CLEANROOMEQUIPMENTAir and Containment Sterilization

MORE THAN 1000 INSTALLATIONS WORLDWIDE

• The only Indian company, o�ering a complete Tech Package inclusive of Turnkey Engineering for Pharma, Vaccineand Biotech projects

• First Indian company to manufacture and supply end-to-end Clean room products and technology

• 650+ employees, with strong technical and design skill sets

• Strong consistent presence in international markets Established footprint in 42 countries

• First Indian company to develop its own proprietary range of Isolation suites, including Isolators for a range ofequipment

• Growing at a CAGR of 23% with 77% repeat clients in India and Internationally

• Strong International and Domestic technical support, alliances and associations

COMPANY OVERVIEW

Bangladesh

China

India

Pakistan

UAE

Iran

Tanzania

Iraq

Syria Jordan

KSA

UKraine

Nigeria

TurkeyEgypt

Sudan

South Africa

Denmark

AlgeriaMorocco

Portugal

UK

BelgiumUSA/Canada

Mexico

Peru

Argentina

Head o�ce & branch o�ce

Agent & consultants

Covered by FVE's Sales team

GLOBAL PRESENCE

Russia

• Global & region speci�c pharmaceutical industrytrends

• “Critical Factor Analysis” for the market

• SWOT analysis of the client organization

• Corporate strategy

• Global business Plan

• Strategic product portfolio

CUSTOMIZED ANALYSIS AND RECOMMENDATION

• Sales projections and P&L formats

• Tech transfer/ Product Knowhow

• Manufacturing line suggestion & capacityplanning

• Financial feasibility and break even analysis.

• Becomes the basis of client's presentation toinstitutions, �nancing their projects.

• Vast experience in design and building of internationalprojects since last 17 years

• Well versed with regulatory guidelines & engineeringstandards

• Well-trained design team with hands on experience indesigning over 200 projects

• Multi layer checking system to verify design

• In-house expertise of pharma process, know-how;implementing latest guidelines as per regulatorynorms of local bodies

• Guidance from Interactions with internationalconsultants – USFDA and EMEA

360° Project ManagementIn-House Design Capability

Quality framework

Quality is a fundamental aspect of the value system we follow at FVE. While our leaders drive continued improvement in quality and customer satisfaction, our team is also equally committed and responsible towards ensuring �awless quality management system. Which is why, we have specially trained quality personnel in our project management team who are monitored by our Quality experts

Our core area of focus being Pharmaceutical and Biotech industry, where quality is a highly critical component for ensuring safe and controlled environments

Our special panel of quali�ed experts work with us as our exclusive Quality Management Consultants. They add value to our systems and processes with their in-depth knowledge on international quality standards to be benchmarked and adhered to

From pharmaceutical engineering to implementation, documentation and validation, we ensure strict adherence to the standards of EHS and other regulatory bodies. We also ensure US FDA compliance and EMEA guidelines to maintain consistent quality approach for every project cycle of design, supply, installation and commissioning

De dusting tunnel is designed to reduce initial non-viable particles from the raw materials received in drums, cartoons bags etc before they are transferred to ware house while protecting personnel and environment

DE DUSTING TUNNEL

Technical Details• MOC: SS 304/ SS 316/ Customized with integrated drain

system• Conveyor for materials transfer ( SS 304 roller / MS coated roller / Mesh/ Belt )• High velocity HEPA FILTER Jet system ( 8000 fpm to 10000

fpm )with manual adjustable direction control• Dust extract system HEPA protected at discharge ensuring no air escape from the system• Control system ( PLC / Manual ) with di�erential pressure gauges• Removable dust collection tray on wheel• LED concealed light providing light intensity in excess of

400 Lux• Motor Blower provided are statically and dynamically

balanced, su�cient capacity and static pressure maintainedto take care of air�ow requirement for entire life to HEPA

Options

• Integration with on line weight check• Integration with on line sampling and dispensingsystem

• Adjustable brushing system to maximize removalof non viable particle

• Customized design to suit speci�c requirement likemotorized sliding shutter , anti-static PVC strips etc

• Sequentially controlled PLC operation and processspeci�c instrumentation

• Modular construction for retro�tting to other system• CE declaration of conformity

Dynamic Pass Box material airlocks enable products to be transferred into clean rooms. A clean and low-turbulence air �ow (laminar air �ow) vertically �ows into the working area of the material airlock and is exhausted at table or �oor height (recirculation). Airborne substances are collected in a controlled manner. The material airlock serves as a barrier between the grey room and the clean room

