GMP Pass Box of Công ty CP Kỹ Thuật Việt Phát
A GMP (Good Manufacturing Practice) pass box from VIETPHAT is designed to comply with stringent regulatory standards required for pharmaceutical and biotech manufacturing. Here's a detailed overview of its features, benefits, and applications:
Key Features of GMP Pass Box of Công ty CP Kỹ Thuật Việt Phát:
High-Quality Construction:
- Materials: Typically constructed from stainless steel (SS 304 or SS 316) to ensure durability, easy cleaning, and corrosion resistance.
- Seamless Design: Smooth, seamless interior surfaces to prevent microbial growth and facilitate easy cleaning.
HEPA/ULPA Filtration:
- Equipped with HEPA (High-Efficiency Particulate Air) filters or ULPA (Ultra-Low Penetration Air) filters to maintain a sterile environment within the pass box.
- Filters ensure that air entering the pass box is free from contaminants, meeting ISO cleanliness standards.
Interlocking Doors:
- Mechanically or electronically interlocked doors to prevent both doors from being opened simultaneously, reducing the risk of cross-contamination.
- The interlocking mechanism ensures a secure transfer process.
UV Sterilization:
- UV-C lights installed inside the pass box to sterilize the interior and any items placed within it, effectively reducing microbial load.
- UV lights can be programmed to operate for a specified duration after each transfer.
Air Shower Option:
- Some models feature an air shower system that blows filtered air over the items being transferred, further minimizing particulate contamination.
Control System:
- Integrated control panels for managing door interlocks, UV light operation, and air shower cycles.
- Touchscreen interfaces for easy operation and monitoring.
Alarm Systems:
- Visual and audible alarms to indicate door open status, UV operation, and filter replacement needs.
- Alarms ensure adherence to SOPs (Standard Operating Procedures) and prompt maintenance actions.
Advantages of GMP Pass Box of Công ty CP Kỹ Thuật Việt Phát:
- Regulatory Compliance: Meets GMP requirements, ensuring compliance with regulatory standards for pharmaceutical and biotech manufacturing.
- Enhanced Contamination Control: Minimizes the risk of cross-contamination between clean and non-clean areas.
- Efficiency and Safety: Streamlines material transfer processes, reducing the need for personnel movement and associated contamination risks.
- Customizable Design: Can be tailored to specific operational needs, including size, filtration requirements, and additional features like air showers.
Applications of GMP Pass Box of Công ty CP Kỹ Thuật Việt Phát:
- Pharmaceutical Manufacturing: Critical for transferring raw materials, intermediates, and finished products while maintaining sterility.
- Biotechnology Labs: Used for the transfer of biological samples, reagents, and culture media.
- Microelectronics: Essential for handling sensitive electronic components that require a contamination-free environment.
- Healthcare and Hospitals: Facilitates the safe transfer of sterile instruments, samples, and medications between controlled environments.
Maintenance and Best Practices of GMP Pass Box of Công ty CP Kỹ Thuật Việt Phát:
- Regular Cleaning and Sterilization: Routine cleaning of the pass box and sterilization of UV lamps and HEPA filters to ensure optimal performance.
- Scheduled Validation: Periodic validation and testing to confirm the pass box meets GMP standards.
- Staff Training: Ensuring that personnel are well-trained in the correct use of the pass box, including understanding the control system, interlock mechanisms, and proper loading/unloading procedures.
Conclusion:
A GMP pass box from VIETPHAT is an essential tool for maintaining contamination control in environments where regulatory compliance is critical. With features like HEPA/ULPA filtration, UV sterilization, and interlocking doors, these pass boxes support sterile and efficient material transfer processes, making them invaluable in pharmaceutical, biotech, microelectronics, and healthcare settings.
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Thông tin liên hệ:
Zalo: 0971.344.344
Nhân viên phục vụ 24/7: 0827 077 078
Nhân viên phục vụ 24/7: 0829 077 078
Tổng đài 24/7: 0971 344 344
Yêu cầu báo giá: sales@vietphat.com
Website: www.vietphat.com
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CÁC DÒNG SẢN PHẨM CÔNG TY CỔ PHẦN KỸ THUẬT VIỆT PHÁT ĐANG CUNG CẤP:
- Lọc cuộn: G1, G2, G3, G4, M5
- Lọc thô dạng tấm: G1, G2, G3, G4
- Lọc thô dạng túi: G1, G2, G3, G4
- Lọc tinh dạng tấm: M5, M6, F7, F8, F9
- Lọc tinh dạng túi: M5, M6, F7, F8, F9
- Lọc EPA: E10, E11
- Lọc HEPA/ULPA: H13, H14, U15, U16, U17
- Lọc phòng gió vào, gió ra phòng sơn
- Lọc chịu nhiệt độ cao: G1, G2, G3, G4, M5, M6, F7, F8, F9, E10, E11, H13, H14, U15, U16, U17
- Hộp chứa lọc: G1, G2, G3, G4, M5, M6, F7, F8, F9, E10, E11, H13, H14, U15, U16, U17
- Hộp kết nối AHU: G1, G2, G3, G4, M5, M6, F7, F8, F9, E10, E11, H13, H14, U15, U16, U17
- Hộp lọc khí FFU/Fan Filter Unit (FFU): H13, H14, U15, U16, U17
- Bộ hộp lọc chảy tầng cho phòng mỗ bệnh viện: H13, H14, U15, U16, U17
- Buồng thổi khí/Air Shower, buồng trung chuyển/Pass Box, phòng sạch di động/clean booth
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