Tailor made solutions are becoming more and more important. Let's be honest about it. You want to achieve the highest possible efficiency, lowest cost and – increasingly important – a minimum amount of disposals. Our experience with the industries for last 30 years is available to assist you in achieving these objectives.
Following a general assessment, we study the feasibility of the system, design it keeping in view the critical parameters / requirement ensuring the optimum filtration in your facility in most economical way.
Prior to any order, our proposal for the filtration method and the filtration system is based on the project specification, customer requirements, engineering practices and the applicable design codes.
For decades the technocrats of Melius has been a partner to the demanding world of the process and health industry. We know filtration and we know that a solution for a filtration problem entails much more than just installing a filter.
We also renovate old Clean Rooms and Operation Theatres as per latest standards and requirement.
Last, but not the least, we manufacture Clean Room Equipment e.g. Dispensing Booth, Safety Cabinet, Laminar Flow Bench, Globe / Pass Box etc. on regular basis.
We also test and validate Filtration Systems, Clean Room Systems and Operation Theatres as per US Fed. Std. 209E, ISO 14644, GMP and NABH Standard.
We also do the Compressed Medical Air / Gas purity test as per NABH standard and other relevant standards.
Melius, formed in the year of 2011 is engaged in Designing, Engineering and Manufacturing of the following :
The Chief Executive of the company, Mr. B. Chakraborty, is a Doctorate in Management Studies with degree in Foreign Trade and advance level degree in IT, is having more than 26 years experience in various field of Filtration technology, Entrepreneurship and Operation.
In brief, Melius is focused to cater best available technology in the field of filtration – separation, Clean Room and Clean Room Equipment, with high degree of care in respect of quality, safety, human welfare and environmental cleanliness
Regd. Office : Fullorhat, Ahutibagan,
Near Fullorhat Yuba Sangha, Sonarpur, Kolkata - 700150, West Bengal, India
Biswajit Chakraborty - Chief Executive
Cell : (+91) 8335801001 | 9836248448
e-mail : info@melius.in, meliusmail@gmail.com
Offering a complete line of Hardwall and Softwall Clean Rooms
to meet your exact size and Class requirements
With each technological advancement,
airborne molecular contamination (AMC) has evolved as a serious threat to clean Room
environments. Contamination effects from AMC include corrosion on metal surfaces of
wafers, wafer and optics haze, unintentional doping and interference with packaging
operations.
Under the revised USP Chapter 797 regulation, all compounding pharmacies are required
to protect their products by utilizing a laminar flow workbench within a clean Room.
Greater care and cleaner facilities are now required for Compounded Sterile
Preparations (CSPs).
USP 797 refers to these ISO Global Clean Room Standards; specifically the ISO 14644
series of standards. The current air cleanliness requirement for a Compounding Clean
Room is an ISO Class 8. A separate ISO Class 5 Device is required for the compounding
of patient preparations. All sterile compounding is to be performed in an ISO Class 5
Device surrounded by an ISO Class 7 or ISO Class 8 Clean Room Buffer Zone. “Risk
Level ” determines the required ISO clean Room air cleanliness
classification.
With over three decades of clean room design and installation experience, we're able to
offer our clients a choice of services from site supervision to consultation, and
conceptual design to full turn key construction, including final certification.
Melius’s approach to a new project is flexible to meet the complete needs of our
clients. We develop custom projects, often incorporating existing site conditions and
using local, preferred contractors or in-house labor for our engineering and
construction efforts.
Melius’s wide range of capabilities allows us to design and construct a proven,
practical and affordable clean Room for any application. From ISO Class 1 to ISO Class
9 (FS209E Class 1 to Class 100,000), we design and build modular self-contained clean
Rooms, softwall enclosures, prefabricated kits, as well as custom-built permanent
facilities. We provide Comprehensive Project Management from Start to Finish.
We provide comprehensive turnkey service, managing your
Clean Room project from design through completion. We can support your needs after
construction with complete system maintenance. Our professional team works with you to
determine your application's specific Clean Room needs, considering both your immediate
and long-term goals.
