METISAFE CLEANROOM AND BIOSAFETY CO., LTD.

Metisafe’s Unique Approach to Building Modular Cleanrooms

Adaptation of Metisafe’s instrument manufacturing line into cleanrooms have been achieved by keeping the following criteria:

Applying box-in-box design, which is independent of the facility building
Using low noise high-efficiency particulate air (HEPA) fan units instead of only HEPA filters
Integrating optimal airflow patterns of safety cabinets or laminar airflow (LAF) units
Designing negative plenum wall panels and ceiling
Using precise machined full steel structure
Integrating total automation control

With this concept, Metisafe has taken LAF cabinets as the base for its several pre-engineered positive pressured cleanroom models.

Validation guaranteed application-specific models have been operating since 2006 in cell culture labs and non-hazardous sterile compounding units, to name but a few.

Building material
Ex-factory standardized negative pressured biosafety models have been transformed from biological safety cabinets (BSC). Tuberculosis labs, virology labs, hazardous drug compounding, BSL-2 and BSL-3 facilities have been running without reconstruction needs of units.

Usage of the sheet steel material in cleanroom components makes it possible to build stronger free-standing structure and leak-proof panel connections. Manufacturing of mono-block and corner radiused wall panels are the other advantages of steel material.

Negative plenum technology
Metisafe uses negative plenum technology in all of its designs as default. Pre-engineered recirculation ducts and leak-proof ceilings provide increased particle sweeping efficiency and energy saving.

Particle leakage from surroundings through increased pressured ducts of the building is also prevented by using this method. Achievement of more homogenous temperature distribution by the help of negative plenum increases airflow pattern safety and personnel conformity while operations are in progress inside.

In general, traditional cleanrooms are designed as building dependent and construction based. The Metisafe cleanroom concept, however, is designed as an individual operating instrument.

By using standard equipment and dimensions, Metisafe is having the advantage of sustainable comfort and performance developments in its designs such as more energy-saving methodologies, active noise control applications and automated decontamination.

User-friendly
On the user side, having an instrument concept cleanroom has much more advantages than traditional designs. These benefits include:

Design & manufacturing phase:
More than 100 models for selection suitable to any empty space
Cleanroom performance validated more than 30 models without the need for new design qualification
Minimal installation requirement: Only the power source, chilled water supply and air ducts

Installation and set-up phase:
Fast assembly at the site. In general, days to a couple of weeks depending size of the model
Clean and easy assembly and installation at the site without disturbing the other rooms
Easy commissioning and acceptance because of manufacturing with predefined criteria like a standard instrument

Operation:
Proven increased cleanroom life without loss of operational performance
More accurate measuring & warning system for improper operation
Demounting and reassembling availability by keeping its specifications
Years of cleanroom performance test success without any reconstruction

Maintenance:
Defined breakdown rates based on more than ten years of field data
Optimized cleanroom performance with much lower energy use
Incompatible low maintenance cost
Decreased yearly validation costs
Performance and maintenance data of sites in operation for more than 10 years prove that the total investment and operation cost are much lower than conventional cleanroom constructions.

Metisafe® isolators provide contamination preventing particle-free workstations for aseptic applications in pharma industry and pharmacology. Material transfers into work chamber are accomplished by leakproof gloves assembled at front panel ports through interlocked mechanism dynamic pass-box. Metisafe isolators are equipped with full automatic decontamination system which provides pre or post-operation sterility of air contacted surfaces. The controlled aseptic environment is achieved by all of those physical and air barrier mechanisms and automatic decontamination to be used in sterility tests. Depending on the hazard level of work materials isolators are classified as positive or negative pressured cabinets.

Reliable Sterility Test Cabinet
Isolated work chamber with leakproof glove ports
Full automated decontamination
Validation guaranteed biosafety and cleanliness class
Extra air barrier protected Negative plenum 
GMP conformity

Integrated Automation Systems
Integrated hydrogen peroxide pulverization
Sensitive H2O2 sensor and control system
Precise decontamination with temp.& humidity rates
The one-touch button decontamination process
Online particle counting integration (optional)
 
Advanced Microprocessor Control
Touch-sensitive large screen control panel
Real-time detailed information displays 
Safety parameter increased alarm system
Process follow-up screen displays

Fume Hoods are full air exhausted negative air pressure primary air barriers protecting the operator and indoor environment from hazardous gases, vapours and odours. Proper and reliable removal of toxic gases and vapours are mostly depended on perfect work performance of fume hoods. Metisafe High-Performance Fume Hoods (HP Fume Hood) are designed by advanced fluid dynamics methods and ensures optimal non-turbulent air exhaust to the outer atmosphere with perfect airflow patterns without any leakage to the indoor environment. Metisafe® HP Fume Hoods are manufactured & tested according to ASHRAE 110 guidelines and have EN14175 certification.

