Frequently Asked Questions

A cleanroom is a controlled environment where airborne particle counts are maintained at specified levels, with precise regulation of temperature, humidity, and pressure. It is used in pharmaceutical, electronics, food, aerospace, and healthcare industries. Cleanrooms are classified according to ISO 14644-1 standard, ranging from ISO 1 (cleanest) to ISO 9 based on particle concentration.

ISO 14644-1 classifies cleanrooms from ISO 1 to ISO 9 based on airborne particle count. GMP (Good Manufacturing Practice) uses grades A, B, C, and D specifically for the pharmaceutical industry. GMP Grade A ≈ ISO 5 (in operation), GMP Grade B ≈ ISO 5 (at rest) / ISO 7 (in operation), GMP Grade C ≈ ISO 7/8, GMP Grade D ≈ ISO 8. GMP classification also includes microbiological limits in addition to particle counts.

A HEPA (High Efficiency Particulate Air) filter captures 99.97% of particles at 0.3 microns in size. H13 and H14 classes are commonly used in cleanrooms. ULPA (Ultra Low Penetration Air) filters capture 99.999% of particles at 0.12 microns and are preferred for ultra-clean environments like ISO 3-4. For most hospital and pharmaceutical facilities, HEPA H14 (99.995% efficiency) is sufficient.

Air changes per hour vary by cleanroom class: ISO 5 requires 240-480 ACH, ISO 6 requires 90-180, ISO 7 requires 30-60, and ISO 8 requires 10-25 ACH. Operating rooms require a minimum of 20 total ACH (ASHRAE 170). The correct ACH value is determined through engineering calculations based on particle generation rate, room volume, and intended use.

A minimum positive pressure differential of 10-15 Pascal is maintained between the cleanroom and adjacent lower-class areas. This prevents contaminated air from entering when doors are opened. Operating rooms require at least +2.5 Pa (preferably +5 Pa) positive pressure. Negative pressure is applied in special applications like isolation rooms. Pressure differentials are continuously monitored and recorded.

HPL (High Pressure Laminate) panels are lightweight, offer wide color variety, and are cost-effective; commonly used in hospital and laboratory environments. Stainless steel (SS 304/316) panels have the highest chemical resistance and are ideal for GMP environments in pharmaceutical and food industries. Sandwich panels consist of two surface sheets with insulation (PIR, rock wool, or EPS) in between, manufactured in 50-100 mm thickness. Rock wool-filled panels are preferred for fire resistance (Class A1).

A pass box (pass-through chamber) is a device that enables material transfer between two areas of different cleanliness classifications without personnel movement. Static pass boxes are used for simple material transfer, while dynamic (HEPA-filtered) pass boxes clean particles from materials passing through. The interlock system prevents both doors from opening simultaneously, maintaining cleanroom pressure and cleanliness levels. It is mandatory equipment in GMP and ISO 14644 compliant production facilities.

Cleanroom validation is a systematic testing process that verifies the room meets its design requirements. It consists of four stages: DQ (Design Qualification) — document compliance review, IQ (Installation Qualification) — physical installation verification, OQ (Operational Qualification) — testing of operational parameters (airflow velocity, pressure differential, temperature/humidity, particle count, HEPA filter leak test), PQ (Performance Qualification) — performance verification under actual production conditions. Periodic re-certification (typically 1-2 times per year) is required after validation.

Modular cleanrooms are assembled on-site using factory-manufactured panels; installation time is 40-60% shorter than conventional construction. They are relocatable, expandable, and easily integrate into existing buildings. Conventional cleanrooms are built on-site, take longer but can accommodate complex architectural requirements. In terms of cost, modular systems are typically 15-25% more economical. Megalife modular systems are fully compliant with ISO 14644 and GMP standards.

A turnkey cleanroom project includes: engineering design and project management, wall/ceiling/floor panel manufacturing and installation, HVAC and air filtration systems, lighting and electrical infrastructure, doors (hermetic/cleanroom doors), pass-through chambers and air showers, automation and monitoring systems (temperature, humidity, pressure, particles), IQ/OQ/PQ validation services. Megalife manages all these processes under one roof and provides certified validation reports upon project completion.

An operating room HVAC system must provide: HEPA H14 filtered fresh air supply, minimum 20 air changes per hour, 20-24°C temperature, 30-60% relative humidity, and at least +5 Pa positive pressure relative to adjacent areas. Laminar flow (unidirectional airflow at 0.25-0.45 m/s) is preferred in the surgical zone. Air return grilles should be positioned near floor level. The system must be designed according to DIN 1946-4 and ASHRAE 170 standards.

