Who Is Cleanzonn?cleanzonn.com/Dokumanlar/Cleanzonn_Tanitim_Katalog_Eng.pdf · 32 CLE ANZ ONN TEMiZ OD A TEKNOL OiLERi CLEANZONN® carries out all phases, starting from the projecting

C L E A N Z O N N T E M İ Z O D A T E K N O L O J İ L E R İ 31

CLEANZONN® is a registered technology trademark of GMP Panel with 100% domestic capital that starts the production of clean room technologies with the project phase and is able to realize all phases of the work plan, up to the plant licensing phase, within its own structure.

The experienced project department of CLEANZONN®, creates the projects according to the requests of the customers, according to the quality of the products and international standards such as cGMP-FDA, and presents its customers 2D-3D visuals. All our projects are presented to our customers after consulting with the supervisory departments of the Ministry of Health and the Pharmaceutical Society.

After the opinion and approval has been received from the competent authorities, the departments for HVAC, mechanics, clean room hygienic panel and system automation carry out detailed exploration and quantity and specification works. In line with these documents we prepare a detailed offer to our customers.

Who Is Cleanzonn?

C L E A N Z O N N T E M İ Z O D A T E K N O L O J İ L E R İ32

CLEANZONN® carries out all phases, starting from the projecting phase to the licensing phase, for investors that want to invest into a Clean Room, finishes all processes with a professional team and submits the key of the licensed facility to the investor.

The success of the project depends on the close dialogue and collaboration that we establish with the customer during the planning and developing phase. This is why CLEANZONN®:

• Supports processes such as design, coordination, reviewing of the structure, commissioning of the facility and start-up of the turn-key project with its expert teams.

• Strives to maximize the cost savings and minimize the construction process.• Provides turn-key and engineering services for especially pharmaceutical production facilities, laboratories for especially

defense and electronics industry production facilities (microbiology, stem cells and BSL-2, Bsl-3) and raw material production facilities.

• Is experienced in terms of turn-key service in clean room setups.• Designs and applies its projects according to the requirements of cGMP/GLP (EC and FDA).

Contrary to the contract-based industry, CLEANZONN® is also very experienced in terms of documentation. Documentation is very important for clean room projects. CLEANZONN® owns knowledge about SOPs, all validations for design and performance conditions, FAT and SAT. As CLEANZONN® we are able to provide GMP certification services by our expert teams for our completed production facilities in only a short time.

What Can Cleanzonn® Do?


CLEANZONN® carries out the production for all the needed products of the Clean Room in its own production facilities.

Products


Ventilation Channels

Hepa Box

Wall And Ceiling Panels

The most important part of the HVAC-system, the ventilation channels, are produced in our own facilities with our full automatic channel machines in series and in a rapid matter. Our ventilation channels are installed under the supervision of experienced engineers and in accordance with the project. The completed HVAC system is tested during the validation phase by us, which guarantees that the validation tests are passed with success.

The Hepa Boxes and all vents of the HVAC system in the clean room are produced by CLEANZONN©. The ceiling panel structure for the Hepa boxes and vents, produced in accordance with the clean room ceiling panels, are produced in our factory according to the project and are installed perfectly on sight.

After completion of the HVAC system we continue with the installation of the clean room wall and ceiling panels. Our clean room wall and ceiling panels, produced with CLEANZONN® expertise, are produced with 3D-projecting and special coding systems and installed by our expert team with utmost care.


Products We Manufacture In Terms Of Clean Room

TechnologyOur company consists of expert teams in the fields of modular clean room panel design, engineering and installation. Our team of experts start with the project phase and accompany our customer step by step. This style of ours has itself proven to be the key for success and customer satisfaction. We don’t make concessions in terms of quality, which is our permanent policy. Our company has been certified according to the OFISAS 18001:2007—ISO 9001: 2008—ISO 10002:2006—OHSAS 18002:2007 standard procedures. Our R&D department works constantly to serve the challenging and fast changing clean room industry and to develop new technologies.

