Does the system support data integrity?

Yes, it is compliant with computerized verification software featuring audit tracking and electronic signatures.

Aseptic Inspection Isolator for Sterile Medical Device Packaging Quality Assurance with CE

Name: Aseptic Inspection Isolator for Sterile Medical Device Packaging Quality Assurance with CE
Brand: Suzhou Pharma Machinery Co., Ltd.
SKU: 1957623431

Jiangsu, ChinaSuzhou Pharma Machinery Co., Ltd.

US$19,800.00

1 Piece

Product profile

Customization

Available

Certification

CE, ISO9001

Noise

60-70db

Application

Industrial

Control Mode

Touch

Usage

Dust Removal, Sterilization

Transport Package

Export Wooden Case

Specification

Customized

Trademark

suzhou pharma machinery

Origin

Jiangsu

Key features

Advanced Leak Detection: Automatically inflates cabin to verify sealing before sterilization, ensuring system integrity.

Zero Decomposition Sterilization: High-precision temperature control ensures 100% hydrogen peroxide conversion to steam with no decomposition.

Rapid Residue Removal: Configured decomposer quickly eliminates both spatial and surface hydrogen peroxide residues.

Comprehensive Process Recording: Automatically detects concentration and generates sterilization process curves for audit tracking.

Safety Door Interlock: Equipment prevents door opening during operation to ensure operator safety.

Antibacterial Interior Surface: Special treatment makes the interior permanently free of microbial habitats.

FDA Compliant Software: Includes audit tracking, electronic signatures, and data integrity functions.

Company profile

Experienced TeamImporters and ExportersHigh Repeat Buyers Choice

Suzhou Pharma Machinery Co., Ltd.

Jiangsu, China

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: ≤1.49h

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:How does the leak detection work?

The system automatically inflates the cabin to check sealing. If requirements are not met, it continues inflating until sealed.

Q:What materials are used for the construction?

The exterior is made of 304 stainless steel, and the internal chamber uses 316L stainless steel.

Q:Is customization available for this product?

Yes, we offer full customization, flexible customization, and customization from samples.

Q:What is the minimum order quantity?

The minimum order quantity is 1 set.

Q:What are the lead times for delivery?

The average lead time is one month for both peak and off-peak seasons.

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Aseptic Inspection Isolator for Sterile Medical Device Packaging Quality Assurance with CE