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Sterile Isolator Aseptic Negative Pressure Isolator
US$20,000.00-60,000.00
1 Set
Product profile
Customization
AvailableWarranty
1 YearType
Preparation MachineryModel NO.
SGL-15Finished Dosage Form
CapsulePrecision
High PrecisionCertification
CE, GMP, ISOVoltage
380VComputerized
ComputerizedCustomized
CustomizedCondition
NewTransport Package
Wooden Case PackingTrademark
MedigradeOrigin
Shanghai, ChinaHS Code
8422303090Production Capacity
100 Sets/YearKey features
VHPS Sterilization: Dry vaporized hydrogen peroxide sterilization achieving 6-log spore killing level with concentration monitoring.
GMP Compliance: Meets GMP, 2015 Pharmacopoeia, USP/EP standards and 21CFR part11 electronic signature requirements.
High Precision PLC: Siemens PLC controller with industrial-grade tablet for fully automatic pressure and airflow control.
Leakage Alarm: Hourly volume leakage rate less than 0.5% under 2 times test pressure with integrated alarm function.
Customizable Design: Customized type with options for glove thickness and anti-breakage features to suit specific needs.
Class A Environment: Internal dynamic environment meets Class A cleanliness standards for aseptic filling and sampling.
Low Residual Concentration: VHPS concentration drops below 1ppm after ventilation, meeting residual concentration detection standards.
Company profile
CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 10 years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤4.65h
AI-Powered supplier vetting
SummaryThe supplier offers filling, sealing, labeling, washing, packaging, capsule, tube, sachet, track-and-trace, and cartoning equipment or services, with product scope covering labeling, filling, packing, and capping machines. It reports OEM service for popular brands, ODM capability, and broad customization options. Production information includes five production lines, 11–20 quality-control staff, inventory capability, and twelve qualified service suppliers. However, the supplier has no overseas agents or branches, overseas warehouse, showroom, or offline trade-show participation, and offers no service in any stated country. Quality assurance is reported, but complaint handling, corrective/preventive actions, and supplier-service assessment lack written procedures or records. The supplier reports no new products in the past year and has no available SDK. Certification is listed only as “Others,” without a specified certification. Financial figures are excluded; the provided financial indicators are...
Supplier typeThe supplier is a limited company with no stated affiliation to a larger group. Its stated product scope includes labeling, filling, packing, and capping machines, while its description also covers multiple vial, ampoule, and packaging processes.
After-Sales capabilityThe supplier lists debugging, maintenance, repair, training, and equipment installation services, and has in-stock service capability. However, it has no overseas agents or branches, no overseas warehouse or showroom, no stated overseas service countries, and no written complaint-handling, corrective/preventive-action, or service-assessment procedures.
Production capacityThe supplier reports five production lines, 11–20 quality-control staff, inventory capability, quality assurance, and twelve qualified suppliers for service capability. It also reports one-month lead times in both peak and off-season data in one record, while another record states two-to-three-month production lead times, creating inconsistent timing evidence.
Customization capabilityThe supplier explicitly offers customization from samples, designs, full or minor customization, flexible customization, and ODM services. Its equipment and packaging-process description further supports relevance to customized filling, sealing, labeling, and packaging solutions.
Product Q&A
Q:What is the warranty period for the isolator?
A:
The warranty period is 1 year.
Q:What sterilization method is used?
A:
It uses dry vaporized hydrogen peroxide (VHPS) sterilization, reaching a 6-log spore killing level.
Q:Does the system comply with GMP standards?
A:
Yes, the system design meets GMP, 2015 Pharmacopoeia, USP/EP requirements and 21CFR part11 electronic signature rules.
Q:What is the internal environment classification?
A:
The internal environment is dynamic Class A, suitable for aseptic filling and sampling.
Q:Can the pressure be customized?
A:
Yes, the isolator pressure can be adjusted from -80pa to 80pa, with normal operation at 40pa~60pa.
Send Inquiry
*To:
Shanghai Medigrade Industry Co., Ltd.
Shanghai Medigrade Industry Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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