Isoclean® Healthcare Platform Isolator - Inflatable Seal – BioVap™ (HPI-IS-BVP)

Optimized Solution for Sterile/Aseptic Applications

The Isoclean® Healthcare Platform Isolator – Inflatable Seal - BioVap™ Model (HPI-IS-BVP) ensures the isolation of a product/process while providing the required ISO Class 5 / Grade A environment.

HPI-IS-BVP is equipped with inflatable seals and automated dampers. As standard, the standard unit is fully integrated with both the auto-pressure hold testing and BioVap™ (hydrogen peroxide biodecontamination system with H2O2 sensors and catalytic converter).

Integration of Esco BioVap™ allows both master and independent biodecontamination process of main chamber and pass-through chambers (PTCs). This improved design facilitates ease of isolation control especially during pressure decay testing and bio-decontamination process.

This model can be adjusted on-site to operate in positive or negative pressure regime. It is also available in recirculating or total exhaust configuration.

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Applications:

Aseptic and/or Potent Compounding
Pharmacy Compounding
Sterility Testing
Cell and Gene Therapy
Peptide Production
Biosafety Facility Level 3 or 4

Benchtop/Small-scale Aseptic Formulation and Filling
Small-scale Potent Material Handling
Cosmeceutical
R&D and Clinical Trials

Features

This model is capable of expanding up to 3 modules of 2-glove main chamber with 2 modules of pass-through chamber (left and right).
Capable of automated pressure hold testing (APHT) and biodecontamination with log 6 reduction in bioburden.
HEPA (H14) filter (as per EN 1822) with a typical efficiency of > 99.999% at 0.1 to 0.3 microns; provide superior ISO Class 5 air cleanliness as per ISO 14644-1.
Containment enclosure classification: Class 2 as per ISO 10648-2.
Electromagnetic interlocking doors with time delay effect ensures safety and containment during material transfer.

* With built-in air compressor to support inflatable seals in the window and dampers, and the BioVap™ biodecontamination system.

Principle

Single Pass/Total Exhaust Configuration

The main chamber and passthrough chamber are independent systems equipped with its own blower and filter.

Ambient air is pulled through the inlet prefilter and downflow filter placed on top of the isolator. The HEPA (H14) filter provides a laminar airflow providing ISO Class 5 air cleanliness to the main chamber and the passthrough chamber. The exhaust fan pulls the air and passes through the HEPA (H14) filter below the work zone, resulting to the air being pulled to the back plenum. It is then exhausted through the optional HEPA (H14) or carbon filter at the top portion of the isolator.

Recirculating Configuratiom

The main chamber and passthrough chamber are independent systems equipped with its own blower and filter.

Ambient air is pulled through the inlet prefilter and downflow filter placed on top of the isolator. The HEPA (H14) filter provides a laminar airflow providing ISO Class 5 air cleanliness to the main chamber and the passthrough chamber. The exhaust fan pulls the air and passes through the HEPA (H14) filter below the work zone, resulting to the air being pulled to the back plenum. A percentage of the air is recirculated back to the main chamber/passthrough chamber, while a smaller percentage is then exhausted through the optional HEPA (H14)/Carbon Filter filter at the top portion of the isolatorm

Models

ISOCLEAN® Isoclean® Healthcare Platform Isolator - Inflatable Seal Model (HPI-IS)		2-glove Main Chamber	3-glove Main Chamber	4-glove MainChamber	Passthrough Chamber	3-way Passthrough Chamber
External Dimension (W x D x H)		1340 x 800 x 2350 mm	1645 x 800 x 2350 mm	1950 x 800 x 2350 mm	730 x 800 x 2350 mm	730 x 800 x 2350 mm
Internal Dimension (W x D x H)		1290 x 620 x 700 mm	1595 x 622 x 700 mm	1900 x 622 x 700 mm	680 x 620 x 700 mm	680 x 620 x 700 mm
Passthrough Chamber - Tray Dimension		N/A	N/A	N/A	270 x 660 mm	270 x 660 mm
Isolator Construction	External Body	ISOCIDE™ Powder-coated electrogalvanized steel
	Internal Chamber	Stainless steel 316L
Airflow		Unidirectional/Laminar Airflow (Recirculating or Total Exhaust/Single-Pass Airflow Models are available)
Process Chamber Pressure		+37 Pa			+25 Pa
		Selectable between -60 Pa to +75 Pa
Process Chamber Downflow Velocity		0.45 m/s +/-20%
Chamber Lighting	Normal Operating Mode	Warm White, Minimum 500 Lux			no lighting for PTC Module
	Bio-decontamination Mode	Blue			no lighting for PTC Module
	Alarm Mode	Red			no lighting for PTC Module
Aeration Mode		With Integrated Catalytic Converter
Pressure Hold Test	During FAT and IQOQ	Class 2 Containment as per ISO 10648-2
	Automated Daily Routine	Class 3 Containment as per ISO 10648-2 (Pressure hold test prior to each biodecontamination
Net Weight		525 Kg	650 Kg		328 Kg
Inflatable Sealed Side Adaptor Plate/ Retrofit Option		RTP for sizes 105 mm, 190 mm, or 270 mm			N/A
		Up to 4 x 1” Tri-clover connection			N/A

Accessories

Available in Recirculating or Total Exhaust configuration
Integration of a side-mounted CO2 Incubator
Glove Leak Tester
Glove Port sizes
- 300 x 300 mm
- 300 x 200 mm
CCTV integration
Access to rear view monitor system
Addition of sterility test pump
Mechanical integration of viable/non-viable particle monitoring (with separate software)

Brochures & Sell Sheets

Esco Pharma Product Guide

Healthcare Platform Isolator – Inflatable Seal – BioVap™ Brochure

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