Aseptic isolators for sterility testing, and containment for potent-compound weighing, dispensing and open powder handling, built for EU GMP Annex 1 and revised Schedule M.
ISO Class 5 positive-pressure aseptic isolator for sterility testing and aseptic processing. H₂O₂ VHP decontamination cycle integrated. ESCO isolator…
Negative-pressure containment isolator for OEB4/OEB5 potent compound weighing and dispensing. Protects operators from highly potent APIs during dispensing…
Walk-in downflow booth providing operator protection during open powder handling, granulation, and coating operations. HEPA-filtered top-down airflow…
Dedicated powder weighing enclosure providing operator protection and sample integrity during potent powder weighing. HEPA-filtered downflow with ergonomic…
Compact ventilated enclosure for analytical balance protection from drafts and airborne contamination, while venting chemical vapours away from the operator.
The 2022 revision of EU GMP Annex 1 strongly favours barrier technology (isolators and RABS) for Grade A operations, and India's revised Schedule M aligns closely with WHO and EU GMP. ESCO isolators are designed to these expectations, and Saksham supports URS, FAT/SAT coordination, IQ/OQ and lifecycle service.
It is a sealed, positive-pressure enclosure with glove ports and Grade A internal air, decontaminated with vaporised hydrogen peroxide. Pharmacopoeial sterility tests can then be run with a very low risk of false positives.
Occupational Exposure Band 5 covers the most potent compounds, typically with exposure limits below 1 µg/m³. Handling them needs high-integrity negative-pressure containment isolators.
A downflow booth is an open-front, walk-in workspace with HEPA downflow that reduces operator exposure during powder handling. An isolator is a fully closed barrier with glove ports, giving much higher containment (OEB4/OEB5).
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