GMP and FDA Compliant Negative Pressure Isolator Glovebox

Name: GMP and FDA Compliant Negative Pressure Isolator Glovebox
Brand: Hebei Findu Mechanical Technology Co., Ltd.
SKU: 2240062215

Hebei, ChinaHebei Findu Mechanical Technology Co., Ltd.

US$200,000.00

1 Piece

US$180,000.00

2+ Pieces

Product profile

Application

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

Automation Grade

Automatic

Features

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

Model NO.

FDNPI05

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 and FDA Compliance: Fully integrated solution developed in strict compliance with new GMP requirements and FDA standards.

Advanced Containment Technology: Utilizes ISPE-recommended RABS, ORABS, and CRABS to minimize cross-contamination risks.

Automated Aseptic Processing: Supports sterile lyophilization, crystalline drying, spray drying, and automated filling/capping.

High-Grade Sterilization: Features VHP sterilization with H14 HEPA filters, ensuring Grade A positive-pressure laminar airflow.

Customizable Dimensions: Equipment dimensions and interfaces can be adjusted according to your existing production lines.

Comprehensive Warranty: Provides a 24-month warranty covering mechanical defects with free parts and labor.

Trusted by Industry Leaders: Trusted by over 1,000 pharmaceutical companies including Merck, Pfizer, and Novozymes.

24/7 Technical Support: Offers 24-hour response, remote support, and localized after-sales service with spare parts in stock.

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: ≤0.73h

AI-Powered supplier vetting

SummaryThe supplier operates in mechanical, electromechanical, and electronic automation equipment, covering R&D, production, sales, installation, commissioning, maintenance, and related technical services. It provides broad customization, 3D software design, and reports new products within the past year, supported by five R&D engineers. ISO9001:2015, ISO45001:2018, and ISO14001 certifications are stated. Production evidence is limited to one production line, with no continuous batch quantity reconciliation and no outsourcing SOP. Overseas service infrastructure is limited: no overseas agents, branches, warehouse, showroom, or countries served, although installation, debugging, maintenance, repair, and training are offered. Financial credibility cannot be fully assessed because the supplied financial figures are inconsistent and are not evaluated here. No Fortune 500 customer collaboration is reported, while repeat-buyer preference is stated at 80%–100%.

Supplier typeThe supplier is positioned as an equipment and technical-services provider, with stated activities covering R&D, production, sales, installation, commissioning, maintenance, and electronic automation project services. This indicates an integrated manufacturer/service supplier rather than a pure trading entity.

CertificationsThe supplier states that it holds ISO9001:2015, ISO45001:2018, and ISO14001 management-system certificates. These explicit certifications support its quality, occupational safety, and environmental management credentials.

R&D capabilityThe supplier provides 3D software design services, has five R&D engineers, and reports launching new products during the past year. These facts explicitly support active product-development and design capability.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization, together with 3D software design services. This is direct evidence of broad customization coverage.

Product Q&A

Q:Can the equipment be customized?

Yes, our professional technical team provides comprehensive solutions. All equipment dimensions and interfaces can be adjusted according to 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. We also offer free storage services.

Q:What after-sales service is provided?

We provide 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?

We provide a comprehensive 24-month warranty for all our mechanical equipment.