Laminar airflow is a ventilation system that provides vertical, unidirectional, and uniform air movement from ceiling to floor. This air curtain created above the surgical zone prevents particle and microbiological contamination from reaching the surgical site. It can reduce surgical site infections (SSI) by up to 60%. Laminar airflow units (LAF) are typically manufactured in 2.4 m × 2.4 m or 3 m × 3 m sizes and mounted directly above the operating table.

Operating room wall cladding must be non-porous, easy to clean, resistant to chemicals and impact, antibacterial, and fire-resistant. Common options: Stainless Steel (SS 304) — highest hygiene and chemical resistance, ideal for GMP operating rooms. HPL (High Pressure Laminate) — cost-effective, wide color range, suitable for general operating rooms. Both materials should feature R-shaped coving at wall-floor junctions with seamless or minimal joint applications. Megalife manufactures modular wall panels in both material types.

A standard general surgery operating room should have a minimum net usable area of 35-40 m². Operating rooms for orthopedic and cardiovascular surgery requiring large equipment should be 45-55 m². Hybrid operating rooms (including imaging equipment) can be 60-75 m² or more. A minimum ceiling height of 3 meters is recommended. These areas should be planned considering HVAC infrastructure, laminar flow units, surgical pendants, and personnel movement space.

Cleanroom classification by operating room zone: Surgical zone (above operating table) — ISO 5 (under laminar flow), General operating room area — ISO 7, Sterile corridor — ISO 7-8, Scrub/preparation area — ISO 8, Non-sterile corridor — ISO 8-9. This classification is based on DIN 1946-4 and VDI 2167 standards. Particle limits differ between operational (in operation) and resting (at rest) states.

DIN 1946-4 is a German standard that defines ventilation requirements for operating rooms and other hospital areas. It specifies two main classes: Class 1a — High-risk surgeries (orthopedic, cardiovascular); full laminar flow required, ISO 5 surgical zone. Class 1b — General surgery; partial laminar or turbulent flow sufficient, ISO 7 general area. The standard also defines temperature (19-26°C adjustable), humidity (30-65%), air change rates, and filtration requirements. Operating room projects in Turkey are typically designed according to both DIN 1946-4 and ASHRAE 170.

An HPL (High Pressure Laminate) door features a durable surface material produced by pressing kraft paper and decorative layers under high pressure at 1400°C. Advantages include: high resistance to impact and scratches, antibacterial surface options (ISO 22196), water and moisture resistance, easy cleaning and disinfection, wide color and pattern range, fire resistance (up to B-s1, d0 class), UV resistance (no fading). Commonly used in hospital corridors, patient rooms, laboratories, and cleanroom entrances.

A hermetic door is a specialized door system that provides complete isolation with an airtight gasket system when closed. When closed, the door leaf is pressed tightly against the frame by a mechanical or pneumatic mechanism, achieving EN 12207 Class 4 air permeability level. This maintains the pressure differential between cleanrooms and operating rooms. Available in sliding and swing types. Automatic models feature contactless opening via radar sensors, foot sensors, or elbow switches. Megalife hermetic doors are certified for 100% airtightness.

6 key factors in hospital door selection: 1) Usage area — operating room (hermetic), patient room (HPL hinged), ICU (hermetic sliding), corridor (fire door). 2) Hygiene — antibacterial surface, easy cleanability, seamless construction. 3) Air permeability — cleanroom/OR doors require EN 12207 Class 4. 4) Fire resistance — EI30-EI60 for corridors, EI90-EI120 for escape routes. 5) Durability — impact resistance suitable for stretcher and wheelchair traffic, kick plates. 6) Accessibility — minimum 90 cm clear opening for disabled access, automatic opening option.

An antibacterial door features a special coating on its surface containing silver ion (Ag+) or copper-based additives. This coating can be effective against up to 99.9% of bacteria (per ISO 22196 testing). It plays a critical role in preventing hospital-acquired infections (nosocomial infections). It is especially important on frequently touched surfaces such as door handles, push plates, and door surfaces. Megalife antibacterial HPL doors are ISO 22196 certified and effective against many pathogens including MRSA, E.coli, and Staphylococcus aureus.

A regular automatic door (commercial type) only provides ease of passage with no airtightness capability. A hermetic door provides complete air isolation with special gaskets and mechanisms when closed. Key differences: air permeability class (hermetic: EN 12207 Class 4, regular: none), pressure differential maintenance (hermetic: yes, regular: no), usage area (hermetic: OR/cleanroom/ICU, regular: corridor/lobby), hygienic design (hermetic: antibacterial/seamless, regular: standard). Hermetic doors are 2-3 times more expensive than regular automatic doors but are mandatory in critical areas.

