Marya Aseptic Production Cleanroom for Biopharmaceutical Manufacturing

• Customization: Available
• After-sales Service: 1 Year
• Layers: Customized
• Model NO.: MARYA AA
• Usage: Dust-Proof Workshop, Electrostatic Workshop, Food And Chemical Industry, Heavy Industry, High-Voltage Power Plant, Research Facility, Specialized Workshop, Textile And Electronic Processing, Warehouse, Pharmaceutical Factory
• Cleanroom Panel: Color Steel Panel, Stainless Panel, HPL Panel
• Panel Thickness: 0.5mm, 0.6mm, 0.7mm, 0.8mm
• Cleanroom Door: Wing Door(Single Door, Double Door, Unique Door, G
• Requirements: GMP/ FDA
• Design: Customized
• Application: Clean Workshops Such as Pharmaceuticals, Laborator
• Humidity Design: 30-60%
• Equipment Supply: Air Shower, Pass Box, Weighing Booth, Isolator
• Auto-Control Supply Scope: PLC Controller, Sensors for Humidity &Temperature
• Machinery Test Report: Provided
• Transport Package: Standard Export Package
• Specification: customized
• Trademark: Marya
• Origin: China
• Production Capacity: 5000pieces/Year
• Package Size: 100.00cm * 100.00cm * 20.00cm
• Package Gross Weight: 20.000kg

Product Description

Marya Aseptic Production Cleanroom for Biopharmaceutical Manufacturing

Product Description

I. Marya Cleanroom Engineering Advantages:

(1)Our cleanroom construction class standard: Class 100-100000; ISO 5-8; Class A-D, meeting the requirements of  GMP, FDA, WHO, and other pharmaceutical standards;

(2)Modular design, fast installation;

(3)CE-certified construction material;

(4)High degree of safety, the important passages are equipped with safety doors, and the air duct system is designed and installed with fire dampers;

(5)One-stop service, including design, manufacturing, construction, validation, training and after-sale service;

(6)Can accurately control the temperature, humidity, pressure difference, dust particles and the number of        planktonic bacteria in the room, and the cleanroom is constructed in strict accordance with the standards of different cleanliness levels in the GMP specification;

(7)Professional installation engineers with rich experience, able to send workers abroad for installation;

(8)We have a strong design team with 20 years of experience in clean room areas, able to design according to customer's different needs and solve their difficulties and pain points;

(9)Channel advantage: self-owned material production plant and production and R&D capabilities of purification equipment, can provide customized services and quick action.

Bangladesh project

This customer is a Bangladesh cleanroom contractor,cooperatedwith us for the 1st clean room project in
2019, and we have successfully completed the 2ndclean room project for them in 2020.The new clean
room project for year 2021 is still in production.For these 3 projects, We have provided this customer
with quick delivery time, flexible payment, andhigh quality products(cleanroom doors, sandwich panels,
windows, weighing booth, pass box, and other materials and equipment). So our services can win great recognition
from customers.

Israel project
This customer is very loyal, they are a cleanroom contractor in Israel. We started to cooperate on the first clean room project in 2018 and have completed 3 clean room projects for them till 2019. We have provided customers with cleanroom doors, sandwich panels, windows, epoxy floors, air shower, pass box, and other materials and equipment and on-site installation services for all 3 projects. Customers are very satisfied with our sales service and installation service, and are impressed by the professionalism and dedication of our on-site construction staff.
 

II.Cleanroom Material:
Cleanroom material is composed of cleanroom panel, cleanroom door, cleanroom window, relative connections and attachments

STRUCTURE	Cleanroom Material
	Cleanroom HVAC System
	Cleanroom Piping System
	Cleanroom Electrical System
	Cleanroom Automatic Control System
	Cleanrooms Equipment

1. Cleanroom Panel

 

• Standard thickness: 50mm, 75mm, 100mm;
• Panel material: color steel panel, stainless panel, HPL panel;
• Panel thickness: 0.5mm, 0.6mm, 0.7mm, 0.8mm;
• Filling material: glass magnesium, rock wool, rock wool with glass magnesium(rock wool with one side glass magnesium, rock wool with double side glass magnesium), aluminum honeycomb, paper honeycomb, EPS, PU, etc.
• Cleanroom panel can be divided into hand-made panel and machine made panel:

1. Hand-made panel: Double-sided panel with high-grade polyester paint color coating, or stainless steel plate,with strong corrosion resistance. With the core material of A grade fire resistance and B grade flame retardant material(except paper honeycomb, EPS), it will not melt when burning, and will not produce high temperature decomposition drops. The hand-made panel is a high grade fire proof building material decorative composite board in China at present. It has the characteristics of high strength, impact resistance, high anti-seismic performance and convenient construction.
2. Machine made panel: Double-sided panel with high-grade polyester paint color coating, or galvanized steel plate, stainless steel plate,with strong decorative. With the core material of A grade fire resistance and B grade flame retardant material(except paper honeycomb, EPS), it will not melt when burning, and will not produce high temperature decomposition drops. Through the mechanism production line pressing, the machine coating molding. It has the characteristics like fast processing speed, low construction cost, flexible size and so on.