Clean Room Door SystemsSingle wing - Double wing hinged doors

Single wing - Double wing automatic hermetic doorsFast PVC spiral doors

Our Clean Room HVAC ProductsGalvanized and stainless air channels

Hepa-boxes in all sizesHepa-boxes that are exchangeable from the top

Ventilation Diffusers specially produced for hepa-boxesExhaust and Blowing Boxes

Air Shower and Air TunnelsTwo-door Air Shower

Three-door Air ShowerSide Nozzle Air TunnelTop Nozzle Air Tunnel

Interlock Electromagnetic lock systemOur patented Prolock interlock lock systems

Clean Room Pass-BoxDynamic Pass-box

Static Pass-box

Hygienic Glass Partition PanelsPDLC Intelligent glass systems

Manual or automatic jalousie glass panels

Automatic Under-Door Guillotine


Clean Room PanelsThe CLEANZONN® modular clean room panels are manufactured in the CLEANZONN® factory in prefabricated from (such as Electrical socket, installation and medical gas). This why no deformation of the panels occur on the field and a fast and clean installation is secured.

CLEANZONN® clean room panels can be provided within short delivery times. Our high-capacity facilities and high-efficiency production line ensure short production times.

With the CLEANZONN® modular clean room panels a fast installation can be realized with the unique installation system.

The CLEANZONN® clean room panels are, contrary to most of the modular panels on the market, designed for a prefabricated, fast and easy installation. Our clean room panels that are first designed with 3D drawing techniques are installed in our factory and windows and auxiliary elements are embedded. There is no need for cutting or attaching on the building site. The prefabrication of the clean room elements in our factory ensures consistent quality, flexibility, fast delivery and minimizes the risk of breaking and installation time.

Shorter Installation Time

Modular Prefabricated Panels


Our Cleanzonn Clean Room Hygienic Partition

Panel Products

Epoxy Polyester Painted Steel Hygienic Panel: The most frequently used and most economical option of primed finish in metal coating processes, which can be used both inside and outside. High corrosion resistance. Good UV and chemical resistance. Can be applied with a wide range of brightness alternatives.

• PVDF Painted Steel Hygienic Panel: Primed finish coat with polyvinylidene fluoride and acrylic resin (70%/30%) with the highest level of indoor and outdoor durability. High corrosion resistance. Along with being a costive and low-coverage paint, UV and chemical resistance is excellent. The color and brightness permanence are at the highest level.

• PUR-PA Painted Steel Hygienic Panel: These paints, which can be applied at higher thicknesses than polyester and PVDF based paints, are thanks the polyamide reinforcement they contain, at the front planes in terms of their hardness and friction resistance. They have high resistance against scratching and are suitable for deep drawing and bending operations. Can be applied simple or patterned.

• PLASTISOL Painted Steel Hygienic Panel: Applied in high thicknesses, they are a top coat with a high level of outdoor and corrosion resistance. They provide a good balance of elasticity and hardness. Resistant to friction and scratches and the moisture and salt resistance is at the highest level. Bending and shaping ability is excellent. These paints that provide superior protection in cold and humid climates and conditions can be used indoors and outdoors.

Special Coated Steel Hygienic Panel Types


Epoxy Polyester Painted Steel Modular Panel Construction

Fast installation and removal

Integration into different installation types

Class A2 fire resistant

Self-bearing system structure

Airtight locking mechanism

Economical installation

Epoxy polyester painted steel sheet with special stretch coating (0.8 mm)

Rock wool (100 kg / m3 or EPS 30 density)

Aluminum profiles

Yes

RAL color chart

100 - 1228 mm

100 - 3000 mm

50 -100 mm

Last coat :Filling material : Reinforcement : Glass possibility : Color of last coat :

Width :Height : Panel thickness :

Modular Panel Dimensions

Advantages Of Steel Hygienic Partition Walls


Special Coatings

Silver antimicrobial technology is safe, natural and sustainable. Silver’s ability to help to protect has been used for centuries. Before the use of antibiotics in hospitals they used silver to fight the bacteria and today it is also used in a wide range of medical products. The silver ion was used by specialist and educated chemists with this antimicrobial technology in conjunction with special coatings by adding them to the paint systems. Silver is an ideal antimicrobial agent because of its effectiveness against a comprehensive range of microorganisms and lack of toxicity to non-target cells.

