The Importance of Safety and Containment
The growing demand for APIs and HAPIs has led the market to require ever-more advanced equipment, highly qualified personnel, and the implementation of rigorous procedures with targeted safety controls. However, safe handling of these compounds goes beyond operator protection: containment is equally vital to ensure drug quality, minimize waste, and safeguard the economic and strategic value of these high-potency ingredients.
When selecting a containment system, flexibility is crucial. The ability to handle a range of products or adapt to future production needs is a fundamental requirement for any company seeking to remain competitive and compliant.
In summary, effective containment of APIs and HAPIs is necessary to:
- Protect operators from exposure to highly potent and/or toxic substances.
- Prevent the dispersion and loss of high-value products.
- Ensure the quality and safety of the final pharmaceutical product.
Classification and Exposure Management: OEL and OEB
To protect operator health, Occupational Exposure Limits (OELs) have been defined. These represent the maximum concentration of an active substance per cubic meter of air to which an operator can be exposed for eight hours without risk. Additionally, Occupational Exposure Bands (OEBs) define the required containment level based on the hazardousness of the active ingredient:
- OEB 1: Open systems with local extraction (>1000 µg/m³)
- OEB 2: Downflow booths, valve containment systems (100–1000 µg/m³)
- OEB 3: Split valves, cone valve drum containment (10–100 µg/m³)
- OEB 4: Isolators, split valves, continuous liners (1–10 µg/m³)
- OEB 5: Isolators, split valves with dedicated extraction/washing, drum containment (<1 µg/m³)
HAPI drugs typically require OEB 4 or OEB 5 containment, as they are highly potent and/or toxic, such as those used in oncology.
Italvacuum’s High-Containment Solutions
To ensure maximum safety in API and HAPI handling, Italvacuum has developed advanced containment systems for its patented CRIOX® System and Bi-EVOLUTION® industrial rotary vacuum dryers. These systems feature a closed, perfectly sealed interface, minimizing the risk of environmental contamination during both loading and unloading phases. The design includes a fixed connection point and a mobile docking element that connects to the hopper securely and hermetically.
The containment solution is based on an active valve and a passive valve, engineered to guarantee perfect sealing of both loading and unloading stations. The active valve, equipped with actuators, is installed on a steel structure or reinforced concrete base, ensuring operational stability and reliability. The passive valve, designed for vacuum operations, is mounted directly on the rotary vacuum dryer, ensuring a safe and efficient workflow.
Both the CRIOX® System and Bi-EVOLUTION® dryers are designed to optimize the production process, delivering uniform drying thanks to their rotating bi-conical chambers, which enables homogeneous mixing and continuous mass movement. Their vacuum operation makes them ideal for drying wet masses from centrifugation or filtration, ensuring maximum efficiency and final product quality.
Active and Passive Valves: Operation and Safety
The active valve forms the core of the docking system. It consists of the seal housing, the seal itself, and the valve semi-disc. Two bayonet locking pins in the active flange ensure precise centering with the passive valve. All drives are equipped with limit-switch micro-switches to detect their status and automatically manage operational sequences. For docking and undocking, the active valve with its lifting unit is extended and retracted via pneumatic cylinders. Bellows, attached to the base plate, extend or retract in line with the cylinder’s movement.
The passive valve, with no actuators or manual levers, is mounted on the dryer and consists of a seal housing, seal, and a second semi-disc. Once docked and locked, the two semi-valves form a perfect seal.
The coupling of the active valve semi-disc with the passive one allows, via the actuator on the active part, simultaneous actuation—connecting upstream or downstream process equipment to the dryer for both wet product loading and dry product unloading.
Performance and Compliance with Safety Standards
This valve and coupling system enables OEL values below 1 μg/m³, making the system fully compliant with OEB 4 and OEB 5 requirements. Actual containment performance depends on the application and product characteristics. Precise and regular maintenance of the valves is crucial to achieving and maintaining high containment levels.
Materials, Customization, and Automation
Valves can be manufactured in stainless steel or nickel alloys based on process requirements, with various non-metallic contact materials available (EPDM, PTFE). PTFE, a chemically resistant plastic, is often chosen for its durability, though its lifespan depends on the abrasiveness of the product.
The containment system is fully integrated into Italvacuum’ s dryer hardware and software controls, enabling a safe and efficient automated process.
Conclusions
Italvacuum’s CRIOX® System and Bi-EVOLUTION® rotary vacuum dryers are manufactured with maximum surface care, featuring internal mirror polishing (Ra < 0.4 μm) to minimize product accumulation and ensure maximum vacuum tightness. The integration of high-containment loading and unloading systems provides exceptionally versatile and effective equipment for vacuum drying processes—especially for high-value APIs and HAPIs—using proven and consolidated technology suitable for varied process conditions.
Andocksysteme: Italvacuum’s Partner for Reliability and Custom Solutions
Italvacuum collaborates with Andocksysteme, a world leader in high-performance containment systems for the pharmaceutical industry. This strategic partnership integrates Split Butterfly Valves (SBV) and safe transfer systems for HPAPI powders into Italvacuum dryers, ensuring the maximum containment level (OEB 5) required for the safe handling of highly potent active ingredients.
Andocksysteme valves, recognized for their reliability and precision in the pharmaceutical sector, guarantee safe transfer of active materials, perfectly complementing Italvacuum’s vacuum drying technology. This synergy provides customers with complete and certified solutions for the safe handling of high-potency active ingredients.
Watch how the Andocksysteme Split Butterfly Valve for high-containment powder transfer works with Italvacuum CRIOX® System and Bi-EVOLUTION® rotary vacuum dryers.
Exonder is the official distributor for Italy of Andocksysteme, supporting customers with tailored containment and handling solutions.