High-Performance Fume Hood

• High-Performance Chemical/Toxic Protection
• EN 14175 Certified
• Superior Performance in ASHRAE 110 Tests
• Advanced Air Fluid Dynamics Automation
• Advanced Microprocessor Control
• New Generation Ergonomics & Ease of Use
• Back Sloped Front Panel
• Chemical Resistant Monoblock Work Table
• Integrated Chemical Storage Cupboard
• Low Noise Level & Energy Consumption

Class II Type B Biological Safety Cabinet
Metisafe® Class II Type B Biological Safety Cabinets work under principles with the full exhaust of Pre/HEPA filtered fresh air to the outer atmosphere without recirculation. Exhausting through HEPA filter protects also the environment. Those Airflow principles of Class II Type B Cabinets provide safe work with biological risk level 2+/3 agents and also with cytotoxic gas & materials. The room air is pulled in through the perforations located in front of the work plate and directed to blower plenum (inflow air). This airflow direction prevents reaching dirty air to the materials over the working plate. Pre/HEPA filtered air supplied through the top of the cabinet provides the work area protecting the work zone under ISO-5 class laminar airflow. Total air in the working cabinet fully exhausted without recirculation through exhaust blower fan to the atmosphere by keeping the working area under negative air pressure. In addition to the primary air barrier accomplished in the working zone negative plenum design of the Metisafe® cabinet prevents particle escape and zero leakage is ensured.

Metisafe® Laminar Air Flow (LAF) cabinet instruments ensures extreme clean environment for product & material/sample protection against airborne dust, particle or microorganisms. Metisafe Vertical LAF cabinets works under air filtration, recirculation and indoor exhausting principle. Room air pass through pre-filters that blocks coarse particles at device top and reaches to work cabinet area with air velocity of 0.40 m/s (± %5) by passing through HEPA filter. Built in laminator in fan filter module supplies the airflow at homogenous and laminated way. Designs of working cabinet and air diffusion assures trimmed airflow and sweeping dead zones. Air moves in two way in working cabinet, one part exhausted to room at front by preventing room air move into the working zone. The rest of the internal air is recirculated from the back holes of the cabinet by increasing HEPA filter life.

PCR workstations decrease the risk of DNA/RNA contamination with unwanted airborne materials in molecular biology applications.

PCR (Polymerase Chain Reaction) cabinets create air-barrier to prevent contamination of airborne particles with molecular reactive, and reaction mixtures or any material that has to stay clean during the reaction mixture preparation process. Two types of PCR workstations are produced by Metisafe; Non-Air streamed or HEPA filtered.

Metisafe UV PCR WORKSTATION
Closed box design without air movement, UV PCR workstations create a physical air-barrier against airstreams of the environment. By this way, it reduces sample contamination risk and provides an ideal condition for preparing PCR mixtures and other samples. Metisafe UV PCR Workstations have also built-in shortwave ultraviolet (UV) decontamination system that inactivates DNA and RNA remains in the work chamber between the experiments.

Metisafe HEPA/UV PCR WORKSTATION
HEPA/UV PCR Workstations work with the principle of full air exhausting after filtrating all intaken air without any recirculation. In the cabinet, airflow patterns and routings are electronically controlled.

Class I biological safety cabinets are primary barriers for the investigation of non-volatile materials or samples with unknown biological risk. After the entrance of indoor air through front window aperture of the cabinet, the air sweeps the work cabinet and surfaces in a non-turbulant way. The internal air exhausted from cabinet after passing through HEPA filter and protects the indoor environment from potentially dangerous particles. Since the Class I BSC does not protect sample/material, further, aseptic or sterile analysis of working material is not suitable.

Metisafe® Class II Type A Biological Safety Cabinets works under principles of air circulation, air filtration and keeping the working area under negative air pressure. In BSC, 70% (+/-%5) of total air is recirculated and filtered through the main HEPA filter located at work zone top. The rest of the air, 30% (+/-%5), is exhausted to the surrounding area environmentally protected after passing through the exhaust HEPA filter. The room air is pulled through the perforations located in front of the work plate and directed to blower plenum (inflow air). This air flow direction prevents reaching dirty air to the materials over the working plate. Inflow air together with recirculated air is mixed at the blower plenum then pass through the main HEPA filter and laminarizator and reaches into the work area protecting the work zone under ISO-5 class laminar airflow. In addition to the primary air barrier accomplished by the negative pressure within the working zone double wall negative plenum design of the Metisafe® cabinet prevents particle escape to surroundings and zero leakage is ensured.