The silver ions added to the silver ion dye product during manufacturing concentrate on the surface of the coated surface and are effective against contaminating bacteria. Silver ions bind with bacteria and damage their cells in various ways, disrupting their normal functioning and stopping their reproduction. They do this by passing the bacteria through the cell wall and accumulate themselves in the cells that are damaged in some form. Silver ions combine with bacterial proteins found in the cell wall and affect their normal functioning. These proteins are vital for the healthy functioning of the cell, so the loss of their function results in the death of the bacteria. It is known that silver ions promote the formation of harmful chemicals called reactive oxygen species (ROS) in bacterial cells. ROS are harmful to living cells because they cause significant damage to cell structures. Damage caused by ROS lead to the death of the cell. It is known that silver ions affect the way bacteria copy genetic material or DNA. Bacteria, like most living cells, must make copies of their DNA when they produce new cells. Silver ions stop the replication of bacteria by inhibiting the replication of genetic material. Most importantly, the population of non-copied bacteria will not grow because the dead cells have not been replaced by feed cells. Eventually the bacterial population disappears completely.

Antimicrobial protection! As shown in the graph, the levels of bacteria on a silver ion-protected surface are reduced by up to 99% in two hours compared to an unprotected surface, on which they can grow at high rates.

Silver Ion Coated Cleanzonn® Clean Room Panels

What Is Silver Ion Technology?

How Does Silver Work?



Clean Room Hygienic Partition

Panel ProductsHpl Wall Panels

CLEANZONN© high pressure laminate (HPL) are modular panel elements that are characterized by partition walls with good chemical and high surface resistance against mechanical effects. HPL partition walls are preferably used in environments with the high

possibility of mechanical shocks and damage.

HPL partition wall systems are completely modular. Each panel can be removed separately in a short amount of time. Connections between the panels are covered with special silicone,

which covers all requirements of international accepted standards such as the GMP and FDA.

The medical gas facilities and electrical channels need to be prepared in our production facility beforehand in accordance with the requirement of the project. Detailed and predictive

engineering ensures the best quality and an efficient on-site installation process.

CLEANZONN© HPL Panels consist of approved modular panel elements that fulfill all the requirements for bio-decontamination processes that use hydrogen peroxide.

CLEANZONN© HPL Wall Panels are 3-4-6 mm thick and are clean room panels produced with HPL compact materials.


Hygienic Glass PanelsOur glass panels (6+38+6) are produced with a total thickness of 50 mm. Our glasses are produced laminated and tempered and in the desired colors. If required blinds and jalousie systems can be integrated manually or with an automatic system.

Glass Panel Dimensions

200 - 1128 mm

100 - 3000 mm

50 mm

Width :Height : Thickness :


Clean Room Door ChoicesCLEANZONN® clean room doors can be configured with one or two winged hinged doors (manual or motorized) and if required be personalized 100%.

We also offer automatic single-wing or double-wing sliding doors and high-speed spiral PVC doors. We have a wide variety of materials available for our door productions.

• Compact Laminate Door• Aluminum Composite Door• Stainless Steel Door• Glass Door• PMMA Door

All our doors are sealed, have a smooth surface and are resistant to corrosion. Doors are important in the design of clean rooms. Their role is not limited to the access of staff and products. Door glass panels ensure the observation of monitoring processes and the natural light is maximized.


Cleanzonn© Air Lockers And Interlock Connections

Clean Room Window Choices

To maintain pressure differentials in clean rooms, the passage between chambers must be ensured through air locks and are ideally controlled by interlock (Prolock) locks. Air locks are mostly used for material transfer and staff’s arrival and departure. The air locks prevent the passage of potential particles and air between the two clean rooms, when two doors accidentally open at the same time.

