High-Containment Barriers for Safe Drug Formulation
In pharmaceutical processing, isolation barriers protect two critical targets: the drug product from ambient microbiological contamination and the operator from exposure to highly potent active pharmaceutical ingredients (HPAPIs).
Industry Challenges
- Regulatory Compliance: Meeting strict FDA, GMP, and ISO Grade A cleanliness requirements.
- Decontamination Validation: Requiring complete compatibility with aggressive vaporized sanitizing agents (VHP).
- HPAPI Exposure: Handling toxic powders with exposure limits below 1 µg/m³ safely.
The BET Solution
Our custom Pharmaceutical Glove Box Isolators are engineered with SS316L mirror-polished internal surfaces to prevent microbial buildup, HEPA/ULPA laminar flow loops, and VHP sanitization connections. For hazardous API weighing, we offer negative pressure designs with Bag-In/Bag-Out safe-change filtration, protecting technicians from volatile powder inhalation.
