Is the system suitable for sterile powder production?

Yes, it is designed for sterile lyophilization, crystalline drying, spray drying, and sterile powder injections, ensuring aseptic process integrity.

Safe Handling Sterile Isolator for Active Pharmaceutical Powders

Name: Safe Handling Sterile Isolator for Active Pharmaceutical Powders
Brand: Hebei Findu Mechanical Technology Co., Ltd.
SKU: 2120576662

Hebei, ChinaHebei Findu Mechanical Technology Co., Ltd.

US$8,500.00-150,000.00

1 Piece

Product profile

Customization

Available

Application

Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry

Automation Grade

Automatic

Model NO.

FDNPI03

Features

Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging

Machine Material

Stainless Steel

Packaging Material

Aluminum, Glass, PVC

Warranty

24month

Transport Package

Wooden Package

Specification

Customized

Trademark

Findou

Origin

China

Production Capacity

1000 Pieces/Year

Key features

GMP Compliant Sterile System: Fully integrated solution for sterile powder production, ensuring aseptic process integrity and minimizing cross-contamination risks.

Advanced Containment Protection: Utilizes ISPE-recommended RABS/ORABS/CRABS systems to maximize personnel and material isolation, reducing particle and microbial contamination.

Automated Aseptic Processes: Features automated lifting, mixing, filling, capping, nitrogen purging, and heat sealing to overcome traditional discontinuous operation limitations.

High-Grade Cleanliness: Chamber maintains Grade A positive-pressure laminar airflow with HEPA H14 filters, ensuring ultra-clean environment for sterile operations.

Efficient VHP Sterilization: Equipped with VHP sterilization capability (0-5000 ppm) with biological indicator 6 log, ensuring thorough sterilization within 20-60 minutes.

Comprehensive CIP/SIP Station: Integrated Clean-in-Place and Sterilize-in-Place station to eliminate risks associated with manual cleaning and ensure process reliability.

Flexible Customization Options: Equipment dimensions and interfaces can be adjusted according to existing production lines, supporting full and minor customization.

Reliable After-Sales Support: Provides 24-hour response, remote technical support, localized service, and long-term spare parts stock for timely supply.

Company profile

Hebei Findu Mechanical Technology Co., Ltd.

Hebei, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 1 year CertifiedNearest Port: Tianjin PortAverage Response Time: ≤2.44h

AI-Powered supplier vetting

SummaryThe supplier specializes in the research, development, production, and sales of mechanical and electromechanical equipment, offering comprehensive design services and customization capabilities. They hold several ISO certifications, indicating adherence to quality and safety standards. However, they lack overseas infrastructure and partnerships with Fortune 500 companies. Financial data suggests limited financial operations, and they appear to have minimal export trade experience. Despite this, they have a high preference rate among repeat buyers, suggesting customer satisfaction.

Supplier typeThe supplier's business scope includes R&D, production, sales, and maintenance of mechanical and electronic equipment, indicating a technical and diverse manufacturing focus.

CertificationsThe supplier holds ISO9001:2015, ISO45001:2018, and ISO14001 certifications, demonstrating compliance with quality management, occupational health and safety, and environmental management standards.

R&D capabilityThe supplier launched new products last year and has R&D capabilities, supported by a small team of 5 engineers, indicating some level of innovation capacity.

Production capacityThe supplier has limited production capability, with only one production line and no standard procedures for outsourcing or volume reconciliation.

Customization capabilityThe supplier offers extensive customization services, including full customization from designs and samples, which indicates strong flexibility and adaptability.

Client casesDespite not collaborating with Fortune 500 companies, the supplier has a high repeat buyer preference rate, suggesting strong customer satisfaction.

Product Q&A

Q:Can the equipment be customized for my production line?

Yes, our professional technical team provides comprehensive solutions. All equipment dimensions and interfaces can be adjusted to fit your existing production lines.

Q:What is the production lead time?

Standalone equipment is available from stock. For engineering equipment, lead time is shorter than industry peers with on-time delivery guaranteed. Free storage is also available.

Q:What after-sales service is provided?

We offer 24-hour response, remote technical support, and localized after-sales service. Spare parts are kept in long-term stock to ensure timely supply at stable prices.

Q:What are the payment terms?

We provide comprehensive quotation documents with separate listings for equipment, packaging, testing, transportation, and services. Flexible payment terms are available.

Q:What is the warranty period for the system?

The system comes with a 24-month warranty covering mechanical defects and ensuring product reliability.