The view into the inside of the clean room increases the comfort of the personnel and operational efficiency. With strategically positioned window panels between to separate rooms the operators can communicate without leaving their own position. Windows generally are positioned in the guest room for aesthetic reasons but it also enables the supervisions of the tasks without breaking the strict protocols that occur during entering of the operational and control areas. In places with risk of impact Laminated or polycarbonate glass is used. The windows that are integrated into the panel structure don’t create ledges in the clean room wall. Since there are no edges where dust particles and microorganisms can be collected, they are easy to clean.

Rounded-CornerFull Size Windows


Flex Ceiling Panels

Pass-Box (Material Trap)

The CLEANZONN© flex ceiling panels have been previously structured for filtering and lighting. HEPA and ULPA filter units, lighting and fire detectors have been directly integrated into the ceiling. In our walkable ceiling systems we leave a ceiling space for the maintenance of the lighting elements and HEPA/ULPA filters. All technical controls, maintenances and changes can be carried out without entering the clean room and thus protecting it.

Lighting Sprinklers

HEPA/ULPA filtersStrobe/alarm systems

CamerasSpeakers

Gas penetrationOther devices

Stainless steel, PR special painted steel etc. material options are optional.Can be produced in any size.

UV lighting and UV counter can be used.Used with an interlock (Prolock) lock system.

Can be produced DYNAMIC or STATIC.


Air-Shower(Air Tunnel)

Cleanzonn Fan Filter Unit (Ffu)

• Durable, Aluminum, Stainless Steel, Painted steel construction• High speed and the air exchange for fast and efficient use• Microprocessor controlled cycle times• Touch screen controls• Interlock (Prolock) lock system• LED illumination• Control panels for high pressure feed channels• Silicone-free sealant• Standard sized HEPA filters and hermetically sealed pre-filters• Easy service / maintenance

• Filter fan unit, high efficiency, low noise and vibration level and equipped with a fan with infinitely variable air velocity control • Air velocity and air volume option at all desired stages• Infinitely adjustable speed controller• HEPA filter (efficiency> = 99.995,% 0,3 um)• Standard sized HEPA filters and hermetically sealed pre-filters


What Is A Clean Room For Cleanzonn©?

Modular Clean Room

Modular clean rooms (or “clean rooms”) are frequently used in production and research facilities but the field of use is expanding day by day in new industries. According to the definition a clean room is a space where the control of agents such as dust, particles in the air, aerosol particles and chemical gases are controlled. A clean room maintains a level of controlled contamination determined by the particle size allowed. The modular clean room is used in a wide range of critical processes involving the following production areas:

• Semiconductor manufacturing• Medication• Manufacture of biotechnology and medical devices• Military and space industry• Optics• Medical

When considering the areas, where the regulations to reduce particulate pollution of the modular clean rooms take place, we can see that HEPA filters are the main element of the rooms. All of the air sent to the modular clean room passes through these High Efficiency Particulate Air filters (HEPA), which hold particles as large as 0.3 microns. Some applications that require more cleaning use ULPA (Ultra Low Particle Air) filters, which keep particles as small as 0.12 microns.CLEANZONN®, provides ‘Modular Cleanrooms’ with different dimensions and features for different industrial applications. We can define the components of our special modular cleanrooms as follows:

• HEPA filtration• Temperature control• Moisture control• Particle control• Monitoring and control systems

This control parameters vary according to application; When we consider these differences, CLEANZONN© offers different wall coating options to meet different needs. For example, a smooth surface and easily cleanable wall covering is ideal for most modular clean rooms up to ISO-7. However, due to the chemical resistance of sterile wiping operations, a FRP (fiberglass reinforced plastic) coating or Aluminum composite panels, are better for modular clean rooms in pharmaceutical applications and other environments where microbials may be present. For applications involving human tissues or implantable medical devices, we suggest a smooth, composite aluminum coated modular clean room to reduce the presence and/or growth of microorganisms.


