GMP-Compliant BMD-600A Shrink Wrapper for Medical Device Sterilization Packaging
Product Spotlights
As a trusted manufacturer since 2011, Zhejiang Zhong Shark Industrial Technology Co., Ltd proudly presents the BMD-600A Shrink Wrapper - engineered specifically for medical device sterilization packaging. Operating from our 30,000-50,000 sqm facility in Zhoushan, China, we combine ISO9001-certified quality with GMP compliance to deliver packaging solutions that meet stringent medical industry standards. This machine ensures hermetic sealing critical for maintaining sterility in healthcare environments.
Key Technical Specifications:
| Sealing Method | Continuous Heat Sealing with Shrink Tunnel |
| Max Packaging Speed | Up to 15 cycles/minute (product-dependent) |
| Temperature Range | Ambient to 300°C ± 5°C |
| Power Requirements | 380V/50Hz (configurable for regional standards) |
Operational Advantages:
- • Validation Support: Documentation packages assist with FDA 510(k) and CE Marking technical files
- • Material Versatility: Handles medical-grade pouches from 50mm to 300mm width
- • Contamination Control: Stainless steel construction with smooth surfaces prevents particle retention
- • Precision Sealing: Microprocessor-controlled temperature ensures consistent seal integrity
With over a decade of industrial expertise and a workforce of 101-200 specialists, our company ships globally through Shanghai and Ningbo ports. We serve medical manufacturers across 15+ regions including North America, Europe, and Southeast Asia. The BMD-600A represents our commitment to creating packaging solutions that protect patient safety while optimizing your production efficiency.
Frequently Asked Questions:
-
Q: What documentation comes with the machine for regulatory compliance?
A: We provide IQ/OQ templates, calibration certificates, and material compatibility reports. -
Q: Can it handle Tyvek®-to-plastic pouches?
A: Yes, the precision temperature control handles challenging medical-grade materials effectively. -
Q: What's the lead time for delivery to North America?
A: Standard delivery is 30-45 days ex-works, with expedited options available. -
Q: Does it include validation services?
A: Basic documentation is included, with full validation support available as an add-on service. -
Q: What maintenance is required?
A: Daily cleaning and quarterly professional maintenance are recommended for medical applications. -
Q: Are spare parts readily available?
A: We maintain global spare parts inventory with same-day shipping for critical components.
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