Modular Operation Theater

Pre-Fabricated Modular Operationmodular ot

Modular OT is a finished steel structure with joint less sterile coating providing a high quality finish.

Pre-fabricated modular OT offer the advantage of

speedy construction,

high quality finish in prevention of contamination build up,

long durability,

robust and flexibility design for future expansion,

ease of maintenance etc.

MODULARITY

MODULARITY is a design approach that subdivides a system into smaller parts called modules, that can be independently created and then used in different systems.  A modular system can be characterized by functional partitioning into discrete scalable, and reusable modules.

Advantage of Modular Systems:-

Besides reduction in cost (due to less customization, and shorter learning time), and flexibility in design, modularity offers other benefits such as :-

 augmentation (adding new solution by merely plugging in a new module).  Modular buildings generally consist of universal parts (or modules) that are manufactured in a factory and then shipped to a build site where they are assembled into a variety of arrangements.

 Modular buildings can be added to or reduced in size by adding or removing certain components Operation Theatre*:- 

Animation video showing the modular OT design , components and construction .

Designing an ideal operating room complex

The establishment and working of the operation the­atre (O.T.) needs specialised planning and execution and is not a simple civil engineering work. A “civil-mechanical-elec­trical-electronic- bio medical” combo effort driven and co­ordinated by the needs, preferences and safety of the medi­cal/ surgical team forms the basis for starting and maintain­ing an operation theatre. Anaesthesiologists, by virtue of their knowledge of the intricacies of physiology, physics and bio­medical aspects of medicine and constant proximity to the operation theatre should preferably be involved from the early stages of planning of operating theatres.

WALLS & CEILING CONSTRUCTION: 

The room wall to have two independent surfaces with a minimum opening in between. The external walls of the room to be constructed with solid bricks with cement plastering. 

The inner surfaces walls to be constructed with 1.60 mm thick EGP steel.

The total distance between the inside and outside surfaces of the operating room should be sufficient for the flush mounting of equipment. 

The individual wall panels should be spot welded together at equal intervals .All the sharp edges and corners should be in radius to avoid bacteria contamination. 

The internal surfaces of the room walls should be sprayed with water based liquid plastic, wall glaze or equivalent, approved by the architect to a minimum dry film thickness of 300 microns. 

CEILING FILTRATION SYSTEM

The ceiling filtration system should be designed to ensure unidirectional distribution of sterile air with differential flow velocities decreasing from centre to perimeter of the surgical theatre to ensure the cleanliness of all the area covered by the air flow.

The ceiling system should be equipped with HEPA filters with different performances according to their position in the ceiling to achieve different flow velocities. 

The complete filtration ceiling system should be factory assembled its holding structure, Filter frames and top plenum should be made of AISI 304 stainless steel.

Filtration ceiling system should have HEPA filters, H according to EN 1822.

The air management system should be designed to achieve the following parameters:

F.S. 209 classification = 100 (100 particles/ft3) 

Bacteriological class =B (5 CFU/m3)* 

Particle decontamination kinetics CP =5 min 

Biological decontamination kinetics CB = 5min ECG-GMP 

Annex 1 classification = Class A ISO 14644/1 classification = ISO 5 11 3. 

DOOR AND FRAMES  (HERMETICALLY SEALED DOORS)

Should maintain sterically and the correct air pressure in the room, all doors into and out should be of the sliding, hermetically sealing type.

The door should meet the following specifications: *International quality & safety requirements. • 

Doors should be wired to the current IEE regulations & BS7971 standard. 

Motor should be DC 24V 70 W brush less DC Motor. 

Noise level of movement should not be more then 60 decibel.

Controller should be microprocessor based and be CE marked. 

Power efficiency should be .95 (in AC 100V full load). 

The track should be made up of single piece extruded aluminum. 

Environment temperature should be -20°C to +55°C. 

Starting time should be able to regulate from .5second to 23 second & starting speed should be 600 mm per second. 

Electrical safety codes for high & low voltage system • Design should meet HTM 2020/2021 standards. 

The doorframe should be made of high quality anodize aluminum and the door panel should be made of compact laminate that can withstand high abrasion.

To ensure efficient sealing of the doors frames 

They will consist of reinforced plasterboard panels faced with the same laminate as the doors.

The door should seal on all four edges in the closed position & should be surface installed type.