Metisafe® Class III Biological Safety Cabinets works under principles with %100 HEPA filtered fresh air to work chamber without recirculation. Exhausting through HEPA filters also protects the environment. Airflow principles of Class III Cabinets which can also be applicable with carbon filter provides safe work with biological risk level 3/4 agents and also with cytotoxic gas & materials. Pre/HEPA filtered air supplied through the top of the cabinet and pass-box provides the work zones protection under ISO-5 class laminar airflow. Total air in the work chamber is fully exhausted without recirculation through exhaust blower fan to the atmosphere by keeping the working area under negative air pressure. In addition to the primary air barrier accomplished by the negative pressure within the working zone double-wall negative plenum design of the Metisafe cabinet prevents particle escape to surroundings and zero leakage is ensured.

Metisafe® Laminar Air Flow (LAF) cabinet instruments ensure an extremely clean environment for product & material/sample protection against airborne dust, particle or microorganisms. Metisafe® Horizontal LAF cabinets work under air filtration and indoor exhausting principle. Room air pass through pre-filters that blocks coarse particles at device top and reaches to work cabinet area with an air velocity of 0.40 m/s (± %5) by passing through HEPA filter. Built-in laminator in the fan filter module supplies the airflow at homogenous and laminated way. Designs of working cabinet and air diffusion assure trimmed airflow and sweeping dead zones. Air moves in one way in a working cabinet by exhausted to the room at the front by preventing room air to move into the working zone. The automatic air compensation through microprocessor control system keeps a steady airflow rate at set point.

In the pharmaceutical industry, Metisafe Containment Booths are mainly used to prevent operators from hazardous dust accumulated during powder handling activities.

Metisafe containment / weighing booths

Handling of toxic, allergic or hazardous raw materials in pharmacy and cosmetic mass productions require sampling-weighing rooms (containment booths) for personnel protection. Beside of personnel safety keeping material clean from airborne contamination, sources are the basic functions of those units.

Metisafe containment/dispensing booths indoor environment protected against particle entrances by proper airflow dynamic designs and automatic air velocity compensations while providing personnel traffic between room and outdoor.

Metisafe downflow containment booths are differentiated (Positive, Negative or Neutral Pressure) depending on material MSDS specification and/or requirements of a production plant. Metisafe powder containment booth designs also allow to make type revisions in the request or need at the preinstalled unit. Validation and accredited test company test conformity is guaranteed when installation and setup are made by Metiafe and/or Metisafe certified technical service.

Full compliance to the regulations

As a supplier and partner to pharma companies, Metisafe follows and complies the latest international health and safety standards for providing the best solution for its clients. Our containment solutions and associated documentation meet the relevant: EC GMP, ISO and other standard and guidelines.

 General features

Modular stainless-steel main body
Easily reachable mechanical control unit
Homogeneous Illumination
Advanced automation system
Pre and high performance HEPA filters
DOP test port
Technology

CFD Analyzed Laminar, Homogenous and Non-Turbulent Air Flow Dynamics
Detailed CFD Configured Non-Dead Zone Diffuser
Cruise Controlled Filter Compensation Against Increasing Filter Resistance
EC Fan Motor Conforming Continuous Work and Low Energy Consumption
Easy Central HVAC System Integration
Easy-Clean Monoblock Radiused Corner Panels
Negative Plenum High-Performance HEPA Fan Filter Unit

Metisafe cleanroom equipment is used to ensure a controlled clean environment and has critical importance to keep quality at various workplaces and manufacturing plants.

Pass-box

High quality Dynamic Pass-Box for material transfers in clean room and biological safety units
Electro-magnetic interlock lid system
Lid opening without handles / touch-push mechanism
Full view internal chamber monobloc glass door
Positive /Negative / Neutral air pressure adjustment flexibility
Extended radius curved corners
GMP compatible (E-Series)

Metisafe air lock units are used for personnel entrance to controlled clean environments. Those units have critical importance to keep quality at GMP/cGMP qualified production/manufacturing plants.

Metisafe®’s instrumental design, manufacture, and performance concept for standard airlock modules have an advantage of installation without reconstruction at sites.

All Volume / Area Effective Air Movement by High Velocity Air Jets.
H14 HEPA Filtration
Energy Efficient Low Resistance Unique HEPA Unit (E Series)
Positive / Negative / Neutral Pressure Working Position Flexibility
Stainless-Steel Inner Surface
GMP Compatible (E-Series)

Fan filter units & recirculated FFU

Safe And Efficient Air Particle Removal
DIN1946, VDI2167, ISO14644 Standards
Advanced Airflow & Air Dynamics Design
Zero Leakage HEPA Filter System
Negative Plenum