Glove Boxes-isolators
  Chimical
  Pharmaceutical
In the field of isolation technology the main solution is represented by glove boxes, also known as isolators, in relation to the type of configuration; we are talking about work chambers specially designed and built to handle tools and substances in a confined environment completely separate from the one in which the operator is located, in order to guarantee a multiple level of protection; for the operator, for the product, for the surrounding environment
Nuova Guseo containment isolators are developed by combining high levels of user protection with an ergonomic design aimed at simplifying the actions and movements of the operator during the process.
Containment in the
chemical-pharmaceutical
industry

The issue of containment is of ever-increasing importance in the chemical-pharmaceutical field, especially in relation to the increased toxicity of the products treated, such as API (Active Pharmaceutical Ingredient) and especially HAPI (Highly Active Pharmaceutical Ingredient). When handling active ingredients, it is necessary to classify these substances according to the OEL (Occupational Exposure Level, operator exposure limit) or OEB (Occupational Exposure Band, operator exposure range) index, according to the in order to identify the most suitable management system.

The OEL index defines the average concentration (g / m3) of a substance measured for 8 hours in the air breathed by an operator in the workplace. Therefore, the term "containment" refers to the input process of a biological agent (active medicinal products, pathogens) or of another substance within a defined room.

The OEB index (1, 2, 3, 4, 5) is assigned on the basis of the toxicity of a given substance in its pure state in order to carry out a risk assessment and select the most suitable procedures and systems for a given product.

Function of the isolators
The isolation technology production takes place inside isolators, which are in effect chambers of variable dimensions depending on the type of process to be carried out, which ensure the confinement of a series of operations guaranteeing a triple level of protection: 01 OPERATOR PROTECTION; 02 PRODUCT PROTECTION; 03 EXTERNAL ENVIRONMENT PROTECTION.
01 - The operator's protection from dangerous product contamination is guaranteed by the physical barrier represented by the isolator, by the negative air pressure regime towards the external environment as well as by the handling and transfer devices suitable to avoid any direct contact with the produced during different stages of the process.
02 - The protection of the product from contamination from the external environment is guaranteed by an absolute filtration system (Hepa) placed on the suction side. This device ensures that the external air comes into contact with the substance to be treated only after appropriate filtration, thus ensuring the control of airborne pollutants.
03 - The protection of the external environment is guaranteed by an additional absolute filtration system (Hepa) placed at the exhaust. This device ensures adequate treatment of the internal atmosphere before expulsion to protect the environment and also the operator.
Characteristics of the isolators
Nuova Guseo isolators are offered in multiple configurations: single or multi-chamber, in active or passive version (with or without integrated ventilation system and relative control system).
The proposed systems can be interfaced with various process machines such as reactors, filter dryers, centrifuges, static ovens, etc., they can also integrate devices for kilolabs, weighing, dispensing, grinding and various other process activities.


The design and construction criteria of the isolators, in compliance with the reference standards, provide for: • a high degree of internal finishing in order to avoid the accumulation of treated substances while the control of the air flows minimizes the contact of the product with the internal surface processing chambers; all this in order to facilitate cleaning operations when changing the product • internal cleaning devices with relative draining bottom in which the contaminated liquid is conveyed • an ergonomic design for easy access to all internal surfaces and work areas in relation to the process performed - possibility of performing ergonomic test ( mock up test) • use of glove ports of variable shape and size and feasible in different materials, suitable for easy replacement of the gloves used while maintaining the integrity of the system, • use of gloves of different sizes and materials in relation to the operational needs, the characteristics of the washing solvents used and the product to be handled • use of high efficiency filters of different types (screwed, push-through, push-push, bag in bag out), which can be replaced in safe conditions for the operator. • prearrangement for the installation / integration of product transfer systems, process tools and waste material outlet (continuous liner, Rapid Transfer Port, split valve, etc.) • instrumentation and alarms appropriate according to operational and safety requirements • possible integration with automatic non-electric pressure regulation valve (PV) and control systems that can be implemented in various ways, from basic configurations to control the internal pressure regime and any interlocks, up to the most sophisticated solutions with PLC and GAMP 5 and CFR 21 compliant software.

An integral part of the Nuova Guseo production range is represented by glove box and isolators designed for particular applications, i.e. systems capable of maintaining inert atmosphere conditions for the processing of oxygen-sensitive products, realizations in materials / coatings suitable for the processing of acid products.
REGULATORY REFERENCES:

cGMP's (Current GOOD MANUFACTURING PRACTICE'S)
ISO 14644-7 Separative devices (clean air hoods, glove boxes, isolators, and mini-environments)
ISO 10648-1 Containment enclosure
– Part 1 Design principles ISO 10648-2 Containment enclosure
– Part 2 Classification according to leak tightness and associated checking method AGS-G001-2007 (American Glovebox Society)

AVAILABLE TESTS:

Leak test (leak test, according to ISO 10648-2)
Helium test
SMEPAC TEST (Standardized Measurement of Equipment Particulate Containment)
Particle counter at rest for internal environmental class verification according to ISO 14644-1
Integrity test of installed filters according to ISO 14644-3
Glove breach test (According ISO 14644-7),

EQUIPMENTS AND POSSIBLE CONFIGURATIONS
Nuova Guseo systems are the result of know-how and experience acquired in more than 100 years of activity. This allows us to develop cutting-edge innovations and technical solutions.
Filter Dryer discharge isolators
The isolators designed for filter dryer discharge can have the following configurations:
-Active or passive configuration
-Single or double chamber configuration
-Modular configuration for interfacing with pilot dryers

They can be equipped with:
Connection flange to the filter dryer
Front window bolted or hinged to the isolator frame
Product recovery bar, composed of screw-on stainless steel elements and PTFE scraping blade with variable shape
Safety bar on the front of the insulator to prevent access to gloves when the dryer is running
Product discharge with protection grid
Drainage point coinciding with the product discharge point or positioned separately on an inclined bottom
Product unloading implementable with continuous liner bagging device
Implementation with lateral liner or Rapid Transfer Port for product sample and waste outlet
Washing and drying gun
Spray balls
Implementation with unloading chute from the dryer door
Lighting lamp (s)
Reactor charging
Isolators designed for reactor charging can have the following configurations:
Active or passive configuration
Single or double chamber configuration
Double chamber configuration with drum inlet pre-chamber, hermetically sealed guillotine door and drum tilting device integrated in the main chamber.
Windows on the opposite isolator walls in order to allow the access of two operators
Window bolted or hinged to the isolator frame.
Integration with product container support-transfer platform
Product inlet with continuous liner or bag in / bag out system
Roller conveyors for the transfer of product drums
Possible integration with external drum tilting device
Product discharge with protection grid
Implementation with side continuous liner or Rapid Transfer Port for waste outlet
Washing and drying gun
Spray balls
Lighting lamp (s)
Weighing and dispensing isolators
The isolators designed for weighing and dispensing can have the following configurations:
Configuration with product inlet pre-chamber and main processing chamber with independent ventilation and internal cascade pressures
Interlocked doors for product entry and transfer to the main chamber.
Front window bolted or hinged to the isolator frame
Supporting platform for weighing device
Integration of the weighing terminal on the isolator front or integrated in the operator panel of the control system
Cable glands for the wiring of the installed devices
Implementation with side continuous liner or Rapid Transfer Port for product and waste outlet
Support shelves for tools, containers


Washing and drying gun
Spray balls
Lighting lamp (s)
Isolators for calibration and micronization activities
Isolators designed for calibration and micronization can have the following configuration:
Product inlet pre-chamber,
Micronization and calibration main chamber,
Two-stage gas solid separation chamber
Main chamber and gas solid separation chamber hinged windows
Active configuration with independent ventilation for each chamber, differentiated negative pressure levels
Integration with conical mill for calibration of the processing batch and micronizer series MICRONETTE
Dosing unit and conical mill in wall mounted configuration, with motorization in housing outside the main chamber
Upper section of the gas-solid separation chamber with octopus filter equipped with a pneumatic shaking device
Lower section of the gas-solid separation chamber with product discharge cone, with manual butterfly valve and continuous liner bagging device
Possible integration with in-line sampler
Side liners for product and waste material outlet, possible implementation with Rapid Transfer Port
Automated control system with PLC
Washing and drying guns
Lighting lamps
Isolators for micronization activities
Isolators designed with integrated micronization systems can have the following configurations:
Multi-chamber configuration: micronization main chamber with pre-chamber or side continuous liner for product inlet, two-stage solid gas separation chamber
Main chamber and gas solid separation chamber hinged windows
Active configuration with independent ventilation for each chamber, differentiated negative pressure levels.
Possible integration with different sizes of micronizer series MICRONETTE, interchangeable in relation to the characteristics of the processing batches.
Wall mounted feeder, with motorization in housing outside the main chamber chamber
Upper section of the gas-solid separation chamber with octopus filter equipped with a pneumatic shaking device.
Interchangeable polyp filters in relation to the micronization device applied
Lower section of the gas-solid separation chamber with product discharge cone, manual butterfly valve and continuous liner bagging device
Possible integration with in-line sampler
Side liners for product and waste material outlet, possible implementation with Rapid Transfer Port
Automated control system with PLC
Washing and drying guns
Lighting lamps
Paddle dryer sampling isolators
The insulators designed for sampling by paddle dryers can have the following configurations:
Single chamber configuration
Rear flange for connection to the dryer
Passive configuration with blanketing absolute filter
Configuration with angled gloved flanges
Visual on the upper side of the insulator
Side liner for product sample release
Cleaning by spray ball with shaped bottom for waste liquid drainage
Directive 2014/34 EU (Atex)
For use in classified areas (with the presence of hazardous gas and / or dust mixtures) the equipment is manufactured in compliance with the 2014/34 EU Directive.
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