General Processing Platform Isolator (GPPI)

Esco Pharma's General Processing Platform Isolator (GPPI) is a highly adaptable, unidirectional laminar airflow isolator that can be used for sterility testing or other processes that require an ISO Class 5 (Grade A) aseptic environment.

Pharmaceutical isolators are often mentioned in PIC/S, TGA, and USP Guidelines as recommended primary engineering control to minimize operator contact with the aseptic sample being handled, which is highly sensitive and vulnerable to cross-contamination.

The capabilities of GPPI design are multifunctional, that can be used in aseptic processing from weighing and dispensing aseptic hazardous powder to sterility testing as one of go or no-go testing for batch release. The GPPI design is versatile and suitable for various aseptic processes, ranging from weighing and dispensing aseptic hazardous powder to sterility testing, serving as a critical go/no-go test for batch release. Customizing GPPI with a Bag-in-Bag-out Filter exhaust filter with integrated Cleaning-in-Place (CIP) and Wash-in-Place (WIP) provisions reduces the risk of operator and environmental exposure to hazardous powders. Single-layer crevice-free work zones are highly adaptable for third-party integration equipment, streamlining the overall process.

The GPPI’s advanced control system allows the operator to select single-pass or recirculating airflow patterns.

These features, along with the ability of various customization, make the GPPI a highly versatile isolator that can be used for potent or non-potent aseptic materials.

In addition, the Esco GPPI’s design offers standard options and configurations ensuring that Esco can provide a standard solution to fit your specific process and facility requirements.

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Features

Fully welded SS316L internal chambers with rounded coved corners
Unidirectional airflow with 0.45 m/s nominal velocity provides superior product protection
User-adjustable configuration of Single Pass and Recirculating airflow regime
Self-contained design of control system & electrics allow for simple, plug-in installation
Integrated particle monitoring connections and optional inclusion of viable and non-viable monitoring equipment
Class 3 Leak Tight Containment (ISO 10648-2) automated pressure hold test to ensure there are no leaks prior to decontamination and normal run
Validated Hydrogen-Peroxide based decontamination of individual chambers provides a 6-log reduction of bioburden
Pre-programmed system to function with multiple H2O2 system options
Standard design incorporates cGMP-compliant features; with the inclusion of an optional chart recorder or printer the GPPI will meet the data handling requirements for 21 CFR Part 11 requirements
Integration ready for Sterility Test Pump with automatic drain valve
Optional on-board exhaust catalytic convertor allows exhaust into the surrounding room without modifications to the facility and is fitted with an interlocked external H2O2 sensor for safety
Optional mobile air compressor eliminates the requirement for a site-supplied compressed air connection, which allows for the installation of a simple plug-in of electrical power

Optional feature is available to design with FDA-approved hydraulic liquid that not only allows the user to raise and lower for optimal ergonomics but also enables ease of transport through a variety of doorway and ceiling heights

Principle

Models

Guide to General Processing Platform Isolator (GPPI)
GPPI-IS-4G-1PTC(2G)
Base Model	Seal Design	Code	Process Chamber Design	Code	Pass Chamber (PTC) Design	Pass Chamber Size	Code
GPPI	Inflatable Seal	IS	2-glove (1200 mm)	2G	No PTC	Non-glove	NG
			3-glove (1600 mm)	3G	1 PTC	1-glove	1G
			4-glove (2000 mm)	4G	2PTC	2-glove	2G
			5-glove (Custom)	5G

Accessories

BIBO Exhaust Filters

Pass Chamber (Size may vary depending on requirements)
Biodecontamination System (other brands)
Non-viable Particle Counter
Viable Air Sampler
Sterility Test Pump - Mechanical Integration of Sterility Test Pump includes automatic drain valve, cable access, and test pump cut-out. (Brand and model is up to client preference)
Liquid Carboy Container - 10L or 15L
Integrated Glove Leak Tester
Wireless Glove Leak Tester
Sterile Continuous Liner Bag Welder with Table
RTPØ105, 190, 270, 350, 460 - Alpha
RTPØ105, 190, 270, 350, 460 - Beta Canister
RTPØ105, 190, 270, 350, 460 - Beta Liner
Weighing Scale
Spray Gun
H2 O2 Monitoring System
Product Waste Entry/Exit Ports
Liquid Entry/Exit Ports
Integrated Catalytic Converter
Mobile Air Compressor
IV-bar with Stainless Steel Hooks
Stainless Steel Shelves and Racks
Stainless Steel Baskets
IP-Rated Main Control Panel
IPC Control System
Upgrade SCADA Integration