The track of the door should be constructed with high quality door lock with aluminum extrusion, fixed firmly to the walls.

Nylon runner guides should be fixed to the door in such a way they do not obstruct trolley movement through the door.

The doorframes should be edged with an aluminum extrusion & with concealed fixings to be adjustable during installation to ensure a 100% hermetic seal is achieved.

Vision panels, 300mm X 300 mm should be provided in the doors. The door controller should be sensing overload condition and in overload in case the door will automatically stop & reverse the direction of travel.

The controller should be capable of either being operated by elbow switches/foot switches, radar switch (touch less sensor).

All doors should be able to be operated easily manually in the event of failure of the power supply or the automation unit.

OPERATION THEATER CONTROL PANEL

The surgeon control panel should meet Electrical safety codes for high & low voltage system, wired to the current IEE regulations.The room Surgeon’s control panel should be modifiable with changing technology & equipment in operating environments.

Control Panel will be user friendly & ease of operating & maintaining purpose.

The panel should be “Membrane” type; configured to incorporate all the services that operation room staff required. 

The fascia should be made with superior quality UV resistance membrane with sterilization feature. 

The Panel should contain 6 or 9 service tiles as below: 

  1. Time Day Clock.
  2. Time Elapse Day Clock.
  3. General Lighting System.
  4. Medical Gas Alarm Panel. 
  5. Hand Free Telephone set with memory. 
  6. Temperature & humidity indicator with controller. 
  7. HEPA Filter Status module. 
  8. Room Pressure Indicator. 
  9. Music control. 

Time day clock should be digital type & clocks having high brightness characters. 

Time Elapsed Day Clock should be digital type & clocks having high brightness characters.

Temperature indicator should indicate the room temperature which should be connected to the local pressure switches of Air-Conditioning System.

Indicators should be digital type & clocks having high brightness characters, not less than 30 mm in height.

Central Lighting system should incorporate all the necessary controls of the lighting. system inside the theater.

The medical gas alarm should indicate High, Normal & Low gas Pressure for each gas service present in the operating system & should have an audible buzzer with mute facility.

Pressure sensors should be connected to MGPS for monitoring the pressures. A hand free set Telephone System should be incorporated in the panel with memory type card.

The control panel should be designed for front- access only. All internal wires should be marked with plastic Ferrule type cable markers for ease of identification.

DISTRIBUTION BOARD

All high voltage equipment should be installed in a separate enclosure.

The remote cabinet should house the operating lamp transformers, mains failure relays, electrical distribution equipment & circuit protection equipment for all circuits within the operating theater.

All internal wiring should terminate in connectors with screw & clamp spring connections of the clip- on type mounted, on a DIN rail & labeled with clear proprietary labels.

Individual fees or miniature circuit breakers should protect all internal circuits. 

 X RAY VIEWING SCREENS  

The system should have electrical safety codes for high & low voltage system.

The theater should be equipped with a 2 plate X-ray viewing screen.

It should be designed to provide flicker free luminescence for the film viewing purpose.

It should be installed flushed with theater wall for hygienic and ease of cleaning purpose .

The X-Ray viewing screen should be designed for the purpose of front access.

The X-Ray viewing screen should be illuminated by 4 pieces of high frequency fluorescent lamps and the dimming is controlled by the usage of dimming ballast with the PCB that is mounted inside the box.

The diffuser should be able to diffuse the light evenly and to provide enough luminescence for film viewing. It should be made of high quality opaque acrylic sheet. The film should be held firmly by using spring – loaded clips for ease of mounting and demounting. The body should be built by using electrolyzed steel with powder coating. It should work on PCB button control system.

PRESSURE RELIEF DAMPERS

Pressure relief dampers should be provided in each room to prevent contamination of air from clean and dirty areas.

Suitably sized air pressure relief damper should be strategically placed, enabling differential room pressure to be maintained and ensure that when doors are opened between clean and dirty areas.

Counter- weight balancing system should be provided in the PRD to maintain positive pressure inside the operation room.

Air pressure stabilizers should have a capability of controlling differential pressure to close tolerance.

The PRD should remain closed at pressure below the set pressure and should open fully at pressure and should open fully at pressure only fractionally above the threshold pressure.

The body should be epoxy powder coated as per standard BS colors. First class electrolyzed steel plate should be used for body and with high grade SS304 stainless steel for blades.