What Is Contamination?

Contamination Sources

Key Elements of Contamination Control

Contamination is the process or processes that cause contamination of substances or surfaces with contaminants. There are two broad categories of contaminants: Bacteria and particles.

The most common contaminants that can cause problems in some clean room environments are produced from five basic sources. Plants where they are manufactures, people, devices, fluids and polluted products. To better understand the source of the contamination you should look at this list.

• Clean Room Design: Clean rooms are designed to acquire and maintain an airflow through air movement in a confined area, where it moves at equal speeds along the parallel flow lines. This air flow is called laminar flow. The deterioration of this airflow causes turbulences. And turbulences can cause particle motion.

• High Efficiency Particulate Air Filter (HEPA):These filters are extremely important for contamination control. They filter particles up to 0.3 microns with a minimum particle collective efficiency of 99.97%.

• Filtering: In addition to the widely used HEPA filters in clean rooms, there are a number of other filtration mechanisms that are used to remove particles from gases and fluids. These filters are necessary to ensure effective contamination control.

• Cleaning: Cleaning is an indispensable element for contamination control. Decisions regarding clean room maintenance and cleaning must be taken in details. Applications and procedures must be applied established by the company management and applied as written.

• Clean Room Clothing: Clothes are the biggest reason for particles in clean rooms, this is why they must be chosen accordingly. The requirements for clean room clothing vary according to the level of classification and the industry in which you are working. While some clean rooms (ISO 7 and 8) typically require work clothes, aprons, gloves and hair bonnets, more strict clean rooms (ISO 6 and above) require overalls.


Reference Clean Room Types

Nanotechnology Cleanrooms can be thought of as an electronic clean room on steroids. Just as the term “nano”, these rooms are used for the scientific works that reduce the works that are carried out here in size. Generally, Nanotechnology works with materials, devices and other structures that are at least 1 to 100 nanometers in size.

Noise:Typically the equipment is in comparison to other Clean Rooms more susceptible to noise and standard Clean Rooms are usually “noisy environments” with dB readings of 70 to 80 dB. Nanotechnology requires <65 dB. This requires attention to airflow design, volume and speed.

Vibration:Vibration must be kept to a minimum, this is why you will usually find that nanotechnology clean rooms are established in the basement.

Temperature / Moisture Control:The temperature control during the experiments should be @ +/- 0.1 ° C and the humidity fluctuations <0.5%.

Nanotechnology Clean Rooms


Optics Production Clear RoomsElectronic Clean RoomsElectronic clean rooms are used for the installation of printed circuit boards, fiber optics and their components. It is a controlled environment where electronic products are manufactured.

It is an air-conditioned room where the concentration of airborne particles is controlled to a certain limit. Removing submicron air pollution is a real control process. People, processes, facilities and equipment produce these pollutants.

They need to be constantly removed from the air. The extent to which these particles are removed depends on the required standards.

ISO 14644 is the standard document that sets standard air cleaning classes for airborne particulate levels in clean rooms and clean areas. Strict rules and procedures are followed to prevent contamination of the product.

The only way to control contamination is to control the entire environment. Air flow and direction, pressurization, temperature, humidity and special filtration must be precisely controlled. The sources of these particles must be controlled or destroyed as much as possible. Clean rooms are planned and produced under tight protocols and methods.


Biological Safety Controlled Clean Rooms

Our company has experience with the Biological Safety Levels (BSL) 1, 2, 2+ (or 2 Enhanced) and Level 3 for laboratories. BSL Level 4 is a very enhances standard. Tare limited possibilities for the construction of these standards in our country and the preferred modular structure does not conform to our method. Care must be taken in detail during the application of the BSL laboratories and the construction details are very important for the success of the BSL project.

Biological Safety Level 1 and 2 (BSL-1 and 2)

The BSL-1 Lab is used for agents known to cause illness in healthy adults. BSL is normally used as a secondary enclosure, so the requirement for a BSL 1 Lab is minimal and is often a controlled field. The BSL-2 Lab is used for human disease related agents; contamination routes include percutaneous injury, swallowing and mucous membrane exposure.

