MGC Life Science, as a representative of CSV Containment, an Italian company specializing in flexible isolation systems, provides high-quality flexible containment systems (isolators) for various applications. All equipment is manufactured in accordance with Good Manufacturing Practices (FDA/EMEA) and meets global requirements for safety in handling high-power products.
We have a trained technical team in Brazil to guarantee the maintenance and certification (according to APCPPE/SMEPAC guidelines) of “high containment” equipment (OEB 3/OEB 4/OEB 5).
MGC Soluções maintains a stock of spare parts and consumables for quick customer service.
CSV Containment products are the ideal solution for industries that need to achieve high containment in existing processes, with lower usage frequency, requiring greater operational flexibility, or that cannot accommodate a rigid isolator (space).
The production and handling of high-potency products (in gas or particulate form) must be carried out in a completely isolated environment, where there is no contact between the product and the external environment (operator). This is achieved using an isolator, which creates a physical barrier between the product and the operator, and operates under negative pressure to prevent product leakage to the outside of the equipment.
With the product isolated inside the isolator chamber, it can be handled safely using gloves.
The pass-through (ante-chamber) allows for the safe movement of materials and instruments between the exterior and interior of the chamber.
Flexible isolators are custom-made, meeting containment levels up to OEB 5 (<1 μg/m3).
High-potency flexible isolators are available for many applications:
Isolators, also called “glove boxes,” enable high-containment operations when it is necessary to provide complete product protection (aseptic application) or protection of the operator and the environment (high-power application).
High-containment solutions are common in the Northern Hemisphere and have gone from being a trend to a necessity for the specialized industry in the Southern Hemisphere.
Isolators can be designed and built in monolithic structures, according to the user’s needs, and around new or existing equipment, with excellent operation and ergonomic performance.
Isolators are selected according to the occupational exposure limit (OEL) of the application, which are segmented into levels called “occupational exposure band” (OEB). For a detailed explanation of the classification of closed systems, see the following topics.
With their application flexibility and ease of operation, isolators are the most reliable containment technology available on the market, representing the future of aseptic operations or those requiring guaranteed user protection.
Literally, it involves the encapsulation of hazardous materials. The escape of hazardous substances from the workplace (operator protection) or the contamination of a product by impurities in the environment (product protection) is prohibited.
Most of us probably wondered about this when we first encountered this topic. The following sections will provide a better understanding step-by-step.
Primary containment: a containment system that prevents the escape of dust or critical substances into the immediate work environment or production equipment. This includes continuous systems, glove boxes, or butterfly valves.
Secondary containment: a containment system that is deployed to reduce any subsequent spread of the primary containment. This includes, for example, cleanrooms, locks, or pressure cascades.
Containment applications are almost exclusively carried out in closed systems.
Closed systems are machines and installations specifically used in connection with hazardous substances.
As a basic prerequisite, there must be no open connection between the environment and the interior of the system. Material leakage must be avoided at all costs. This also applies to cleaning or maintenance. Thus, integrated dust removal systems are indispensable. When using dust-free systems, the Ex zone can also be lowered or omitted completely.
With a view to the operator, handling should be as easy as possible, and operator error should not result in contamination.
Closed systems have two application perspectives: operator protection and product protection.
Operator protection: means protecting the operator against hazardous products.
Product protection: means protecting the product against impurities and cross-contamination in particular.
Therefore, it depends on the point of view whether product protection, operator protection, or both are relevant. What they have in common is the approach to achieving them: the use of closed systems.
Not all compounds/materials are equally hazardous or sensitive; therefore, containment systems are divided into different “categories” according to their application and field of use. This is because the client authority and/or legislation determines the specific limit values for the product.
The objective of this classification is to select the appropriate production facility and, respectively, the “right” work process for the product used. In practice, a distinction is made between the following classifications or limit values:
– OEL (Occupational Exposure Limit) is the average concentration load of a substance in the air at the workstation measured over a defined period of time, such that no acute or chronic harm to the worker’s health is expected. It is calculated from the ADE (Acceptable Daily Exposure) and some other values. Not all known values are used for the calculation of a classification.
– OEB (Occupational Exposure Group) considers only the toxicology of the pure substance. The more toxic the product, the higher the OEB.
