
GMP Grade A cleanroom environments demand precise surface sterilization measures before biological products, active pharmaceutical ingredients, or other sensitive goods enter manufacturing lines. As a specialized custom dynamic pass-through box manufacturer, Farclean designs and builds automated transfer enclosures engineered for complete microbial reduction and seamless integration with your cleanroom infrastructure including validated cleanroom doors and precision modular wall panels.
Farclean dynamic pass-through boxes feature cutting-edge sterilization technology and versatile packaging solutions tailored to the most rigorous contamination control standards, ensuring your products maintain integrity throughout transfer:
| System Parameter | Technical Specification | GMP Compliance |
|---|---|---|
| Microbial Reduction | 6-log kill reduction (Bacillus atrophaes spores) | Conforms to ISO 14644-4 and EU GMP Annex 1 requirements. |
| Chamber Construction | Type 304/316L SS with electropolished surfaces | Full compatibility with ISO Class 1 to Class 7 environments. |
| Control Technology | Fanuc servo automation with dual redundant PLC | Validated operation meeting FDA 21 CFR Part 11 regulations. |
Boasting deep expertise in cleanroom systems, Farclean provides full engineering validation documentation, from Design Qualification to Performance Qualification, ensuring rapid regulatory approval and seamless integration with your existing cleanroom infrastructure. Interface with our specialized cleanroom doors engineers for optimum layout interlocking.