OPERATION THEATER FLOORING (ANTISTATIC CONDUCTIVE TILES)

A floor screed should be provided, flat to within a tolerance of +/- 3mm over any 3 metre area.

Onto this sub-floor, a self –leveling compound should be laid prior to lying of the floor finish. Copper grounding strips (0.05 mm thick , 50 mm width) should be laid flat on the floor in the conductive adhesive and connect to copper wire of grounding .

The floor finish in the operating room should be 2mm Conductive PVC tiles, laid on a semi-conductive adhesive base.

The floor finish should terminate at the room perimeter passing over a concealed cove former and continuing up the wall for 100mm.

All joints should be welded with electrodes of the same compatible material to provide a continuous sealed surface.

The floor should have an electrical resistance of 2.5 * 10 to 106 Ohms as per DIN 51953 ATM F-150 or NFPA 99, B1 class of fire resistance and should meet UL standard 779. Fulfils product requirements as per EN 649. 

STORAGE UNIT

The storage unit should be made with 1.50 mm thick EGP Zinc coated steel panels.

The storage unit should be divided 2 equal parts and each part should have individual glass doors with high quality locking system.

Each part will be provided with glass racks.

OPERATING LIST BOARD

One operating list board should be provided in each operating theater.

It should be made of ceramic having Magnetic properties and should be flushed to the wall of the operating room.

SCRUB STATION

Compact surgical scrub sink should be designed for use in OT complex providing Surgeons with a convenient sink for pre – OT scrub up.

Each fixture should be fabricated from heavy gauge type 304 stainless steel and should be seamless welded construction, polished to a stain finish.

The scrub sink should be provided with a front access panel which should be easily removed for access to the water controlled value, waste connections, stoppers and strainers.

Hands free operation should include infra red sensors with built-in range of adjustment.

Thermostatic mixing, valve control should be located behind the access panel and maintain constant water temperature.

User defined setting of 1 to 3 min are available. This timing should be adjustable to meet individual application requirements.

Provided with infrared sensors, thermostatic control taps with fail safe temperature controls.

All units should have reduced anti- splash fronts. Knee operated switch should be there.

HATCH BOX:

A Hatch should be provided in each operation theater to remove waste materials from the operation theater to Dirty linen area just adjacent to Operation Theater.

Each Hatch should be equipped with two doors and the door should be operated electronically.

The Hatch should be designed in such a way that only one door should be opened at one time ,

The UV light should be so installed that it is kept on while both the doors are closed. This UV light has to be automatically turned off in case of opening of either of the doors.

There shall be indicators on both side of the OT so that door open / close status can be monitored from both ends.

VIEW WINDOW

The view window of specified size to be provide:

Double insulated fixed glazing with not less than 5mm thick toughened glass.

Window frame shall be powdered coated Aluminium of approved shape flush mounted with wall paneling Motorized horizontal Venetian Blinds of powder coated Aluminium strips of vista level or equivalent of approved shade including necessary accessories.

The motor shall be of reputed brand The Venetian blinds should be motorized for 90 degree rotational. Minor Parameters.

Manufacturer should be ISO certfied for quality standards. Comprehensive warranty for 2 years and 5 years AMC after warranty.

Complete Documents to be provided. User/Technical/Maintenance manuals to be supplied in English. Certificate of calibration and inspection. List of Equipments available for providing calibration and routine.

Preventive Maintenance Support. as per manufacturer documentation in service/technical manual. List of important spare parts and accessories with their part number and costing to be given. Log book with instructions for daily, weekly, monthly and quarterly maintenance checklist.

The job description of the hospital technician and company service engineer should be clearly mentioned

Special requirement OTs

If the client has special requirement like Radiation resistant OT or Shock resistant OT, it should be discussed with supplier in advance .

one should lso discuss the otio of adding it in future.

Sharp edges,

if the component or are manually cut and attached, they might lead to sharp exposed edges which can cause injury.

one should insist to supplier that has to be no manual cutting so as to avoid sharp edges,

IDENTIFICATION OF INDIVIDUAL COMPONENTS

For maintenance and repair , it is important that details of the location and specifications of every component is available. often the person installing the OT is not the one doing maintenance and repairs.

Most of the suppliers provide  a detail designed document for records and future reference.

One should demand it from the supplier.