Specifications

GENERAL SPECIFICATIONS General Processing Platform Isolator (GPPI)			GPPI-2G	GPPI-3G	GPPI-4G
Nominal Size Main Chamber (Width)			1200 mm (47.2")	1600 mm (63.0")	2000 mm (78.7)
External Dimensions (W x D x H)*		Process Chamber	1504 x 881 x 2430 mm (47.40" x 34.69" x 95.67")	1904 x 881 x 2430 mm (74.96" x 34.69" x 95.67")	2304 x 881 x 2430 mm (90.71" x 34.69" x 95.67")
		Pass Chamber**	710 x 772 x 2430 mm (27.95" x 30.4" x 95.67")
Internal Dimensions (W x D x H)**		Process Chamber	1200 x 540 x 700 mm (47.24" x 21.26" x 27.56")	1600 x 540 x 700 mm (62.99" x 21.26" x 27.56")	2000 x 540 x 700 mm (78.74" x 21.26" x 27.56")
		Pass Chamber	606 x 458 x 790 mm (23.86" x 18.03" x 31.10")
Glove Port Height			1150 mm (45.3")
Chamber Environment			ISO Class 5 (Grade A)
Filtration	Prefilter		M6 pre filter with ≥ 60% as per EN 779:2012
	Supply	Filter Type	ULPA (U15) with Knife Edge Gel Seal
		Filter Efficiency	99.9995% at Most Penetrating Particle Size (MPPS) as per EN1822:2009
	Exhaust	Filter Type	HEPA (H14) with Gasket Seal and Integral Mesh Guard
		Filter Efficiency	99.995% at Most Penetrating Particle Size (MPPS) as per EN1822:2009
Lighting Level			≥ 600 Lux
Sound Level			≤75 dBA
Isolator Construction		Internal Chamber Wall	SS 316, 2.0mm thickness
		External Front Door Frame	SS 304, 2.0mm thickness
		Support Stand Stretchers	SS 304, 2.0mm thickness
		Main Control Panel (MCP)	In-house SS304 (IP-20), 2.0mm thickness
		Instrumentation Control Panel (ICP)	In-house SS304 (IP-20), 1.5mm thickness
		Chamber Glass Outer Door	10 mm (0.39") Tempered Glass
		Pass Chamber Inner Door	25 mm (0.98") Acrylic
Isolator Finish		Internal Chamber	≤ 0.4 Ra
		External Chamber and Service Housing	≤ 0.6 Ra
Electrical Requirements		220-240V, AC, 50Hz, 1Ø	✓
		110-120V, AC, 60Hz, 1Ø	✓
		220-240V, AC, 60Hz, 1Ø	✓
Compressed Air Requirement (By Client) (If no mobile compressor)			Min 6 Bar - Max 12 Bar, ≥ 200L/min
Exhaust Duct Requirements (By Client) (Unless Integral Catalytic Converter is Included)		Ducting size	10” Duct from Isolator to outside
		Process chamber	Total exhaust: 1021 cmh Recirculating: 510 cmh	Total exhaust: 1363 cmh Recirculating: 680 cmh	Total exhaust: 1703 cmh Recirculating: 850 cmh
		Pass chamber	Total exhaust: 518 cmh	Total exhaust: 518 cmh	Total exhaust: 518 cmh
Shipping Dimension (W x D x H)			2500 x 1100 x 2500 mm (98.4" 43.3" x 98.4")	2800 x 1100 x 2500 mm (110.23" x 43.3" x 98.4")	3250 x 1100 x 2500 mm (128.0 x 43.3 x 98.4)
Shipping Weight			1400 kg (3086.5 lbs)	1600 kg (3527.4 lbs)	1800 kg (3968.3 lbs)