• The BH0400-C01 represents a new generation of primary packaging made from premium Cyclic Olefin Polymer (COP). This material is specifically engineered for biopharmaceuticals, offering high resistance to pH variations and eliminating the risk of delamination. Its superior barrier properties provide a robust defense against water vapor and oxygen permeation, ensuring long-term drug stability.

• Designed for sensitive formulations, this COP container features low protein adsorption and a purity profile free from heavy metal ions or flake generation. The product is highly versatile across extreme thermal conditions, maintaining its structural integrity within an operable temperature range from 121°C to -80°C. Comprehensive extractables and biocompatibility reports are available to support regulatory filings.

• Our manufacturing excellence is reflected in the GMP-managed cleanroom production environment, ensuring every unit meets strict ISO 9001 and YBB standards. The containers support both Ethylene Oxide (EO) and Steam sterilization, providing flexible processing options for manufacturers. Delivered in a 6×8 Nest Packaging configuration, it integrates seamlessly into automated filling lines for maximum efficiency.

Category	Technical Specifications	Details
Basic Info	Product Model	BH0400-C01
	Material	Cyclic Olefin Polymer (COP)
Performance	Drug Stability	High resistance to pH variations; no delamination
	Barrier Properties	High resistance to water vapor and oxygen permeation
	Adsorption	Low protein adsorption
	Temperature Range	Operable from 121°C to -80°C
Quality & Safety	Regulatory Standards	Compliant with ISO 9001 and YBB standards
	Purity	Free from heavy metal ions and flake generation
	Research Data	Extractables and Biocompatibility reports available
Manufacturing	Production Environment	Produced in GMP-managed cleanroom facilities
	Sterilization Compatibility	Supports Ethylene Oxide (EO) and Steam sterilization
	Packaging Configuration	6×8 Nest Packaging