Ultra-clean environments for the
biopharma industry
Vilair-AAF Pty Ltd Tel: (02) 8811 3703 Applications
Cleanrooms are defined as a room, or suite of rooms, in which the concentration of airborne particles is maintained within established parameters; and where other factors are controlled to within specified limits. The rooms are designed to provide control of
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various environmental factors including some or all of the following:
• Viable and non-viable airborne particles • Air flow patterns
• Temperature and humidity • Air pressure
• Containment of hazardous aerosols • Operating procedures
Applications include the manufacture of
biopharma products, sterile pharmaceuticals, electronics components, medical devices and implants; and the maintenance of nsitive
aviation and avionics systems. GMP codes and specifications for many applications require that the critical process be performed in a Class 5 laminar flow cabinet installed in a Class 7 cleanroom.
Compliance requirements
• ISO 14644 Class 7 (AS 1386 Class 350) air cleanliness to be achieved in the cleanroom and an adjoining ante-room that acts as an air lock. Where installed, laminar flow units should provide ISO 14644 Class 5 (AS 1386 Class 3.5) conditions.
• Validation of the facility to Australian standards by a NATA-registered test laboratory.
HVAC system
Room air should be supplied by an external air conditioning system - preferably one dedicated to the facility. Partial recirculation of room air allows optimal energy utilisation. Sufficient
fresh air should be supplied in accordance with ventilation codes; to balance leakage and exhaust air; and to maintain specified
pressures. Unless otherwi specified, room temperature within the range of 160 C to 190C and rela
tive humidity of 55% to 65% should be maintained. The type of cleanroom clothes may dictate some variation from the levels.
Class 7 cleanrooms with Vilair-AAF filtration system
Airflows
Only HEPA-filtered air should enter the
cleanroom and ante-room from HEPA filters installed at the 'terminal 'point, i.e. in ceilings. HEPA filters should be proprietary cleanroom modules in purpo-designed ceiling frames. The modules are available in fan-assisted configuration with fan-speed control, or non-fan-assisted; and should operate at a velocity of > 0.4 m/s and < 0.6 m/s. The location of
HEPA filters and return air grilles should create air movement from the designated ‘clean’ zone of the room to the ‘less-clean’ zone. Return air grilles should be at low level.
Room air-change rate
Air supply to the cleanroom should provide a room air-change rate of > twenty (20) per hour. Air clea
nliness will be enhanced by higher air-change rates, e.g. > 30/h - typically, heat load calculations result in such a rate. When the doors are open, the supply-air volume should maintain an outward flow of air.
Room pressures
Cleanroom air pressure should be higher than that of the ante-room and the surrounding uncontrolled area. The pressure gradient between the zones should be ≥ 15 Pa. Typical values are:新贵族
Cleanroom: 30 Pa positive pressure Ante-room: 15 Pa positive pressure
Suitable manometers should be installed outside the ante-room to indicate room pressures of the facility.
Ultra-clean environments for the
biopharma industry
Vilair-AAF Pty Ltd Tel: (02) 8811 3703
Equipment and rvices – typical The scope of the supply and installation
requirement will depend on the nature of any existing facility; and that of the new
development. Typical requirements are: • Room construction or modification to
桌子怎么画create the required room configurations. Where existing walls are ud to form all or part of the cleanroom, all joints and
penetrations should be crevice-free and airtight. Expod walls should have a smooth surface and be coated in epoxy, polyester, polyurethane or other durable plastics finish. If sandwich panel
construction is ud, wall panels should be pre-painted, lf-supporting 1200 mm wide, 75 mm or 100 thick panels fitted into a powder-coated channel that is fastened and aled to the floor. Panels should
incorporate tongue and groove interlocking joints. All joints should be aled with a fungicidal, flexible-tting compound. Plaster board and stud construction may offer a cost-effective alternative to sandwich panels if this meets facility operational, life-cycle and compliance needs.
• A dedicated HVAC system, including 415V
electrical supply, cabling, ducting and controls; that is configured and sized to meet both existing requirements and identified future expansion. • AAF®) TM (non-fan-assisted) or FMII (fan-assisted) HEPA filter modules for supply to
cleanroom and ante-room. The units have the capacity to supply the required air volume for the propod expansion of the facility.
• AAF panel, multi-pocket or rigid, extended-surface prefilters for the HVAC installation. • If required, a pass-through hatch to allow
materials transfer between rooms. The are typically of stainless steel construction with door interlocks.
• Dwyer Magnehelic gauges located at the
大宋王朝赵匡胤ante-room entry to monitor room pressures.
• Validation of the facility confirmed by
independent NATA-accredited testing and certification.
如何野钓大鲫鱼Australian and ISO cleanroom standards The withdrawal of AS 1386 and the adoption of ISO 14644 will change classifications for air cleanliness as shown below. AS 1386 Class ISO 14644-1 Class
- 1 - 2 0.035 3 0.35 4 3.5 5 35 6 350 7 3,500 8 - 9
维生素b1功效TGA and EU GMP define air cleanliness Class A-D inclusive, with various zone classification requirements as ‘operational’ or ‘at rest’.
Our capability
Vilair-AAF is a specialist supplier of laminar airflow and containment equipment for high technology manufacturing. Our modular
systems are engineered to meet the needs of any application that requires ultra-clean air or containment of hazardous aerosols.
Our aim is to provide highly cost-effective equipment solutions that meet stringent
industry and government regulations. We have designed, manufactured and installed purpo-engineered systems for Australia’s leading manufacturers of pharmaceuticals and medical devices. As the Australian distributor for American Air Filters® (AAF) – the world’s
largest air manufacturer of air filters - we have online access to world-class cleanroom technologies, rearch and support. Vilair-AAF cleanroom products
• Laminar flow enclosures and workstations • Dispensary & sampling containment booths • AAF HEPA & ULPA filters and modules • Cleanroom ceiling and lighting systems • Clean garment-storage cabinets • Pass-through hatches • Air showers三湖缸
• Absorption filter systems for odour control • AAF and Vilair ® filters for general
猪肝怎么保存ventilation and air conditioning
