Fully Enclosed Aseptic Sieving Equipment

I. Industry Challenges: The Dilemma Between Sterilization and Activity

In the production of high-value pharmaceutical products such as drug-loaded microspheres and vaccine adjuvants, traditional open sieving processes face three core pain points:

 

Ø Contamination Risks: Environmental microbial intrusion leads to batch contamination, threatening drug safety.

Ø Activity Loss: High-temperature sterilization risks microsphere collapse and reduced drug encapsulation efficiency.

Ø Regulatory Pressure: FDA/EMA continuously upgrade requirements for aseptic production environments (e.g., GMP Annex 1 2022).

Navector’s fully enclosed aseptic sieving system breaks through these barriers, integrating "zero-exposure sieving" with"in-situ sterilization" to provide critical process assurance for innovative drug R&D and mass production.

 

II. Technological Core: Triple Protection for Aseptic Integrity

Ø Fully Sealed Dynamic Clean System

Integrated positive-pressure laminar airflow maintains ISO Class 5 cleanliness in the operation chamber.

Dual-door airlock design ensures zero open contact during material transfer.

Real-time particle monitoring system alerts microbial aerosol risks.

Ø Intelligent Non-Destructive Sterilization

Dual sterilization modes: VHP (Vaporized Hydrogen Peroxide) and SIP (Steam-in-Place).

VHP Mode: Low-temperature sterilization (40-50°C), PLGA/PLA microsphere survival rate >99.8%.

SIP Mode: Rapid 121°C saturated steam sterilization, 100% pass rate in biological indicator challenge tests.

Preloaded sterilization protocols for automatic compatibility with microsphere materials and drug properties.

Precision Grading & Data Traceability

Pneumatic grading technology avoids mechanical stress, achieving <0.3% breakage for 10-2000μm microspheres.

Particle size distribution CV value <5%, meeting sustained-release formulation design requirements.

Automated electronic batch records comply with FDA 21 CFR Part 11 data integrity standards.

III. Pharmaceutical Applications

Terminal sterilization of embolic microspheres for tumor interventional therapy.

Size control of PLGA adjuvant microspheres for vaccines.

Closed production of cell therapy carrier microspheres.

Scale-up of sterile microsphere formulations for Class III medical devices.

IV. Why Choose Navector?

Risk Control: Reduces 90% of sterility test failures and shortens process validation cycles by 30%.

Cost Efficiency: Integrates sieving-sterilization steps, lowering batch operation costs by 25%.

Future-Proof Design: Modular architecture supports 300% capacity scalability for future expansion.

Transform Aseptic Sieving from a Technical Bottleneck to a Process Advantage

 

Navector’s technical team provides end-to-end support from equipment validation to process development. Serving innovative pharmaceutical companies across 23 countries, we have successfully supported over 400 global aseptic process audits.