Drug Manufacturers

What We Do

In Pharmaceutical Manufacturing, the Air Is Part of the Product

Airborne particulate contamination in a drug manufacturing environment does not just pose a risk to workers — it poses a direct risk to product integrity, batch outcomes, and regulatory standing. A single contamination event can trigger a recall, a failed inspection, or an FDA warning letter that takes years and millions of dollars to resolve.

prePaer adds a continuous ULPA filtration layer at the room level — capturing airborne particles, microbial contaminants, and active pharmaceutical ingredient (API) dust before they can compromise product quality or exceed occupational exposure limits for manufacturing personnel.

The Regulatory Reality

GMP Compliance Requires Demonstrable Air Quality Control at Every Stage of Manufacturing

FDA 21 CFR Part 211 and EU GMP Annex 1 set explicit requirements for environmental monitoring, particulate limits, and microbial contamination control in pharmaceutical manufacturing areas. Meeting these requirements is not a one-time achievement — it is an ongoing operational commitment that must be documented, monitored, and maintained across every production run. prePaer supports that commitment by providing continuous active filtration at the manufacturing room level, complementing validated HVAC systems with an additional source-control layer that reduces the ambient particle burden throughout the working shift.

Consider This: The Airborne Contamination Risks on the Manufacturing Floor

Where Airborne Particles Threaten Product Quality and Worker Safety

API Dust Aerosolization: Weighing, blending, granulating, and tableting operations generate fine API dust that becomes airborne and poses both contamination and occupational exposure risks simultaneously — threatening product purity and worker health in a single event.
Cross-Contamination Between Production Runs: Residual airborne particles from one batch can settle into open vessels, equipment surfaces, or work-in-progress materials for subsequent runs — a GMP violation risk that room-level filtration directly addresses.
Microbial Contamination: Personnel are the primary source of microbial contamination in manufacturing environments. Skin cells, respiratory particles, and clothing fibers carry viable organisms that become airborne during normal movement and activity throughout the shift.
Occupational Exposure Limits (OELs): Many APIs carry strict OELs measured in micrograms per cubic meter of air. Workers who exceed these limits face serious long-term health consequences. Continuous active filtration reduces ambient API concentrations during processing operations.
Environmental Monitoring Failures: Particulate counts and microbial colony-forming unit (CFU) excursions during environmental monitoring are immediate GMP deviations requiring investigation, documentation, and corrective action — with direct cost and schedule implications for production.
Downtime from Contamination Events: A confirmed contamination event can halt production for days or weeks while root cause analysis, remediation, and revalidation are completed. The cost of prevention is a fraction of the cost of a single contamination-related shutdown.

Our Solution: The prePaer AER System

prePaer is freestanding and requires no HVAC integration or facility modification. It deploys alongside existing validated environmental controls, adding a room-level source-control filtration layer that operates continuously throughout the manufacturing shift — reducing the ambient airborne particle burden that monitoring programs measure and regulators inspect.

The prePaer AER System

A Continuous Filtration Layer for Every Stage of the Manufacturing Process

ULPA Filtration at 0.12 Microns — Pharmaceutical Grade:

prePaer’s proprietary ULPA filter captures 99.999% of particles at 0.12 microns — the same filtration standard used in ISO-classified cleanrooms and hospital isolation suites. This threshold addresses API dust, microbial carriers, and fine particulate matter well below the sizes that standard HVAC filters retain.

Supports Environmental Monitoring Compliance:

By continuously reducing the ambient particle load in manufacturing areas, prePaer supports lower baseline particulate counts during environmental monitoring sampling — reducing the frequency of excursion events that require GMP deviation documentation and investigation.

Occupational Exposure Limit (OEL) Support for API Handling:

Positioning prePaer adjacent to weighing stations, blending equipment, and other API-handling operations reduces the airborne API concentration in the worker’s immediate breathing zone — supporting OEL compliance as part of a broader industrial hygiene program.

No HVAC Modification — Preserves Validated Systems:

Modifying a validated HVAC system in a GMP environment requires revalidation — a costly and time-consuming process. prePaer operates independently as a supplemental room-level control, adding filtration capability without touching the validated environmental control infrastructure.

Portable Between Manufacturing Areas:

prePaer can be repositioned between production areas, staging zones, and material handling areas based on where API exposure and contamination risk are highest during any given production campaign — making it a flexible resource across the full manufacturing floor.

Worker Safety & OEL Compliance

Protecting the People Who Handle Active Pharmaceutical Ingredients Every Day

Manufacturing personnel who work with potent APIs face occupational exposure risks that accumulate across every shift, every campaign, and every year of a career. Engineering controls — closed systems, local exhaust ventilation, and containment isolators — address the highest-risk operations. prePaer addresses the ambient air in the broader manufacturing environment where residual API dust and other particles circulate between those primary controls.

A layered approach to occupational exposure control is both good industrial hygiene practice and a regulatory expectation. prePaer fits naturally into that framework as the room-level active filtration layer that reduces background airborne concentrations throughout the working shift.

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Frequently Asked Questions

Does deploying prePaer require revalidation of our existing environmental controls?

No. prePaer operates as a standalone supplemental filtration unit — it does not modify, connect to, or alter any validated HVAC or cleanroom system. It functions as an additional engineering control at the room level. As with any new equipment introduced into a GMP environment, your quality team should assess its impact through your standard change control process, but it does not inherently trigger HVAC revalidation.

Can prePaer be used in ISO-classified manufacturing areas?

prePaer can be deployed in manufacturing and support areas where its introduction is assessed and approved through your quality management system. The appropriate classification areas and any operational protocols for its use should be determined in consultation with your quality and validation teams based on your facility’s specific contamination control strategy.

How does prePaer support API containment during weighing and dispensing operations?

Positioning prePaer adjacent to weighing stations and dispensing operations reduces the airborne API concentration in the immediate work zone by continuously capturing fine dust particles generated during those operations. It complements primary containment measures such as weighing booths and local exhaust ventilation rather than replacing them.

How is filter replacement handled in a GMP environment?

Filter replacement should be incorporated into your preventive maintenance program with appropriate documentation. Under normal operating conditions, replacement every two weeks is standard. In high-volume manufacturing environments with elevated API dust loads, more frequent replacement may be warranted — monitor filter condition as part of your maintenance schedule. Used filters containing API-laden particulate should be handled and disposed of in accordance with your facility’s pharmaceutical waste procedures. Claerosol provides replacement guidance based on your operational volume.

Is prePaer safe for workers in areas handling potent compounds (HPAPIs)?

For HPAPI environments, primary containment — isolators, restricted access barrier systems, and local exhaust ventilation — remains the required approach for the highest-risk operations. prePaer is best deployed in HPAPI environments as a supplemental ambient air control in surrounding areas, corridors, and support zones. Your industrial hygienist should determine the appropriate role for room-level filtration in your specific HPAPI containment strategy.

Contamination Prevention Is Always Cheaper Than Contamination Response

A single batch rejection due to particulate contamination represents the cost of materials, labor, equipment time, investigation, documentation, and corrective action — in addition to the supply impact of lost product. An FDA 483 observation or warning letter tied to environmental control deficiencies carries costs that extend far beyond the immediate remediation effort.

prePaer is a practical, cost-effective addition to the environmental control framework of any pharmaceutical manufacturing facility — reducing the ambient particle burden that monitoring programs measure, supporting OEL compliance for manufacturing personnel, and demonstrating the continuous improvement commitment that regulators expect to see documented in quality management systems.

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