Detail clean room system

Clean room system control

Cleanliness - number of dust particles

Differential pressure

1. The pressure difference between rooms in adjacent clean areas should be 10-15 PASCAL (guideline value). -- EUCGMP (EU)

2. The pressure difference between clean area and non-clean area, between different levels of clean area should not be less than 10 PASCAL, the same cleanliness level of different functions should be maintained between the operation of the appropriate pressure gradient, in order to prevent pollution and cross pollution. - the new GMP

3. The pressure difference between rooms in adjacent clean areas should be 12.5 pascals. --FDA

Airflow organization and self-purification

The various airflow modes should be shown to be free from the risk of contamination. For example, appropriate measures should be taken to ensure that airflow does not blow particles from operations or equipment and operators towards areas of high cleanliness requirements.The clean area should meet the "static" standard after all production operations are completed and the operators leave the site and clean themselves for 15-20 minutes (guidance value).

Cleanroom retaining structure

Wall Panels

The wall panel with melamine resin surface layer

1. The surface layer will not rust, superior impact resistance.

2. Good processing performance, can be arbitrarily cut hole, cutting, saw.

3. Good surface smoothness.

Wall panel of PCGI surface layer

1. Match with the unique keel system;

2. It can be connected with various components completely flat.

3. Two kinds of panels can be interchangeable in the same system.

Many options panels

Second layout design, factory production, all without the cut, handmade

Machine made rock wool panel

Hand made rock wool panel

1. Handmade rock wool panel, surrounded by galvanized sheet cold-drawn frame or plastic steel frame.

2. Both sides can use color coated plate, galvanized, stainless steel and other specific materials.

3. Core material can be inorganic (glass magnesium board, gypsum board), rock wool, aluminum silicate cotton, glass magnesium cotton, pearl cotton.

4. The product has beautiful surface, sound insulation, heat insulation, heat preservation, earthquake resistance, fire performance in line with the national standard.

Glass magnesium rock wool panel

1. Fire prevention and flame retardant. According to the standard of GB25970-2010 grade A non - combustible plate.

2. Waterproof and moisture-proof. Soak in water for more than 48 hours, the plate is not deformation, no change.

3. Anticorrosion, acid and alkali resistance. Ensure the permanence of building materials decoration.

4. Sound insulation and heat insulation. Excellent heat insulation performance, a strong sound insulation effect.

5. Low expansion rate, hygroscopic deformation rate is less than 0.20%, heat deformation rate is less than 2%;

6. Light weight and high strength. The overall density is low, because of the strength advantage, so that it can be constructed with ultra-thin plate, the overall construction quality is light, with a certain seismic effect.

7. Fire resistance. Firewall made of 12mm thickness plate, fireproof for 4 hours, no cracking, no collapse, excellent integrity.

Paper honeycomb panel

Paper honeycomb sandwich panel is a real sense of green products, 100% of the waste recycling. It by the national fire prevention building materials quality supervision and inspection center inspection to meet the requirements of flammable materials (according to the provisions of GB8624-2012 inspection flammable level). It has good flame retardant performance, anti-static, no dust, good overall steel and other advantages. Fire does not produce toxic substances, waste can be fully recovered and reused, it is the replacement of polystyrene board, polyurethane, rock wool and other materials.

Hollow glass magnesium panel

Commonly known as magnesium oxide sandwich panel is made of magnesium oxide, magnesium chloride, and water ternary system, by configuration and adding modifier, stable performance of magnesium cementing material, in the alkaline glass fiber net as the reinforcement material, with light material as the filling compound and become a new type of non-combustible decorative material. Adopt the special production process and become, with fireproof, waterproof, tasteless, non-toxic, no freeze, no rot, no crack, unchanged, non-flammable, high strength, light weight, convenient construction, long service life and so on.

Aluminum honeycomb panel

Aluminum panel is non-combustible material. Honeycomb panel belongs to pure aluminum products, do not volatilize any harmful gas to human body, no radioactivity and can be completely recycled, 100 percent environmental protection products.

Clean room wall

1. High quality surface materials with chemical corrosion resistance, wear resistance, scratch resistance and other excellent properties.

2. The four sides of the wall panel are sealed to avoid the leakage of the sandwich material and the pollution of the clean room.

