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.
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
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
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
* External height stated is WITHOUT Exhaust Collar. The provision of Exhaust Collar will increase +70 mm (2.8") of total external height
** The dimension stated is for 1-Glove Pass Chamber.