FCIS

Isolation and sterility testing

A modular pharmaceutical isolator for controlled handling, dispensing and aseptic process integration.

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FCIS

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Designed around your process

Isolation and sterility testing

FCIS separates the working area from the surrounding environment. Configurations can support API handling, aseptic filling or continuity with other sterile-processing equipment, with the scope defined around the application.

FCIS
Tailored to your application

Technology with local support

From choosing the right configuration to coordinating a quotation, the EZ GMP automation team connects your production requirements with the appropriate manufacturer specialists.

Tell us about your product, batch size, packaging format and facility. We’ll help define the next steps for your project in Vietnam.

FEDEGARI
FCIS

FCISHighlights

01

Modular chamber and transfer arrangements.

02

Integrated hydrogen peroxide vaporizer.

03

Chamber and glove leak testing.

Technical information

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FCIS
ParameterDetails
ApplicationsAPI handling, aseptic filling and sterile unloading continuity
Working surface finishBright annealed stainless steel; Ra ≤ 0.4 µm
Exhaust filtrationH14 HEPA
Leak testingPressure-decay tests for chambers and gauntlets
Door sealingDouble-gasket system
VaporizerIntegrated Fedegari FHPV
Transfer optionSide transfer hatch
Process controllerThema4

Published specifications are taken from Fedegari’s product page. Chamber sizes, options and process results depend on the selected configuration and load. Confirm requirements with EZ GMP; older brochures may describe different configurations.