Characteristics of Cleanroom Panel

• Cleanroom panel standard installation and connection: panels are connected with built-in aluminum keel or PVC square tube, forming a continuous self-supporting structure wall; seams between two panels are sealed by silica gel. Roof is fixed by M-8 twisted steel and holder on the top of the building;
• To enhance the strength of the roof, gypsum or glass magnesium board can be added into color steel panel, so that people can walk on it and maintain it. Load capacity over 100 kg.
• With high quality surface material, cleanroom panel has excellence performance like chemical resistance, wear resistance, scratch resistance, etc.
• Cleanroom panel uses high quality thermal isolation materials as sandwish materials, and we seal the four edges of panels to avoid pollution due to leakage of sandwich material;
• The cleanroom panel can be pre-embedded according to the design needs to facilitate the passage of various pipelines, and can also be pre-embedded with reinforcing ribs to ensure the strength of the wall panel;
• Cleanroom panels has a wall system that is quick and easy to install, flexible and multi-selectable components to meet various requirements, and all components of the wall system are connected smoothly and without protrusions.

 

2. Cleanroom Door

• It is used in all level of cleanrooms, purified rooms, dust free rooms, sterile rooms, movable rooms and places where steel plates are used as partitions. The surroundings are double-sealed, heat-perserving and heat-insulating. Color steel plates or stainless steel plates can be used to customized cleanroom doors of different specifications; the door locks, colors and sweeping strips can be configured as required;
• Classification: swing door(single door, double door, unique door, glass door), electric sliding door, fast roiling door;
• Classification by different materials: color steel plate door, steel door, melamine resin door, steel door;
• The door and the wall panel are connected evenly on both sides, all corners use arc transitions, sanitary lifting hinges;
• Door lock and hinge: The structure and design can achieve a smooth connection on both sides, and the door lock system should avoid hand contact pollution;
• Automatic lifting sealing strip at the bottom of the door: three sides of the door frame should use sealing tape and automatic lifting sealing strip at the bottom of the door to ensure the air tightness of the door system;
• Electronic interconnection lock classification: electric plug interconnection lock, electromagnetic interconnection lock, cathode interconnection lock;
• Clean door thickness 50 mm, face panel can be stainless steel plate, color coating, cold plate baking paint.

 

Characteristics of Cleanroom Door

• The design meets GMP design and safety requirements. No dust, easy to clean. Door seal with high-quality sealing tape, with good air tightness. Easy to clean and air tightness, with strong impact resistance, paint wear resistance, anti-fouling;
• Internal filling paper honeycomb, aluminum honeycomb or polyurethane foam into one;
• Door mold is with high strength, good sealing. Windows are made of high-quality double-layer tempered glass;
• With high-quality 304 stainless steel hinges, can also be customized;
• Handle,silencing bar etc.have different grade for the customer to choose;
• Adopt high quality lifting rubber strip to ensure air tightness;
• Adopt high quality stainless steel door lock, optional stainless steel door suction;
• Open mode: door closer, swipe cards, fingerprints, passwords, remote control;
• Suitable for cleaning workshop, hospital, pharmaceutical factory, food factory, etc.
• Adopting high quality lifting rubber strips to ensure air tightness.

 

3. Cleanroom Window

• Materials: Aluminum frame clean window; stainless steel frame clean window; one-time forming steel frame clean window;
• Cleanroom window shape: round corner clean window, square frame clean window;
• Cleanroom window type: midship clean window, wafer window;
• Frame color: black printing, white printing;
• Glass form: tempered glass, fireproof glass, yellow light glass, black silk screen is optional on the four sides;
• The cleanroom window is made of double-layer tempered glass. it has good sealing performance, the wall and the window are on the same plane, and the installation is flexible and beautiful;
• Can be made according to different wall thickness, especially suitable for 50-100mm thick color steel plate;
• Application: suitable for clean workshops such as pharmaceuticals, laboratories, food, biology, electronics factories, etc.
• The hollow double-layer clean window can accept non-standard products of different specifications and models, and can choose different shapes and different grades of glass, such as: tempered glass, fire-resistant glass, bulletproof glass, etc.