In addition, our vast experience in clean Room system design enables us to identify and
supply individual component needs. Other products and services include Clean Room
Components, Separative Devices, and Clean Room Testing and Certification. For extended
project support, we offer a variety of maintenance contracts specifically suited to
meet the long-term requirements of your filtration application.
Clean Room Standards and Classifications
Cleanrooms, Products and Servicing acquired from Melius will comply with the applicable standards
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International Clean Room Class Comparison
ISO Classification Number |
US FED 209E |
BS 5295 |
cGMP (operational) |
ISO 1 |
|
|
|
ISO 2 |
|
|
|
ISO 3 |
M1.5 (1) |
'C' |
|
ISO 4 |
M2.5 (10) |
'D' |
|
ISO 5 |
M3.5 (100) |
'E' or 'F' |
A (B*) |
ISO 6 |
M4.5 (1,000) |
'G' or 'H' |
|
ISO 7 |
M5.5 (10,000) |
'J' |
B (C*) |
ISO 8 |
M6.5 (100,000) |
'K' |
C D |
ISO 9 |
|
|
|
* at rest conditions |
ISO 14644-1 Clean Room Standards
ISO Classification Number |
Maximum concentration limits (particles/m³ of air) for particles equal to and larger than the considered sizes shown below |
|||||
|
0.1 µm |
0.2 µm |
0.3 µm |
0.5 µm |
1 µm |
5 µm |
ISO 1 |
10 |
2 |
|
|
|
|
ISO 2 |
100 |
24 |
10 |
4 |
|
|
ISO 3 |
1,000 |
237 |
102 |
35 |
8 |
|
ISO 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
|
ISO 5 |
100,000 |
23,700 |
10,020 |
3,520 |
832 |
29 |
ISO 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
ISO 7 |
|
|
|
352,000 |
83,200 |
2,930 |
ISO 8 |
|
|
|
3,520,000 |
832,000 |
29,300 |
ISO 9 |
|
|
|
35,200,000 |
8,320,000 |
293,000 |
Laminar Flow Workstations provide a high degree
of localized control for critical processes. The Laminar Flow Workstations
operate by drawing ambient air, under negative pressure, into the top of the
unit. This air first passes through a pre-filter which traps the larger dust and
dirt particles. The blower then directs this pre-filtered air, now under positive
pressure, through the 99.99% efficient HEPA filter engulfing the entire work area
with sterile, unidirectional ultra-clean air. This air travels at a velocity
calculated to prevent the intrusion of unfiltered room air into the work area. It
also washes away particles that may be generated by manipulations within the
Workstations. Sterile, particle-free air is essential in such diverse processing areas as electronic assembly, sterile packaging and hospital pharmacy I.V. preparation. These processes and products require isolation from the contaminant typically found in ambient air. This clean environment can be best achieved and maintained by utilizing filtered laminar flow air in an appropriate workstation. |
Vertical Laminar Flow Workstations
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Horizontal Laminar Flow Workstations
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Melius air curtains are quiet, attractive, and affordable and can help you create a more comfortable front-end entrance. Non re-circulating air curtains are used on a variety of doorways where additional climate control is desired, Melius's units are attractive and easy to install above any existing entrance where a minimum of 14" of headroom is available. The unit is for single or double doors, both automatic and manual. Air curtains are designed to provide an invisible barrier between your sterile processing area and un-controlled environment. Prevents entry of dust, smoke, flies etc. Drugs & Pharmaceutical Hospitals & Clinics Food processing industries Cleanroom Cold storage Electronic industries Computer facilities Showrooms & Restaurants
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There are basic policy decisions required for the construction of an operation theatre department and it is imperative that a high standard of discipline be maintained to minimize the incidence of infection and cross-infection. In order to determine this, the hospital department has been divided into zones as given bellow:
1. Protective Zone: The protective zone is the entrance area for patients, staff and supplies where normal hospital standards of cleanliness apply and where normal everyday clothes can be worn.