Damage to the OT Components

Chipping, scratching, fading of components are notices.

The suppliers provide powder coated components to solve this problem.Powder Coating

Site Requirement

The Modular OT suppliers  bring per -fabricated components of modular OT and assemble them on the site.

The  completion of incomplete civil works,or electric fitting are done by the clients end. The requirements of the civil and electric works are given by the suppliers after sight visit.

The Modular OT suppliers  bring trained manpower and required equipment with them.

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Designing an ideal operating room complex

The establishment and working of the operation the­atre (O.T.) needs specialised planning and execution and is not a simple civil engineering work. A “civil-mechanical-elec­trical-electronic- bio medical” combo effort driven and co­ordinated by the needs, preferences and safety of the medi­cal/ surgical team forms the basis for starting and maintain­ing an operation theatre. Anaesthesiologists, by virtue of their knowledge of the intricacies of physiology, physics and bio­medical aspects of medicine and constant proximity to the operation theatre should preferably be involved from the early stages of planning of operating theatres.

Operating theatre quality and prevention of surgical site infections

Many international scientific societies have produced guidelines regarding the environmental features of operating theatres (positive pressure, exchanges of filtered air per hour, air-conditioning systems with HEPA filters, etc.) and issued recommendations on healthcare-associated infection, including SSI, concerning surveillance methods, intervention to actively prevent SSI and approaches to monitoring the implementation of such strategies.

Therefore, the prevention of SSI requires a multidisciplinary approach and the commitment of all concerned, including that of those who are responsible for the design, layout and functioning of operating theatres.

Operation theaters and sterilization requirements — Design consideration and standards for infection control

 A “civil-mechanical-electrical-electronic-biomedical” combo effort driven and coordinated by the needs, preferences, and safety of the medical/surgical team forms the basis for starting and maintaining an OT. Hospitals should exercise great care in proper maintenance of the OR environment, heating ventilation and air-conditioning system (HVAC) system, and medical and nonmedical equipment inside the OR. Personnel involved in disinfection and sterilization process should follow aseptic protocols. Aseptic protocols mean following safe and disciplined procedures to minimize or eradicate the microbiological load in the environment and in the instrument brought into the sterile field during the surgery.

NABH guidelines for Modular OT

NABH Guidelines for Modular OT

NABH.

OT Complex is divided into four following zones :

Zone 1– Protective

Reception, Waiting, Trolley Bay, Change Rooms, Rooms for administrative
staff, Stores & Record and Conference Room

Zone 2– Clean Area

Pre Operative, Post Operative, Plaster Room, Staff lounges, Stores

 Zone 3– Sterile Area

Operating Theatre, Scrub Room, Anesthesia Room, Setup Room

Zone 4– Disposal Area

Dirty Utility, Disposal areas from each OT & Corridor leading to disposal
zone, Disposal Corridor

OT Complex

OT Complex should have unidirectional flow movement.

OT complex should have One entry and One exit

No criss-cross of the movement inside the OT complex.

Double door airlock should be at the entry and exit of the OT Complex.

Corridors, lifts and sinks  in OT complex

Dirty corridor should be leading to Dirty lift/Dirty Dumb waiter/Dirty tube.

Clean corridor also leading to Clean lift/Clean Dumb waiter.

Dirty lift/Dirty Dumb waiter/Dirty tube should preferably at nearby place of the dirty area of Bio Medical Waste area, Laundry and CSSD.

Sink should be fitted in the Dirty corridor.

OT should be linked to the Dirty corridor through Pass Box/Hatch Box.

Clean corridor is linked to the OT through door.

Pre-OP and Post OP Rooms in OT complex

Pre-OP and Post OP Rooms should be placed as such that there will not be any criss-cross of the Pre and Post Op patient.

Entry into Pre-Op should preferably be at the entry Airlock of the OT complex

Scrub Room in OT complex

Scrub Room should preferably in between OT or at the nearby place of OT.

Srub room should always be equipped with plumbing line for supply of water and drain line for outflow of the water from scrubber.

TSSU room in OT complex

One TSSU room should be within the OT complex.

TSSU room should be well ventilated and equipped with plumbing system and drainline.

Toilet room in OT complex

OT complex should not have any toilet inside the clean area. Toilet should be before entry to the change room.

No toilet should be placed in the upper floor of the OT

Seepage or dampness inside the OT should not be present.

