cGMP

CleanFlow – Clean Air Workstations by IsoTech Design

DESCRIPTION The CleanFlow is a unidirectional, positive pressure, laminar air flow workstation. • Positive pressure unidirectional laminar air flow hood: vertical & horizontal • Primary Engineering Control (PEC) with ISO 5 classification: compliant with USP <797> within an ISO 7 cleanroom • Flexible: Model availability (2′ to 8′) for different volume of CSP’s • Easy to …

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IsoSphere™-ST – Sterility Testing by IsoTech Design

DESCRIPTION The Hardwall IsoSphere™-ST is a positive pressure non-unidirectional airflow isolator or unidirectional CRABS for small, medium, and large volume sterility testing with vaporized hydrogen peroxide decontamination integration. • ISO 4 classification • Eliminates the need for a cleanroom, and the risk of a false positive test • Complete product/operator protection • Small critical area: increased …

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IsoSphere™-AF – Aseptic Filling by IsoTech Design

DESCRIPTION The IsoSphere-AF is a positive pressure unidirectional airflow isolator or RABS for small, medium and large volume aseptic filling. • ISO 4 unidirectional airflow • Eliminates the risk of high start-up costs, extended deadlines, and possible contamination • Complete product/operator protection • Small critical area: increased SAL • Minimal energy requirements • Filling equipment integration, interface …

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ChemoSphere – Chemo Compounding by IsoTech Design

DESCRIPTION The ChemoSphere is a safe, clean, cost-effective C.A.C.I. for chemo compounding that is USP <797 / 800>, OSHA, AND NIOSH compliant.   • ISO Class 4 in the main chamber & ISO Class 5 in the antechamber • Unidirectional and negative pressure C.A.C.I • Alarms and interlocks for prevention and safety • Fast recovery rate (less than 1 minute) • Ease of …

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MicroSphere – Sterile Compounding by IsoTech Design

DESCRIPTION The MicroSphere is a clean, cost-effective C.A.I for sterile compounding, that is USP <797> compliant. • Physical barrier between products and operators: eliminates the need for a cleanroom • ISO 4 in the main chamber & ISO 5 in the antechamber • Cost efficient unidirectional positive pressure C.A.I. • Recovery rate of less than 60 seconds • Ease of …

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Stainless Steel Bulk Powder Enclosure

Stainless Steel Bulk Powder Enclosure with 99.99% HEPA filtration and BIBO option. Integrated velocity alarm and minihelic pressure gauge ensure optimum airflow and containment. Stainless frame fitted with laminated safety glass panels and reinforced with industrial strength vertical power bars. Unit equipped with a 304 Stainless Steel table with leveling feet and seismic anchors to …

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Glovebox Workstation

LFBC™ Lateral Flow Bio Containment Isolator for HPAPI Processing HEPA inlet filter for internal ISO 5 or better cleanliness Containment for OEB 3-5 below 30ng/m3 depending on process and application Designed for working with HAPI, ADCs, Oncology and biologic products in many applications and equipment, including balances, ovens, FTIR, sieves, and many more Previous Next …

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