The rise of HPAPI (Highly Potent Active Pharmaceutical Ingredients) is profoundly transforming pharmaceutical production practices. These molecules (cytotoxic, hormonal, anticancer, antiviral) exhibit high therapeutic activity, but also pose a significant toxicological risk to personnel and the environment.
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Challenges and Field Issues
Powder weighing and transfer steps are particularly critical: even small quantities can generate airborne concentrations exceeding occupational exposure limits (OELs).
Consequences of Inadequate Control:
- operator exposure (respiratory pathologies, systemic effects);
- cross-contamination of other products or batches;
- quality deviations, leading to batch recalls;
- shutdowns or penalties in case of GMP/EHS non-compliance.
Audits in HPAPI Weighing Workshops Highlight:
- resuspension during unloading, sieving, or transfer;
- leaks at seals, hoppers, valves, and containers;
- heavy maintenance (filter clogging, surface cleaning) which extends downtime;
- containment difficulties during batch changes and manual operations.
Conventional methods (simple general ventilation or remote capture) are insufficient to ensure particle levels comply with targeted OELs (< 1 μg/m3 or even < 0.1 μg/m3 depending on the OEB).
Limitations of Traditional Practices
Some Units Continue to Rely on:
- dilution ventilation (HVAC) without direct capture;
- open hoods or simple booths with clogged or poorly positioned filters;
- filters not regularly tested, or even of a class lower than H13.
These solutions do not allow for achieving low OELs, and expose operators during dynamic phases (drum opening, weighing, transfer).
The OberA Solution: the ePURBOX BRS (ATEX)
Source Capture, Maximum Proximity
One of the basic principles of contamination control is to capture dust at its emission source. The fact that the EpurBox BRS can be positioned very close to the weighing point (or hopper) limits resuspension, reduces dispersion in the workshop, and decreases the load on other ventilation systems.
Flexibility for Multi-Product or Pilot Use
In sites that use multiple molecules or are in the development/pilot phase, it can be impractical to install a fixed system for each weighing point. The EpurBox BRS allows for “on-demand” use: it is brought in when the operation is underway, then moved. This limits fixed investments, increases agility, and reduces risk areas.
Ensuring Safety for Manual Operations
During manual tasks such as drum opening, dosing, or funnel transfer, the EpurBox BRS can be positioned to capture dust flows emitted during these manipulations, reducing the operator’s occasional exposure.
ATEX Compliance in Combustible Dust Environments
ATEX certified, the EpurBox BRS is suitable for classified areas (e.g., Zone 22 for dust). This allows pharmaceutical sites that handle powders that are potentially combustible (organic excipients, sugars, lactose, etc.) to use it without compromising their safety zoning.
Ease of Qualification and Operation
Should a filter change be necessary, the casing can be isolated/depressurized, limiting emissions.
The casing allows for documenting its performance (flow rates, pressures, filtration efficiency) within the framework of IQ/OQ/PQ.
Differential pressure monitoring, alarms, and planned maintenance ensure controlled operation.
Implementation Scenario: Typical Use Case
Consider a Practical Example:
- A pharmaceutical site needs to weigh an HPAPI with OEB = 4 (target OEL ~ 1 μg/m3) in a pilot lab.
- The EpurBox BRS is positioned next to the balance, with an arm or a suction nozzle directed towards the weighing area.
- The machine operates, powders slightly escape during deposition or transfer: the EpurBox extracts locally, returning the filtered air to the workshop or to a dedicated exhaust.
- During operation, differential pressure is monitored: if the filter clogs, an alert is triggered for change/cleaning.
- After use, the EpurBox can be moved to another line or stored in standby.
With this device, the workshop avoids installing fixed hoods around each workstation and has a high-performance mobile containment tool.
To discover our products and together envision THE solution adapted to your spaces, contact our teams. We will assist you in choosing the most suitable devices for your constraints and objectives.