OT complex should have auto sliding door or double swing door with vision panel at the entry and exit for ease of movement.

Layout

Major OT/Modular OT/Normal OT room should preferably be Square (6m x 6m) Height of concrete ceiling preferably > 4m for effectiveness of Laminar flow system avoiding convenient pockets of stagnant air caused microbial growth and for better asepsis.

There should not be any projected portion or any sharp corner of column/wall inside the OT.

Double brick wall/wall panel should be made to cover-up
projection of column.

Anything to be fixed on wall should be flushed on the wall.

There should not be any shaft inside the OT

No sewage/drain pipe should be inside the OT

No fire pipe and sprinkler should be inside the OT

The beam inside the OT should be avoided for convenience of fitting of internal ducting and installation of Laminar Plenum.

The area of the OT for CTVS, Hybrid and Robotic surgery should be ≥8.0m x
8.0m x 4.0m H.

Scrub Area

Each OT must have Scrub station and Anti Room in its adjacent for regulating
traffic in OT.

Walls , Flooring and Roof  of OT

Flooring of OT should be made with 2 mm thick antistatic PVC Roll/Tile/Epoxy coating.

The floor finish should pass over a concealed cove former and continue
up the wall upto 100mm.

Wall and Ceiling Panel may be Stainless Steel (SS-304)/EGP/SMS.

OT wall/ Metallic panel should be coated with antibacterial/epoxy painting by 300
micron thickness.

Copper grounding of OT

Copper grounding strip (0.05 thick, 50 mm width) should be laid flat on the floor in the conductive adhesive and connect to copper wire of grounding.

One earthing Copper lead should be brought out of from every 150 Sq.ft. area and attaching it to main earthing Copper strip/ground.

Doors and Windows in OT

Each OT should have one for patient entry and another for doctor’s entry from Scrubber’s room.

Location of the door of OT for patient entry should be in the middle of wall and the Sliding door from the Scrubber side must be at least 1m away from each corner of the Room for placement of Return air ducts at the corners.

Door preferably shall be Automatic Hermetically sealed sliding door of HPL
board with vision panel-300 x 300 mm for Modular OT/Major OT and Double leaf hinge typed flushed door of PCGI/SS-304 material with vision panel-300 x 300 mm for Major OT/Normal OT/Minor OT.

Each major/modular OT should have preferably one hermetically sealed window (1500 x 1500) with blinds to prevent claustrophobia of the Surgeon and other OT staff and it should preferably be opened towards outside the building.

OT window should be flushed to inside wall of the OT.

Lighting in OT

Sealed (Air tight) Peripheral light with dimmable facility shall be required to
generate 500 Lux inside the OT.

LED light (2’x1’)/Fluorescent lights with anodized Aluminum reflectors and optical antiglare system for adjustable light distribution.

Air Handling Unit of OT

Every OT should have dedicated AHU of more than 4500 CFM capacity.

AHU for OT should be placed in the nearby of OT to prevent energy consumption.

Laminar flow system with two mono filament precisely woven polyester sheet and terminal HEPA filter of 0.3micron should be installed in the Major/Modular OT.

Laminar plenum with built-in light may be optional.

Laminar size shall be 2400 x 2400 mm or 2400 x 1800 mm to be fitted at the
centre of the OT room.

Internal ducting inside OT should be of prefabricated Aluminium insulated with Nitrile Rubber/Polyethylene

AHU should be of double skinned PCGI wall with corner coving and VFD.

Exhaust cabinet should be equipped for ease of fumigation in OT

If wall panel is not used in OT, the return air ducts at the four corners should be covered with Corner panel and coving or Brick wall and coving.

SS-304 Grill with inclined fins should be fitted at the entry of return air duct.

Such grill in each return air duct should be fitted at its top and bottom.

Required condition of air management in the Modular OT (Super specialty OT)

Classification – 100 (particles measuring 0.5 microns or larger/cu.ft as per
NABH for Super specialty OT)

Bacteriological class -B (5 CFU/ m³)

Particle decontamination kinetics -5 min

Biological decontamination kinetics -5 min

GMP Annex I classification -Class A

ISO 14644/1/NABH classification -ISO 5(at rest condition)

The air quality at the supply i.e at the grill level should be class 1000 (particles measuring 0.5 microns or larger/cu.ft as per NABH) /ISO class 6(at rest condition) for General OT.  25 ACPH with 5 fresh should be mentioned inside the OT.