Cleanroom doors must meet the following requirements: air permeability (EN 12207 Class 3-4), non-particle-generating surface material, flat and easily cleanable design (no protrusions or recesses), interlock system compatibility (preventing two doors from opening simultaneously), antibacterial coating option, non-static structure, ESD (electrostatic discharge) compliance (for electronics cleanrooms). Available in hinged and sliding types; sliding types are generally preferred in cleanrooms as they create less air turbulence during opening.

A fire door is a tested and certified door system that prevents the passage of flames and hot gases from one compartment to another for a specified period during a fire. In Turkey, fire doors are mandatory in: fire stairwell exits, fire compartment boundaries, escape route corridors, mechanical/electrical shafts, kitchen-dining transitions (commercial), hospital patient-corridor connections. Fire doors are mandatory in residential buildings over 3 stories and all commercial and public buildings.

The EI classification indicates the fire door's resistance time in minutes. E = Integrity (preventing flame passage), I = Insulation (limiting temperature rise on the non-fire side). EI30: 30 minutes — internal partition doors, office corridors. EI60: 60 minutes — hospital corridors, fire compartments. EI90: 90 minutes — fire stairwell doors, high-risk areas. EI120: 120 minutes — industrial facilities, large fire compartments. Testing standard is EN 1634-1, classification per EN 13501-2.

Fire door certification documents that the door has undergone a real fire test at an accredited laboratory per EN 1634-1 standard and proven its durability for the specified period. Using uncertified fire doors can lead to legal sanctions (fines, closure) and void insurance coverage. Certification process: manufacturer submits door sample to accredited laboratory, fire test is conducted per EN 1634-1, EN 13501-2 classification report is issued upon successful results. Megalife fire doors are tested at internationally accredited laboratories and certified from EI30 to EI120.

A panic bar (panic exit device) is a horizontal bar mechanism that allows the door to be opened with a single push action in emergencies. Tested per EN 1125 standard. It is mandatory on doors in fire escape routes: areas with more than 50 occupants (Turkish fire regulation), all hospital fire exit doors, public access buildings. The panic bar itself must also be fire-rated certified (same EI class as the door). Megalife fire doors come with CE certified panic bar hardware as standard.

Yes, special fire-resistant glass (pyro glass) can be used in fire doors. The glass must be certified to the same EI class as the door. Glass types: insulated fire glass (EI class — both integrity and insulation), non-insulated fire glass (E class — integrity only). Glass area generally should not exceed 25% of the door area (depending on standards and test reports). Small rectangular vision panels (200×400 mm etc.) are common. The glass must be the brand and size specified in the door manufacturer's test report.

Steel fire doors: high fire resistance up to EI120, superior impact and vandalism resistance, ideal for hospitals and industrial facilities. Wood fire doors: typically EI30-EI60 resistance, more aesthetically appealing, preferred in commercial spaces like hotels and offices. Steel doors are recommended for hospitals, factories, and public buildings — they offer higher EI ratings, lower maintenance, and longer lifespan. Megalife steel fire doors are manufactured with EI30, EI60, EI90, and EI120 certifications.

Megalife serves the pharmaceutical and biotechnology (GMP cleanrooms), healthcare (operating rooms, ICU, sterilization units), electronics and semiconductor (ESD cleanrooms), food production (hygienic production areas), defense and aerospace, and research laboratories sectors. With over 25 years of experience, it exports to more than 15 countries.

Megalife holds the following international certifications: ISO 9001:2015 (Quality Management System), ISO 14001:2015 (Environmental Management System), ISO 45001:2018 (Occupational Health and Safety Management System). Our products also undergo EN 13501-1 fire classification, EN 1634-1 fire resistance testing, EN 12207 air permeability, and ISO 14644 cleanroom compliance testing. All certificates are available for download on our Documents page.

Yes, Megalife actively exports to more than 15 countries. Our main export markets include: Middle East (Saudi Arabia, UAE, Iraq, Qatar), North Africa (Libya, Algeria), Central Asia (Turkmenistan, Uzbekistan), and Europe. Our logistics processes are managed with reliable shipping partners, working with FOB, CIF, and EXW delivery terms. You can quickly receive a quote for your international projects via WhatsApp or email.

The fastest way to get a quote is to use the WhatsApp button on our website. You can send us a message specifying your project type, estimated area, and required products. Alternatively, you can email info@megalife.com.tr or visit our contact page. Quotes are typically prepared within 24-48 hours. For large projects, on-site surveys and free technical consultation services are available.