DYNAMIC PASS BOX

Technical Details

• MOC: SS 304/ SS 316/ Customized• Self-supporting stainless steel construction• Interlocked, electrically monitored airlock doors

with static seals• FVE Make Fresh Air Pre-Filter behind the

perforated plates• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically & dynamically

balanced, su�cient capacity and static pressuremaintained to take care of air�ow requirement forentire life to HEPA

• Laminar air �ow recirculation system• Perforated plate or membrane distributor air outlet

surface• Automatic fan control for a constant LAF speed• Integrated control system• Technical documentation according to the

Machinery Directive• Quali�cation documentation• GMP-/FDA-compliant design

Performance

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ When

Ambient Is Not Greater Than 55 Db On Scale ‘A’• Vibration Level- Minimum

• CE declaration of conformity• Gasket doors• Single Pass Thru• Support stand• VHP integrated

Options

Technical Details

• MOC: SS 304/ SS 316/ Customized• Laminar Air Flow System• FVE Make Fresh Air Pre-Filter• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically

balanced, Su�cient capacity & static pressure maintainedto take care of air�ow requirement for entire life to HEPA

• Perforated Plate Or Membrane Distributor Air OutletSurface

• Automatic Fan Control For A Constant LAF Speed• LED Lighting• Integrated Control System• Technical Documentation According To The MachineryDirective

• Quali�cation Documentation• GMP-/FDA-Compliant Design

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Performance

Options

• Integrated Cooling System• ATEX Model• Supporting Legs With Or Without Rollers• Suspended Building Ceiling• Flow Restriction By Means Of A PVC Curtain, PVC

Blades Or Closed Wall Elements• Tubular Frame Construction With Electrically

Monitored Safety Glass Doors And Glove Ports(Glove Material: CSM/EPDM)

• CE Declaration Of Conformity

VERTICAL LAMINAR AIR FLOW UNITLAF booths provide product protection for working areas of varying sizes such as, for example, sampling, general process technology and the sterile �lling of pharmaceutical and food products. Product protection is ensured by means of targeted air �ow. A clean and low-turbulence air �ow (laminar air �ow) vertically �ows into the work area of the booth and is released back into the surrounding area close to the bottom. Airborne particles are collected in a controlled manner and discharged

STATIC PASS BOXStatic pass box material airlocks enable products to be transferred into clean rooms. Static Pass Box is speci�cally designed that aids in the material transfer without much personnel movement. Furthermore, the Static Pass Box also acts as a hindrance for entrance of contaminants in clean room and other classi�ed areas

• MOC: SS 304/ SS 316/ Customized• Self-supporting stainless steel construction• Interlocked, electrically monitored airlock doors withstatic seals

• Microprocessor based control system• Technical documentation according to the MachineryDirective

• Quali�cation documentation• GMP-/FDA-compliant design

Technical Details

• CE declaration of conformity• Gasket doors• Support stand

• MOC: SS 304/ SS 316/ Customized• Flow restriction at the back by means of an installed sheet metal cassette element, at the side by means of polycarbonate panes

• Folding polycarbonate panes at the front• Laminar air flow system (vertical or horizontal)• FVE Make Fresh Air Pre-Filter• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically balanced, Sufficient capacity and static pressure maintained to take care of airflow requirement for entire life to HEPA

• Perforated plate or membrane distributor air outlet surface• Automatic fan control for a constant LAF speed• LED lighting• Integrated control system• Technical documentation according to the Machinery Directive• Qualification documentation• GMP-/FDA-compliant design

Technical Details Performance

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Options

• ATEX model• Front Doors (hinged/Pneumatic Cylinder)• Air/Gas Coak• Front sliding panes with glove ports for increasedpersonnel protection

• Integration of a weighing system• CE declaration of conformity

LAMINAR AIR FLOW WORK STATION

LAF workbenches provide product protection for small to medium-sized work processes on a laboratory scale. Product protection is ensured by means of targeted air flow. A clean and low-turbulence air flow (laminar air flow) vertically or horizontally flows into the work area of the workbench and is released back into the surrounding area at table height. Airborne particles are collected in a controlled manner

www.FabTechnologies.com

Mist shower is a contamination control system basically designed to provide respiratory protection during degowning process to person besides reducing contamination in degowning area.Wherever there is open handling of highly potent materials.Wherever there is possibility of an isolator breach as emergency exit. Wherever maintenance is required on high containment system Can be used as an intermediate stage between processing area and degowning area Any process speci�c requirement

AIR SHOWER Air showers are specialized enclosed antechambers which are incorporated as entryways of clean rooms and other controlled environments to reduce particle contamination. Air showers utilize high-pressure, HEPA- or ULPA-�ltered air to remove dust, �brous lint and other contaminants from personnel or object surfaces.