OT should be kept under positive pressure (15 pascal) as per ISO 14644

The temperature at 21 +/- 3 Deg C with corresponding relative humidity between 40 to 60% should be maintained inside the OT all the time.

Medical Gas pipeline system with medical graded copper pipeline and Gas outlets should be fitted inside the OT.

OT should be equipped with the following equipment/items in Modular OT package.

Anaesthetic Pendant (To be fitted at the right and Top of the head end of the patient)

Surgeon Pendant (To be fitted at the left and bottom of the foot end of the patient)

LED OT Light (To be fitted at the centre of the OT Room)

Surgeon Control to be flushed on the OT wall

X-Ray viewer to be flushed on the OT wall

Writing Board to be flushed on the OT wall

Built in storage cabinet to be flushed on the OT wall

Pressure relief dumper to be placed to the clean corridor.

Pass Box to be flushed on the OT wall and to be connected with Dirty corridor.

A Scrubber made of SS-304 material should be installed in the scrubber room adjacent to OT. The Scrubber sink should be 2/3 bay equipped with thermostatic control hands free operation through infra-red sensors and have manual foot and operation mode.

Integration of equipment inside the Modular OT

Integration of Modular OT with the Conference Room, consultant room and outside hospital Integration requires following features in the OT:

  • Digital Display Monitor
  • Audio Visual communication system
  • Central Control System
  • High definition Monitor for Image data management system
  • PTZ camera

Size of Minor OT may be same as/ smaller than the Major OT

Antistatic Epoxy/ PVC flooring

Antibacterial/Epoxy painting on wall and ceiling

Corner coving

SS-304 / EGP ceiling with heat insulation

Sealed (Air tight) Peripheral light with dimmable facility shall be required to generate 500 Lux inside the OT. LED light (2’x1’)/Fluorescent lights.

Diffusers for supply air shall be placed at the centre of the OT and diffusers for return air at the periphery inside the Minor OT.

The temperature at 21 +/- 3 Deg C with corresponding relative humidity between 40 to 60% should be maintained inside the OT all the time.

Medical Gas pipeline system with medical graded copper pipeline and Gas outlets should be fitted inside the OT.

Double leaf Hinge door(SS-304 / PCGI) with view panel.

LED/Halogen ceiling light light to be placed at the centre of the OT room.

Sealed window with blinds

The Revised Guidelines for Air-Conditioning System for Operation Theatres

A. The air conditioning requirements for Operation Theater in an HCO have been deliberated at length with manufacturers, engineers, technical committee members and other stake holders and the following guidelines have been finalised.

B. For this purpose operation theaters have been divided into two distinct groups:

a. Superspeciality OT: Superspeciality OT means operations of Neurosciences, Orthopedics (Joint Replacement), Cardiothoracic and Transplant Surgery (Renal, Liver etc).

b. General OT: This includes Ophthalmology and all other basic surgical disciplines. District hospital OTs and FRU OT would fall under this category.

C. The following basic assumptions have been kept in view:

• OT Size: Standard OT size of 20’ x 20’ x 10’ (Ht. below the false ceiling level is considered).

• Occupancy: Standard occupancy of 5-8 persons at any given point of time inside the OT is considered.

• Equipment Load: Standard equipment load of 5-7 kW considered per OT.

• Ambient temperature & humidity at each location to be considered while designing the system.

I. Air Changes Per Hour:

Minimum total air changes should be 30 based on international guidelines although the same will vary with biological load and
the location.

The fresh air component of the air change is required to be minimum 5 air changes out of total minimum 30 air changes.

If HCO chooses to have 100% fresh air system than appropriate energy saving devices like Heat Recovery Wheel, Run around Pipes etc should be installed.

II. Air Velocity:

The vertical down flow of air coming out of the diffusers should be able to carry bacteria carrying particle load away from the operating table. The airflow needs to be unidirectional and downwards on the OT table. The air velocity recommended as per the international and
national guidelines is 90-120 FPM at the Grille/ Diffuser level.

III. Positive Pressure:

There is a requirement to maintain positive pressure differential between OT and adjoining areas to prevent outside air entry
into OT. The minimum positive pressure recommended is 15 Pascal (0.05 inches of water) as per ISO 14644 Clean Room Standard.

