What certifications does the machine have?

The machine has CE, GMP, and ISO certifications.

What is the sterilization method used?

It uses dry vaporized hydrogen peroxide (VHPS) sterilization, reaching a 6-log spore killing level.

Sterile Negative Pressure Inspection Isolator Aseptic Filling Machine Isolator

Name: Sterile Negative Pressure Inspection Isolator Aseptic Filling Machine Isolator
Brand: Shanghai Medigrade Industry Co., Ltd.
SKU: 2033728985

Shanghai, ChinaShanghai Medigrade Industry Co., Ltd.

US$20,000.00-60,000.00

1 Set

Product profile

Customization

Available

Warranty

1 Year

Type

Preparation Machinery

Model NO.

SGL-10

Finished Dosage Form

Capsule

Precision

High Precision

Certification

CE, GMP, ISO

Voltage

380V

Computerized

Customized

Condition

New

Transport Package

Wooden Case Packing

Trademark

Medigrade

Origin

Shanghai, China

HS Code

8422303090

Production Capacity

100 Sets/Year

Key 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 Control: Siemens PLC controller with industrial tablet for automatic pressure and airflow management.

Leakage Alarm: Hourly volume leakage rate less than 0.5% under 2 times test pressure with alarm function.

Flexible Pressure: Adjustable pressure from -80pa to 80pa with preset modes for positive and negative pressure.

Customizable Design: Full customization options available including samples, designs, and minor adjustments.

Class A Environment: Internal dynamic A-level clean environment with unidirectional airflow for aseptic filling.

Low Residual Concentration: VHPS concentration less than 1ppm after ventilation, meeting residual detection standards.

Company profile

Years of Export ExperienceHigh Repeat Buyers ChoiceCustomization from DesignsQuality Assurance

Shanghai Medigrade Industry Co., Ltd.

Shanghai, China

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: ≤4.74h

AI-Powered supplier vetting

SummaryThe supplier is a limited company specializing in various packaging solutions such as vial filling and sealing, and offers both OEM and ODM services. While they have a range of customization capabilities, they lack a strong presence in overseas markets and do not participate in offline trade shows. Their R&D capability is limited with no new products in the past year. The supplier holds a quality assurance process but lacks formal procedures for handling customer complaints. They have a stable financial status but provide limited financial data.

After-Sales capabilityThe supplier provides after-sales services such as debugging, maintenance, and repair but lacks formal procedures for corrective actions and handling customer complaints.

R&D capabilityThe supplier does not have any new products from its R&D efforts in the past year, indicating limited innovation capability.

Customization capabilityThe supplier offers extensive customization options, including full customization and ODM services.

Client casesThe supplier does not have documented procedures for assessing and maintaining effective supplier service capabilities.

Product Q&A

Q:What is the warranty period for this machine?

The warranty period is 1 year.

Q:Does the machine support customization?

Yes, customization is provided. Options include customization from samples, designs, full customization, minor customization, and flexible customization.

Q:What is the minimum order quantity?

The minimum order quantity is 1 set.

Q:What are the payment terms?

Payment terms include LC, D/P, T/T, PayPal, Western Union, and Small-amount payment.

Q:What is the lead time for production?

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