

• Preparing

Production• Flow of goods

• Enter

• Work instruction handling

• Work instruction preparing

• Material-related work

• instruction

• Production flow

Quality control• Validation of half-used items

• Microbiological production validation

• Microbiological ambient monitoring

• Cleanroom monitoring

Documentation• Cleanroom and air condition, Isolators and Workbenches

• Personnel

• Cleaning

• Production

• Quality control

Malfunctions and accidents

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Cytotoxic Isolator (CMR) with H2O2-Rapid-Gassing-Hatch and attached Cytotoxic Safety Workbench

• H2O2 gassing in the hatch ≤ 25 min

• H2O2 gassing of the complete installation

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Cytotoxic Isolator (CMR) ENVAIR eco safe CMR 1.2 m2-Hand, 2 Hatches

ENVAIR eco safe CMR 1.5 m2-Hand, 2 Hatches


Isolator dimensions:

Outer dim. (mm) W×H×D complete 2510 × 2450 × 868 2815 × 2450 × 868 3120 × 2450 × 868

Inner dim. work chamber (mm) W×H×D 1192 × 740 × 580 1497 × 740 × 580 1802 × 740 × 580

Outer dim. (mm) W×H×D Isolatorwithout hatches 1350 × 2450 × 855 1655 × 2450 × 855 1960 × 2450 × 855

Work height Isolator (mm) 750

Dim. inner door material hatch(mm) 370 × 338

Dim. outer door material hatch(mm) 370 × 324

Sleeves Neoprene (certified) / Polyurethane with textile ling (not certified)

Sleeve dimensions Dimensions at wrist 90 mm / Glove port Ø 300 mm

Electrical connection & weight

Connected value 230 V, 50 Hz, singlephase ≤ 240 Watt

230 V, 50 Hz, singlephase ≤ 280 Watt

230 V, 50Hz, singlephase ≤ 320 Watt

Weight (approx. kg) 450 480 520

Lighting work surface (Lux) ≥ 1200

Noise level (dB(A)) ≤ 48 ≤ 50 ≤ 51

Filter

Prefilter dim. G4 (mm) 305 × 457 × 20

Intake Hatch Filter H14 (mm) 305 × 457 × 115

Exhaust Hatch Filter H14 (mm) 305 × 457 × 69

Main Filter V-Filter Box H14 (mm) 305 × 235 × 400 (Qty. 3) 305 × 235 × 400 (Qty. 4) 305 × 235 × 400 (Qty. 5)

Circulation Air Filter H14 (mm) 1220 × 610 × 115 1525 × 610 × 115 1830 × 610 × 115

Exhaust Air Filter H14 (mm) 457 × 610 × 115 457 × 762 × 115 457 × 915 × 115

Filter Life Time approx. 10 years

Technical Specification

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Cytotoxic Isolator (CMR) ENVAIR eco safe CMR 1.2 m2-Hand, 2 Hatches



Materials

Isolator Housing Steel Sheet powder-coated / Option: Stainless Steel 1.4301

Material Hatches Stainless steel sheet powder-coated / Option: Stainless Steel 1.4301

Work Surface Stainless Steel 1.4404, electro-polished

Air Change

Air change rate work zone /h 1800

Air change rate hatch /h 3400

Air change rate exhaust /h 860

Exhaust air volume m³/h 160 200 240

Temperature increase in workzone (with constant roomtemperature 20°C)

1,5 – 3°C depending on filter condition



Air Flow (Laminar Flow) m/s 0,45

Air Flow Supervision Flow sensors in downflow and exhaust air

Negative pressure Pa -75

Pressure Pressure monitoring

Pressure test

Valve control semi-automatic / optionally: fully-automatic

Data Log History 5 years or 32 messages

Spare Parts Availability ≥ 10 years


1.3

20

18/0

1

Legend:

Service in pure culture

Envair offers service in pure culture. We do not simply sell our units to you but will assist you gladly from A to Z.

Delivery: We deliver all units ex works.Set-up service and packaging disposalare included upon request.

Service: • 24h at site service and 24h free

of charge phone hotline • 7 days a week

Spare parts guaranty: 10 yearsAvailability within 24h Ex stock Emmendingen

Qualification: • IQ/OQ• GMP• GAMP• 21 CFR Part 11

Decontamination:We carry out microbiological decontaminations with most modern H2O2 generators in Cleanrooms, Isolators and Safety Cabinets.

Maintenance: • Microbiological Safety Cabinets DIN 12469• Cytotoxic Dispensing Cabinets with KI-discus

test DIN 12980 • Laminar Flow Cabinets• Laboratory Fume Hoods• Cytotoxic Dispensing Isolator EN 14644-7 • Isolator EN 14644-7• Cleanrooms• Autoclaves• CO2 Incubator• Ultra Low Temperature Freezer -86°C

Service by professional staff. All works are carried out by service technicians qualified by TÜV Nord

Maintenance contract: Regular terms of maintenance increase your safety. With a maintenance contract we guaran-tee the complete check of all functions of your units. We will contact you reliably in regular terms.

Guaranty and Warranty: Combined with an ENVAIR maintenance con-tract we offer a 2-year warranty to all units. Excepted are consumables and wearing parts as well as compressed air components.

Should you have requirements which need to be discussed and agreed upon, please contact ENVAIR.

TÜV-tested

electrical socketsinstalled

Work zone rear wall varnished

Stainless steelwork zone rear wall

Hinged front visorfor optimal cleaning

Ergonomic

Media connections installed

Low power consumption

isolator technology · maximum leg/knee clearance ... the isolator is fitted with transfer...

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