IV. Air handling in the OT including air Quality:

Air is supplied through Terminal HEPA filters in the ceiling. The minimum size of the filtration area should be 8’ x 6’ to cover the entire OT table and
surgical team. The minimum supply air volume to the OT (in CFM) should be compliant with the desired minimum air change. The return air should be picked up/ taken out from the exhaust grille located near the floor level (appx 6 inches above the floor level). The air quality at the supply i.e. at
grille level should be Class 100/ ISO Class 5 (at rest condition). Class 100 means a cubic foot of air must have no more than 100 particles measuring
0.5 microns or larger.

V. Temperature and Humidity:

The temperature should be maintained at 21 +/- 3 Deg C inside the OT all the time with corresponding relative humidity between 40 to 60% though the ideal Rh is considered to be 55%. Appropriate devices to monitor and display these conditions inside the OT
may be installed.

VI. Air Filtration:

The AHU must be an air purification unit and air filtration unit. There must be two sets of washable flange type pre filters of capacity 10 microns and 5 microns with aluminum/ SS 304 frame within the AHU. The necessary service panels to be provided for servicing the filters, motors & blowers. HEPA filters of efficiency 99.97% down to o.3 microns or higher efficiency are to be provided in the OT and not in the AHU.

I. Air Change Per Hour:

Minimum total air changes should be 25 based on international guidelines although the same will vary with biological load and the location.

The fresh air component of the air change is required to be minimum 4 air changes out of total minimum 25 air changes.

II. Air Velocity:

The vertical down flow of air coming out of the diffusers should be able to carry bacteria carrying particle load away from the operating table. The airflow needs to be unidirectional and downwards on the OT table.

III. Positive Pressure:

There is a requirement to maintain positive pressure differential between OT
and adjoining areas to prevent outside air entry into OT. The minimum positive pressure recommended is 15 Pascal (0.05 inches of water) as per ISO 14644 Clean Room Standard.

IV. Air handling in the OT including Air Quantity:

Air is supplied through HEPA filters in the AHU. The minimum size of the air supply area should be 6’ x 4’ to cover the entire OT table and surgical
team The minimum supply air volume to the OT (in CFM) should be compliant with the desired minimum air change.

The return air should be picked up/ taken out from the exhaust grille
located near the floor level (approx 6 inches above the floor level). The air quality at the supply i.e. at grille level should be Class 1000/ ISO Class 6 (at
rest condition). Class 1000 means a cubic foot of air must have no more than 1000 particles measuring 0.5 microns or larger.

V. Temperature and Humidity:

The temperature should be maintained at 21 +/- 3 Deg C inside the
OT all the time with corresponding relative humidity between 40 to 60% though the ideal Rh is considered to be 55%. Appropriate devices to
monitor and display these conditions inside the OT may be installed.

VI. Air Filtration:

The AHU must be an air purification unit and air filtration unit. There must
be two sets of washable flange type pre filters of capacity 10 microns and 5 microns with aluminum/ SS 304 frame within the AHU. The necessary
service panels to be provided for servicing the filters, motors & blowers. HEPA filters of efficiency 99.97% down to o.3 microns or higher efficiency
may be provided in the AHU.

a. The AHU of each OT should be dedicated one and should not be linked to air conditioning of any other area.

b. During the non functional hours AHU blower will be operational round the clock (may be without temperature control). VFD devices may be used
to conserve energy.

 

c. Window & split A/c should not be used in any type of OT because they are pure re circulating units and have convenient pockets for microbial growth which cannot be sealed.

d. The flooring, walls and ceiling should be non porous, smooth, seamless without corners and should be easily cleanable repeatedly. The material should be chosen accordingly.

e. Validation of system to be done as per ISO 14664 standards and to be necessarily include:

• Temperature and Humidity check

• Air particulate count

• Air Change Rate Calculation

• Air velocity at outlet of terminal filtration unit /
filters

• Pressure Differential levels of the OT with reference to
ambient / adjoining areas

• Validation of HEPA Filters by appropriate tests like DOP etc.

f. Maintenance of the system: It is recommended that periodic preventive maintenance be carried out in terms of cleaning of pre filters at the interval
of 15 days.

Preventive maintenance of all the parts is carried out as per manufacturer
recommendations.