 

Characteristics of Cleanroom Window

• The cleanroom window is installed on the color steel plate or melamine resin panel. It is composed of white or black painted aluminum frame and double-layer glass and is completely flush with the wall panel with a special structural sealant, and can be integrated with the color panel. It is convenient to install and clean;
• Double-layer glass is used to avoid condensation and can be produced in a separate environment to avoid dust accumulation in the cavity. Special treatment in the cavity to absorb moisture in the cavity and smoothly connect to the wall;
• Sound insulation: to meet people's needs for lighting,viewing, decoration, environmental protection, general hollow glass can be reduced about 30 decibels,and filled with inert gas hollow glass can be reduced on the original basis of about glass can be reduced about to 45 decibels very quiet;
• With thermal insulation properties: thermal conductivity system K value, a single piece of 6mm glass K value of 5.75 kcal/mh ºC, the general insulating glass K value of 1.4-2.9 kcal/mh ºC, for the argon and sulfur fluoride gas-filled insulating glass K value can be reduced to a minimum of 1.19 kcal/mh ºC, argon is mainly used to reduce the thermal conductivity of K value, and sulfur fluoride gas is mainly used to reduce the noise dB value. The two gases can be used individually or mixed in a certain proportion;
• Anti-condensation: in the winter indoor and outdoor temperature difference is large, single glass doors and windows will appear condensation phenomenon, while the use of insulating glass is no condensation phenomenon;

4. Cleanroom Floor

• According to the different needs of the occasion, various materials such as epoxy self-leveling, PVC coiled material, and epoxy colored sand flooring are used for the flooring. Special flooring materials with anti-static surfaces can also be provided, and different colors can be designed in a single project to distinguish different levels of cleanliness on the floor.
• Characteristics of PVC floor: Safety and protection: The PVC flooring injection molding passivation process, so that the product surface without air holes, so that dirt can not penetrate deep inside. Antimicrobial properties provide permanent sterilization and bacteriostatic treatment, preventing microbial reproduction inside and outside the floor. PVC flooring adopts a multi-layer structure, the use of a reasonable coefficient of friction, as well as clever dispersion of the walking pressure and shock absorption performance, to ensure the walking safety. PVC flooring the top of the abrasion-resistant layer of the structural design of the multi-layer structure highlights the advantages of the multi-layer structure, containing fiberglass reinforcing layer, to ensure the dimensional stability of the floor, and to ensure that the floor No deformation, no damage. At the same time, the elastic cushioning of the foam layer structure can avoid abrasions caused by falls. Good practicality and cost-effective, especially suitable for aseptic laboratories, electronic clean room, pharmaceutical production workshop and other areas.
• Characteristics of epoxy resin self-leveling floor: Seamless coating on the surface, dust-free, wear-resistant, anti-permeable, and resistant to heavy pressure, easy to clean, and has good compressive and impact strength, making the floor durable and long-lasting. The intermediate layer construction thickness can locally flatten the unevenness of the base, ensuring a smooth finished surface, improving usability and aesthetics.
• Characteristics of epoxy quartz sand floor:The epoxy quartz sand floor is a new type of composite decorative floor made of color quartz sand and epoxy resin in a seamless integrated form. It can be freely matched with one or more different colors of color quartz sand to form a variety of decorative colors and patterns. It has the advantages of elegant decorative texture, wear resistance, pressure resistance, chemical corrosion resistance, anti-slip, fire resistance, and waterproofness. The color can be freely matched, with bright colors and good decorative effects. The color quartz sand can form an aesthetic surface; high cleanliness, no continuous joints; excellent wear resistance, acid and alkali resistance, and can inhibit the growth of mold and bacteria; the surface has sufficient smoothness and roughness. The coating thickness of the epoxy quartz sand floor is generally 3.0mm and 5.0mm, with an effective service life of up to more than 10 years. The floor surface forms include glossy type, anti-slip type, rolling surface, and self-leveling surface. The epoxy quartz sand floor is mainly used for occasions that require wear resistance, strong impact resistance, and high-grade decoration. It has a certain floor style and is particularly suitable for places that value external cleanliness and durability, such as airports, large shopping malls, exhibition halls, subways, electronic communications, medical and health, high-end commercial places, food production workshops, grease and meat joint factories, offices, and laboratories of schools.

 

Cleanroom HVAC System

The cleanroom HVAC system is designed to maintain the required parameters of temperature and humidity, air velocity, pressure and cleanliness in the cleanroom. The most commonly used method is to continuously feed a certain amount of treated air into the room to eliminate all kinds of heat and humidity interference and dust contamination inside and outside the clean room. In order to get into the clean room with a certain state of the air, you need a set of systems for air processing, and constantly sent to the room, and constantly from the room to exclude a part of the whole system constitutes a clean room HVAC system, see the following schematic diagram:

Functions of Cleanroom HVAC System:

• Air filtration removes all microbial particles from the supply air;
• Airflow technology makes the room sterile and dust-free;
• Positive pressure control realizes orderly pressure gradient distribution in the whole clean room;
• Appropriate temperature and humidity regulation inhibits the propagation of bacteria and reduces the amount of human germs;
• Excluding indoor undesirable gases and maintaining good indoor air quality;

Company Profile