2. Clean Zone: In order to pass between the protective zone and the clean zone everything must undergo a system of transfer. This is the main area of the department and all patients, staff and supplies must be clean. A strict cleaning routine applies and everybody must undergo a complete changing routine to enter.
3. Aseptic Zone: The aseptic zone is the inner area where conditions are as near sterile as possible. It applies to two rooms in each suite: the theatre and the theatre supply room. All staff who might handle exposed instruments must be scrubbed and gowned.
4. Disposable Zone: In the disposable zone all exposed instruments (used or unused), pathological specimens, lotions, suction jars and soiled linen are passed from the theatre to a disposal corridor and returned for cleaning, sterilizing or any other necessary process.
Any hospital which has been a large operating department also has a great deal of traffic, to preserve the departmental character, a control system must be imposed over all people entering or leaving the hospital.
Air handling system, OT interior & OT equipments. There are several options available in each part from where options are selected as per need, choice & budget. OT being most critical area in a hospital complex, it is necessary to control OT air in respect of temperature, humidity & particulate matter content of air, micro-organisms, i.e. bacteria, viruses, fungi etc.
Air handling systems process air through various stages. Air is cooled, moisture is removed, air is filtered to remove dust particles, bacteria, viruses; some air handling systems additionally remove gases, odors and other volatile organic compounds.
Laminar Air Flow is non-turbulent air flowing in parallel lanes vertically. LAF is filtered air coming over operative area from diffuser plenum above it. Plenum is fitted with HEPA (High Efficiency Particulate Air) filters of 0.3micron at 99.99% efficiency. Many times it is seen that plenum also works as light source above operative area; it has CFL/LED lights inside which provide clear shadow less light over operative area.
It is necessary to maintain particular air velocity in LAF so that filtered air coming over operative area carries bacterial load away from it. According to international standards it should be between 90-120 FPM (feet per minute). NABH (National Accreditation Board for Hospitals & Healthcare) also recommends the same.
Highly clean air of LAF falls in CLASS 100/ISO 5 category. When this air moves further in OT after leaving LAF area it mixes with less clean air of the room along with heat, moisture, bacterial load carried from operative area. It gradually looses it's clean state and while it reaches the last point in OT from where it is sent back to Air Handling Unit. Air in peripheral area of LAF normally falls in CLASS 10,000 - 100,000 categories depending on Air Handling Unit & OT size.
LAF can be made in various sizes. Apart from these standard sizes any other customized size can also be made.
Air Handling Unit has 3 filtration stages in total. First is 10 micron pre-filter, second 5micron fine-filter and third 0.3 micron HEPA filter. Out of three, first two are fitted in Air Handling Unit and last i.e. HEPA is fitted in plenum above operative area.
Fresh air is added to this within AHU. Positive pressure is created to restrict outside air entering OT though door etc. Necessary cascade pressure relief dampers are provided in wall to relieve excess pressure in hermetically sealed areas.
Air conditioning is done within Air Handling Unit to provide required cooling; no extra a/c is required in OT apart from this. HEPA plenum can be made in GI powder coat, Aluminum powder coat, SS304.
Wall & Ceiling panels are of 80mm thickness and have a composite structure of one side EGP sheet and the other side powder coated GI sheet with PUF filler in-between. The panels will be made from 0.8mm EGP sheet with a PUF insulation of density 40 in between. The PUF will have a thickness of 48.6mm and GI panel of 0.6mm on the upper side. The total ceiling will have a thickness of 50mm. the ceiling will also have a PU antibacterial paint.
EGP sheet will be finished with putty and a antibacterial antifungal coat to give a seamless coat.
A core of CFC frees rigid Poly Urethane Foam with typical physical properties:
2mm Conductive flooring with Carbon backing having weight of 3kg/m². the product will be Poly Urethane reinforced (PU-Shield), scratch resistant, fire resistant, chemical resistant, slip resistant, antifungal, antibacterial growth, with a dimensional stability of &li; 0.4%, static electrical charges &li; 2KV, impact sound reduction (approx). The floor should have an electrical resistance of 2.5 x 10 to 10 6 Ohms.