Technical Details

• MOC: SS 304/ SS 316/ Customized• Fabtech Make Fresh Air Pre-Filter behind the perforated plates• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically balanced,su�cient capacity and static pressure maintained to take care of air�ow requirement for entire life to HEPA• High velocity shower jets in excess of 20 m/s ensure e�cient scrubbing action to remove particulate matter• Operating modes can be programmed in the �eld• Microprocessor controller supervises all functions • An emergency stop button is mounted on both sides of the shower• Indicator lights mounted on both sides of the air shower exterior regulate tra�c �ow in and out of the clean room• Permanently lubricated direct drive centrifugal blowers are used in conjunction with stainless steel/ PVC air nozzles

• CE declaration of conformity

OPTIONS

MIST AIR SHOWER

Technical Details

• MOC: SS 304/ SS 316/ Customized with integrated drain system• Sequentially interlocked doors• Mist nozzles placed at appropriate points to ensure complete wetting• Appropriate filteration system to comply with adjoining areas cleanliness level

• Removable flooring• LED concealed light providing light intensity in excess of 400 LUX

• 2 stage filteration at supply and safe change at exhaust• FVE Make Fresh Air Pre-Filter behind the perforated plates

• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically balanced, sufficient capacity and static pressure maintained to take care of airflow requirement for entire life to HEPA

• Dedicated skid mounted water system as per speci�c requirement, like water heating arrangement etc• Combo system (Air system cum mist shower)• Customized arrangement for disposal for PPE• Custom built to suit any layout• Sequentially controlled PLC operation and process speci�cinstrumentation

• Modular construction for retro�tting to other system• CE declaration of conformity

Options

DISPENSING/SAMPLING BOOTHThe Dispensing/Sampling Booth is a LAF recirculation booth with product and personnel protection (working principal of a Dispensing/Sampling Booth). These conditions are ensured by means of targeted air recirculation. A clean and low-turbulence air �ow (laminar air �ow) vertically �ows into the work area of the dispensing/sampling booth and is vacuumed in the bottom area. Airborne substances are collected in a controlled manner. The integrated exhaust air system, which generates a slight negative pressure in the work area of the dispensing/sampling booth, permanently protects the ambient area against contamination (cross contamination).The dispensing/sampling booth can be loaded and unloaded with the material to be sampled manually using the lateral high-speed Pharma doors or automatic conveyor technology. Optionally with material entry and exit air locks. In order to install the sampling booth in a non-classi�ed room (e.g. Material income store), there is the possibility of expanding a turbulently ventilated clean room (vestibule) with an integrated personnel airlock

• MOC: SS 304/ SS 316/ Customized• Reverse Laminar air �ow system• front �ow restriction with anti-static PVC curtain• FVE Make Fresh Air Pre-Filter• Intermediate Filter• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically & dynamically balanced, su�cient capacity & static pressure maintained to take care of air�ow requirement for entire life to HEPA• Perforated plate or membrane distributor air outlet surface• Integrated cooling system incl. mixed water control for condensate-free cooling• Automatic fan control for a constant LAF speed• LED lighting• Control system in a separate switch cabinet• Technical documentation according to the Machinery Directive• Quali�cation documentation• GMP-/FDA-compliant design

Technical Details

Options

• Turbulently ventilated clean room (vestibule) /house-in-house system

• High-speed doors for inward and outward transfer• Bag in/bag out pre-�lter for contamination-free�lter changes Conveyor and/or lifting technology

• CE declaration of conformity

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Performance

AIR SHOWER Air showers are specialized enclosed antechambers which are incorporated as entryways of clean rooms and other controlled environments to reduce particle contamination. Air showers utilize high-pressure, HEPA- or ULPA-�ltered air to remove dust, �brous lint and other contaminants from personnel or object surfaces.