3. High quality heat insulation material as filling material.

4. Embed reinforcement to ensure the strength of wall panels as required.

5. Embed line pipe according to the design needs to facilitate the passage of various pipelines.

6. Quick and easy install wall system.

7. Flexible and optional components to meet various requirements.

8. Strong and tight system avoids air leakage.

9. The system is equipped with complete doors and Windows to form a complete set of product system.

10. The connections of all components are smooth connections without protrusions.

Clean room panel advantage

1. The advantages of the wall panel with the melamine resin surface layer:

2. The surface layer is made of special amine resin materials with various superior properties.

3. Surface layer will not rust. Excellent impact resistance.

4. Good processing performance, can be arbitrarily cut hole, cutting, saw.

5. Excellent corrosion resistance. Excellent anti-scratch performance. Good surface smoothness.

The advantages of PCGI plate surface layer of the wall panel

1. The galvanized steel plate base material and the roller coating material determine the high strength of the wall surface layer.

2. The steel plate is galvanized on both sides to enhance the corrosion resistance of the surface

3. Match with unique keel system.

4. It can be connected with various components completely flat.

5. Special structure, ingenious board air return, save space, ensure reasonable air distribution.

Outer stick arc aluminum connection panel systems

Built-in keel exterior plaster color steel wall panel system

Bascule: Standard floor keel with horizontal adjustment base, can quickly and accurately adjust the horizontal height of the floor keel.

Return air wall:100 series keel hanging board, special return air wall structure with hollow wall, lining steel plate; The width of the return air channel is variable; The standard return air volume is 560CMH.

The conventional air return alley can be replaced by the air return wall, which occupies less space and has a flexible layout. It is specially designed for the compact layout of the medical plant.

Ceiling

The panel adopts sandwich structure:Both sides for the steel plate, paint, steel plate thickness is 0.5 mm; The middle is the insulation sandwich with high density insulation. The sandwich materials for this type of ceiling are rock wool, paper honeycomb, aluminum honeycomb and other materials. In order to enhance the strength of the ceiling, gypsum or glass magnesium plate can be added into the steel plate, and the personnel can walk on it and carry out various maintenance work. The bearing capacity is above 100 kg.

The panels are connected by built-in aluminum keel or PVC square pipe to form a continuous wall of self-supporting structure. The joints between the two panels are sealed with silica gel. The ceiling is fixed on top of the building with M-8 threaded steel bars and brackets.

Completely flat connection on both sides

1. Flat connection with the wall panel on both sides, with arc transition for all corners;

2. Sanitary lift hinge, press door lock, automatic lower seal strip.

Options: Electronic interlocking, Windows, door locks, emergency push rods, magnetic locks, automatic door closers (with hinges).

A variety of materials for the door for options

1. Steel door; 2.Melamine resin plate door; 3.PCGI door; 4.Stainess steel door

Multiple forms of clean door for different occasions

1.Swing door; 2.Sliding door; 3.Electronic sliding door; 4.Quick rolling shutter door

Door

Locks and hinge

1. Unique structure and design can achieve complete smooth connection on both sides;

2. Smooth door frame and door body aluminum alloy profile design;

3. Special door lock system to avoid hand contact with pollution.

Door bottom sealing automatically

The three sides of the door frame use sealing adhesive strip and the door bottom automatic lifting sealing strip to ensure the air tightness of the door body system.

Hinges

The hinges are adjustable from top to bottom and the door is removable.

Electronic Interlock

A variety of electronic interlock form meet the demand of pharmaceutical factory

1.Electric plug interlock; 2.Electromagnetic interlock; 3.Cathode interlock

Window

1. Three air tight treatment; Built-in desiccant;

2. Two kinds of special sealant seal; Toughened safety glass;

3. Flat with the wall panels on both sides;

4. The rounded window is installed on the color steel plate or melamine resin plate, made of white or black paint aluminum frame and double glass, sealed with special structural adhesive, completely flush with the wall plate, the four corners of the window are circular design. Can be integrated with steel plate, easy to install, easy to clean.

5. The square corner window is installed on the sandwitch panel or melamine resin panel through typesetting. It is composed of white or black painted aluminum frame and double glass, which is completely flush with the wall panel and integrated with the wall panel, and it is easy to clean.

6. Double glazing to avoid condensation; Production in a separate environment to avoid dust collection in the cavity.

7. Special treatment in the cavity adsorb moisture in the cavity, and smooth connection with the wall.

Flooring

According to different user needs, we can provide epoxy self-leveling, PVC coil and epoxy colored sand floor and other different kinds of materials. Special floor materials with antistatic surfaces can be provided, and different clean levels of floor can be designed for different colors in a project.

PVC, epoxy colored sand or epoxy artesian floor and wall panels connection.

Three kinds of ground material

Connector

Aluminum alloy world rail profiles, other aluminum alloy profiles, 1/4 arc aluminum alloy profiles, 1/8 arc aluminum alloy die-casting parts and other auxiliary materials.