To maintain sterility and the correct air pressure inside the rooms, all OT suite entrance doors would be of the sliding, hermetically sealing type. The door will meet following specifications:
The doorframe would be made of high quality anodized aluminum and the door panel will be made of compact laminate that can withstand high abrasion. To ensure efficient sealing of the doors, the door frames will be provided. They should consist of reinforced plasterboard panels faced with the same laminate as the doors. The door will seal on all four edges in the closed position & should be surface installed type. The track of the door will be constructed with an aluminum extrusion, fixed firmly to the walls. Nylon runner guides will be fixed to the floor in such a way that they do not obstruct trolley movement through the door. The doorframes will be edged with an aluminum extrusion and with concealed fixings that are adjustable during installation to ensure a 100% hermetic seal is achieved. Vision panels, 300mm x 300mm will be provided in the doors. The door controller will be sensing overload condition and in overload case the door will automatically stop & reverse the direction of travel. The controller will be capable of either being operated by elbow switches/foot switches, radar switch (touch less sensor). All doors will be able to be operated easily manually in the event of failure of the power supply or the automation unit.
The door shall be equipped as standard with two large size elbow-operated pushbuttons, a double pair of miniature 13 mm diameter safety sensors positioned to monitor the presence of obstacles on the threshold, back-up battery unit for emergency opening during power outages (the door stops in the open position in order to identify the presence of a fault in the electrical circuit).
The Ceiling Pendant Systems designed to provide convenient positioning of medical equipment, medical gas terminal units, electrical and specialty services. The Ceiling Pendants will comply with NFPA 99, USA /HTM 2022. The support arms will be extremely robust and revolve on high quality bearings, so that the pendant head glides smoothly and quickly to any desired position.
Single Arm (1000mm) with horizontal movement and load carrying capacity of 80 kg. The arm will be rotated up to 330 degree to 340 degree with adjustable stopper. The Pendant will have pneumatic brakes system will be adaptable to various safety requirements and construction facilities. Surgeon Pendant will have 1 arm with shelves as per points :
The Surgeon Control Panel will meet Electrical Safety codes for High & Low voltage system, wired to the current IEE regulations. The room Surgeon’s Control Panel will be designed to cope with changing technology and equipment in operating environments. Control panel should be user friendly and ease of operating and maintaining purpose. The control panel will be of membrane type. The Control Panel shall be designed for front – access only. All internal wires shall be marked with plastic ferrule type cable markers, for ease of identification. The panel shall contain services as below :
Copper gas pipe line inside OT will be as per EN standard to cover Oxygen, Nitrous Oxide, Compressed air, Vacuum with accessories and CO2 Gas. The copper tube will be installed in conformity with the requirement of HTM.
Copper pipes will be seamless solid drawn, half hard, tempered, phosphorus deoxidized, non-arsenical and degreased conforming to BS 2871-1971 (Part) Table X and chemical composition as per BS 6017 – 1981, Table 2, Cu-DHP of size. After laying the copper pipes the line will be tested for leaks at a pressure 1.5 times of working pressure. In case any pressure drop is observed in 24 hours, the same will be rectified and the test is repeated till there is no pressure drop for 24 hours. The pipeline will be supported at regular intervals with PVC saddles and painted with 2 coats of enamel paint as per International color codes.
Pressure Relief Dampers will be provided in each OT to prevent cross contamination of air from clean and dirty areas. Suitably sized air pressure relief damper will be strategically placed, enabling differential room pressure to be maintained and ensure that when doors are opened between clean and dirty area. Counter-weight balancing system will be provided in the PRD to maintain positive pressure inside the operation room. Air pressure stabilizers will have unique capability of controlling differential pressure to close tolerance. The PRD will remain closed at pressure below the set pressure and should open fully at pressure only fractionally above the threshold pressure. The body will be epoxy powder coated as per standard BS colors. First class electrolyzed steel plate will be used for body and with high grade SS304 Stainless Steel for blades.
