It is kind of auxiliary equipment for dust-free room, whose function is to transfer items inside and outside the dust-free roomto the buffer area, to prevent damages tothe dust-free room airflow and chamber pressure caused by opening the door to transfer items. Futher, it can reduce the ambulatory time of operators and the entry of dust from external area to reduce the pollution of clean area to the utmost.
Principle
Provide the best solution to move raw materials from classless/low class clean areas to class A/B areas, fully meeting the control
requirements of GMP-2010 on sterile manufacturing environment.
The sterile pass box is used for biological decontamination on the surface of raw materials to avoid materials carrying
contamination from classless/low class clean areas to class A/B areas. It is used to pass various clean and dry goods
in sterile production, such as packaging materials, instrument, raw material packaging, accessories, and environmental
monitoring equipment.
Features:
The sterile pass box uses vaporized hydrogen peroxide (VHP) as the biological detergent to effectively kill fungi,
bacteria propagules and spores, viruses, mycoplasmas and other microorganisms.VHPS is a decontamination process
under low temperature and atmospheric pressure, featuring broad spectrum, high efficiency and environmental protection;
The running of sterile pass box is controlled by SIEMENS programmable logic controller (PLC)automatically, and the system
is stable and reliable; In biological decontamination and exhaust phase, the air sent into the cabin is filtered by H14
HEPA filter to prevent materials from contamination;
The sterile pass box has independent ventilation and exhaust unit, including fan, pneumatic butterfly valve and exhaust pipe,
which can quickly replace the hydrogen peroxide gas in the cabin and avoid it entering HVAC system; material inlet/outlet
is of double-door structure with pneumatic sealing, pneumatic locking and two-door interlock in operating state;
The inner wall is polished, and the welding and the fillet meet GMP requirements;The sterile pass box has a trolley-type
bracket with a track system to facilitate material handling.The system monitors the temperature, relative humidity and pressure
in the pass box in real time. Testing ports of hydrogen peroxide concentration, dust particles and planktonic bacteria are optional;
The sterile pass box features easy verification and good reproducibility, with complete IQ, OQ and PQ files, and on-site verification.
Online Contacts
Please Contact us online for more details
Whatsapp No +8613507449007
Wechat No +8613507449007
We are waiting for you online for 24 hours
Technical data
Product Dimensions
Model 1500: overall dimensions (L×W×H): 1795×1200×1800mm
Chamber size (L×W×H): 1100×1100×1200mm
Model 600: overall dimensions (L×W×H): 1495×900×1600mm
Chamber size (L×W×H): 800×800×1000mm
Model 125: overall dimensions (L×W×H): 1000×880×1790mm
Chamber size (L×W×H): 500×700×500mm
Note: Other sizes can be customized.
Company Information
Shanghai Marya Pharmaceutical Engineering&Project Co.,Ltd is a professional Pharmaceutical Turnkey projects Contractor .We have 3 our own factories and more than 30 OEM factories under quality Control of Shanghai Marya,We have a 30 year experienced professional team for doing the turnkey project from design to construction.
Our Pharmaceutical projects can be done according to international standard like EU cGMP, USA FDA, WHO GMP, UK MHRA, Australian TGA, etc
We are not noly a manufacturer but also a designing and construction company. We can provide much better price and better technical support and service than other companies
We can design and manufacture machines based on Customer's request ,Your satisfaction is our top Priority.
With 30 year experienced professional design team and construction team.Under the support of our factory ,We can provide customer with high efficiency and quality in project, save your time and cost.
Our machineries and projects have sold all over the country and they are exported to America, Europe and middle east ,South east Asia, Africa and other countries and regions.
Welcome to Visit Our factory in China
Our Services
WHY US?
We can provide Pharmaceutical Turnkey project Service including all the pharmaceutical machineries and clean room projects from designing to construction
We can provide our project according to the international regulations like EU cGMP, USA FDA, WHO GMP, UK MHRA, Australian TGA, etc
We can provide 30 year experience engineer team go give you free Consultation service We Can provide FAT and SAT Service
We can provide DQ,IQ,PQ,OQ documents service
We can provide overseas machine installation and commissioning
We can provide free training service for your employee
We can provide One year guarantee for the machine and project
We can provide 24 hours technical support by email
We can provide our installation team to your country to do the installation
We can provide user friendly English Software ,user manual and detailed video
You have nothing to worry if you cooperate with us for the pharmaceutical Project
Looking forward to cooperating with you.