Technical Details

• MOC: SS 304/ SS 316/ Customized• FVE Make Fresh Air Pre-Filter behind theperforated plates

• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically balanced,sufficient capacity and static pressure maintained to take care of airflow requirement for entire life to HEPA

• High velocity shower jets in excess of 20 m/s ensure efficient scrubbing action to remove particulate matter

• Operating modes can be programmed in the field• Microprocessor controller supervises all functions• An emergency stop button is mounted on both sides of the shower• Indicator lights mounted on both sides of the air showerexterior regulate tra�c �ow in and out of the clean room

• Permanently lubricated direct drive centrifugal blowers areused in conjunction with stainless steel/ PVC air nozzles

• CE declaration of conformity

Option

Versatile storage cabinets provide optimal storage space for clean room garments, tools, wipes, process equipment, and other materials. These rugged, economical cabinets provide a clean storage area for clean room garments, boots, wipes, and other materials

GARMENT STORAGE CABINET

Technical Details

• MOC: SS 304/ SS 316/ Customized• Self-supporting stainless steel construction• Removable perforated shelves• Garment rack (holds up to 30 garments)• Laminar air flow system (horizontal flow)• FVE Make Fresh Air Pre-Filter behindthe perforated plates

• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically and dynamically balanced, sufficient capacity and static pressure maintained to take care of airflow requirement for entire life to HEPA

• Heater bank• Perforations reduce obstructions to laminarair flow

• Automatic fan control for a constant LAF speed• Integrated control system• Double doors with self-closing hinges allow easy access with minimal clearance requirement

• Technical documentation according to the Machinery Directive

Performance

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Option

• CE declaration of conformity

• Quali�cation documentation• GMP-/FDA-compliant design

MOBILE LAMINAR AIR FLOW TROLLEY

Mobile trolley with battery operation provides product protection and enables sterile transportation through inferior clean rooms (e.g. manual dry freezer loading). Product protection is ensured by means of targeted air �ow. A clean and low-turbulence air �ow (laminar air �ow) �ows horizontally into the work area of the transfer cart and escapes into the surrounding area. Airborne particles are collected in a controlled manner. All safety-relevant functions are constantly monitored electronically.

BIO SAFETY CABINET Biological Safety Cabinet provides protection for the user, product and the environment from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with positive pressure ISO 5/Class 100 HEPA-�ltered air to protect the product from contamination while an inward air�ow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA �lter while the remaining air is discharged from the Bio-safety cabinet through the exhaust HEPA �lter. CGMP Compliant And Factory Tested As Per NSF#49 (National Sanitation Foundation) Standards, Providing “Cleaner Than Class 100” Conditions.

• MOC: SS 304/ SS 316/ Customized• Self-supporting stainless steel construction on wheels• Removable perforated shelves• Battery-operated• Laminar air flow system (horizontal flow)• FVE MAKE Fresh Air Pre-Filter• Digital Guages• Motor Blower provided are statically and dynamically balanced, sufficient capacity andstatic pressure maintained to take care of airflow requirement for entire life to HEPA

• Perforated plate air outlet surface• Automatic fan control for a constant LAF speed• Integrated control system• Technical documentation according to the Machinery Directive

• Qualification documentation• GMP-/FDA-compliant design

Technical Details

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Performance

• CE declaration of conformity

Option

Technical Details

• MOC: SS 304/ SS 316/ Customized• FVE Make Fresh Air Pre-Filter behind the perforated plates

• HEPA Filter H14/H13• Digital Guages• Motor Blower provided are statically & dynamically balanced, sufficient capacity and static pressure maintained to take care of airflow requirement for entire life to HEPA

• Side Glass Panels• Interlocking of supply #exhaust motor blower with logic control to ensure the system stops if either motor stops

• Minimal turbulence, unidirectional, vertical down flow re-circulating laminar flow cabinet

• Provides a safe work area for handling particles & aerosols down to the sub-micron size range

• Chamber eliminates cross-contamination and accidental release of pathogenic microorganismsor carcinogenic aerosols to the outside atmosphere

• Air Cleanliness- ISO Class 5 [ISO 14644-1:1999 (E)]• Air Velocity- 0.45 ± 0.05 Mps• Air Flow- Vertical• Noise Level- Less Than 67 Db On Scale ‘A’ WhenAmbient Is Not Greater Than 55 Db On Scale ‘A’

• Vibration Level- Minimum

Performance

• Chamber with glove ports• CE declaration of conformity

Options

• Other applications include handling materials suchas pollen, powders, allergens, dust, pathogen-freeanimals and plants where both clean air andcontainment are required