Grills shall be of extruded aluminum construction having concealed screws for fixing. These shall be duly powder coated in the shade approved by TMH/ TSL. The grills shall have horizontal bars at 15/30 deg. inclination and flanges on top and bottom. The grills at the end shall have flange on the side as well as per the site requirement. The size of main extruded section for flanges shall be minimum 15 x 15 mm and the louvers shall be 15 mm deep having thickness of mm in the front and 2.8 mm at the rear.
Ducting shall be made of Aluminum for supply & for return with curves and bends where indicated for easy flow of air and ensured to be air tight by applying Silicon sealant after fabrication .hanger shall be provided to ducts & shall be suspended by means of GI coated rods & these shall not be more than 2.5mtrs apart .Thermal Insulation with 12mm XPE with aluminum foil for supply & return air ducts. Joints should be lapped with Nitrile rubber tape for better insulation.
The Caracas of the plenum will be made of extruded aluminum sections in such a manner that the air is passed only through the filters only. Plenum unit for laminar flow diffuser will be made of thick aluminum sheet. The complete unit will have factory prepared fine sealing system. The plenum will be supplied at site duly sealed in factory made packing. The Laminar flow system will have anodized aluminum perforated diffuser grill. The laminar flow system will have such design that it provides cleanliness of class 1000.
All filters are having genuine fiber Glass media manufactured in Europe or USA (either by Lydall Corporation or Hollingsworth & Vose), not the cheapest one manufactured in China. So, the life and efficiency of the filters are nearly double in comparison to available so called filters in Indian market whose country of origin in China.
A clean room or a clean space is defined as a room, a suite of rooms or an area of controlled environment. The concentration of airborne particulate matter in the area is strictly controlled, and other factors may be controlled within limits necessary to cater for the purpose of the controlled space.
The use of
clean spaces for the manufacturing, packaging, laboratories and research has
traditionally been the domain of the pharmaceutical, biotechnology, semiconductor,
microelectronics and aerospace industries however application to other sectors is
becoming more prevalent.
Hospital theatres utilise similar design and operation principals to clean rooms,
however the objective with such facilities is to control particular types of
contamination, rather than the quantities of particles present.
Typically a
clean room will be specified by a classification from a certain standard. The
classification relates to the definition of a maximum allowable number of particles of
a range of sizes, related to a standard volumetric air sample size.
Clean rooms are grouped according to the type of activity performed and are thus:
Class 3.5 : Laminar flow clean rooms |
Class 350 : Laminar flow clean rooms |
Class 3500 : Non laminar flow clean room |
Class 7000 : Clean room |
Melius has the expertise and experience to perform particle counting to a variety of cleanliness classes, ranging from 0.035 to 3500, as well as US and other classes. We can also offer design and use advice to fit your clean room to your requirements.
Operation Theatre (OT) is one of the most critical areas of any hospital.
Surgical site infection (SSI) represents the most frequent type of infection in our country. It is the leading infection in the general patient population, affecting up to two third of operated patients.
To reduce it, there are Standards and Regulations in place by Govt. of India (i.e. IPHS, NABH etc.). As per National Accreditation Board for Hospitals & Healthcare Providers (NABH), Operation Theatres of any Hospital must carry out validation twice in a year.
Melius is one of the leading organizations in Eastern Region involved in 3rd party testing and validation of the OT’s. We not only test the OTs but also can provide detailed analysis and solution to the issues which ultimately can reduce Surgical site infection (SSI) and Health Care Associated Infections (HCAI), as a whole.
The NFPA 99 Health Care Facilities, 2005 specification provides requirements for medical gas systems in health care facilities. Melius provides air and gas analyses in support of these guidelines.
Medical Gas Testing Requirements Include:
All of our systems provide fast and accurate results while still meeting the specifications of air purity standards. Standards such as NABH, CGA Grade D and E, DIN 3188, NFPA 1500, CSAZ180.1-M85 and EN12021 can be fulfilled.