PureFlex™ Single-Use Process Container Films by Merck – Robust, Chemically Resistant Films for Mobius® & Novaseptum® Pharma Applications

PureFlex™ Single-Use Process Container Films by Merck are engineered for pharma and biopharma manufacturing environments that demand safety, scalability, and chemical resistance. Offering high-purity, low extractable, robust materials designed for Mobius® and Novaseptum® single-use bioprocessing assemblies, PureFlex™ films minimize contamination risk and optimize productivity across every stage of drug production.

Why Choose PureFlex™ Single-Use Process Container Films?

• Full-process compatibility: Supports use of a single fluid-contact material across all stages of drug manufacturing, reducing validation and implementation effort.
• Contamination risk reduction: Zero animal-derived components and a low extractable profile help protect product integrity throughout biopharmaceutical processes.
• Scalable process design: Available in sizes from 100 mL to 200 L, enabling biomanufacturers to scale operations without changing film materials.
• Enhanced integrity assurance: Helium Integrity Manufacturing Release Testing is available for applications requiring the highest level of container integrity confidence.
• Broad regulatory compliance: Passes USP, Ph. EUR., ISO, and FDA biocompatibility standards, supporting regulatory submissions with confidence.

PureFlex™ Film Construction & Key Features

• Film architecture: High-purity, medical-grade coextruded, multi-layer construction comprising an ultra-low-density polyethylene (ULDPE) fluid contact layer, a polyethylene vinyl alcohol copolymer (EVOH) gas barrier layer, and an ethylene vinyl acetate (EVA) flexibility layer.
• PureFlex™ Plus outer layer: Constructed with linear low-density polyethylene (LLDPE) in place of ULDPE for a tougher outer surface, while retaining the same ULDPE fluid contact layer.
• Gas barrier performance: Low gas permeability design achieved through the EVOH barrier layer, limiting oxygen and CO₂ transmission.
• Gamma irradiation compatibility: Both PureFlex™ and PureFlex™ Plus films are validated post-gamma irradiation, with PureFlex™ tested at >45 kGy and PureFlex™ Plus at 25–40 kGy.
• Operating temperature range: Rated from -112°F to 140°F (-80°C to 60°C), with freezing applications requiring film support.

Technical Specifications of PureFlex™ Films

Physical Data (Post-gamma irradiation)

¹ PureFlex™ film values reported after gamma irradiation at >45 kGy.
² PureFlex™ Plus film values reported after gamma irradiation at 25–40 kGy.
³ Freezing requires the film to be supported.

Biocompatibility Data for PureFlex™ and PureFlex™ Plus Films (Post-gamma irradiation at ≥40 kGy)

Biopharmaceutical Applications of PureFlex™ Single-Use Process Container Films

• Media and Buffer Preparation: PureFlex™ films provide a chemically resistant, inert contact surface suitable for preparing and holding media and buffer solutions prior to use in downstream processes.
• Cell Culture: The film’s low extractable profile and inert ULDPE contact layer make it appropriate for direct use in cell culture process containers where product purity is critical.
• Purification: Process containers constructed from PureFlex™ films support fluid handling during purification steps, maintaining chemical resistance throughout.
• Intermediate Product Storage and Mixing: PureFlex™ film-based assemblies are used to store and mix intermediate drug substances, with the film’s operating temperature range supporting both ambient and frozen storage conditions.
• Sterile Sampling: PureFlex™ films are used in the construction of Novaseptum® sampling bags for sterile sampling applications within biopharmaceutical processes.
• Fill and Finish Operations: The film’s robustness and flexibility support its use in final fill and finish stages of drug manufacturing.

Chemical Express, with over 23 years of expertise, is the official distributor of Merck in Thailand. PureFlex™ Single-Use Process Container Films and related Merck and Novaseptum® products can be ordered directly from us, ensuring quality assurance and dedicated technical support throughout your fluid management and bioproduction needs.