Normal requirement: The Primary Scope is a Class I or Class II Biosafety Cabinet (BSC) with doors and no airflow leaks. It is important to have gas-tight doors and hydrogen peroxide air lock points, an eye wash station and wash basins for handwashing, and the presence of an autoclave inside the facility.

Biological Safety Level 2 Developed (BSL 2+) Clean Rooms

It is a combination of BSC 2+ and BSL 2 &3. Although it is not officially recognized, it is a phase from level 2. BSL 3, uses 100% Make Up Air and Exhaust Air and thus significantly increases operational costs. In our works we generally use HEPA filtration in both the ‘Feeding Air’ and ‘Return Air’, and we calculate a safe amount of fresh air after a risk analysis, depending on the exhaust requirements. First we will carry out the following:

Normal requirements: The secondary scope is a Class II BSC Visual Directional Airflow Indicator, a safety cabinet that certifies internal airflow. Surfaces must be easily cleaned and disinfected, two automatic closing and locking doors (Airlock) must ensure the entrance into the laboratory and approved devices must be used for cleaning.

Biological Safety Level 3 (BSL-3) Clean Rooms

In BSL-31 we are working with domestic or exotic agents that can cause serious or potentially fatal illness through inhalation. In addition to the secondary scope requirements for a BSL-2 we need Primary Scope Class II or III BSC. A Visual Directional Airflow Indicator should be used. Surfaces should be cleaned and disinfected easily. There must be a handwashing basin in each area. It requires 100% clean air that is 100% free from exhaust, thus directional flow must be provided. The entrance to the laboratory must be ensured with double closing and locking doors (airlock) and only approved disinfection methods must be used.



Facility Management In Clean Rooms

References

System Automation’ is very important for the systems to work in clear harmony within the clean rooms. CLEANZONN© has a very experienced team in the field of clean room system automation. In terms of site devices we work with international expert companies and don’t compromise on quality.

The Facility Management Systems are the brain of the temperature / humidity and air pressure measurement systems in clean rooms. In the clean room, the inputs from the sensors in the air system are analyzed by the controller and with control algorithms he measures the ON and OFF components. The system provides control signals to the Module to provide the necessary conditions.

Inclinations may require compliance with 21 CFR Part 11 to demonstrate compliance with the requirements and for data integrity in a well regulated environment.

Remote access for alarm notifications and quick response alarm conditions, in case a system is not operating, is indispensable for a proper operation and management of the facility.

Our company CLEANZONN® provides you with a complete system, helps you to understand various available types of systems and choose the best option for your project.


UPS Medical

GEOGEN Medical

UPS Medical

500 m2

2.480.000,00 TL

Project Name :Clean Room Area : Cost of Project :

GEOGEN

600 m2

1.850.000,00 TL



Genkok Genome And Stem Cell Center

GENKOK

2100 m2

6.500.000,00 TL



Osel Medicine

Niğde Ömer Halisdemir Üni. Lithography Laboratory

OSEL

1500 m2

3.200.000,00 TL


NİĞDE UNIVERSITY

100 m2

300.000,00 TL



ACTO PharmaACTO PHARMA

1000 m2

2.000.000,00 TL



Land Forces Command Clean Room Application

K.K.K.

400 m2

800.000,00 TL



Aziz Sancar’s Stem CellResearch Center

MINISTRY OF HEALTH

2000 m2

3.450.000,00 TL



Çetinkaya Pharmaceutical Factory

FDN Pharmaceutical Factory

ÇETİNKAYA DRUG

6500 m2

8.280.000,00 TL


FDN DRUG

5500 m2

10.650.000,00 TL


Documents

Who Is Cleanzonn?cleanzonn.com/Dokumanlar/Cleanzonn_Tanitim_Katalog_Eng.pdf · 32 CLE ANZ ONN TEMiZ OD A TEKNOL OiLERi CLEANZONN® carries out all phases, starting from the projecting