Cleanroom aluminum profile and others

1. Material- aluminum alloy extruded profiles and aluminum alloy die casting parts.

2. Surface treatment - the aluminum alloy profile is anodized surface treatment, except for the aluminum alloy profile without exposure;

3. Material Thickness - Most aluminum profiles are 1.2mm thick, with high strength, precision dimensions and easy installation.

4. The arc radius of the rounded corner - the arc material is made of PVC and aluminum alloy material, or cross collocation, which meets the requirements of GMP and is easy to clean.

5. Sealant - Dow Corning white silica gel is used to seal the gap between the plate and a variety of gaps between the plate and the fillet. Black Dow Corning silicone is used to seal the gap between the plate and the window.

6. Sanitary aluminum parts: easy to clean, used for horizontal and vertical direction of color plate convex Angle connection. The concave edging installed at the corner is completely flat with the wall, beautiful and generous, convenient and sanitary.

Wall and floor connection diagram

Unique keel form, to ensure that PVC or epoxy color sand surface connect the wall up t 100mm, and completely flush with the wall, to ensure that the clean room is completely airtight, easy to clean, fully in line with GMP requirements.

Wall connected to the ceiling of the diagram

The completely independent lifting ceiling system not only ensures the ceiling strength, but also ensures the flexible disassembly of all walls.

Schematic diagram of wall to wall "L" connection

Accessory

The WHO recommended swirling diffusing plate, which is good for removing corners in rooms. Selection of liquid tank sealing HEPA filter, to ensure zero leakage, to meet PAO test requirements.

Clean cameras

Clean telephone and wall flat installation surface can be cleaned and sterilized.

The stainless steel sheath of the micro differential pressure gauge keeps clean after disassembly, which is convenient for meter calibration.

Clean electronic clock

Negative pressure weighing cover or laminar flow facilities

The negative pressure weighing cover ensures that the weighing process of ingredients is safe and reliable, and there is no need to worry about cross contamination. The design and use of the uniform flow film with high efficiency ensures that the wind speed in the A-class zone is uniform, within the range of 0.45m/s plus or minus 20%, in line with the requirements of FDA and EU cGMP.

Clean room enclosure

Plan review - confirm the design standard

Clean air conditioning - wind speed, ventilation times, filter:

Audit efficient arrangement and air distribution

Remarks: A-level unidirectional flow, B/C/D disorder.

HVAC

Design key points - air purification

1. Filtering; 2. Sterilization; 3. Common purification equipment; 4. Sealing treatment of filter; 5. Ventilation times and sectional wind speed.

Filtration

It refers to the selection of qualified substances from the existing batch of substances, remove the other part of substances that do not meet the conditions. Air filtration sieves out clean air to remove dust particles. The device used to filter air is an air filter.

Air supply filter unit FFU

HEPA diffuser

The lower part of the plenum is equipped with an air volume adjusting button, which can be directly adjusted below.

Filter seal processing

The installation and sealing of HEPA filter is the key to air purification, and it is also a difficult point for a long time. Filter leak testing is the most difficult to pass the test after installation, many clean room is not successful because of the seal is not good. Even if cleanliness standards, the leak may not be up to standard. This may not be a big problem in other clean rooms, but in the pharmaceutical industry biological clean room leakage means bacteria, so sealing is the key of the key for biological clean rooms.

At present, the commonly used sealing methods are

1. Negative pressure sealing: the best effect. FFU is a typical example of this.

2. Mechanical compaction: the effect is general. There are many efficient air supply outlets.

3. Liquid tank seal: the effect is very good, but the construction is difficult. The sealing effect is often affected by construction.

Air-conditioning ventilation systems, air handling unit

Air handling units, air conditioning capacity calculation

Calculate the cooling capacity, heat and humidification of air conditioning according to the enthalpy and humidity chart of air volume and indoor load.

Pipeline resistance calculation

The fan pressure is determined by the sum of pipe resistance, filter resistance and equipment resistance.

Type selection of fan

Matters needing attention of design type selection of air handling unit

Air-conditioning ventilation system, ventilation pipe

Air conduit

Air duct installation

1. Adopt high quality galvanized steel plate, on-site installation, production workshop closed and dust-free;

2. Before processing, galvanized sheet is cleaned with neutral detergent, wiped and dried before use;

3. The air duct shall not have transverse joints, and the longitudinal joints shall be minimized as far as possible. The galvanized steel plate air duct shall be processed to avoid damaging the galvanized layer;

4. After the air duct is closed, it is necessary to seal both ends with plastic cloth and put them in the clean protective shed or workshop. After the installation, the air duct is removed from the site and cleaned again before the installation.

5. According to the requirements of the design and construction drawings and the measured size on site, the processing sketch is drawn and then the system is processed, manufactured and installed one by one.