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Aseptic Inspection Isolator for Single-Use Medical Device Validation with CE
US$19,800.00
1 Piece
Product profile
Customization
AvailableCertification
CE, ISO9001Noise
60-70dbApplication
IndustrialControl Mode
TouchUsage
Dust Removal, SterilizationTransport Package
Export Wooden CaseSpecification
CustomizedTrademark
suzhou pharma machineryOrigin
JiangsuKey features
Automatic Leak Detection: Inflates cabin to verify sealing before sterilization, ensuring system integrity.
Zero Decomposition Sterilization: High-precision temperature control ensures 100% hydrogen peroxide conversion to steam.
Rapid Residue Removal: Configured decomposer quickly eliminates spatial and surface hydrogen peroxide residues.
Process Recording & Audit: Automatically detects concentration, draws curves, and supports electronic signatures.
Safety Door Interlock: Equipment prevents door opening during operation to ensure operator safety.
Antibacterial Interior Surface: Special treatment achieves permanent sterilization and eliminates microbial habitats.
High Purity Materials: External 304 stainless steel and internal 316L stainless steel for corrosion resistance.
Company profile
CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Full Customization, etc. CertifiedExport Year: 9 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤1.73h
AI-Powered supplier vetting
SummaryThe supplier is identified as a manufacturing factory in Suzhou, China, supplying pharmaceutical machinery, packaging machinery, cleanroom equipment and materials, laboratory equipment, and related products. It provides 3D software design, ODM, OEM, SDK, and multiple customization options, indicating broad technical and customization capabilities. Production evidence includes a stated annual cleanroom capacity of 10,000 square meters and a 500 m² manufacturing plant, with most materials reportedly stocked and shipment possible within seven days except for specially made air conditioners. Quality assurance is stated, but documented service procedures, complaint-handling records, corrective actions, and approved-supplier lists are absent. No overseas warehouse, showroom, agents, branches, or offline trade-show participation are reported. No new products were developed in the past year. Customer project experience is described for national and international pharmaceutical and laboratory projects, but...
Supplier typeThe supplier is explicitly classified as a factory and operates in manufacturing and processing, with business scope covering pharmaceutical machinery, packaging machinery, cleanroom equipment, water treatment equipment, laboratory equipment, and related products. This supports classification as a specialized industrial equipment manufacturer rather than only a trading company.
After-Sales capabilityThe supplier has quality assurance, but reports no written procedures or records for service assessment, corrective and preventive actions, or effective customer-complaint handling. It also has no overseas warehouse, showroom, agents, or branches, limiting demonstrated overseas service infrastructure.
R&D capabilityThe supplier is identified as a professional technical supplier, provides 3D software design, ODM services, OEM services for well-known brands, and an available SDK. However, it also reports no new products during the past year, so current innovation output is mixed rather than consistently demonstrated.
Production capacityThe supplier states annual cleanroom productivity of 10,000 square meters, operates a 500 m² manufacturing plant, and reports fast production with most materials stocked and shipment within seven days except for specially made air conditioners. These statements provide explicit evidence of production capacity and responsiveness, although the capacity data covers cleanrooms rather than every product category.
Customization capabilityThe supplier offers customization from samples, full customization, and flexible customization, together with 3D software design, ODM, OEM, and customized tools and parts. Its broad cleanroom and pharmaceutical equipment scope further supports the ability to deliver tailored industrial solutions.
Product Q&A
Q:What materials are used for the isolator?
A:
The exterior is made of 304 stainless steel, while the internal chamber uses 316L stainless steel.
Q:Does the system support customization?
A:
Yes, we offer full customization, flexible customization, and customization from samples.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 1 set.
Q:What is the lead time for production?
A:
The average lead time is one month for both peak and off-peak seasons.
Q:What certifications does the product have?
A:
The product is certified with CE and ISO9001 standards.
Send Inquiry
*To:
Suzhou Pharma Machinery Co., Ltd.
Suzhou Pharma Machinery Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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